Six I s HIV/TB Communication and Advocacy Toolkit

Transcription

1 Six I s HIV/TB Communication and Advocacy Toolkit

2 According to the World Health Organisation (WHO), it is estimated that one-third of the 36.7 million people living with HIV and AIDS worldwide are co-infected with tuberculosis (TB). Sub- Saharan Africa is the hardest hit region, with a 70% co-infection rate. If TB is left unaddressed, in the next 20 years almost one billion people will become newly infected, and 35 million will die of it. In response to this concern, the WHO has issued a policy on TB/ HIV collaborative activities recommending interventions to reduce TB morbidity and mortality in people living with HIV, namely the Six I s for HIV/TB: Infection Control, Intensified Case Finding and Isoniazid Preventive Therapy, TB/HIV Integration, Initiating ARV treatment and Involvement of the Community; which should be integrated into HIV programmes of national health services in addition to the provision of Antiretroviral Therapy (ART). Immediate and full adoption of the Six I s for HIV/TB is an essential element of the HIV response in high-prevalence countries however, in-context support is also needed to accelerate implementation of these simple measures that will have a tremendous impact on the HIV/ TB co-epidemic. This in turn requires enhanced communication and scaled up dissemination of the WHO s TB/HIV control recommendations to support the efforts of civil society and health workers to accelerate their implementation. In the spirit of joint responsibility and ownership for a targeted effort to address the dual epidemics, the AIDS and Rights Alliance for Southern Africa (ARASA), with support from the WHO and in collaboration with partner organisations from across the Southern African region, undertook to create accessible and scientifically accurate training and advocacy materials to promote the accelerated implementation of the Six I s for HIV/TB. The toolkit development process was shaped by the collective participation of TB/ HIV community activists, health workers, journalists, traditional healers, government representatives, and WHO/TB technical and medical experts, from seven different Southern African countries. The process, which included a workshop in December 2010, followed by toolkit design and piloting in 4 countries (Swaziland, Botswana, Lesotho and Zambia) between December and March 2011, provided the opportunity for these key stakeholders to come to grips with the latest recommendations from WHO; understand and brainstorm on initiatives to respond to the current obstacles and identify opportunities as they relate to the implementation of the Six I s for HIV/TB in the region. This process informed the development of the toolkit in accordance with regional needs. ARASA is delighted to introduce the superhero-themed Six I s HIV/TB Communication and Advocacy Toolkit, which includes a variety of resources intended for use by a wide range of stakeholders at grassroots level. The toolkit includes: 1. Frequently Asked Questions on the Six I s for HIV/TB for health workers and communities 2. Glossary to define commonly used terms 3. Congregate settings examples to highlight the impact of HIV/TB in settings outside of health care facilities 4. Posters to promote the adoption of the Six I s for HIV/TB to be used both by health care facilities and communities 5. Checklists for patients and communities as well as health care workers to assess the safety of health facilities and the availability of essential HIV/TB services therein; 6. WHO recommendations on the Six I s for HIV/TB 7. Presentation on the Six I s for HIV/TB to developments in scientific research for HIV/TB 8. Best practices of HIV/TB related activities in the region ARASA will work with country partners to support the use of the toolkit in community settings and with national HIV and TB programmes to advocate for the use of these innovative communication strategies in public health facilities. The toolkit is open for use by any interested parties and can be downloaded from the ARASA website ( For Monitoring and Evaluation purposes we kindly request that you notify ARASA about any intended use of this toolkit. This will enable us to record its impact, and to keep you updated on any revisions or similar initiatives that we may undertake in future. As we are committed to constant improvement of our efforts, we also welcome any feedback, positive or negative. Should you require assistance with adaptation, translation and/or dissemination, we will try to connect you with organisations that may be able to support with this. For further information on the toolkit, please contact lynette@arasa.info or communications@arasa.info TB TOOLKIT 1

3 LEAD WRITERS: Donela Besada and Lesley Odendal LEAD EDITOR: Keneilwe Lynette Mabote The following people and organisations were active participants in the toolkit development process. Their input in the formulation and piloting of these materials is greatly appreciated: ALFRED THOTOLO - Adventist Development and Relief Agency, Lesotho KHAIRUNISA SULEIMAN - TB Consultant, Kenya ELLEN SCOUT - Partners in Health, Lesotho NTATE MOKHELE - Partners in Health, Lesotho BACTRIN KILLINGO - International Treatment Preparedness Coalition, South Africa MARA KARDAS-NELSON - NAM/HATIP, South Africa MDUDUZI MAGAGULA - Swaziland Times, Swaziland TENGETILE HLOPHE - Swaziland Positive Living, Swaziland SIBUSISO DLAMINI - Swaziland Nurses Association, Swaziland NHLAVANA MASEKO - Traditional Healers Organisation, Swaziland CINDY KELEMI - Botswana Network on Ethics, Law & HIV/AIDS, Botswana RODGERS BANDE - Botswana Network on Ethics, Law & HIV/AIDS, Botswana SINDY KOLOLO - Botswana National TB Programme, Botswana CHIRWAH THULI MAHLOKO - Botswana Network on Ethics, Law & HIV/AIDS, Botswana ARNOLD SOKWA - Botswana Network on Ethics, Law & HIV/AIDS, Botswana PAUL KASONKOMANA - Civil Society Health Forum, Zambia MOSES MAZYOPA - Treatment Advocacy and Literacy Coalition, Zambia WILSON ZULU - Zambia Association for the Prevention of HIV & Tuberculosis, Zambia GLORIA NYAMUZUWE - Mozambican Treatment Access Movement, Mozambique CLAIRE WINGFIELD - Treatment Action Group, USA The AIDS and Rights Alliance for Southern Africa and its partners further wish to thank the World Health Organisation for supporting this civil society-led initiative. A special thank you goes to Reuben Granich, Colleen Daniels and Caoimhe Smyth from the HIV department in WHO Geneva, who provided critical technical guidance at all stages of the project. For further information or downloading of the Six I s for HIV/ TB Toolkit, please see AIDS and Rights Alliance for Southern Africa: 2 TB TOOLKIT

4 INTRODUCTION...1 ACKNOWLEDGEMENTS...2 GLOSSARY...5 Meet People in Your Community...8 BACKGROUND ON TB and TB/HIV 1. What is TB? How is TB spread? Where does TB infection happen in the body? What is extrapulmonary TB? What is disseminated TB? What is latent TB? What is active TB? What is the epidemiology of HIV and TB? Why is TB a problem for people living with HIV? What are the Six I s for HIV/TB?...15 Intensified Case Finding (ICF) What is Intensified Case Finding (ICF) for TB? How often should people living with HIV be screened for TB? What is the WHO recommended screening algorithm for ruling out active TB, including extrapulmonary TB in people living with HIV? What diagnostic tests exist to detect latent tuberculosis infection and confirm active TB disease? Should a positive skin test result be a requirement for administering IPT to people living with HIV? Do the 2011 WHO IPT ICF Guidelines recommend Interferon Gamma Release Assay (IGRA) for the screening of people living with HIV for IPT?...22 Isoniazid Preventive therapy (IPT) What is TB chemoprophylaxis and why is it recommended in people living with HIV? What drug is used for TB chemoprophylaxis? What is the optimal duration of IPT? How long does the protective value of IPT last? Should repeated courses of IPT be administered? How important is adherence to IPT? Is it safe to administer IPT together with ART? Does IPT have any added benefit in people whose immune systems are already strengthened by ART? Is it safe to administer IPT together with ART? Does IPT increase the risk of isoniazid resistance in people with latent tuberculosis? Is IPT safe in pregnant women? When is IPT not recommended for patients? Can IPT be administered safely in children? How would active TB be excluded in children? Is IPT recommended for PLHIV with MDR/XDR TB after they are successfully treated?...26 TB infection control (IC) What is meant by TB infection control? Why is it important? What is nosocomial transmission and what is the risk of nosocomial transmission of TB? What are congregate settings? Why are there increased chances of spread of TB in congregate settings?...28 TB TOOLKIT 3

5 30. What are the different levels of infection control in health care settings? Should infectious TB patients be separated in health care facilities? How important is cough etiquette in preventing transmission of TB? Have personal masks and respirators proven to be effective in prevention TB Transmission? What are the types of environmental ventilation? How effective is ventilation in TB infection control? Are UVGI devices recommended for TB infection control? What specific measures are recommended for HIV positive health workers in order to prevent them from getting infected with M tuberculosis? For persons with infectious TB, what actions can be taken to reduce the risk of transmission of TB to their household members?...31 initiating Antiretroviral treatment How does HIV weaken the immune system? What is ART? When does the WHO recommend you start ART? What does the WHO recommend for people who are co-infected with HIV and TB? How does initiating ART prevent TB in people living with HIV? What is ART TB-associated immune reconstitution inflammatory syndrome (TBIRIS)? What are the signs and symptoms of TBIRIS? What are the risk factors for TB-IRIS? How should TB-IRIS be managed?...38 TB/HIV Integration What is the impact of TB/HIV co-infection? Who are the at risk populations? Why is integration important? What are the WHO recommendations for the integration of HIV and TB services? What progress is being made with regards to TB/HIV integration? What are the barriers to integration? What are the different models of TB/HIV integration? Can integrated services happen beyond health facilities? What are some examples of TB/HIV integration being implemented? What are the WHO recommendations for M&E for TB/HIV integrated services What are things to consider when developing the monitoring system? Are there tools developed already for M&E around TB and HIV activities?...50 Involvement of the community How can communities be involved with treating and preventing TB/HIV? What are some examples of how communities can be involved in TB and HIV activities? How can you or your community become involved in TB/HIV care and prevention? How can you be involved in helping people living with TB or to prevent the spread of TB in your area?...59 STATiSTICS...61 TB IC FOR PATIENTS CHECKLIST...79 TB IC CHECKLIST FOR HEALTH CARE FACILITIES...80 WHO RECOMMENDATIONS FOR TB INFECTIONS TB TOOLKIT

6 ACTIVE TB: The symptoms of active tuberculosis include cough, weakness, weight loss, fever, no appetite, chills and sweating at night. Other symptoms of TB disease depend on where in the body the bacteria are growing. A person is infectious with active tuberculosis disease when they are not on / responding / adhering to TB treatment. ALGORITHM: Recommended patient management strategies designed to assist in direct decision making. ANTIBODIES: Proteins that are found in blood that are used by the immune system to identify and control infections. ANTIGEN: Substances from an infectious agent that produce an immune response. ANTIRETROVIRAL THERAPY (ART): Medication for the treatment of HIV. When several such drugs, are taken in combination, it is known as highly active antiretroviral therapy, or HAART. BCG: A vaccine for TB named after the French scientists Calmette and Guerin. This vaccine is currently used to help prevent tuberculosis. CD4: A protein on the surface of the cells of the immune system that helps in activating the body s response to infection Chemoprophylaxis: The administration of anti-tuberculosis drug(s) to prevent tuberculosis infection. Chest x-ray: A picture of the inside of the chest. Chest x-rays are used to determine whether TB bacteria have damaged the lungs. Congregate setting: A setting in which three or more usually unrelated persons reside in close physical proximity. These settings may include hospitals, long term care facilities, assisted living facilities, correctional facilities, etc. Contact: A person who has spent time with a person with infectious TB. Directly observed therapy (DOT): A way of helping patients take their medicine for TB in which the patient meets with a health care worker or sometimes a friend or family member, and is observed taking their TB medication. Extrapulmonary TB: TB disease in any part of the body other than the lungs First line treatment: Therapy that is recommended for the initial treatment of disease Hepatitis: An inflammation of the liver caused by certain viruses and other factors such as alcohol abuse, some medications and trauma. Symptoms of early hepatitis infection: decreased appetite, fatigue, abdominal pain, nausea, vomiting, jaundice, itching, and flu-like symptoms. TB TOOLKIT 5

7 HIV infection: Infection with human immunodeficiency virus, the virus that causes AIDS (acquired immunodeficiency syndrome). Immunocompromised: A condition in which an person s ability to fight infection is weaker or absent. Incidence: The risk of developing a new infection over a particular period of time. Incidence is used to measure the number of new infections over a particular period of time. Infectious person: A person who can spread TB to others because he or she is coughing TB bacteria into the air. Infectious TB: Active tuberculosis disease which presents a risk of transmission of infection to others. Interferon- Gamma Release Assays IGRA: A test to measure a person s immune response to M. Tuberculosis. When an individual is infected with M. Tuberculosis, their white blood cells will release a substance called interferon gamma. The level of interferon gamma is measured by this test. Isoniazid: Antibiotic drug used to prevent TB disease in people who have TB infection. It is also one of the five drugs used to treat TB disease. Isoniazid preventive therapy (ipt): TB chemoprophylaxis (also known as Isoniazid preventive therapy IPT) is giving anti-tb drugs to PLHIV with latent TB infection to kill off the bacteria before it develops into active disease. Latent TB: A state in which mycobacteria are present in the body without causing active TB disease but have the potential to reactivate and cause disease. People with latent TB do not show symptoms are noninfectious. Multi-drug resistant TB (MDR TB): Tuberculosis resistant to isoniazid and rifampicin, with or without any other resistance. Mycobacteria: The classification of bacteria which includes the organisms which cause tuberculosis, but also includes bacteria which are not transmitted person-to-person. Mycobacteria tuberculosis: A group of closely related mycobacterial species which can cause tuberculosis. Nosocomial transmission: Infection that occurs while in a health facility PLHIV: People living with HIV Pulmonary TB: TB disease that occurs in the lungs. Symptoms usually include a cough that lasts longer than 2 weeks. Most TB disease is pulmonary. Prevalence: The number of people with a particular disease within a population 6 TB TOOLKIT

8 Reactivated tuberculosis: Old tuberculosis infection which has become active. Re-infection: Active tuberculosis due to new infection in someone who has had previous tuberculosis infection. Resistant bacteria: Bacteria that can no longer be killed by a certain drug. Respirator: Protective mask with a filter to protect the wearer from inhaling harmful objects in the air. Rifampicin: A drug used to prevent TB disease in people who have TB infection. Rifampicin is also one of the five drugs used to treat TB disease. Second line treatment: Treatment that is given when first line treatment does not work or stops working Sputum: Substance coughed up from inside the lungs. Sputum is examined for TB bacteria under a microscope; part of the sputum can also be used to do a culture. Stbp: stop tb Partnership The Partnership is recognized as a unique international body with the power to align actors all over the world in the fight against TB. The participation of a wide range of constituencies gives us credibility and the broad range of medical, social and financial expertises needed to defeat TB. Surgical masks: Surgical masks that cover the nose and mouth designed to protect others from bacteria released from the wearer. Surgical masks offer only minimal protection for the wearer. Tuberculosis infection: A condition in which M. tuberculosis organisms are present in the body without necessarily causing active tuberculosis disease. Tuberculosis (TB): Disease due to infection with Mycobacterium tuberculosis. Tuberculin: Parts of the tubercle bacilli that is injected under the skin on the lower part of your arm in doing a TB skin test. Tuberculin skin tests: A skin test is carried out to determine whether an individual is infected tuberculosis. A positive skin test occurs when a person is infected with tuberculosis and the formation of a hard red bump where the individual has been injected within hours can be seen. UVGI: A system that uses ultraviolet light to break down the bacteria in the air. World Health Organisation (WHO): A global agency linked to the United Nations responsible for the coordination of international health activities and helping governments improve health services. XDR-TB: Extensively drug-resistant tuberculosis (XDR-TB) is TB that is resistant to rifampicin and isoniazid (Multi-drug-resistant tuberculosis or MDR-TB), as well as to any member of the quinolene family and at least one of the following second-line anti-tb injectable drugs: kanamycin, capreomycin, or amikacin. TB TOOLKIT 7

9 Hello, my name is Phumla and I am a health care worker at the clinic. HOSPITAL The risk of TB transmission in hospitals can be, but should not be, higher than in the general population. TB infection in hospitals can be high when facilities are overcrowded and TB infection control measures are not in place. People living with HIV are at an increased risk of TB infection because of weakened immune systems, as are hospital staff who can have frequent contact with TB patients. Rapid diagnosis and management of TB cases, training and education for hospital staff and patients on cough etiquette and respiratory hygiene and the implementation of appropriate environmental and physical controls are key to ensuring that our hospitals are TB transmission free zones and are safe places for us to come to. CHURCH Hello, my name is Pastor Loyiso. TB transmission can take place in churches if there are a large number of people sitting closely together and the windows are closed. It is important when we are in church to cover our mouths when we cough and to open windows so that there is good ventilation in the church. Many treatment literacy programs take place in the Church in which TB related information is shared with the congregation. Hello, my name is Linda and I am a school teacher. SCHOOL TB is a problem amongst children. Every year, over 250,000 children develop TB and 100,000 die from it. Young children are at a high risk of developing active TB because of their less developed immune systems. Diagnosing TB in children under the age of 10 is a challenge because of difficulties in getting sputum samples and unclear chest x-rays. Diagnosing TB in children depends on symptoms including cough, weight loss, fever and night sweats as well as a history of close contact with an infectious adult. TB infection can spread in schools because of the close interaction school children have with each other. TB education in schools provides an opportunity for information to be given to children which in turn can be relayed back to family members. 8 TB TOOLKIT

10 Hello, my name is Nomazizi and I am a nurse working at the refugee camp. REFUGEE CAMPS TB transmission is a problem in refugee camps. Over 85% of refugees come from and remain in settings with a high burden of TB. As many as 50% of refugees may be infected with TB. The risk of TB transmission in refugee camps is high because of: Overcrowding, poor nutrition, high prevalence and transmission of HIV, a high level of other diseases, high levels of stress, challenges to access and quality of health care, an unstable and frequently mobile environment. PRISONS TB transmission in prisons is a very big problem, and has been found to be up to 100 times higher than that in the general population. TB transmission in prisons is a problem because of a number of reasons including: Late diagnosis of TB, inadequate treatment, poor ventilation and frequent prison transfers. Other factors that lead to the development of active TB and increased TB transmission include: HIV infection, malnutrition and substance abuse. Multi drug resistant TB (MDR-TB) in prisons is also a problem, making up 24% of cases in some settings. Causes of MDR-TB in prisons are multiple-a poor TB program probably means that many people living with HIV are not on earlier ART, develop TB, and then are mis-managed. Others without HIV may also be mismanaged. Some people are infected with MDR-TB in prisons. Others who develop TB there are mis-managed with mono or dual therapy and no access to second line treatment. TB in prisons spreads to the general population through prison staff, visitors and former inmates. Prisoners also have the right to the same level of TB treatment and care as the general population. Hello, my name is John and I am a prison warden. TB TOOLKIT 9

11 01 What is tuberculosis? Tuberculosis or TB (short for tubercles bacillus) is an infectious disease caused by various strains of mycobacteria; most often Mycobacterium tuberculosis (M. tb). 02 How is tuberculosis spread? Tuberculosis is spread when people with active TB disease cough, sneeze, speak or spit droplets that contain the mycobacteria, which are then inhaled by surrounding people. Less than ten droplets may cause infection, but a single sneeze can release up to 40,000 droplets. Taking TB treatment rapidly removes a person s ability to spread TB, but someone with active TB, if untreated, can infect other people per year.1 03 Where does TB infection happen? Tuberculosis is transmitted in the air so most often attacks the lungs but may also affect other parts of the body such as the kidney, spine or brain. People who are living with HIV and are infected with TB develop extra-pulmonary disease much more often because of their weakened immune system. Infection with M. tuberculosis triggers an inflammatory response from a human s immune system, and damages the site of infection through the formation of tubercules hard, round structures. 1 Fact Sheet on Tuberculosis (TB) No. 104, World Health Organisation Available at fs104/en/ (Reviewed March 2016) 10 TB TOOLKIT

12 BRAIN 04 What is extrapulmonary tuberculosis? SPINE LUNGS KIDNEYS Extrapulmonary TB occurs when the bacteria infect parts of the body, other than the lungs. The most common types of extrapulmonary TB include the lymph nodes and kidney, but TB can also infect the brain, bones, abdomen and area surrounding the heart, and reproductive organs. What is disseminated tuberculosis? Disseminated or miliary tuberculosis is a serious form of extrapulmonary TB, where the bacteria have spread from the lungs and infect several organs at the same time. Symptoms of disseminated TB are specific to the location of the body that is infected. Generally, extrapulmonary TB is rare, making up 15% of cases, however, up to 50% of people living with HIV develop extrapulmonary TB. 2 According to the 2015 Global TB report, 20.5% of the total notified cases in Africa were extrapulmonary TB. 3 In places like South Africa, with an especially high burden of HIV, 39% of cases of TB notified have extrapulmonary TB. 4,5 2 Golden MP, Vikram HR. Extrapulmonary tuberculosis: an overview. Am Fam Physician Nov 1;72(9): World Health Organisation, Global Tuberculosis Report Geneva, Switzerland. Available at publications/global_report/gtbr15_main_text.pdf 4 Directorate Drug-Resistant TB, TB&HIV. Management of Drug-Resistant Tuberculosis: Policy Guidelines. Pretoria: Government Press, World Health Organisation, Global Tuberculosis Report Geneva, Switzerland. Available at publications/global_report/gtbr15_main_text.pdf TB TOOLKIT 11

13 05 What is latent tuberculosis? Latent tuberculosis (LTB) is when a person is infected with M. tuberculosis without becoming sick. With latent infection, a person s immune system is able to fight the bacteria and stop them from growing and spreading in the lungs. However, when the immune system becomes suppressed, this sleeping or latent TB may become active TB and cause sickness within a person. Globally, 1 in 3 people have latent TB.6 What is active tuberculosis? Active TB or TB disease occurs if the immune system is not able to stop the TB bacteria from multiplying in the body. TB disease makes people sick, and they can spread the infection to others. Active TB disease can develop soon after becoming infected before the immune system can fight the bacteria or many years later when the immune system becomes weak because of ageing or because of another sickness, such as HIV or diabetes. Among the general population, 5-10% of people will develop active TB in their life-time7 while in people living with HIV the risk of active TB is 10-15% per year.8 6 Kaiser Family Foundation, The Global Tuberculosis Epidemic, (TB Fact sheet), Available at newscenter/resources/kff%20tb%20factsheet.pdf 7 Fact Sheet on Tuberculosis (TB) No. 104, World Health Organisation Available at en/ (Reviewed March 2016) 8 Getahun H, Gunneberg C, Granich R, Nunn P. HIV Infection-Associated Tuberculosis: The Epidemiology and the Response. Clin Infec Dis 2010;50:S TB TOOLKIT

14 06 What is the epidemiology of HIV and TB? Globally, approximately 36.7 million people are HIV-infected and almost one-third of people in the world are also infected with TB.9 There were estimated 9.6 million new TB cases in 2014, with approximately 1.2 million people who are HIV-coinfected million people died from TB in 2014, including people coinfected with HIV, of which are women and which are men.11 The risk of TB infection is 24 to 28 times greater for PLHIV than those without HIV.12 Approximately 74% of those co-infected with TB and HIV live in Africa.13 79% of patients infected with TB tested positive for HIV in Africa in The Difference between Latent TB Infection and TB Disease A PERSON WITH LATENT TB Has no symptons Does not feel sick Cannot spread TB bacteria A PERSON WITH TB DISEASE Has symptoms that may include: - a chronic cough (2-3 weeks) - pain in the chest - coughing up blood or sputum - weakness or fatigue - weight loss - no appetite - chills - fever - sweating at night Feels sick Can spread TB bacteria to others 09 World Health Organisation and UNAIDS estimates for Fact Sheet on Tuberculosis (TB) No. 104, World Health Organisation Available at factsheets/fs104/en/ (Reviewed March 2016) 11 Fact Sheet, HIV-Associated Tuberculosis, World Health Organisation, Available at hiv/tbhiv_factsheet_2015.pdf?ua= 12 Ibid 13 Ibid 14 World Health Organisation, Global Tuberculosis Report Geneva, Switzerland. Available at publications/global_report/gtbr15_main_text.pdf 10 TB TOOLKIT 13

15 07 Why is TB a problem for people living with HIV? HIV infection weakens the human immune system by damaging the CD4 cells which helps the body fight infection. As a result, HIV is the strongest risk factor for developing TB disease in those with latent or new M. tuberculosis infection. The risk of developing TB is at least 20 times greater in people living with HIV. The Bacillus Calmette-Guerin (BCG), is a vaccine against tuberculosis. It works by activating the body s immune response to the bacteria without causing disease, and protecting against future infection. BCG is not safe in individuals with HIV because it relies on the body s ability to control the spread of the bacteria in the body, and people with HIV who receive BCG have a high risk of infection spreading in the body. The WHO recommends that in countries with a high burden of tuberculosis, a single dose of the vaccine should be given to infants as soon as possible after birth unless they are HIV-positive. The vaccine may be as effective as 80% in children, but is unable to prevent TB in adults as the immunity wears off with age. The BCG vaccine is not effective in adults, and varies in effectiveness between 0-80% for a period of 15 years, with further variation according to geography. 15, 16 Furthermore, BCG is most effective in severe forms of TB in children including TB meningitis and miliary TB Venkataswamy, Manjunatha M.; Goldberg, Michael F.; Baena, Andres; Chan, John; Jacobs, William R., Jr.; Porcelli, Steven A. (1 February 2012). In vitro culture medium influences the vaccine efficacy of Mycobacterium bovis BCG. Vaccine (in English) 30 (6): Fine PEM, Variation in protection by BCG: implications of and for heterologous immunity,2009. Lancet 346 (8986): Rodrigues LC, Diwan VK, Wheeler JG, Protective Effect of BCG against Tuberculous Meningitis and Miliary Tuberculosis: A Meta-Analysis, Int J Epidemiol22 (6): TB TOOLKIT

16 08 What are the Six I s for HIV/TB? The six essential HIV/TB collaborative activities that the WHO has recommended for all HIV programmes in order to: i. Protect people with HIV from TB infection, ii. Help prevent active TB disease from developing, and iii. Identify active TB disease early to improve the chances of cure. The Six I s for HIV/TB are: 1. Intensified case finding (ICF) for active TB: Involves active screening that leads to early diagnosis of TB, the provision of treatment and reduced spread of infection to others. It also protects people living with HIV who do not have TB. 2. Giving them Isoniazid preventive treatment (IPT): Get TB while it s still sleeping Isoniazid is an antibiotic which can reduce the risk of PLHIV from developing active TB, by killing the dormant TB bacteria before they become active TB. 3. TB Infection Control (IC) - Are you in a TB factory? Involves different measures that can be taken to reduce the airborne spread of TB to people, including key populations such as, (but not limited to) people living with HIV, health care workers, miners, prisoners and the community at large which include: i. Managerial - The planning stage ii. Administrative - The service delivery stage iii. Environmental - What s floating in your air? iv. Protective - Are you protected? 4. When TB and HIV programmes are assisted by the Involvement of the Community, people are aware of the risks and protective measures against TB. It also means that the health sector can take on more interventions, including focusing on very sick patients who need additional care, as community members become expert patients and lay health workers. 5. Integration of TB/HIV services allow for people with both diseases to receive treatment in one place and to be treated holistically for both infections. 6. Initiation of ART in PLHIV prevents TB from developing into active TB-disease Combination prevention is when a combination of protective methods are used to avoid infection. It is encouraged that HIV and TB programmes implement all Six I s for TB/HIV together to prevent TB infection in HIV-infected people or to treat TB/HIV co-infected people. TB TOOLKIT 15

17 INTENSIFIED TB CASE FINDING My friends call me Intensified Case Finding (ICF) I undertake regularly screening all people with, or at high risk of HIV, for symptoms of TB in health care facilities, communities as well as in homes. This is an important task because once we identity people who present with these signs and/ or symptoms, these friends are promptly diagnosed and immediately initiated on treatment. How do I go about my investigations keep reading and learn more! 16 TB TOOLKIT

18 09 What is Intensified Case Finding (ICF) for TB? Intensified Case Finding (ICF) for TB means regularly screening all people with, or at high risk of HIV, for the symptoms of TB, followed promptly with diagnosis and treatment, and then doing the same for household contacts. Current cough Active case finding and the provision of treatment to infected individuals is beneficial because: Active TB disease, if left untreated kills more than 50% of people infected. TB treatment also reduces the spread of infection; a person on TB treatment for at least 2 weeks can no longer spread TB to others. Screening for TB should be taking place both in health facilities, when people first seek HIV services and in other congregate settings (mines, prisons, schools, churches, and the home); in particular amongst people living with HIV. 10 How often should people living with HIV be screened for TB? People living with HIV should be screened for TB at every clinic or home visit, regardless of whether they have received or are receiving IPT or ART. 11 What is the WHO recommended screening algorithm for ruling out active TB, including extrapulmonary TB in people living with HIV? 18 Fever & Night Sweats As recommended by the WHO, all people living with HIV should be regularly screened for TB at every visit using a clinical algorithm whenever they are receiving care. At the minimum PHIV should be screened for common TB signs and symptoms for all types of TB disease. The WHO recommended screening algorithm for adults and adolescents living with HIV include a set of four symptoms: Current cough Fever Night sweats Weight loss The WHO recommends that adults and adolescents living with HIV who do not have any of these four symptoms are unlikely to have active TB and should be offered IPT. However, if any of these four symptoms are present, it may indicate the presence of active tuberculosis and the patient should be further evaluated for TB and other diseases. Weight Loss 18 DAl-Orainey IO. Diagnosis of latent tuberculosis: Can we do better? Ann Thorac Med, 2009; 4:5-9 TB TOOLKIT 17

19 12 What diagnostic tests exist to detect latent tuberculosis infection and confirm active TB disease? 19 DIAGNOSTIC TEST HOW DOES IT WORK ADVANTAGES DISADVANTAGES Tubercilin Skin Test (TST) Small HOW amount DOES of IT TB WORK protein injected into the skin. If a person is infected with TB then a firm red bump will develop on the skin within hours. An induration of 5 or more millimeters is considered positive in: HIV-infected persons A recent contact of a person with TB disease An induration of 15 or more millimeters is considered positive in any person, including persons with no known risk factors for TB. However, targeted skin testing programs should only be conducted among high-risk groups 20 Allows detection of latent TB. Inaccurate positive results for patients who received BCG vaccine or exposed to a different mycobacteria Inaccurate negative results in people living with HIV, people with poor nutrition and those with disseminated TB. Difficult to administer and interpret, costly, and has to be stored in cool temperatures. Patient has to return after 2 days to interpret results, which causes loss to follow up. Chest X-rays TB creates cavities in the lungs that may be visible through x-rays. Addition of abnormal chest radiographic findings to the four symptom based rule increases accuracy of diagnosis Increased cost and work load Requires qualified staff Only useful for detecting pulmonary TB, which is less common in PLHIV 19 UNITAID, Tuberculosis Diagnostic Technology Landscape, 2012, Available at assets/documents/unitaid-tuberculosis-landscape_2012.pdf 20 Centers for Disease Control and Prevention (CDC), Tuberculin Skin Testing, 2016, Available at publications/factsheets/testing/skintesting.htm 18 TB TOOLKIT

20 DIAGNOSTIC TEST HOW DOES IT WORK ADVANTAGES DISADVANTAGES Smear microscopy Biological samples (normally sputum) are dyed, placed on a glass slide and looked at under a microscope. The dye makes mycobacteria easier to see, allowing for a diagnosis to be made. 21 Cost-effective test. 22 Improvements in automated smear testing and light-emitting diodes (LED) 23 microscopy have the potential to greatly improve testing due to improved accuracy in testing TB in PLHIV and less workload. 24 Poor results in identifying TB if co-infected with HIV since 24%-61% of PLHIV with TB are smear negative Further developments are needed regarding capitalising on smear microscopy. The process remains relatively unchanged 25 Light-emitting diodes fluorescence microscopy (LED) Smears are stained with a fluorescent dye and examined under a microscope LED-FM could reduce the high workload required for smear microscopy as it is automated. With LED-FM, smears can be examined in 90 seconds- a quarter of the time it takes to examine samples using smear microscopy. 26 Higher sensitivity but lower specificity than smear microscopy. Therefore the method should detect more cases of TB but may also treat people who do not have TB. There are also electricity and laboratory requirements. 21 Smart, T, Background on smear microscopy in TB diagnosis, 2012, Available at: 22 If a patient tests smear-positive transmitting TB is very likely. High TB transmission occurs in facilities with poor infection control. Thus (smear microscopy testing) has the potential to curtail infection. 23 LED: Fluorescent Light Emitting Diode. LED microscope lamp is inexpensive when compared to the mercury vapor or halogen lamp used in regular fluorescent microscopy and has a life span of more than 10,000-50,000 hours ( finddiagnostics.org/programs/tb/find_activities/led_microscopy.html_ 24 Minion J. et al, Comparison of LED and Conventional Fluorescence Microscopy for Detection of Acid Fast Bacilli in a Low- Incidence Setting, 2011, PLoS ONE 6(7): e doi: /journal.pone Smart, T, Determine LAM urine antigen TB test is highly cost-effective for use in hospitalised people living with HIV, 2012, Available at 26 Cuevas LE, Al-Sonboli N, Lawson L, Yassin MA, Arbide I, Al-Aghbari N, et al, LED Fluorescence Microscopy for the Diagnosis of Pulmonary Tuberculosis: A Multi-Country Cross-Sectional Evaluation, 2011, PLoS Med 8(7): e doi: /journal.pmed Retrieved from TB TOOLKIT 19

21 DIAGNOSTIC TEST ADVANTAGES Light-emitting diodes fluorescence microscopy (LEDFM) (continued) Compared to conventional mercury fluorescence microscopes, LED microscopes are less expensive and have lower maintenance requirements. The diodes are very durable, do not require warm-up time, and do not contain toxic products. Importantly, they are reported to perform equally well without a darkroom. These qualities make them attractive for use in low- and middle-income countries. 27 DIAGNOSTIC TEST HOW DOES IT WORK ADVANTAGES DISADVANTAGES Line Probe Assay Is a molecular diagnostic (LPA) test which amplifies the DNA of TB. If TB is present in a sample, it will amplify the TB DNA and yield a positive result. The test detects both TB bacteria and TB strains that are resistant to Isoniazid and Rifampicin. Hence the test diagnoses MDR-TB. 28 LPA testing can be used with sputum samples and culture isolates, and when used with sputum samples, LPA can deliver results within 2 days, rather than 6 weeks. Both INH and Rif resistance can be detected by this test. A new version can be used for all samples irrespective of smear result (both smear positive and smear negative). A 2nd-line line probe assay also in development. 29 Instrument requires specialised facilities and access to a stable electricity supply, and are best utilised on smear positive TB cases. However, the new version of this diagnostic test is expensive. Xpert MTB/RIF Xpert is a molecular diagnostic test, which amplifies the TB DNA within a sample. Sample (unprocessed sputum or sediment from concentrated specimen) is incubated for 15 minutes in a tube. Diluted sample is put into cartridge with a pipette, which is then inserted for the test. It is used for the diagnosis of pulmonary TB, by use of sputum samples. The sputum samples require minimal manipulation and results are available in 2 hours. There are ongoing studies showing varying sensitivities for diagnosis of EPTB The test detects TB and TB strains with rifampicin resistance. Suitable for individuals at risk for MDR-TB and smear negative specimen from PLHIV as it has better sensitivity than smear microscopy to detect TB in PLHIV. Xpert is the fastest molecular TB diagnostic test. Not cost effective cannot be used in all types of facilities (e.g. stable electricity and air conditioning are needed). Costs $10 per cartridge test yet studies in South Africa show costs such as shipping etc increase this to $ Only detects Rifresistance and not INH resistance, and hence confirmatory testing is needed. Staff training required to ensure treatment initiation and testing is on same day. Sample processing of at least 15 minutes is required; although there is minimal handling of sample. 27 Smart, T. Determine LAM urine antigen TB test is highly cost-effective for use in hospitalised people living with HIV Minion J et al. Comparison of LED and Conventional Fluorescence Microscopy for Detection of Acid Fast Bacilli in a Low- Incidence Setting, 2011, Available at 29 Molecular Line Probe for Assays for Rapid Screening of Patients at Risk of Multidrug-Resistant Tuberculosis (MDR-TB), 2008, World Health Organisation, Available at TB TOOLKIT

22 DIAGNOSTIC TEST HOW DOES IT WORK ADVANTAGES DISADVANTAGES Determine TB-LAM assay Urine antigen is tested from the urine cell wall. LAM is a protein found in the outer cell wall of TB. The test requires no processing and is preferred for high burden setting in combination with other tests. It is used as rule in test to detect active TB. It is a molecular diagnostic (LPA) test which amplifies the DNA of TB. If TB is present in a sample, it will amplify the TB DNA and yield a positive result. The test detects both TB bacteria and TBs Relatively cost-effective at $ /test. 31 Easy sample processing required. Easy storage conditions for diagnostic kit. Easy readability of results. Handling urine decreases the risk of infection that can occur with blood and sputum. Urine is easier to obtain than sputum; which is especially useful for people coinfected with HIV and extrapulmonary TB who have difficulty producing sputum. Rapid diagnostic test; only takes 25 minutes. This is a point of care test which is suitable for basic health facilities (in limited resource settings). Test is not sensitive. It is most sensitive (57%) in PLHIV with CD4 counts below 100, used in combination with other tests for confirmation. 32 WHO has not yet endorsed this test although there is much evidence on accuracy of the test. 31 Dheda. K, TB diagnostic tests Why and when to use them? 2011, Available at presentations/keertan%20dheda%20(3).pdf 32 Fluorescent light-emitting diode (LED) microscopy for diagnosis of tuberculosis, Policy Statement, World Health Organisation, Geneva, Switzerland, Avaialble at pdf?ua=1&ua=1 TB TOOLKIT 21

23 13 Should a positive skin test result be a requirement for administering IPT to people living with HIV? The WHO recommends that TST is not a requirement for administering IPT to people living with HIV. Symptom screening to exclude those with active TB should be the method used to administer IPT. 14 Do the 2011 WHO IPT ICF Guidelines recommend Interferon Gamma Release Assay (IGRA) for the screening of people living with HIV for IPT? IGRA35 is a test used which diagnoses latent TB in BCG vaccinated individuals, using blood samples. It is a more sensitive test than TST to diagnose latent TB in BCG vaccinated people. The TB specific antigens in the test activate the release of Interferon Gamma from the blood of a person who is infected with TB. 33 IGRA tests cannot distinguish between latent infection and active TB disease and should not be used for diagnosis of active TB, as was the case in India, until the Government banned it for use for the false diagnosis of active TB. 34 IGRA tests are not recommended by WHO for the screening of children and adults living with HIV for IPT, since IGRAs cannot accurately predict the risk of infected individuals developing active TB disease. IGRAs are more costly and technically complex to do than the TST 35 Significantly higher rates (11.5% vs 4.3%) of indeterminate test results were found in persons with HIV compared to persons without HIV, and in persons with low CD4 cell counts compared to persons with higher CD4 cell counts Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resourceconstrained settings, 2011, World Health Organisation, Geneva, Switzerland. Available at publications/2011/ _eng.pdf. 35 Also marketed as QuantiFERON Gold- TB Gold or TB platinum 36 Fact Sheet, Testing for Tuberculosis (TB), 2011, Centers for Disease Control and Prevention (CDC), Available at cdc.gov/tb/publications/factsheets/testing/tb_factsheet.pdf TB TOOLKIT 22

24 Isonazid preventive therapy Hey there, my name is Isoniazid Preventative Therapy You may call me IPT. My power includes helping to reduce the risk of active TB developing in those friends who are living with HIV, by targeting my spear at TB, while it is still sleeping in their bodies. Find out more about how I am able to reduce the risk of TB disease (in people living with HIV) by 33-67%, for up to 48 months 23 TB TOOLKIT

25 What is TB chemoprophylaxis and why is it recommended in people living 15 with HIV? What drug is used for TB chemoprophylaxis? TB chemoprophylaxis (also known as Isoniazid preventive therapy IPT) is giving anti-tb drugs to PLHIV with latent TB infection to kill off the bacteria before it develops into active disease. The provision of IPT to PLHIV does not increase the risk of developing Isoniazid (INH) resistant TB. 37 The drug being used for IPT is INH at 300mg/day. Many studies around the world have shown that IPT reduces the risk of TB disease by 33%- 67% in people living with HIV for up to 48 months It is recommended that IPT be given for 6 months to adults (including pregnant women), children, PLHIV, those receiving ART and those whose TB treatment has been successful. In places with a high number of people infected with HIV and TB however, the WHO has recommended providing IPT for 36 months 42 (or as a life-long treatment). 17 The protective benefit of IPT ranges from 6 months to 5 years. The loss in protective benefit could be due to the high prevalence of TB in the community and re-infection or within high risk populations including health care workers, household contacts of TB patients, prisoners, and miners. Despite the loss in the protective benefit, current recommendations are for a single daily dose of IPT to be given for 6 months because of concerns with lifelong or periodic treatment with IPT that include risks of the development of toxicity or high costs. However two recent clinical trials track a benefit of IPT treatment for 36 months or longer, especially for those who are TST positive What is the optimal duration of IPT? How long does the protective value of IPT last? Should repeated courses of IPT be administered? How important is adherence to IPT? Various studies have shown that adherence rates for IPT vary significantly from 34%-98%. However, there is no data indicating that poor adherence, results in adverse outcomes such as resistance to isoniazid. 40 WHO Guidelines emphasise that concerns about adherence should not hinder IPT implementation. 41 It is reported that adherence could be enhanced by co-formulation of INH with other drugs such as ART or Co-trimoxazole Prophylaxis (CPT), reducing the pill burden. 42 While adherence to IPT is important for the prevention of active TB, the more important focus for patients on IPT should be on regular clinical follow up, prompt evaluation for TB if symptoms appear and/or stopping IPT if signs of toxicity appear. A critical and overlooked factor is data capturing tools for patients who are on IPT which allows for ease of monitoring and evaluation of patients and programme performance Pai M. Promoting affordable and quality tuberculosis testing in India, (2013). J Lab Physicians. ;5:1-4. Available at New WHO recommendations on use of commercial TB Interferon-Gamma Release Assays (IGRAs) in low- and middle-income countries. World Health Organisation (2011). Available at 39 Granich, R and Getahun, H. Three I s for HIV/TB: WHO 2011 guidelines for ICF/IPT. World Health Organization (2011). Available at S Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings, World Health Organisation (2011). Available at publications/2011/ _eng.pdf. 41 Ibid P Ibid P 11 TB TOOLKIT

26 19 Is it safe to administer IPT together with ART? Isoniazid has potential adverse effects, including nausea, vomiting, rash, fever, hepatitis, and peripheral neuropathy. Hepatoxicity, sometimes severe and even fatal, has been found in a very small proportion of individuals receiving isoniazid treatment. It is important to inform clinicians and patients about this possibility and be aware of the signs and symptoms of hepatitis, especially if the person taking IPT has other risk factors for liver disease such as regular alcohol consumption. Among patients receiving both ART and IPT, the risk of peripheral neuropathy is increased if stavudine or didanosine is used, although the addition of vitamin B6 (pyridoxine) may prevent peripheral neuropathy. 43 Studies in South Africa suggest increased risk of liver toxicity. 44 Symptoms of early hepatitis infection include decreased appetite, fatigue, abdominal pain, nausea, vomiting, jaundice, itching, and flu-like symptoms. When using IPT it is important to provide patients with careful counselling, clinical monitoring, and good patient education regarding when to stop treatment and seek advice so as to reduce the risk of toxicity Does IPT have any added benefit in people whose immune systems are already strengthened by ART? Even though ART reduces the incidence of TB infection, TB incidence rates, remain high in HIV-infected patients. 46 The use of both IPT and ART in HIV-infected patients has been shown to significantly reduce tuberculosis incidence. A study on the effects of using IPT with ART found that while patients receiving ART had a 64% reduced risk for tuberculosis, patients receiving ART after IPT had a 89% reduced risk. 47 Therefore, it is recommended that IPT be given regardless of whether a patient is on ART. In addition, being on IPT should not delay starting ART in eligible people living with HIV, such as those without active TB. A separate study affirmed that administering ART with IPT reduces the chances of TB infection. And people on effective ART may be able to take IPT intermittently, every second or third year due to effects of IPT being longer than previously hypothesised Is it safe to administer IPT together with ART? IPT should be provided to patients regardless of CD4 count. The REMEMBER trial is a multicountry study that compares the provision of ART and TB treatment with ART and IPT in people with HIV with a CD4 count below 50 cells/mm3 and presumed not to have active TB. The trial showed no evidence of reduced mortality, reduced incidence of AIDS-associated illnesses or increased viral suppression as a result of presumptive therapy in individuals in whom TB was not suspected and in whom it had been ruled out by extensive investigations Landry J, Menzies D. Preventive chemotherapy. Where has it got us? Where to go next? Int J Tuberc Lung Dis; 12: Smart, T. Taking isoniazid preventive therapy for one year reduces the risk of TB in people taking antiretroviral therapy, Available at: TB-in-peopletakingantiretroviral-therapy/page/ / 45 Granich R, Akolo C, Gunneberg C, Getahun H, Williams P, Williams B. Prevention of tuberculosis in people living with HIV. Clin Infect Dis, 2010; 50(Suppl 3):S215 S Clinical Guidelines: Managing Common Co-Infections and Co-morbidities World Health Organisation (2015). Available at 47 Golub JE, Pronyk P, Mohapi L, et al. Isoniazid preventive therapy,haart and tuberculosis risk in HIV-infected adults in South Africa: a prospective cohort. Aids, 2009,23: GSmart, T. Taking isoniazid preventive therapy for one year reduces the risk of TB in people taking antiretroviral therapy, Available at: 49 Clinical Guidelines: Managing Common Co-Infections and Co-morbidities World Health Organisation (2015). Available at TB TOOLKIT 25

27 22 Does IPT increase the risk of isoniazid resistance in people with latent tuberculosis? IPT is only recommended for patients with latent tuberculosis and it is very important that a patient does not have active TB disease when given IPT. If active TB develops, which rarely occurs while on IPT, IPT should be stopped. 50 It is important to thoroughly screen people for TB symptoms to eliminate the possibility of active TB before beginning IPT. In individuals with latent TB, few bacilli exist in the lungs which are slowly dividing, making the likelihood of developing drug resistance low. There is still a slight possibility that the use of isoniazid alone for the treatment of latent TB infection may result in isoniazid resistance. However, this should not prevent the use of IPT amongst those living with HIV. The WHO recommends regular TB screening for those taking IPT in order to help identify those who develop active TB. 23 Is IPT safe in pregnant women? The existing evidence suggests that IPT is safe in pregnant women. 51 It is recommend that pregnancy should not exclude women living with HIV from symptom based TB screening and receiving IPT. 24 When is IPT not recommended for patients? Patients with active TB should not be put on IPT. Individuals with active hepatitis (acute or chronic), regular and heavy alcohol consumption and symptoms of peripheral neuropathy are also not recommended to start IPT. However, past history of TB and current pregnancy should not prevent initiation of IPT. 25 Can IPT be administered safely in children? How would active TB be excluded in children? IPT is an important intervention for preventing and reducing tuberculosis amongst people living with HIV. IPT is proven to be effective and safe in both adults and adolescents as well as children. The algorithm for screening HIV-infected children older than than one year is the same as the algorithm for screening adults. All available data suggest that INH is not toxic for children, even in those receiving ART. HIV-infected children, over one year of age who present with no evidence of active TB (weight loss, fever, night sweats and current cough), despite the availability of contact history, should be given IPT. IPT in children should be given at a dose at 10mg/ kg/day for 6 months (not to exceed a maximum daily dose of 300mg). Simultaneous administration of vitamin B6 25 mg daily is recommended, to prevent neuropathy. 26 Is IPT recommended for PLHIV with MDR/XDR TB after they are successfully treated? The use of IPT in patients who have successfully completed treatment for MDR or XDR TB is not recommended. 50 Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings, World Health Organisation (2011). Available at publications/2011/ _eng.pdf. P Ibid 26 TB TOOLKIT

28 Tb Infection Control (Ic) My name is Infection Control (IC) My job is to stop TB from spreading. I use a combination of measures aimed at minimising the risk of TB transmission within populations. This requires widespread knowledge in the community around the signs and symptoms of TB and ways to control and treat it. I promote essential measures to prevent the spread of TB to vulnerable patients, health care workers, the community and those living in congregate settings. Learn below how I do my work and see me in action 27

29 27 What is meant by TB infection control? Why is it important? TB infection control is a combination of measures aimed at minimising the risk of TB transmission within populations. Successful infection control requires widespread knowledge in the community around the signs and symptoms of TB and ways to control and treat it. TB Infection Control measures are essential to prevent the spread of Tuberculosis to vulnerable patients, health care workers, the community and those living in congregate settings. With the increasing numbers of people with drug resistant tuberculosis, community based innovations need to be strengthened, as this is becoming a state of emergency for public health systems. 28 What is nosocomial transmission and what is the risk of nosocomial transmission of TB? Nosocomial transmission is TB infection that happens in a hospital or health care facility. The risk of TB among health workers in health-care facilities is higher than the risk among the general population. Various studies have shown that as compared to the general population, health care workers were 6 to 10 times more likely to develop latent TB infection, and 2 to 6 times more likely to develop TB disease. The greatest risk of transmission occurs when patients remain undiagnosed and untreated. 29 What are congregate settings? Why are there increased chances of spread of TB in congregate settings? Congregate settings are places where people live close to each other. They range from correctional facilities and military barracks, to homeless shelters, refugee camps, dormitories and nursing homes.the risk of TB in congregate settings is higher than other settings because of the crowded living conditions, poor nutrition and other illnesses that weaken the immune system and make people in congregate settings more vulnerable to developing active TB What are the different levels of infection control in health care settings? All health-care settings need a TB infection control program designed to detect and treat people for TB (or referral of persons to health facilities who have suspected TB disease in other settings), as well as ensuring clean breathing air. The following levels of TB infection control measures are recommended in health care settings: FACILITY-LEVEL MEASURES Develop an infection control plan for the health facility and identify a person responsible for its implementation. If possible, rethink the use of available spaces and consider renovation to improve infection control. Monitor TB disease among health workers and patients. Promote and educate health workers, patients and visitors on infection control. Monitor and evaluate the implementation of TB infection control measures. ADMINISTRATIVE CONTROLS Promptly identify people with TB symptoms, separate infectious patients, control the spread of TB (cough etiquette and respiratory hygiene), and minimise time spent in healthcare facilities. Provide a package of prevention and care interventions for health workers, including HIV prevention, antiretroviral therapy and isoniazid preventive therapy (IPT) for HIVpositive health workers WHO Policy on TB Infection Control in Health-Care Facilities, Congregate Settings and Households, World Health Organisation (2012). Available at

30 30 Continued... ENVIRONMENTAL CONTROLS Use natural ventilation. Use ultraviolet germicidal irradiation (UVGI) fixtures when adequate ventilation cannot be achieved. PERSONAL PROTECTIVE EQUIPMENT Use particulate respirators 31 Should infectious TB patients be separated in health care facilities? It is important to separate infectious patients after they have been screened and diagnosed for TB. People suspected of having or with confirmed drug-resistant TB should be separated (preferably according to the type of resistance they have from other patients, including other TB patients). 32 How important is cough etiquette in preventing transmission of TB? Cough etiquette, which includes covering the nose and mouth when sneezing or coughing reduces the spread of droplets that contain TB. 33 Have personal masks and respirators proven to be effective in prevention TB Transmission? There are usually two types of personal protective wear that are used in health care settings to protect against TB transmission. It is recommended that N95 respirators be used for health workers when caring for patients with suspected or confirmed TB, along with other infection control measures. Respirators should not be used by patients or people suspected of having infectious TB; instead, surgical masks and proper cough etiquette should be used. TYPE HOW DOES IT WORK ADVANTAGES DISADVANTAGES Surgical masks Provides a physical barrier between the mouth and nose of the person wearing it Effective in limiting the spread of infection from patients with TB to others Prevent the spread of microorganisms from the wearer Do not provide protection to the wearer against TB Not able to block out small particles spread through coughing and sneezing of others. Can only be used once and must be discarded right after use. 29

31 TYPE HOW DOES IT WORK ADVANTAGES DISADVANTAGES Respirators/N95 masks Filters out the air breathed in by users Fluid resistant and able to filter out very small particles. Disposable, but can be reused (should be stored in a clean, dry location) Protects the wearer against TB Respirators are expensive 34 What are the types of environmental ventilation? How effective is ventilation in TB infection control? Environmental ventilation is the process of bringing in air from the outside, and/or removing the bacteria from the air. There are three main types of ventilation: 1. Mechanical ventilation uses fans to move air through a building. Mechanical ventilation can be combined filtration systems. 2. Natural ventilation uses the wind to drive the air flow through a building. 3. Mixed-mode ventilation system combines the use of both mechanical and natural ventilation Health facilities lacking appropriate ventilation systems have reported TB transmission. Therefore it is recommended that health facilities put in place a ventilation system to control the spread of TB. 35 Are UVGI devices recommended for TB infection control? Ventilation is essential for preventing transmission of TB in the air. When it is not possible because of climate or building structure, an option is to use upper room or shielded ultraviolet germicidal irradiation (UVGI) devices. These devices use ultraviolet light to break down bacteria in the air. 36 What specific measures are recommended for HIV positive health workers in order to prevent them from getting infected with M tuberculosis? HIV positive health workers should be offered a package of prevention, treatment and care that includes: a. Regular screening for active TB and a full regimen of anti-tb treatment, should they be diagnosed b. Isoniazid preventive therapy (IPT) for latent TB c. Access to antiretroviral therapy. It is recommended that HIV-positive health workers should not be working with patient with known or suspected TB (in particular, they should not be working with patients with MDR-TB and XDR-TB). 30

32 37 For persons with infectious TB, what actions can be taken to reduce the risk of transmission of TB to their household members? Household members of persons with infectious TB are at high risk of becoming infected with TB. Therefore, detecting TB early remains one of the most important interventions for reducing the risk of TB transmission in the household. TO REDUCE EXPOSURE IN HOUSEHOLDS: Houses should be adequately ventilated, particularly rooms where people with infectious TB spend considerable time. Anyone who coughs should be educated on cough etiquette and respiratory hygiene, and should follow such practices at all times TB patients should spend as much time as possible outdoors sleep alone in a separate, adequately ventilated room, if possible spend as little time as possible in congregate settings or in public transport. practice cough etiquette (including use of masks) and respiratory hygiene when in contact with people. Ideally, family members living with HIV should not provide care for patients with infectious TB. If there is no alternative, HIV-positive family members should wear respirators, if available. Children below five years of age should spend as little time as possible in the same living spaces as infectious TB patients. Such children should be followed up regularly with TB screening. Potential renovation of the patient s home should be considered if possible, to improve ventilation (e.g. building of a separate bedroom, or installation of a window). 31

33 Initiating Antiretroviral Treatment Hi, my name is Initiation I work with my other Hero colleagues to ensure that persons with TB disease or those who are suspected of having active TB are diagnosed and initiated on treatment. Following the World Health Organisation (WHO) guidelines, I ensure that people are tested for HIV and screened for TB. Want to learn more? Well let s go! 32

34 38 How does HIV weaken the immune system? HIV needs host cells to replicate (make more HIV copies). It makes more copies by turning the host cell into HIV cells. The host cells that HIV uses and attacks are called CD4 cells. CD4 cells are immune cells, which alert the body to respond to infections. HIV attaches to and enters the CD4 cells, while entering, the HIV damages the CD4 cells. The fewer the number of CD4 cells, the weaker the immune system and the more vulnerable a person is to infection and illness What is ART? Antiretroviral Treatment (ART) is anti-hiv medication, which stops HIV from multiplying in the body. This allows for the immune system to stay strong and to fight off illnesses called opportunistic infections. ART is a combination of three types of anti-hiv medicines, which stop the replication of HIV in different ways. Sometimes this means people need to take three kinds of medicines, but sometimes these medicines are combined in a single tablet to make it easier for people to take their medication. This combination of drugs into one tablet is called a Fixed Dose Combination (FDC). ART needs to be taken every day at the same time, for a lifetime of a person living with HIV. The routine of taking medication is called adherence. Adherence is very important because if you do not take your medicine every day at the right time, the virus (HIV) will learn how to become stronger than the medication and will no longer work. When drugs no longer work on viruses and or bacteria, the virus and or bacteria are referred to as being resistant to the drug. Drug resistance is very problematic particularly because stronger and newer drugs are often expensive and unavailable in limited resource settings. ART protects the body for several hours at a time. It is important that you take your medicines at the right time because the medication is made to only protect you for a certain period of time. If you miss your medication, the CD4 cells in your body are no longer protected by ART, and this allows for the virus to make more viral copies while damaging CD4 cells, thereby weakening your immune system. 40 When does the WHO recommend you start ART? The body s immune system is the body s natural defence system, which fights off diseases and illnesses. The CD4 count test estimates the number of CD4 cells in your body and is a measure of strength of the immune system. A high CD4 count means a strong immune system. A low CD4 count, indicates a weak immune system. When one is living with HIV and has a very low CD4 count, one must start ART to stop HIV from multiplying in the body and to strengthen the immune system. 53 Cichocki M, What Are CD4 T-Cells and an HIV Infection? (2016). Available at t-cells

35 Continued... The WHO recommends the following: 54 As a priority, ART should be initiated in all individuals with severe or advanced HIV clinical disease (WHO clinical stage 3 or 4) and individuals with CD4 count 350 cells/ mm3 ART should be initiated in all individuals with HIV with CD4 count >350 cells/mm3 and 500 cells/mm3 regardless of WHO clinical stage ART should be initiated in all individuals with HIV regardless of WHO clinical stage or CD4 cell count in the following situations: Individuals with HIV and active TB disease Individuals co-infected with HIV and hepatitis B virus (HBV) with evidence of severe chronic liver disease Sexual partners with HIV in sero-discordant couples should be offered ART to reduce HIV transmission to uninfected partners. It is very important to initiate ART as early as possible. The lower the CD4 count is, the weaker the immune system and the harder it becomes for the body to heal and to recover. Starting ART earlier reduces the likelihood of death and of other infections such as TB. Taking ART also reduces the risk of infecting sexual partners. Earlier treatment was also shown to lower the chances of infecting others. 41 What does the WHO recommend for people who are co-infected with HIV and TB? All people with TB should be tested for HIV, including: persons with TB disease or suspected of having active TB persons with latent TB infection households or close contacts of TB patients People co-infected with TB and HIV should: Be started on ARVs as soon as possible and within 8 weeks following the initiation of antitb treatment, irrespective of CD4 count. Be started immediately on ARVS within 2 weeks for those with CD4 < 50 cells/mm3 ACTIVE TB LATENT TB 54 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, World Health Organization (2013). Available at: 34

36 INITIATING (ART) TO PREVENT TB IN PEOPLE Among people living with HIV, TB is the most frequent life-threatening opportunistic infection and a leading cause of death. 55 The WHO recommends that all people with HIV with active TB be initiated on ART. 56 This boosts their immune system. ART can prevent latent TB from developing to active TB disease. In this way, initiating ART prevents TB. 42 How does initiating ART prevent TB in people living with HIV? Taking ART decreases the risk of developing active TB disease by between 70% to 90% in people living with HIV People with latent TB develop active TB when their immune systems are very weak. Untreated HIV can severely weaken a person s immune system. By taking ART, HIV stops using CD4 cells to make more copies of HIV and stops destroying CD4 cells. This increases a person s CD4 cell count, thereby strengthening the immune system which allows the body to fight illness and diseases, such as TB. To prevent TB and other HIV-related illnesses and death, current WHO guidelines recommend initiation of ART when a person s CD4 count falls below 500 cells/mm FOR MORE INFORMATION ON HOW TO TREAT TB IN PEOPLE LIVING WITH HIV, SEE: WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. Geneva, World Health Organisation, policy_ /en World Health Organisation Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. June Available online at: download/en/index.html 55 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. World Health Organization (2013). Available at: 56 WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. World Health Organization (2012). Available at 57 Crowe SM, Carlin JB, Stewart KI, et al. Predictive value of CD4 lymphocyte numbers for the development of opportunistic infections and malignancies in HIV-infected persons. J Acquir Immune Defic Syndr. 1991;4: Guelar A, Gatell JM, Verdejo J, et al. A prospective study of the risk of tuberculosis among HIV-infected patients. AIDS. 1993;7: Hanson DL, Chu SY, Farizo KM, et al. Distribution of CD4+ T lymphocytes at diagnosis of acquired immunodeficiency syndrome-defining and other human immunodeficiency virus-related illnesses. The Adult and Adolescent Spectrum of HIV Disease Project Group. Arch Intern Med.1995;155: Antonucci G, Girardi E, Raviglione MC, et al. Risk factors for tuberculosis in HIV-infected persons. A prospective cohort study. The Gruppo Italiano di Studio Tubercolosi e AIDS (GISTA). JAMA. 1995;274: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. World Health Organization (2013). Available at: 35

37 43 The risk of developing TB disease is high in HIV-positive people during the first three to six months after initiating ART, 62 because of TB-associated immune reconstitution inflammatory syndrome (TB- IRIS). When PLHIV are not on ART and have very low CD4 counts, the immune system is too weak to recognise and respond to infections such as TB. Hence infections can remain clinically silent before initiating ART. When a person starts taking ART, their immune system becomes stronger. This means that their body is now strong enough to fight diseases that it was too weak to fight before taking ART. IRIS is when the body presents an exaggerated inflammatory response to existing and undiagnosed infections such as 63, 64 TB, because ART unmasks a previously undetected disease. In most cases, TB-IRIS typically arises within 2 months after initiating ART, but there have been cases of TB-IRIS developing later 65, 66 TB-IRIS is estimated to occur in 11% to 45% of patients co-infected with HIV following initiation of antiretroviral therapy What is ART TB-associated immune reconstitution inflammatory syndrome (TBIRIS)? What are the signs and symptoms of TBIRIS? TB-IRIS can have different signs and symptoms, especially in people with advanced HIV. People with pulmonary TB-IRIS (TB of the lungs caused by IRIS) usually have a fever, swollen lymph nodes, a cough or difficulty breathing. 68 Other signs or symptoms can include a swollen abdomen (stomach), enlarged, inflamed, and tender lymph nodes of the neck, abscesses, excess fluid or substances in the lungs, meningitis or TB of the brain Seyler C, Toure S, Messou E, et al. Risk factors for active tuberculosis after antiretroviral treatment initiation in Abidjan. Am J Respir Crit Care Med. 2005;172: Breen RA, Smith CJ, Cropley I, et al. Does immune reconstitution syndrome promote active tuberculosis in patients receiving highly active antiretroviral therapy? AIDS. 2005;19: Lawn SD, Wilkinson RJ, Lipman MC, et al. Immune reconstitution and unmasking of tuberculosis during antiretroviral therapy. Am J Respir Crit Care Med. 2008;177: Murdoch DM, Venter WD, Van Rie A, Feldman C. Immune reconstitution inflammatory syndrome (IRIS): review of commoninfectious manifestations and treatment options. AIDS Res Ther. 2007;4:9. 66 Huyst V, Lynen L, Bottieau E, Zolfo M, Kestens L, Colebunders R. Immune reconstitution inflammatory syndrome in an HIV/TB co-infected patient four years after starting antiretroviral therapy. Acta Clin Belg. 2007;62: Colebunders R, John L, Huyst V, Kambugu A, Scano F, Lynen L. Tuberculosis immune reconstitution inflammatory syndrome in countries with limited resources. Int J Tuberc Lung Dis. 2006; 10: Lawn SD, Bekker LG, Miller RF. Immune reconstitution disease associated with mycobacterial infections in HIV-infected individuals receiving antiretrovirals. Lancet Infect Dis. 2005; 5: Bhrushundi M, Mishra P. Study of immune reconstitution inflammatory syndrome (IRIS) in resource limited settings. XVI International AIDS Conference; Toronto, ON, Canada; Aug 13 18, Abstract MOAB

38 There is no existing diagnostic test which can confirm whether a person has TB-IRIS or not. Hence health care workers must use clinical judgment to diagnose whether someone has TB-IRIS by looking at signs and symptoms. A case definition of TB-IRIS that could be applied in resource-limited settings was developed in Kampala, Uganda, in 2008 by the International Network for the Study of HIV-associated IRIS panel as: When a patient presents with active TB within the first three months after starting ART (not on TB treatment) and presents with heightened signs and symptoms associated with TB-IRIS (as described above). 70 The case definitions deliberately exclude the use of laboratory tests, such as CD4 and viral load testing, as these tests are often not available in resource-limited settings where HIV-infected patients are often being treated. 45 What are the risk factors for TB-IRIS? There are instances which make an individual more vulnerable to acquiring TB-IRIS (specific risk factors) identified for TB-IRIS include: having many opportunistic infections before initiating ART. low CD4 count at initiation of ART, a rapid increase in CD4 cell count. and/or a rapid decrease in viral load following initiation of ART People in the more advanced stages of HIV or with AIDS also have an increased risk of developing IRIS when they initiate ART, if the ART is working for them and make their immune system stronger Meintjes G, Lawn SD, Scano F, et al. Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in 71 Breton G, Duval X, Estellat C, et al. Determinants of immune reconstitution inflammatory syndrome in HIV type 1-infected patients with tuberculosis after initiation of antiretroviral therapy. Clin Infect Dis. 2004; 39: Breen RA, Smith CJ, Bettinson H, Dart S, Bannister B, Johnson MA, Lipman MC. Paradoxical reactions during tuberculosis treatment in patients with and without HIV co-infection. Thorax. 2004; 59: Lawn SD, Bekker LG, Miller RF. Immune reconstitution disease associated with mycobacterial infections in HIV-infected individuals receiving antiretrovirals. Lancet Infect Dis. 2005; 5: Manabe YC, Campbell JD, Sydnor E, Moore RD. Immune reconstitution inflammatory syndrome: risk factors and treatment implications. JAcquir Immune Defic Syndr. 2007; 46: Valin N, Pacanowski J, Denoeud L, et al. Risk factors for unmasking immune reconstitution inflammatory syndrome presentation of tuberculosis following combination antiretroviral therapy initiation in HIV-infected patients. AIDS. 2010;24: Sharma SK & Soneja M. HIV and Immune reconstitution inflammatory syndrome (IRIS): A Review article. Indian J Med Res 134, December 2011, pp

39 46 How should TB-IRIS be managed? 77 Health care workers should become familiar with the case definitions and clinical symptoms of TB-IRIS and use these definitions in resourcelimited settings. Health-care workers should also evaluate the patient for drug-resistant TB, as cases of multidrug-resistant-tb have been identified in patients with TB-IRIS. 80% of cases of TB-IRIS will not last very long naturally and will resolve with continued treatment with little or no change in the treatment a person receives. Use of non-steroidal anti-inflammatory agents may provide adequate relief of symptoms in mild cases. Patients should continue with anti-tuberculosis therapy without change unless there is a reason to suspect the current treatment regimen is inadequate (for example if MDR-TB is suspected, or drug-drug interactions which could make the anti-tb drug less effective). In nearly all cases, the patient with TB-IRIS should remain on antiretroviral therapy. Certain circumstances, however, may require temporary interruption of antiretroviral therapy, such as when life-threatening complications of IRIS develop. 77 Behrens CB, Manoharan G, Diagnosis and Management of Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) (2014). Available at 38

40 Tb/Hiv Integration Hello, my name is Nurse X My job is to promote integrated HIV and TB prevention, care, treatment and support. This ensures that we, and my team of health care service providers treat everyone who is living with HIV and TB to have all the antiretroviral therapy (ART) and HIV care services are provided with TB diagnosis and treatment at one facility. Services that we provide include * Infection control education * TB screening and diagnosis * HIV testing * Treatment for those who require it * Adherence support 39

41 47 What is the impact of TB/HIV co-infection? TB is the leading cause of death among HIV positive patients in sub- Saharan Africa, and accounts for approximately 1,000 deaths daily. 78 HIV increases the risk of developing active TB among patients with latent TB infection (LTBI), from 10% over a patient s lifetime to 10% per year. 79 HIV leads to rapid development of active TB disease among patients recently infected with TB and those with latent TB infection. HIV increases the rate of recurrence of TB. People with active TB who are co-infected with HIV have a higher risk of mortality compared with HIV- negative patients (16-35% vs 5-8%). 80 Active TB increases the risk of HIV-related mortality both during and after successful TB treatment. 48 Who are the at risk populations? Active TB has been diagnosed at rates of up to 10 times higher in pregnant women living with HIV than in women without HIV. 81 Maternal TB is associated with a 2.5-fold increased risk of HIV infection to the unborn child. 82 HIV infection is a risk factor for active TB disease in infants or children. More severe types of TB and higher mortality rates have been found in children living with HIV. 83 TB-related mortality in HIV co-infected patients is especially high in the first few months of TB treatment. 84 People living with HIV in congregate settings, including prisons and refugee centres and people who use drugs have a higher risk of HIV infection and incidence of TB TB/HIV Factsheet, World Health Organization (2015). Available at factsheet_2015.pdf 79 Latent Tuberculosis Infection: A Guide for Primary Health Care Providers, Centers for Disease Control and Prevention (2014). Available at 80 Smart T, HIV and TB in Practice for nurses: Starting ART for treatment and prevention in people with active TB and HIV, (2012). Available at 81 Kali PB et al. Combining PMTCT with active case finding for tuberculosis. JAIDS, 2006, 42(3): Gupta A et al. Maternal tuberculosis: a risk factor for mother-to-child transmission of human immunodeficiency virus. Journal of Infectious Diseases, 2011, 203(3): Swaminathan S, Rekha B. Pediatric tuberculosis: global overview and challenges. Clinical Infectious Diseases, 2010, 50 Suppl 3:S Mukadi YD, Maher D, Harries A Tuberculosis case fatality rates in high HIV prevalence populations in sub Saharan Africa. AIDS, (2001) 15: Getahun H et al. HIV infection-associated tuberculosis: the epidemiology and the response. Clinical Infectious Diseases, 2010, 50 Suppl3:S

42 49 Why is integration important? Currently, the majority of TB and HIV/AIDS programmes are still being implemented separately, and this leads to: Limited coverage of TB and HIV services. Therefore limited access to care, which translates to missed opportunities in treating HIV in TB patients, or treating TB in HIV patients. Increased risk of loss to follow up of patients when being referred to different locations to access HIV and TB treatment and risks to non-adherence to treatment as patients are being managed by different health providers. Inefficient use of resources both for the health system, where the services can be provided under one roof with one health provider, as well as incurred costs to the patients. TB/HIV integration aims to: Decrease TB and HIV transmission Decrease morbidity and mortality from TB and other HIV related illnesses Improve the efficiency of healthcare services Create a patient-centered approach for co-infected patients to ensure they are not lost to care A study from South Africa showed that ART initiation in TB clinics can be delayed for as long as 116 days, mainly due to prolonged referral times between TB and ART services. 85 Up to 9% of HIV-infected patients are lost to follow-up during TB 86, 87 treatment. 85 Lawn SD, Campbell L, Kaplan R, Little F, Morrow C, et al.. (2011) Delays in starting antiretroviral therapy in patients with HIV-associated tuberculosis accessing non-integrated clinical services in a South African township. BMC Infectious Diseases 86 Varma JK, Nateniyom S, Akksilp S, Mankatittham W, Sirinak C, et al. (2009) HIV care and treatment factors associated with improved survival during TB treatment in Thailand: an observational study. BMC Infect Dis. 9: Makombe SD, Harries AD, Yu JK, Hochgesang M, Mhango E, et al. (2007) Outcomes of tuberculosis patients who start antiretroviral therapy under routine programme conditions in Malawi. Int J Tuberc Lung Dis. 11(4):

43 50 What are the WHO recommendations for the integration of HIV and TB services? 88 In recognition of the devastating impact the HIV epidemic has had on TB control, the WHO released policy guidelines on collaborative TB/HIV activities aimed at creating synergy between TB and HIV programmes through strengthening mechanisms to deliver integrated care, reducing the burden of TB among people living with HIV, and reducing the burden of HIV among both TB suspects and those with confirmed TB. WHO - RECOMMENDED COLLABORATIVE TB/HIV ACTIVITIES A. Establish and strengthen the mechanisms for delivering intergrated TB and HIV services A.1. Set up and strengthen a coordinating body for collaborative TB/HIV activities functional at all levels A.2. Determine HIV prevalence among TB patients and TB prevalence among people living with HIV A.3. Carry out joint TB/HIV planning to intergrate the delivery of TB and HIV services A.4. Monitor and evaluate collaborative TB/HIV activities 51 What progress is being made with regards to TB/HIV integration? There has been a steady increase in the numbers of patients with TB who are tested for HIV. Progress in the African continent is significantly higher than global progress. The number of TB patients tested for HIV went up from approximately 40% to approximately 70% from 2007 to This represents significant progress in the linkage between TB and HIV services. TB PATIENTS TESTED FOR HIV (%) AFRICA GLOBAL REGIONS OTHER THAN AFRICA Source: 89 WHO policy on collaborative TB/HIV activities, guidelines for national programmes and other stakeholders, World Health Organisation (2012). Available at en/ 42

44 The number of TB patients receiving ART has increase steadily since 2007, in Africa (experiencing the highest burden of disease) and globally. The progress is slower in Africa than in other regions of the world. In Africa, the number of patients put on ART increased from approximately 30% to over 40% over the 4 year period. TB PATIENTS RECEIVED ART (%) Source: REGIONS OTHER THAN AFRICA GLOBAL AFRICA The graph below represents country specific coverage of ART among patients who are co-infected. There are significant inter-country variations, with Zimbabwe reporting the highest levels of ART coverage at 67% and Mozambique reporting the lowest levels of ART coverage at 29%. It is essential that all newly diagnosed HIV patients with TB be initiated on ART immediately ART COVERAGE AMONG NEW HIV POSITIVE TB PATIENTS Zimbabwe Kenya Malawi Namibia Zambia Swaziland Botswana South Africa Source: Nigeria Lesotho Ethiopia UR Tanzania Uganda Mozambique 43

45 52 What are the barriers to integration? SERVICE DELIVERY Lack of demand among patients and health providers Poor referrals system including inadequate access and poor communication between services Lack of space at facilities Lack of integrated TB and HIV data collection systems Lack of integrated TB and HIV governance from national to grass root level of care delivery, which deeply affects TB and HIV collaboration in service delivery at all levels Stigma Poor infection control MDR and XDR-TB pose very high mortality risk for HIV positive patients HUMAN RESOURCES Insufficient numbers of health care workers High turnover rates Poor motivation among health workers SUPPLY OF MEDICINES AND PRODUCTS Challenges with the storage and supply of IPT and ART Limited test kit supplies 53 What are the different models of TB/HIV integration? The following section outlines 4 different models through which patients are able to access both HIV and TB services. Patients may either access TB services and be referred for HIV care, access TB care and HIV testing, and those testing positive be referred, access HIV care and be referred for TB services, or through an integrated model, access both services in one location. Entry through TB services Entry through HIV services TB refers: TB service refers for HIV testing REFERRAL HIV refers: HIV service refers for TB testing TB: tests and refers: TB service tests for HIV, refers for treatments HIV: screens and refers: HIV service screens for TB, refers for treatment Increasing integration Single facility : testing and treatment for HIV and TB at one facility Source: Integrating tuberculosis and HIV services in low and middle income countries: A systematic review Legido-Quigley et al TMIH Feb

46 Entry via TB service and referral for HIV testing and care Under this model, once a patient accesses TB services, they would be responsible for referring patients to facilities providing HIV testing: BENEFITS: Simple to introduce Requires minimal additional logistic and financial input REQUIRES: Joint training of health care workers from both programmes, Adapting existing record keeping systems and referral forms Regular meetings of staff from both services to strengthen referral Entry via TB service and referral for HIV care after HIV testing Under this model, TB clinics would offer HIV testing and refer HIV positive people for care: REQUIRES: Additional HIV counseling and testing space and possibly additional staff members WEAKNESS: Loss of patients if referral fails, with increased risk of HIV transmission to partners and children and delays in treatment initiation Entry via HIV service and referral for TB screening, diagnosis and treatment HIV services refer people living with HIV for TB screening, diagnosis and treatment: REQUIRES: Appropriate referral criteria WEAKNESSES: Loss of patients if referral fails Not recommended in high HIV prevalence setting WEAKNESS: Failure of the referral process can lead to ongoing TB transmission and progression of TB disease Entry via HIV service and referral for TB diagnosis and treatment after TB screening People living with HIV are screened for TB and referred for TB diagnosis and treatment based on the outcome of the screening: REQUIRES: Such facilities could provide isoniazid preventive therapy (IPT) Should facilities provide sputum sample collection on site there is a need for increased infection control measures 45

47 TB and HIV services provided at a single facility POSSIBILITIES INCLUDE: TB clinic provides HIV treatment HIV clinic provides TB treatment Primary health centre provides integrated diagnosis and treatment for TB and HIV either in one or separate rooms Hospital provides integrated diagnosis and treatment for TB and HIV either in one or separate rooms BENEFITS: Efficient in settings with high HIV prevalence, high rates of co-infection, and where human resource availability is limited Allows early detection and treatment of undiagnosed TB, and may result in a reduction of TB risk compared with separate services Increase in detection of smear-negative pulmonary and extra-pulmonary TB and of treatment success rates with integrated TB/HIV care Timely initiation of ART in TB patients living with HIV without the necessity for referral Develops staff s skill in managing co-infected patients and results in better management of patients clinical challenges, including drug interactions and toxicity, Immune Reconstitution Inflammatory Syndrome (IRIS), TB deterioration and optimal timing of ART initiation Adherence and social support interventions within integrated programs can reinforce each other rather than competing for scarce resources Helps improve efficiency of service delivery by avoiding duplication of logistic and administrative requirements TB and HIV services provided at a single facility WEAKNESSES: Risk of nosocomial spread of TB. Most resource constraint settings have poor infection control measures or nonadherence to infection control measures Overburdened staff not being able to implement infection control measures Lack of space in clinics leading to overcrowding Poor patient flow within facilities 46

48 INTEGRATION IS MORE TIME EFFICIENT AND SAVES TIME. TIME SPENT FOR CONSULTATION WITH PATIENT: INTERGRATED TB/HIV REPEAT CONSULT = LESS TIME Check combined patient file for monitoring investigation results incl. AFB, culture, ART blood results and previous notes SEPERATED TB AND HIV REPEAT CONSULT = MORE TIME TB REPEAT CONSULT Check combined TB file for monitoring investigation results incl. AFB, culture and previous notes ART REPEAT CONSULT Check patient ART file for monitoring investigation results incl. ART blood results and previous notes Phone lab or send CHW to fetch missing results* Phone lab or send CHW to fetch missing results * Phone lab or send CHW to fetch missing results* Review patients vital signs Review patients vital signs Review patients vital signscons Consult with patient re medical history and TB and ART adherence since last visit. Consult with patient re medical history and TB adherence since last visit Consult with patient re medical history and ARV adherence since last visit Examine patient ito HIV and TB clinical management* Determine any require TB and ART monitoring blood/ sputum investigation, take blood or send for sputum collection*, complete lab form* Examine patient ito TB clinical management Determine any required TB monitoring sputum, send for sputum collection*, lab form* Examine patient ito HIV clinical management* Determine any required ART monitoring blood investigations, take blood*, lab form Dispense TB RX and ART, record in combined patient file and both facility TB and HIV registers Dispense TB RX record in patient TB file and facility register Dispense ART, record in patient ART file and facility ART register Provide single TCB date Provide TCB date Provide TCB date Source: South African Department of Health: A practical guide for TB and HIV service Integration at Primary health care facilities 47

49 54 Can integrated services happen beyond health facilities? INTEGRATED SERVICES SHOULD BE CONSIDERED BEYOND THE CLINIC LEVEL Congregate settings, such as prisons, public transport, mines, factories, taverns and places of worship Households/community 55 What are some examples of TB/HIV integration being implemented? BENEFITS OF INTEGRATION WHERE IT IS BEING IMPLEMENTED 90 In January 2006, MSF and the Ministry of Health in Lesotho launched a pilot programme to provide nurse-driven integrated HIV and TB treatment at the primary health care(phc) level. BETWEEN 2006 AND 2009: Total TB cases identified and treated at PHC level rose from 105 to 332 cases in The proportion of diagnosed sputum negative and extra-pulmonary TB cases increased from 10% to 48% of cases. In 2008, 93% of TB cases were tested for HIV (78% were HIV positive), 92% received Cotrimoxazole prophylaxis and 81% received ART. The treatment success rate in co-infected and non co-infected patients respectively was 65% and 77% in 2007 and 70% and 79% in Therefore, the treatment success rate in co-infected and non coinfected patients improved between due to nurse-driven integrated HIV and TB treatment at PHC level. TB registers and clinical notes of 209 TB/HIV co-infected adults at one primary care HIV/ TB integrated clinic in South Africa were reviewed between June 2008 and May 2009 and found: 91 Full TB/HIV integration led to a 60% increased chance of co-infected patients starting ART. Integration reduced time from TB treatment to ART initiation by an average of 72 days. ASSESSMENT AT AN ART CLINIC DURING TB TREATMENT REDUCED LOSS TO FOLLOW-UP BY 80% 92 In December 2008, a separate integrated TB/HIV clinic was established for patients attending a large urban HIV clinic in Uganda. 93 This resulted in: TB treatment cure or completion increased from 62% to 68%, Death or default decreased from 33% to 25% More patients were started on ART during TB treatment (94% vs. 78%) Furthermore, the majority of patients were initiated on ARVs during the intensive phase of TB treatment (60% vs. 23%) 90 Bygrave H, Trivino L, Makakole L. TB/HIV integration: lessons learned from implementation of a TB/HIV one stop shop at primary health care clinics in rural Lesotho. Vienna, 18th International AIDS Conference, Kerschberger B, Hilderbrand K, Boulle AM, Coetzee D, Goemaere E, et al. (2012) The Effect of Complete Integration of HIV and TB Services on Time to Initiation of Antiretroviral Therapy: A Before-After Study. PLoS ONE 7(10): e doi: /journal.pone Reduces Loss to Follow-up among HIV-Infected Patients. PLoS ONE 7: e doi: /journal.pone Hermans SM CB, Katabira C, Mbidde P, Lange JMA, et al. (2012) Integration of HIV and TB Services Results in Improved TB Treatment Outcomes and Earlier Prioritized ART Initiation in a Large Urban HIV Clinic in Uganda. JAIDS 60: e29 e35. doi: /qai.0b013e318251aeb4. 48

50 OTHER SUCCESSFUL EXAMPLES OF INTEGRATION IN THE REGION: Gandhi NR, Moll AP, Lalloo U, Pawinski R, Zeller K, et al. (2009) Successful Integration of Tuberculosis and HIV Treatment in Rural South Africa: The Sizonq oba Study. J Acquir Immune Defic Syndr 50: Gasana M, Vandebriel G, Kabanda G, Tsiouris SJ, Justman J, et al. (2008) Integrating tuberculosis and HIV care in rural Rwanda. INT J TUBERC LUNG DIS 12: Micek M (2005) Integrating TB and HIV Care in Mozambique: Lessons from an HIV Clinic in Beira. Health Alliance International. Miti S, Mfungwe V, Reijer P, Maher D (2003) Integration of tuberculosis treatment in a communitybased home care programme for persons living with HIV/AIDS in Ndola, Zambia. INT J TUBERC LUNG DIS 7: JB H, SM H, KM R, BH C, NG K, et al.. (2008) Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis What are the WHO recommendations for M&E for TB/HIV integrated services 94 Monitoring and evaluation activities are conducted to assess the quality, effectiveness, coverage and delivery of the collaborative TB/HIV activities. Such activities provide the opportunity for learning across the HIV and TB programme, in order to strengthen the individual services and joint programme performance. Monitor and evaluate collaborative TB/HIV activities RECOMMENDATIONS 1. HIV programme and TB-control programmes should establish harmonised indicators and standard reporting and recording templates to collect data for monitoring and evaluation of collaborative TB/HIV activities. 2. Organisations implementing collaborative TB/HIV activities should embrace harmonised indicators and establish a reporting mechanism to ensure that their data is captured by the national monitoring and evaluation system of the country. 3. THE WHO guide to monitoring and evaluation of collaborative TB/HIV activities and the three interlinked patient monitoring systems for HIV care/art, MHC/PMTCT and TB/HIV should be used as a basis to standardise country-specific monotoring and evaluation activities. MONITORING AND EVALUATION INVOLVES: Collaboration between the HIV care/art, MCH/PMTCT 95, and TB/HIV programmes and the general health system Development of referral linkages between different services Joint supervision 94 WHO policy on collaborative TB/HIV activities guidelines for national programmes and other stakeholders, World Health Organisation (2015). Available at 95 MCH: maternal and child health & PMTCT: prevention of mother to child transmission 49

51 57 What are things to consider when developing the monitoring system? Integrate with already existing monitoring and evaluation systems if they exist. Establish and identify harmonised indicators that should be captured by each service to align and cross-check data between different programmes to verify whether patients have been tested and are accessing care. 58 Are there tools developed already for M&E around TB and HIV activities? The guide below was developed to support the collection of standardised data and facilitate the interpretation and dissemination of information to strengthen the HIV and TB programmes. The guide provides a set of standardised indicators to harmonise data collection, monitor and evaluate programme performance and further highlight the benefits of collaborative HIV/TB activities. The newly revised TB/HIV indicator guide includes: Harmonised indicators with 13 instead of 20 indicators, including 2 Infection control indicators: TB STATUS AT LAST VISIT STARTED TB TREATMENT ART & TB TREATMENT / Estimated HIV&TB cases NEWLY ENROLLED HIV+ ON IPT INFECTION CONTROL PRACTICES HEALTH WORKERS WITH TB % HIV STATUS KNOWN % HIV POSITIVE TB/HIV CASE DETECTION FREE CONDOMS CPT PROVISION % TB/HIV in HIV CARE ART PROVISION Source: 50

52 Current available tools for M&E: Three interlinked patient monitoring systems for HIV care/art, MCH/PMTCT (including malaria prevention during pregnancy), and TB/HIV: standardised minimum data set and illustrative tools pdf Participant training manual pdf Facilitator training guide pdf Set of completed cards, registers and reports. A companion for the Exercise booklet of the three interlinked patient monitoring system Additional tools for integration: A practical guide for TB and HIV service Integration at Primary health care facilities The South African department of health, with the support of partners, developed a guide for the integration of HIV and TB services aimed to support facility managers and health care workers (HCWs). The document includes a step-by-step guide to the integration of HIV and TB services. Source: 51

53 Involvement Of The Community Hi, my name is Nurse Community! My job is to ensure that patient-centered appraoches are prioritised in the TB/HIV response. This includes investing in the core pillars of our society, the community. These pillars include monitoring and accountability, advocacy, social mobilisation, community linkages, collaboration, institutional capacity building, planning and leadership development. Strengthening community systems means investing in an environment that is enabling for communities and places the communities at the centre of TB programming. 51

54 59 How can communities be involved with treating and preventing TB/HIV? Since HIV and TB infection can occur in communities, community members (and not only health care workers) can help to prevent TB and HIV and support people with the diseases. Community involvement can greatly benefit communities where people have been involved in the prevention and treatment of HIV and TB. Examples of the different ways in which communities have been involved in TB/HIV care and prevention are provided in this document. In low- to middle- income countries, there is a shortage of health care workers which may limit provision of services for TB and HIV prevention and treatment. Given the human resources for health challenges in many regions, the WHO has recommended that task-shifting be adopted in health facilities. This is where certain tasks that were traditionally performed by doctors are now performed by nurses and certain nurses tasks are performed by community health workers or lay people. 60 What are some examples of how communities can be involved in TB and HIV activities? Anyone can be involved in TB and HIV treatment and care. Some of the ways that communities have become involved in TB and HIV treatment and care include: Advocacy Awareness-raising Training Peer education Contact tracing Home visits or assisting in the delivery of medication Treatment support TB infection control 52

55 61 How can you or your community become involved in TB/HIV care and prevention? ADVOCACY Advocacy involves people or a group of people (such as professionals, the media, patients and community members) speaking up against an issue or for purposes of gaining support in order to change policies or get support for an idea or movement. Progress in the global and national fight against HIV was driven primarily by advocacy, yet TB has not received as much advocacy support. 96 Advocacy can take many forms such as getting community support for petitions or memorandums, marches, sit-ins and meetings with decisionmakers. Advocacy work often involves several key stakeholders, each with unique ways of providing leverage around issues, working together on one or more issues. CASE STUDY: CALLING SA GOVERNMENT TO INCREASE EFFORTS ON COMBATING TB In South Africa, the Treatment Action Campaign (TAC), Section 27, Oxfam and Médecins Sans Frontières (MSF/Doctors without Borders) identified important steps to be taken in fighting TB at the 2012 South African TB conference. The groups delivered a memorandum containing interventions critical for the reduction of TB cases and mortality in South Africa, such as diagnosing all people living with TB and drug-resistant TB (DR-TB), ensuring access to the best available medicines, improving the affordability of medicines, reducing crowding in prisons, the mines and other congregate settings and implementing active case finding and infection control measures. CASE STUDY: MULEIDE S ADVOCACY WORK The Mozambique HIV, TB and Human Rights Training Advocacy Programme (MULEIDE) is a group of Mozambiquan actors and civil society organisations that formed in 2012 to fight for better access to treatment and health funding. During 2012 there were many drug shortages in Mozambique. MU- LEIDE met with the Minister of Health and campaigned for; Increased knowledge about what goes on in the health system An increase to the national health budget Improvement in the management of the supply process of drugs Through its advocacy (fighting for the above things) it has got a commitment from the government to order more drugs and to work with the World Bank for emergency supplies when needed. Source: 96 Seti, B. Effective Partnerships: A Civil Society Perspective. TB/HIV Workshop. Aids and Rights Alliance for Southern Africa (ARASA).Maputo, Mozambique April S 7.Available at: effective_partnerships.pdf 53

56 AWARENESS Awareness involves making sure that your community knows about the risks of contracting TB and HIV and how and where to get treated. This can be done in many ways such as giving talks at schools, churches, the workplace, taverns or in sports teams. You could ask your local radio station if you could be allowed to talk about TB and HIV on the radio. You could also hold community events or attend community events and ask if you could speak about TB and HIV. Most importantly, remember that even just speaking informally with people around you about TB and HIV is one of the most effective ways of spreading a message. There are many useful tools that you can use to assist in raising awareness- this toolkit is one of them. Raising awareness is a valuable part of overcoming and challenging health issues. It s important that people understand all the information about TB and HIV this might mean speaking in the language most understood by people or getting someone else to talk to people in the most understood language within an area. CASE STUDY: DHAT S DISABILITIES AWARENESS WORK Disabilities, HIV and AIDS Trust (DHAT) is a regional organisation working in southern Africa. It was formed in 2007 to promote the rights of people living with disabilities. DHAT started a programme on the Rights and Needs of Persons with Disabilities in Zambia. The project visited six clinics to inform health care workers (HCW) about DHAT s work and to talk about issues experienced by women with disabilities who have HIV. HCW were very interested in this work and agreed to send two HCW to a workshop with DHAT. DHAT has also held awareness-raising workshops which have been attended by women with disabilities, doctors, nurses and Health NGO workers, in order to spread their message. Source: TRAINING Training about HIV and TB can cover many topics and should be suited to the specific skills or knowledge needs of the people being trained. It gives people skills and knowledge which means they are better informed and better able to fight HIV and TB. You can be involved in the community as a trainer and as a participant in training. Attending training sessions is a good way to get knowledge, which will help you in raising awareness to those around you. This Toolkit is a useful tool for training one or more people could teach the material in this toolkit to the participants of a TB training session. It is important to have clear goals you want to achieve in your training and make sure you remember this when leading the sessions. One of the goals of training must always be that participants understand the issues you are discussing. It is important to remember that not everyone has the same knowledge and/or experience. You may also need to change the speed at which you explain things if you are training people who do not know a lot about HIV and TB. The number of training sessions needed will depend on how complex the issues covered are. Also, if there are lots of people who need to or want to attend, you may need to give the same training in several different locations. 54

57 CASE STUDY: YORD S TRAINING Youth Outreach on Rights and Development (YORD) was started by youth in Namibia. They have held training workshops on Reproductive Health Rights, in the Ohangwena region with HIV support groups. There were three workshops in total. The workshop was put together with information gathered from brochures and pamphlets on HIV prevention, TB and Sexual and Reproductive Health Rights (SRHR) from NGOS, ministries and organisations. This information was handed out at the training. After the workshops, participants recommended for more workshops and materials on topics that had not been discussed. The support groups are still in existence and these workshops have instilled a desire to learn within the groups. Source: TREATMENT SUPPORT People who are taking TB or HIV treatment take their medication for a very long time. There are many ways in which you can support people taking treatment: Start a Support Group: A support group of people with the same disease can be formed. This can be used as an opportunity to provide training to people on treatment, answer questions and assist people in taking their treatment. MSF in Khayelitsha uses its community support group to provide ARV treatment to patients who are stable on their ARV treatment. 97 Be a Treatment Buddy: Treatment buddies are people who support patients on treatment or in the early stages of treatment. This can involve attending the clinic with the patient, collecting their medication at the clinic, reminding patients to take their treatment and supporting people through taking treatment. Delivery of Treatment: Patients who are very sick cannot attend the clinic to collect their own medication. Many people support patients on treatment merely by delivering a person s medication to their home. Support with Chores: People who are starting treatment may experience side effects or still be too ill to attend to their daily chores. By helping someone on treatment to do simple tasks like doing their grocery shopping, cleaning their home, running some errands, taking care of their children or cooking them a meal can allow people on treatment to rest and recover

58 CASE STUDY: PIH TREATMENT SUPPORT For every people in Lesotho, 633 are infected with TB each year. The co-infection rate of MDR-TB and HIV is 70%. It is clearly important for TB and HIV treatment to be addressed together. Staff working for Partners in Health (PIH) in Lesotho are trained in both HIV and TB treatment. The Botsabelo Hospital (which has 24 beds) caters for people who are having side-effects from MDR-TB drug. PIH, through assistance of community health workers closely track Botsabelo patients and the integrated HIV and TB treatment they receive, which includes Directly Observed Treatment (DOT). A Community Health Extension Worker manages one unit (1000 households) and links the unit to a health facility. One community health worker is assigned to 20 households. Houses were visited once a month or more and residents were screened for ailments, including TB symptoms using the TB screening algorithm. Source: PEER EDUCATION Peer education is an important part of community involvement. It means that people who share similar experiences, or have had a disease before, educate others on how to manage their illness. This is a very powerful education model, as people with TB or HIV learn more from others who have the diseases and have first-hand experiences on the disease(s). This type of education is different from attending a training workshop and learning information from a doctor or nurse. It is a way for lay people to teach those in their community about health issues. CASE STUDY: PEER EDUCATION IN ZAMBIAN PRISONS TB prevalence is very high in Zambian prisons with 10 to 20 times higher infection than in general society. TB control guidelines are being developed to combat this. Peer education happens among prison inmates, facilitated by Prisons Care and Counselling Association (PRISCCA). Fellow prisoners who have either had TB or HIV or who have received specialised training on TB/HIV, share knowledge with fellow prisoners. Prisoners are motivated to become counsellors or to learn from counsellors because many fellow inmates contract TB while in prison. The programme is sustainable as new peer educators are trained annually, allowing for new educators to take over if fellow inmates are released. The skills and experience gained through the peer education and training are applicable to other employment opportunities when they leave prison. Source: 56

59 CONTACT TRACING TB contact tracing involves finding out whether someone has come into contact with TB disease (through a person infected with TB disease). Contact tracing may involve screening the household contacts for TB disease and providing treatment or IPT (to prevent TB) where necessary. This is a further way of being involved in your community s fight against TB and HIV, where people assist by going to the homes of contacts and do TB screening and education with household contacts. DELIVERY OF MEDICINES AND HOME VISITS Delivering medication to those with HIV and/or TB and making home visits is another way to be involved in supporting those with TB and/or HIV. You do not have to be a qualified doctor or nurse to deliver medication. Getting medication delivered to people s homes makes life much easier for them. If people are sick it is important for them to rest. Decreasing the times they need to leave home helps in their potential recovery. CASE STUDY: COMMUNITY HEALTH STRATEGY Kenya s National Guidelines for HIV Counselling and Testing (HCT) includes home -based testing as well as workplace programmes for testing and treatment. This was developed in 2006 with the goal of improving the country s health. HCT is part of routine patient care, meaning all patients get tested and counselled. Community Health care workers do door-to-door delivery of health services (deliver medicine, check people are taking medicine, do tests and conduct TB screening). Houses are visited once a month by a community health worker or more if ailments are serious. One HCW is allocated 20 households. The country is divided into units made up of 1000 households in some regions Each unit is managed by a community HCW who provides a referral to a health facility where the person can begin treatment if they are diagnosed with HIV and be provided with adherence support. This initiative is government supported, but is reliant on scarce donor funding. The amount the Government of Kenya s proposed to pay per home-based testers was is not enough to support the livelihoods of staff. Therefore insufficient salaries or stipends lead to demotivation and attrition of community health workers and an unsustainable programme. Sustainability challenges will have to be addressed with adequate resources allocated to the programme to ensure the continued success of HIV/TB prevention, care and support. Source: Source: 57

60 INFECTION CONTROL Infection control is very important when dealing with TB. It is a practical way to stop new TB infections. Infection control can be done in a number of ways such as monitoring the hospital and clinic environment. This can be done by making sure people are not too close together or coughing on each other. One of the steps identified by civil society at South Africa s 2012 TB conference was to reduce crowding in prisons and put in place infection control measures. 98 This shows how important infection control is in fighting TB and HIV. CASE STUDY: TB TESTING IN PRISONS IN SWAZILAND It is easy for TB to spread in the prison environment, because often prisons are overcrowded and it is very easy one for TB to spread out of prisoners have TB in Swazi prisons, and 1900 per officers. TB is one of the most important opportunistic infections among inmates with HIV/AIDS Swaziland for Positive Living (SWAPOL) and Swaziland National Tuberculosis Control Programme (NTCP) are trying to get TB prevention on the Correctional Services agenda along with treatment and care programmes SWAPOL recommends all prisoners with HIV should be tested for TB. TB testing policy needs to be developed in order to establish infection control in prisons. The WHO recommends that all prisoners should be tested for TB before they enter prisons and at least annually, including when they leave prison. Sources: Health Organization, 2009, HIV testing and counselling in prisons and other closed settings. Available at: CASE STUDY: TB INFECTION CONTROL AT BUS STOPS IN SWAZILAND Bus stops and buses are another place where infection can easily spread, as people crowd closely together. SWAPOL, in collaboration with the NTCP, convened three meetings with various partners to plan the Stop TB campaign. SWAPOL conducted TB infection Control (TB IC) campaigns in 5 bus ranks around the country over 5 months. Bus conductors, drivers, travellers and people from the surrounding areas were able to access HIV HTC services and were empowered on accurate information on TB IC. 345 people got tested and were screened for TB by MSF on site. Source: 98 Smart, T. The TB activist agenda in southern Africa: more from the South African TB conference. 18 June Available at: 58

61 62 How can you be involved in helping people living with TB or to prevent the spread of TB in your area? ASSESSMENT OF NEEDS In order to assess the needs of your community you need to be aware of the issues relating to HIV and TB. Different people (age, sex, diagnosis) and different communities have different health problems and needs. Therefore, assessment of needs must be done carefully. A good way to assess the needs of your community is to go out individually or in a group and ask people questions about what their problems are, if they have HIV or TB (if they are happy to talk about this), whether they are getting the correct medicine and in the right dose, what they feel they need, what has helped them, what has not helped them, etc. You could also ask those who are receiving treatment at the clinics in your community a series of questions on HIV and/or TB. Questions could also be asked through an anonymous survey. Asking questions allows you to see the gaps within the community and enables one to identify what is still needed in the community. A needs assessment can help you decide what is most important to work towards in advocacy or what areas need to be taught in training to the community. IDENTIFICATION OF PEOPLE WHO CAN ASSIST After you have done a needs assessment, it is very important to identify who can help fill the gap(s) you have identified. These people may be community leaders, members of the municipality, NGO workers (who may have connections higher up in government and the health ministry) and media representatives (radio, newspapers, television, etc.). This involves approaching people you know who will be able to help and telling them about what you need. It may also involve getting contact details for people you do not know, meeting with them and explaining what you need. TRAINING/EDUCATION/AWARENESS RAISING AS NECESSARY Once needs have been identified, the next steps can be taken. These steps will be different for each need but may be a combination of training strategies, peer education and awareness raising. Handing out written and/or visual information or getting community radio stations to talk about the needs you have identified is a way of doing this. Always remember the problem you are trying to solve. Even though you are working towards fighting TB and/or HIV you must be clear on what exactly you are working on. Doing a needs assessment will define the most priority areas to work on. The training and awareness raising you do will be based on the needs you identified. Asking people who are experienced for help is a good way to make sure your project is successful. 59

62 TOOLS/RESOURCES Doing a needs assessment and getting into contact with people who can help means you should know what resources and tools are needed to address your community s need(s). These resources and tools take many forms and can be brochures, t-shirts, more information about new drugs, funding, etc. It is a good idea to have a group of people in charge of getting the tools and resources needed. This group can also be in charge of awareness raising and education. Having a strong team with good leadership who remember the needs you are trying to address in the community is important if you are going to get tools and resources and then use them properly. MOBILISATION (IF NECESSARY) You may need to gather support and get people together to address the needs you have identified. This is possible if you explain what you want to do in a way that is easily understood by the whole community. If you tell them why a problem needs to be fixed and how each individual and the community will benefit, you may be able to mobilise people and communities. This means people will support the idea and join together to fix the problem. ACTION This is the final stage of community involvement. Action means putting in place your plan for addressing the need and using the people you have identified to help. Again, it is important to remember the needs you are addressing, even in the action stage. It is complicated to deal with issues around HIV and TB, not only because you are dealing with diseases but because you are dealing with different sorts of people who have different reactions to these topics. Some people who may be in a position to help will not be helpful. It is important to stay positive and carry on fighting for what your community needs, even if it does not happen immediately and is not easy. 60

63 2015 HIV/TB Statistics All forms of TB HIV related TB 9.6 million new cases 9.6 million new cases (12% co-infected with HIV) 1.5 million deaths Proportion of Deaths: 16% 12% 16% 72% 1.2 million new cases 1.2 million cases (74% in Africa) 0,4 million deaths Proportion of Deaths: 33% 67% 33% One in three deaths in HIV infected individuals is due to TB. Isoniazid Preventative Therapy: IPT 3.2 million TB patients tested for hiv 0.93 million provided with IPT REST OF THE WORLD South Africa REST OF AFRICA 59% 51% (3.2 million) of TB patients had been tested for HIV, up from 40% in thousand HIV positive people were provided with IPT % (0.55) of 0.93 million recieving IPT globally were in South Africa 36.7 million people estimated to be living with HIV in Roughly one-third of these are infected with latent TB Global TB Report 2015, World Health Organisation (2015). Available at en/ 100 UNAIDS, Factsheet, TB/HIV Factsheet, World Health Organisation (2015). Available athttp://who.int/tb/challenges/hiv/tbhiv_factsheet_2015. pdf?ua=1 61

64 Isoniazid Preventative Therapy: IPT The following table represents a summary of the progress being made with regards to the integration of TB and HIV services, including the numbers of HIV positive people being screened for TB, those receiving IPT and the percent of TB patients being tested for HIV. It is important to note that while countries are making significant progress in testing TB patients for HIV, the proportions of HIV positive people screened for TB is lagging behind. The lack of data highlights challenges with the integration of TB and HIV services, and the need to further strengthen the linkage of data between the two services. It is important to note however that not all countries have adopted IPT as a national policy as per WHO recommendations, citing health facility constraints in being able to accurately and safely exclude active TB amongst other M&E constraints and health care worker shortages. Implementation of IPT in Select African Countries COUNTRY PEOPLE LIVING WITH HIV HIV-POSITIVE SCREENED FOR TB HIV-POSITIVE PEOPLE GIVEN IPT TB PATIENTS WITH KNOWN HIV STATUS BOTSWANA Data unavailable Data unavailable 91% MOZAMBIQUE 1.5 million 2014: SOUTH AFRICA 7 million 1.15 million SWAZILAND : : : : : : % 83% 97% LESOTHO Data unavailable Data unavailable 93% ZAMBIA 1.2 million Data unavailable **2008: % ZIMBABWE 1.4 million 2014: : % KENYA 1.5 million Data unavailable 2014: % * Countries included in table, with the exception of Kenya are those that participated in 2011 ARASA workshop on the 3I s ** Zambia 2008 guidelines do not recommend IPT (preliminary draft on ICF recommend IPT) Source: Tuberculosis country profiles. World Health Organisation (2016). Available at profiles/en/ 62

65 Is IPT effective? A REVIEW OF 12 TRIALS WHICH INCLUDED OVER 8000 PATIENTS FOUND: Preventive therapy (any anti-tb drug) versus placebo reduced the risk of active TB by 32% Among individuals who tested positive for the tuberculin skin test, preventive therapy reduced the risk of active TB by 62% There was no evidence of effect for individuals with a negative tuberculin skin test(tst) 102 MORTALITY One study demonstrated a reduction in mortality with INH monotherapy vs. placebo among individuals with a positive TST (26% reduction) and in 2 trials , where patients were treated with INH plus rifampicin versus placebo regardless of TST status, there was a reduction in risk of death of 31% Overall however, there was no evidence that TB preventive therapy versus placebo reduced all cause mortality A STUDY IN BOTSWANA CONDUCTED TO ASSESS THE BENEFITS OF IPT FOUND: Thirty-six months of IPT was more effective than 6 months and reduced the risk of TB disease by 56% After receiving 6-months of IPT, the protective effect of IPT reduced 6-7 months after the end of treatment Among HIV positive people who had a negative TST, 36 months of IPT reduced the risk of TB disease by 8%, combined with ART, TB risk declined by 50% IPT reduced the risk of TB disease much more among TST-positive people. 36 months of IPT reduced the risk of TB disease by 92% and by 96% when combined with ART Akolo C, Adetifa I, Shepperd S, Volmink J. Treatment of Latent Tuberculosis Infection in HIV Infected Persons (Review). 103 Rivero A, López-Cortés L, Castillo R, Verdejo J, García MA, Martínez-Marcos FJ, Díez F, Escribano JC, Canueto J, Lozano F, Pasquau J, Hernández JJ, Márquez M, Kindelán JM. A Randomized clinical trial investigating three chemoprophylaxis regimens for latent tuberculosis infection in HIV-infected patients. Enferm Infecc Microbiol Clin 2007;25(5): Whalen CC, Johnson JL, Okwera A, Hom DL, Huebner R, Mugyenyi P, Mugerwa RD, Ellner JJ, Nsubuga P, Vjecha M, Myanja H, Kityo C, Loughlin A, Milberg J, Pekovic V. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. NEJM 1997;337: The Cochrane Collaboration. Wiley Publishers Samandari, Taraz, et al. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, doubleblind, placebocontrolled trial. The Lancet (2011):

66 Why not implement IPT? 1. It s too hard to rule out active TB 2. IPT might lead to resistance 3. IPT is not needed for patients on ART 4. IPT leads to toxicities and side effects 5. The benefits of IPT do not last long 6. Health system challenges including insufficient personnel and weak M&E systems for appropriate tracking of patients and health outcomes DIFFICULTY OF TB SCREENING IN HIV-INFECTED PERSONS HIV-infected TB patients do not often show symptoms of infection. When a patient has a low CD4 count, indicative of low immunity-lesions in the lung cavity will not form, making diagnosis of TB using Chest X-ray difficult among PLHIV. Furthermore, chest X-ray is not always accessible and may be costly to patients in settings where the public system does not pay for the test. There is ongoing debate about the cost effectiveness of the use of chest X-ray tests. Up to 30% of HIV-infected TB patients with pulmonary TB have a normal chest radiograph. Sputum smears may be negative in 50% or more in PLHIV. Some patients may have difficulties coughing up secretions from their respiratory tracts (expectorate), and may need assistance using a procedure known as induced sputum in which patients are given a saline solution to inhale to loosen the sputum. It is difficult to diagnose latent TB among HIV positive people because TST is difficult to interpret as a result of limited reaction to the test. There are suggestions to use lower size cut off point to declare positive result among HIV positive individuals, however studies show limited gains by doing that. Proportion of anergy (lack of reaction to TST) was 21% greater among HIV-positive patients. However the difference in the size of TST positive results between HIV positive and negative patients was much smaller. The difference in the average size of TST positive results between HIV positive and negative patients was only 1mm. Changing the cutoff value from 10 mm to 5 mm increased the numbers of HIV-infected patients correctly identified as having active TB by 7%; Test sensitivity did not exceed 71%; therefore, TST is a test with low sensitivity. 64 Sources: Lucas SB, De Cock KM, Hounnou A, Peacock C, Diomande M, Honde M, Beaumel A, Kestens L, Kadi. A. Contribution of tuberculosis to slim disease in Africa. BMJ. 1994;308: Jones BE, Young SM, Antoniskis D, Davidson PT, Kramer F, Barnes PF. Relationship of the manifestations of tuberculosis to CD4 cell counts in patients with human immunodeficiency virus infection. Am Rev Respir Dis. 1993;148: Cobelens FG, Egwaga SM, van Ginkel T, Muwinge H,Matee MI, Borgdorff MW. Tuberculin skin testing in patients with HIV infection: limited benefit of reduced cutoff values. Clin.

67 Intensified case finding for TB? Although TB diagnosis is more complex among people who are HIV positive, symptom screening is very effective, especially among PLHIV with high CD4 counts. In a range of studies of symptom screening for tuberculosis in PLHIV, results suggested that a combination of symptoms (cough, night sweats, fever, and weight loss) correctly identified a large proportion of patients with TB. STUDIES OF SYMPTOM SCREENING FOR TB STUDY 1. SOUTH AFRICA 2. ETHIOPIA 3. CAMBODIA 4. SOUTH AFRICA SAMPLE SIZE AND SETTING 899 HIV+ gold miners-tb preventive clinic 438 HIV+ people-vct centre 441 HIV+ home-care network 129 HIV+ TB preventive trial PERCENT OF CONFIRMED TB CASES 5. CAMBODIA 496-VCT centre 6%(4% HIV+) 6. TANZANIA & BURUNDI 7. DOMINICAN REPUBLIC 8. ZIMBABWE 182 (130 HIV+) hospitalised patients 400 (200HIV+) VCT centre 4668 (874HIV+) occupational health clinic 9. SOUTH AFRICA 825 patients in 2 clinics 5% 7% 9% 9% 23%(16% HIV +) 10%(7% HIV +) 0.6%(0.3% HIV+) 522 HIV+ 9% PTB PERCENT CORRECTLY IDENTIFIED WITH TB WHEN DISPLAYING SYMPTOMS At least one symptom-75% At least one symptom-77% At least one symptom-95% At least two symptoms -100% At least one symptom 100% At least two symptoms -85% At least one symptom-85% 69% of HIV+ reported symptoms Symptom screening missed (48%) TB cases on ART and (9%) not on ART 68

68 STUDY SAMPLE SIZE AND SETTING PERCENT OF CONFIRMED TB CASES PERCENT CORRECTLY IDENTIFIED WITH TB WHEN DISPLAYING SYMPTOMS STUDIES 9,626 PLHIV 5.8% One symptom correctly identified TB cases 78.9% of the time (sensitivity) and correctly ruled out TB 49.6% of the time. (specificity) Abnormal chest x-ray (chest x-ray showing lesions or cavities) increased the proportion of patients correctly diagnosed with TB by 11.7% but a higher number of patients were incorrectly diagnosed as TB free. In areas with a higher prevalence of TB disease physicians usually clinically overdiagnose TB; hence more individuals without TB may be falsely clinically diagnosed as having TB when compared to areas with a low TB prevalence. Sources for studies on symptom screening: 69 Day JH, Charalambous S, Fielding KL, Hayes RJ, Churchyard GJ, Grant AD. Screening for tuberculosis prior to isoniazid preventive therapy among HIV-infected gold miners in South Africa. Int J Tuberc Lung Dis 2006; 10: Shah NS, Demissie M, Lambert LA, et al. Intensifi ed tuberculosis case-finding among HIVinfected persons from a voluntary counseling and testing center in Addis Ababa, Ethiopia. J Acquir Immune Defi c Syndr (in press). Kimerling ME, Schuchter J, Chanthol E, et al. Prevalence of pulmonary tuberculosis among HIVinfected persons in a home care program in Phnom Penh, Cambodia. Int J Tuberc Lung Dis 2002; 6: Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis 2004; 8: Chheng P, Tamhane A, Natpratan C, et al. Pulmonary tuberculosis among patients visiting a voluntary confi dential counseling and testing center, Cambodia. Int J Tuberc Lung Dis 2008; 12: Samb B, Henzel D, Daley CL, et al. Methods for diagnosing tuberculosis among in-patients in eastern Africa whose sputum smears are negative. Int J Tuberc Lung Dis 1997; 1: Espinal MA, Reingold AL, Koenig E, Lavandera M, Sanchez S. Screening for active tuberculosis in HIV testing centre. Lancet 1995; 345: Corbett EL, Charalambous S, Moloi VM, et al. Human immunodefi ciency virus and the prevalence of undiagnosed tuberculosis in African gold miners. Am J Respir Crit Care Med 2004; 170: Khan FA, Verkuiji S, Chikwava F. et al. Evaluation of Symptom-based Screening for TB among People Living with HIV in the Era of ART: Eastern Cape, South Africa. 20th conference of retroviruses and opportunistic infections. Abstract 851. Atlanta, Georgia. March retroconference.org/2013b/abstracts/46743.htm Getahun H, Kittikraisak W, Heilig C, Corbett EL, Ayles H, et al. (2011) Development of a standardized screening rule for tuberculosis in people living with HIV in resource-constrained settings. PLoS Med 8: e

69 Resistance & Adherence There may be concern that IPT promotes drug resistant disease and makes firstline therapy less effective when active TB occurs There is no strong evidence that IPT promotes drug resistant disease. When active TB occurs among those given IPT, standard four-drug first-line therapy works A trial of community wide IPT of South African gold miners found that the levels of INH resistance among those exposed to IPT is similar to the rest of the population. In the Thibela TB study, which includes over 27,000 South Africans working in the mining industry, retention was initially fairly low (58% after 16 months), but it has steadily improved to around 78% in the latest clusters of participants to be enrolled. 108 IN THE BOTSWANA-USA PARTNERSHIP (BOTUSA) STUDY, WHICH INCLUDED 1995 PARTICIPANTS: 109 Adherence rates of IPT were 78% at months. The rate of resistance was lower in the 36-month arm, at 14%, compared with 17% in the 6-month arm. In order to encourage adherence, subjects were asked to bring back remaining medication to every follow-up visit to conduct pill counts and explore reasons for non-adherence. Enablers were provided to study participants in order to maintain their participation in the trial. Enablers included cash (30 Pulas = US$5) for each visit as compensation for transport. Other enablers such as caps, T-shirts and participant mini-workshops for coping with HIV/AIDS were provided at significant milestones in the study. In limited resource settings such enablers may not be available through the public health system; which may reduce the adherence rates. In another study by the Tuberculosis Research Centre (TRC) in Chennai, rates of adherence were also very high. Of those randomised to IPT (36 months) 93% were judged to be taking at least 80% of their pills Balcells ME, Thomas SL, Godfrey-Faussett P, Grant AD. Isoniazid preventive therapy and risk for resistant tuberculosis. Emerg Infect Dis 2006; 12: Cattamanchi A, Dantes RB, Metcalfe JZ et al. Clinical characteristics and treatment outcomes of patients with isoniazidmonoresistant tuberculosis. Clin. Infect. Dis. 2009; 48: Van Halsema, C. L., Fielding, K. L., Chihota, V. N., et al. (2010).Tuberculosis outcomes and drug susceptibility in individuals exposed to isoniazid preventive therapy in a high HIV prevalence setting. AIDS, Churchyard G et al. Community-wide Isoniazid Preventive Therapy Does Not Improve TB Control among Gold Miners: The Thibela TB Study, South Africa. 19th Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 150aLB, Samandari T, et. Al. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. Lancet May7;377(9777): Swaminathan S et al. Efficacy of a 6-month vs a 36-month regimen for prevention of TB in HIV-infected persons in India: a randomized clinical trial. Seventeenth Conference on Retroviruses and Opportunistic Infections, San Francisco, abstract 103,

70 BOTSWANA PROGRAMME: Since the IPT programme began in 2001 up until 2007-over 71,000 HIV positive individuals were screened for TB; 67, 413 people were put on IPT; of those put on IPT only 33% completed treatment. 111 Large numbers of patients were lost to follow-up at least partly because the population is highly mobile there. 112 Other reasons cited for the failure of the programme include incompatible TB and HIV information systems, outdated TB and HIV registers, resulting in challenges with patient tracking and follow up. In addition to limited buy in by HCW, who felt the programme led to an additional work burden. 113,114 IPT does not increase resistance If an individual has latent TB, there are only a few bacteria in the lungs that will be exposed to the drug, and there is a low risk of selecting DR-TB. Most resistance comes from poor adherence to treatment of active disease, so preventing active disease will reduce resistance. 115 There is a need to closely monitor those on IPT for the development of active TB, and any potential toxicities or side-effects Motsamai OI. Isoniazid preventive therapy (IPT): Botswana experience. Stop TB Symposium, Cape Town, Suleiman K, Akugizibwe P, Mabote L. Tuberculosis Programme and Policy Analysis Report Botswana. AIDS and Rights Alliance for Southern Africa (ARASA). August Unpublished Report. 114 Isoniazid preventative therapy Programme (IPT) Evaluation Report, Ministry of Health-Botswana, This refers to the resistance that develops as a result of improper use of treatment. However a large proportion of drugresistant TB is acquired through direct infection from someone with drug-resistant TB 71

71 IPT & ART Because ART reduces the incidence of TB, some feel that IPT is no longer required. IPT and ART work together to reduce TB incidence among people with HIV. IPT has potential to retain patients in care who are HIV positive but not yet eligible for treatment, and may also encourage HIV testing. On its own, ART is known to reduce the incidence of TB by 80%. 116 Observational cohort studies in South Africa (2778 HIV-infected patients) and in Brazil (11,026 HIV infected patients ) showed that a combination of IPT to ART have additional protective effects in comparison to providing either ART or IPT alone. 117 The South African cohort study demonstrated that ART alone reduced the risk of tuberculosis by 64% and when combined with IPT the risk was reduced by 89%. 118 The Brazil cohort study which analysed the effect of ART and IPT on the incidence of TB found that ART alone was associated with a 59% reduction in tuberculosis incidence, while the use of both IPT and ART further reduced the incidence to approximately 24% in comparison to patients who were receiving neither. 119 The BOTUSA study found Among HIV positive people who had a negative TST, 36 months of IPT alone reduced the risk of TB disease by 8%, combined with ART, TB risk declined by 50%. IPT reduced the risk of TB disease much more among TST-positive people. Thirty-six months of IPT alone reduced the risk of TB disease by 92%. IPT and ART when used in combination reduced the risk of TB disease by 96% Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002; 359: Santoro-Lopes G, de Pinho AM, Harrison LH, et al. Reduced risk of tuberculosis among Brazilian patients with advanced human immunodeficiency virus infection treated with highly active antiretroviral therapy. Clin Infect Dis. 2002;34: Golub JE, Pronyk P, Mohapi L, et al. Isoniazid preventive therapy, HAART and tuberculosis risk in HIV-infected adults in South Africa: a prospective cohort. AIDS. 2009;23: Golub JE, Saraceni V, Cavalcante SC, et al. The impact of antiretroviral therapy and isoniazid preventive therapy on tuberculosis incidence in HIV-infected patients in Rio de Janeiro, Brazil. AIDS 2007;21: Samandari, Taraz, et al. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebo-controlled trial. The Lancet (2011):

72 A study conducted in a clinic in Cape Town, South Africa found that 12 months of IPT significantly reduced the incidence of all TB diagnoses among HIV-positive people who were also taking antiretroviral therapy (ART). The study found a 37% reduction in TB in the group receiving IPT compared to those who were receiving ART alone. 121 A trial conducted in Botswana between using patients from public facilities, reported 86% adherence rate among patients receiving IPT and that patients concurrently taking ART were 4.38 times more likely to remain adherent to treatment. 122 TOXICITY IPT is far less toxic than the standard first line 4 drug regimen for TB treatment (HRZE) and has far fewer interactions with ART than Rifampicin. IPT may worsen peripheral neuropathy, especially those still taking d4t, but the risk of illness and death is greater for those not taking IPT than possible side effects. Other possible side effects: nausea, rash, fever. A trial conducted in Uganda to determine the efficacy of three different regiments for the prevention of TB found no serious toxic effects were reported with 6 months of isoniazid. 123 In the Thibela study, IPT was provided to 24, 221 South African miners and it was observed that less than 1% of the study population experienced adverse events MX Rangaka et al. Randomized controlled trial of isoniazid preventive therapy in HIV-infected persons on antiretroviral therapy. Nineteenth International AIDS Conference, Washington DC, abstract THLBB03, Mosimaneotsile, Barudi; Samandari, Taraz; et al. Isoniazid Tuberculosis Preventive Therapy in HIV Infected Adults Accessing Antiretroviral Therapy: A Botswana Experience, JAIDS 54:1 May Whalen, C. C., J. L. Johnson, A. Okwera, D. L. Hom, R. Huebner, P. Mugyenyi, R. D. Mugerwa, and J. J. Ellner A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus: Uganda- Case Western Reserve University Research Collaboration. N. Engl. J. Med. 337: Grant AD, Mngadi KT,. van Halsema CL, et al. Adverse events with isoniazid preventive therapy: experience from a large trial.aids November; 24 (Suppl 5): S29 S36. doi: /01.aids

73 Cost-Effectiveness of prevention vs. treatment of TB A study looking to measure the costs and estimate the cost- effectiveness of a package of TB/ HIV interventions in primary health care facilities in South Africa found it is more cost effective to prevent TB than treat a new TB case. The cost per TB case prevented through; VCT (through preventing HIV): US$ ICF: US$ IPT: US$ The cost of treating a new case of TB: US$ The use of chest X-rays for IPT screening decreases the cost-effectiveness of IPT in preventing TB cases by 36%. 125 A study conducted in 2009 found that the cost of preventing a case of TB using screening and preventive treatment among HIV positive individuals was around $950, while the cost of treating a new smear-positive case of TB ranges between $900-$ Another study conducted in Cambodia in 2009 found that the cost per TB cases prevented through ICF was $363, while the cost per TB cases prevented through IPT was $ Hausler, Harry Peter et al. Costs of measures to control tuberculosis/hiv in public primary care facilities in Cape Town, South Africa. Bull World Health Organ [online]. 2006, vol.84, n.7, pp Is Cost-effective Option, Researchers Find.ScienceDaily. Retrieved August 20, 2013, from com /releases/2009/09/ htm 127 Sutton BS, Arias MS, Chheng P, Eang MT, Kimerling ME. The cost of intensified case finding and isoniazid preventive therapy for HIV-infected patients in Battambang, Cambodia.Int J Tuberc Lung Dis Jun;13(6):

74 A modeling study assessing the cost effectiveness of different TB screening strategies including symptom screening, sputum microscopy, and chest X-rays including different combinations of the three found: The most effective strategy was symptom screening when compared to the other strategies. Symptom screening is the most effective strategy because it achieved the highest proportion of individuals with active TB completing treatment (94%). It was cheaper to use the smear microscopy strategy as opposed to the symptom screening since the average cost of screening and treating someone either for TB or latent TB was $169 using smear microscopy, whereas the cost of using symptom screening was $325. The majority of the TB programme costs come from providing TB treatment or IPT prophylaxis. The cost of providing TB treatment is 4 times the cost of IPT, incorrectly starting TB treatment is very costly with no benefit to the patient nor the health system. The percent of people wrongly treated for TB using sputum microscopy was 1.9% while using symptom screening, 53.1% of people were wrongly treated. 128 HOW LONG DO THE PROTECTIVE BENEFITS OF IPT LAST? More evidence is accumulating for the need to provide longer duration of IPT, especially in areas with high burdens of TB and HIV with high risks of re-infection. A study in Zambia found benefits after 6 months of IPT last 3 years, whereas study in Uganda (Johnson 2001) found benefits only last 1 year. Therefore, there is a variance in data on the duration of protective benefits after being on IPT. The BOTUSA study found that longer treatment duration of IPT has a longer lasting protective effect, especially among TST positive patients-with the protective benefits of IPT with patients receiving 6 months of treatment wearing off after 6-7 months. 128 Maheswaran H, Barton P (2012) Intensive Case Finding and Isoniazid Preventative Therapy in HIV Infected Individuals in Africa: Economic Model and Value of Information Analysis. PLoS ONE 7(1): e doi: /journal. pone

75 The Thibela study, which provided 9 months of IPT had similar findings with the protective effects of IPT diminishing over time. TB incidence was reduced by 63% during the first 9 months after IPT was started, with no effects beyond 9 months. INFECTION CONTROL IN HEALTH FACILITIES TB transmission in health facilities is a big problem and patients and other health care workers are at an increased risk of infection. A review of a range of studies found that the risk of TB transmission varied across work location. The following review demonstrated that TB transmission is highest in laboratory settings, with significant nosocomial transmission also happening in other health settings. ASSOCIATION BETWEEN WORK LOCATION AND RISK OF TB 129 WORK LOCATION TB RATE IN COMPARISON TO GENERAL POPULATION Outpatient facilities General medical wards Inpatient facilities Emergency rooms Laboratories 42.5 to Joshi R, Reingold AL, Menzies D, Pai M [2006]. Tuberculosis among health-care workers in low- and middle income countries: a systematic review. PLoS Med 3(12): e494. Infection Control Measures Sources: Johnson, John L., Okwera., Hom DL.,et al. Duration of efficacy of treatment of latent tuberculosis infection in HIVinfected adults. Aids (2001): Quigley MA, Mwinga A, Hosp M, et al. Long-term effect of preventive therapy for tuberculosis in a cohort of HIV-infected Zambian adults. AIDS 2001; 15: Samandari, Taraz, et al. 6-month versus 36-month isoniazid preventive treatment for tuberculosis in adults with HIV infection in Botswana: a randomised, double-blind, placebocontrolled trial. The Lancet (2011): Fielding K, Grant A, Lewis J, et al. Individual-level effect of isoniazid preventive therapy on risk of TB: The Thibela TB study. 19th Conference on Retroviruses and Opportunistic Infections 2012, Session 41, Oral Abstracts, Number #150bLB. 76

76 Infection Control Measures The following table represents different infection control methods being implemented in health settings across the globe and the resulting benefits with regards to reduced TB transmission. The use of N95 respirators, effective triaging of patients and the rapid detection of TB among infected patients are highly effective in reducing TB transmission in health settings. SETTING ADMINISTRATIVE MEASURES PHYSICAL MEASURES ENVIRONMENT AL MEASURES EFFECT Hospital in Thailand Early TB detection and treatment Use of N95 masks by HCWs and air filters in labs Separate TB wards, ventilation, UVGI devices Drop in latent infections from 9.3% to 2.2% General medical wards Rapid diagnosis and treatment Separation of TB patients Use of N95 masks by HCWs and air filters in labs Negative pressure rooms and air filters Significantly lower rates of latent infection in comparison to other hospitals Inpatient facilities Appropriate Triage Cough etiquette and masks worn Ventilated wards, open windows, patients Significantly lower rates of TB disease Sources: Yanai H, Limpakarnjanarat K, Uthaivoravit W, Mastro TD, Mori T, et al. (2003) Risk of Mycobacterium tuberculosis infection and disease among health care workers, Chiang Rai, Thailand. Int J Tuberc Lung Dis 7: Roth VR, Garrett DO, Laserson KF, et al. (2005) A multicenter evaluation of tuberculin skin test positivity and conversion among health care workers in Brazilian hospitals. Int J Tuberc Lung Dis 9: Harries AD, Hargreaves NJ, Gausi F, Kwanjana JH, Salaniponi FM (2002) Preventing tuberculosis among health workers in Malawi. Bull World Health Organ 80:

77 Infection Control knowledge and practices among HCWs In a study in Malaysia, HCWs with TB disease were 5.9 times more likely to have poor knowledge about TB transmission, and 4.3 times more likely to be unaware of the need for respiratory protection. In a study among medical students in Brazil, although 90% were aware of the risk of TB transmission, only 46% reported the use of personal-protection measures. In a study from Thailand, although 97% of HCWs were aware of TB infectioncontrol policies, only 52% used personal- protection measures (e.g., respirators). Another study in Malawi found that failure to use personal protection was associated with a 2.6 times higher risk of TB disease among HCWs. Given the higher risk of TB transmission among health care workers, it is critical the health system provide workers with a steady supply of the personal protective measures, and it be used by all staff members. Sources: Jelip J, Mathew GG, Yusin Y, et al. (2004) Risk factors of tuberculosis among health care workers in Sabah, Malaysia. Tuberculosis (Edinb) 84: Teixeira EG, Menzies D, Comstock GW, et al. (2005) Latent tuberculosis infection among undergraduate medical students in Rio de Janeiro State, Brazil. Int J Tuberc Lung Dis 9: Luksamijarulkul P, Supapvanit C, Loosereewanich P, Aiumlaor P (2004) Risk assessment towards tuberculosis among hospital personnel: Administrative control, risk exposure, use of protective barriers and microbial air quality. Southeast Asian J Trop Med Public Health 35: Harries AD, Nyirenda TE, Banerjee A, Boeree MJ, Salaniponi FM (1999) Tuberculosis in health care workers in Malawi. Trans R Soc Trop Med Hyg 93:

78 TB ic for patients checklists Infection control measures are important as they prevent TB from entering air, ensure dirty leaves a building and put in place measures to ensure people are protected from TB, including health care workers. TB IC Checklist for facilities: Important questions to ask of your facility s Infection Control measures include: Is there a symptom checklist in place to screen patients for TB? Are the following items included in the checklist: Cough for more than 2 weeks Weight loss Night sweats for more than 2 weeks Fever for more than 2 weeks Close contact with someone with TB in the past year History of TB treatment Is there a designated area away from other patients where sputum specimens are collected? Have you been advised by a health care worker on how to produce a sputum specimen if you needed one? Does the health care worker use a respirator when retrieving the sputum specimen? Environmental Infection Control Measures There are certain environmental control measures to consider for instance: Does the facility: Have open windows on different sides of the room which allows clean air in on one side of the room and dirty air to leave the other side Have open windows on one side of the room Open vents High ceilings Possible extras if resources allow: Desk fans Ceiling fans Outdoor waiting areas Are windows: Kept open during the day Kept open during the night Kept open in the summer Kept open in the winter Kept open during the dry season Kept open during the wet season Kept open when it is windy Are fans available and put on in the facility? Are there other types of mechanical ventilation systems available in the facility (air conditioners, air extraction systems, etc.) Is there a system for ensuring the mechanical ventilation is working? Is there a maintenance plan for the mechanical ventilation systems? Are air cleaning methods used in the facility? (ultraviolet germicidal irradiation-uvgi) 79

79 Personal Respiratory Protection Are N95 respirators available? ALL people working in health facilities (including non-medical staff such as security guards, cleaners and porters) should be provided with, and educated on the importance of wearing N95 respirators to protect themselves from occupational TB. This is recommended by the World Health Organisation. All staff should be provided with fit-testing to ensure they are wearing the respirators properly. The health system must ensure that there is a stable supply of N95 respirators for all staff at all times. Patients can also be encouraged to wear paper masks to prevent germs such as TB, flu and the common cold to be spread within the facility. Patient education and awareness Have you been taught about: Signs and symptoms of TB? Cough etiquette and respiratory hygiene? Have you been given educational materials? Are posters displaying cough etiquette and respiratory hygiene displayed? Patient education is very important. People need to understand how the advice you are giving them works. As a patient, make sure you know about the services that should be made available to you. Use this checklist as a guide to assess your facility and make sure you get the essential care. 80

80 Adults and adolescents living with HIV should be screened with a clinical algorithm and those who do not have current cough, fever, weight loss or night sweats are unlikely to have active TB and should be offered IPT. (Strong recommendation) 130 Adults and adolescents living with HIV and screened with a clinical algorithm for TB and who report any one of the symptoms of current cough, fever, weight loss or night sweats may have active TB and should be evaluated for TB and other diseases (Strong recommendation) Adults and adolescents living with HIV who have an unknown or positive TST status and are unlikely to have active TB should receive at least 6 months of IPT as part of a comprehensive package of HIV care. IPT should be given to individuals irrespective of degree of immunosuppression, and also to those on ART, those who have previously been treated for TB and pregnant women. (Strong recommendation) Adults and adolescents living with HIV who have an unknown or positive TST status and who are unlikely to have active TB should receive at least 36 months of IPT. IPT should be given to such individuals irrespective of the degree of immunosuppression, and also to those on ART, those who have previously been treated for TB and pregnant women (Conditional recommendation) 131 TST is not a requirement for initiating IPT in people living with HIV (Strong recommendation) People living with HIV who have a positive TST benefit more from IPT; TST can be used where feasible to identify such individuals (Strong recommendation) Providing IPT to people living with HIV does not increase the risk of developing isoniazid (INH)- resistant TB. Therefore, concerns regarding the development of INH resistance should not be a barrier to providing IPT. (Strong recommendation) 130 A strong recommendation is one for which the panel is confident that the desirable effects of adherence to a recommendation outweigh the undesirable effects. 131 A conditional recommendation is one for which the panel concludes that the desirable effects of adherence to a recommendation probably outweigh the undesirable effects. Therefore, the recommendation is only applicable to a specific group, population or setting or new evidence may result in changing the balance of risk to benefit or the benefits may not warrant the cost or resource requirements in all settings. 81

81 Children living with HIV who do not have poor weight gain, fever or current cough are unlikely to have active TB. (Strong recommendation) Children living with HIV and who have one of the following symptoms - poor weight gain 3, fever, current cough or contact history with a TB case - may have TB and should be evaluated for TB and other conditions. If the evaluation shows no TB, such children should be offered IPT regardless of their age (Strong recommendation) Children living with HIV who are more than 12 months of age and who are unlikely to have active TB on symptom-based screening, and have no contact with a TB case should receive 6 months of IPT (10mg/kg) as part of a comprehensive package of HIV prevention and care services. (Strong recommendation) In children living with HIV who are less than 12 months of age, only those children who have contact with a TB case and who are evaluated for TB (using investigations) should receive 6 months of IPT if the evaluation shows no TB disease. (Strong recommendation) All children living with HIV who have successfully completed treatment for TB disease should receive INH for an additional 6 months (Conditional recommendation) Source: Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. World Health Organisation (2011) Available at publications/2011/ _eng.pdf 82