Isoniazid Preventive Therapy in Uganda

Transcription

1 CURRENT Ministry of Health Isoniazid Preventive Therapy in Uganda A Health Worker s Guide June

2 Any part of this document may be freely quoted, reproduced, or translated in full or in part, provided the source is acknowledged. It may not be sold or used in conjunction for commercial purposes or for profit. Government of Uganda, Ministry of Health:. Published by: Ministry of Health PO Box 7272 Kampala, Uganda Website: 2

3 FOREWORD The dramatic spread of the HIV epidemic throughout Sub-Saharan Africa in the past decades has been accompanied by up to a fourfold increase in the number of tuberculosis (TB) cases registered by national TB programs, including Uganda. Strategies to control TB must now include interventions to reduce HIV infection. It is estimated that 50 % of new adult cases of TB in Uganda are co-infected with HIV. HIV is the strongest risk factor for developing TB in those with a latent or new Mycobacterium tuberculosis infection. The risk of developing TB is between 20 to 37 times greater in people living with HIV (PLHIV) than among those who do not have the virus. TB is responsible for thirty percent of deaths among people living with HIV in Uganda. Globally, children under 15 years of age account for approximately 6 % of all TB cases and children below the age of five years are particularly at risk of developing TB disease following exposure to a person with active TB. The Ministry of Health (MoH) adopted four key interventions as part of the core components of TB prevention among PLHIV. These include: 1) intensified TB case finding (ICF) and treatment of TB among PLHIV, as it interrupts transmission by infectious cases, 2) Isoniazid preventive therapy (IPT), 3) Infection control for TB, and 4) initiation of ART early in PLHIV. Preventing TB among HIV infected persons and children under five years of age with a history of contact with a TB case should include using Isoniazid Preventive Therapy. Isoniazid Preventive Therapy is the administration of Isoniazid to individuals with a latent infection of Mycobacterium tuberculosis in order to prevent progression to an active TB disease. In PLHIV and HIV negative children under 15 years of age, the risk of developing tuberculosis is reduced by approximately 60% and their chance of survival is also increased. The Uganda national guidelines on collaborative TB/HIV activities for 2013 recommend the provision of IPT to PLHIV who are not infected with TB. The manual of the National Tuberculosis and Leprosy Program recommends IPT for children under five years of age who have had contact with a person with active TB and in whom active TB has been excluded. There is, however, no guide to enable health care workers to offer IPT to this group of people. This guide has therefore been developed to enable health care workers to offer IPT to PLHIV and children under five years of age who are exposed to TB. I would like to extend my gratitude to the Technical Working Group and the consultant for their tireless efforts in developing this guide. Furthermore, I thank the organizations that funded the process of developing this guide. It is my sincere hope that this guide will be used by health care workers to reduce the burden of TB among PLHIV and children under five years of age who have had contact with a TB case, so as to prevent development of TB and reduce the morbidity and mortality among these groups of people. Dr. Aceng Jane Ruth Director General of Health Services Ministry of Health 3

4 ACKNOWLEDGEMENTS The Ministry of Health is grateful to the following institutions and individuals that were instrumental in the development of the Isoniazid Preventive Therapy guidelines for Uganda. Special thanks go to the technical working group (TWG) that worked tirelessly during the development of this guide. The TWG, composed of 12 members, was nominated by the National Coordination Committee (NCC) and the review of the guidelines was done on behalf of the NCC Policy and Guidelines Working Group. The members from the AIDS Control Program (ACP) included: Dr. Eric Ikoona, Dr. Herbert Kadama, Dr. Hudson Balidawa, Dr. Elizabeth Namagala, Dr. Alex Ario, and Dr. Godfrey Kayita; the members from the National TB Leprosy Program (NTLP) included Dr. Eldard Mabumba, Dr. Aldo Burua, Dr. Moorine Sekadde, Dr. Daniel Mwanja, Dr. Annette Nagudi, and Mr. Shaquille Sekalala. Special thanks goes to the TB/HIV focal persons of implementing partners who participated in the technical review meetings and provided invaluable input into the document. These include Dr. Samuel Kiirya and Dr. Alex Batwaula of the Strengthening TB and AIDS Response projects in Eastern and Eastern Central Regions respectively; Dr. Yvonne Karamagi of Mild May Uganda, and Dr. Kenneth Mutesasira of the Strengthening Ugandan Systems to Treat AIDS Nationally (SUSTAIN) project. In addition, we thank Dr. Edgar Kansiime of the AIDS Control Program (ACP), Dr. Abner Tagoola, Senior Consultant Pediatrician at Jinja Regional Referral Hospital, and Ms. Oliva Namuddu of the Kalungu District Local Government who participated in the writing of this document. We also appreciate the inputs from Dr Eric Wobudeya, Pediatrician of Mulago hospital, Dr Imoko Joseph of World Health Organization (WHO) and Dr Alphonse Okwera of Mulago hospital, who reviewed and provided invaluable insight in to the document being developed. Acknowledgement also goes to Dr. Alex Opio, the Assistant Commissioner and Chair of the NCC, who effectively guided both the NCC and the TWG through the process of developing the guidelines. Drs. Frank Mugabe and Joshua Musinguzi, the Program Managers of the NTLP and ACP, and also the cochairs of the NCC, are thanked for taking off time to proof read the proposed guidelines. The NCC members, specifically Dr. Eric Ikoona and Dr. Alex Ario of ACP; Dr. Eldard Mabumba, Dr. Aldo Burua, Dr. Moorine Sekadde, Mr. Shaquille Sekalala of NTLP; Mrs. Barbara Muwonge of the SURE program; Dr. Isaac Lwanga of the Infectious Disease Institute; Dr. Joseph Imoko of the World Health Organization; Drs. Martin Ruhweza, Henry Luwaga, and Mary Mudiope of Management Sciences for Health s TRACK TB project; Dr. Anna Nakanwagi of International Union Against TB and Lung Diseases; Dr. Kaggwa Nswemu of Uganda Prisons Services; Abdul Sessolo Abdul of RTI; Dr. Seyoum Dejene of the United Stated Agency for International Development; and Alex Menyha from the private sector are thanked for initiating the idea of developing the IPT guidelines, appointing the TWG, and for diligently reviewing the working document and suggesting modifications that led to the production of the guidelines. Special thanks go to Dr. Eric Ikoona, Dr. Herbert Kadama, Dr. Aldo Burua and Dr. Moorine Sekadde for leading the process of developing the IPT guidelines, incorporating the suggested comments and editing the document before finalizing. A special recognition goes to the TRACK TB project and the SURE project for funding the development of this guide. Last but not least, the Communicable Disease Control Technical Working Group of the Ministry of Health and Senior Management MoH are thanked for their invaluable contributions in critically reviewing and making the final edits that led to the production of the Isoniazid preventive therapy guidelines for Uganda. 4

5 ACRONYMS AIDS ACP ART HCT HIV ICF IEC IPT IRIS MDR TB M&E MoH NTLP PLHIV STIs TB TST TWG WHO Acquired Immune Deficiency Virus AIDS Control Program Anti-retroviral Therapy HIV Testing and Counseling Human immune deficiency Virus Intensified Case Findings Information, Education and Communication Isoniazid preventive therapy Immune Reconstitution Inflammatory Syndrome Multi Drug Resistant Tuberculosis Monitoring and Evaluation Ministry of Health National TB Leprosy Program People Living with HIV Sexually Transmitted Infections Tuberculosis Tuberculin Skin Test Technical working group World Health Organization 5

6 TABLE OF CONTENTS ACRONYMS... 5 GLOSSARY OF TERMS SUMMARY ACTION POINTS IN THIS GUIDE INTRODUCTION TO THIS GUIDE Background Why this Guide? What is the Purpose of this Guide? What are the Objectives of this Guide? Who Can Use this Guide? What is the Use of this Guide? What is the Structure of this Guide? ISONIAZID PREVENTIVE THERAPY Exclusion of Active Tuberculosis Who is eligible for TB screening in order to receive Isoniazid preventive therapy? Isoniazid preventive therapy screening in PLHIV Screening in HIV negative children under five years of age with a history of contact with a patient with active TB disease Eligibility for Isoniazid Preventive Therapy People living with HIV HIV negative children under five years of age with a history of contact with a patient with active TB disease Isoniazid Preventive Therapy in HIV Positive Pregnant Women Isoniazid Preventive Therapy and ART Isoniazid Preventive Therapy in Patients Previously Treated for TB What are the Contraindications for Isoniazid Preventive Therapy? Recommended Dose Duration

7 3.6 What are the Side Effects of Isoniazid Preventive Therapy? When and How to Start Isoniazid Preventive Therapy? When to start Isoniazid Preventive Therapy? How to Start Isoniazid Preventive Therapy General preparation for all patients starting on Isoniazid Preventive Therapy Follow-Up Frequency What to do during follow-up visits? Isoniazid Preventive Therapy Interruptions When to Stop Isoniazid Preventive Therapy? What Should be Done When a Patient is on Isoniazid Preventive Therapy and is Suspected of Having or is Diagnosed with TB Disease Indicators for Monitoring Implementation of IPT Annexes Annex 1: Screening tool for TB in PLHIV Annex 2: TB screening and Isoniazid Preventive Therapy Algorithm for Adults and Adolescents Annex 3: TB screening and Isoniazid Preventive Therapy Algorithm for Children 12 Months and Above Annex 4: Intensified Case Finding Form Annex 5: INH dosing by weight band BIBLIOGRAPHY

8 GLOSSARY OF TERMS Term Active Tuberculosis Child Current Cough Eligibility Gene Expert Isoniazid Preventive Therapy MDR TB People Living With HIV Poor Weight Gain TB Completion Presumed TB Tuberculosis Skin Test Close TB Contact Household TB Contact Patient's Readiness Index Case Working Definition A person with symptoms and signs suggestive of tuberculosis and found to have the disease (through investigations or clinically) A person under 15 years A person with a cough for 24 hours or more A person who meets the criteria to be offered Isoniazid Preventive Therapy A WHO-approved cartridge-based rapid diagnostic test that uses a molecular technique to simultaneous detect Mycobacterium tuberculosis (MTB) and Rifampicin resistance in a patient The administration of a medicine called Isoniazid to individuals with a latent infection of Mycobacterium tuberculosis in order to prevent progression to active TB disease. TB that is resistant to at least Isoniazid and Rifampicin Children, Adolescents and Adults infected with the HIV virus in their body A child with reported weight loss, very low weight for age, underweight, confirmed weight loss of more than five% of their body weight since the last visit, or a flattened growth curve A TB patient who completed treatment without evidence of failure, but with no record to show that sputum smear or culture results in the last month of treatment and at least one previous occasion were negative, either because tests were not done or because results were unavailable. A person with symptoms suggestive of the TB disease A skin test to determine past or present infection with the tuberculosis bacterium, based on the reaction on the skin due to the tuberculin test A person who is not in the household but shared an enclosed space, such as a social gathering place, workplace, or facility, for extended periods during the day with the index case (initially identified case) during the three months before the commencement of the current treatment episode. A person who shared the same enclosed living space for one or more nights or for frequent or extended periods during the day with the index case (initially identified case) during the three months before the commencement of the current treatment episode. A patient has been assessed, counseled, and agrees to take Isoniazid preventive therapy The initially identified case of new or recurrent TB in a person of any age in a specific household or other comparable setting in which others may have been exposed. 8

9 1.0 SUMMARY ACTION POINTS IN THIS GUIDE 1. Adults and adolescents living with HIV should be screened for TB using the four symptom screening tool for TB in PLHIV. Those who do not report any one of the symptoms of current cough, fever, weight loss, or night sweats are unlikely to have active TB. And those unlikely to have active TB upon screening should be offered Isoniazid preventive therapy. 2. Adults and adolescents living with HIV who report any one of the symptoms of current cough, fever, weight loss, or night sweats may have active TB. These individuals should be evaluated for TB and other diseases. 3. Adults and adolescents living with HIV who are unlikely to have active TB should receive at least six months of Isoniazid Preventive Therapy (IPT). This should be irrespective of: The degree of immune suppression, Whether the patient is on art or not, Whether the patient has previously been treated for TB or not, and Whether the patient is pregnant or not. 4. Adults and adolescents living with HIV who have successfully completed treatment for TB disease should receive Isoniazid for an additional six months. 5. A Tuberculin Skin Test (TST) is not a requirement for initiating IPT in PLHIV. 6. PLHIV who have a positive TST benefit more from IPT. TST should be used where feasible to identify such individuals. 7. Providing IPT to PLHIV does not increase the risk of developing isoniazid resistant TB. Therefore, concerns regarding the development of Isoniazid resistance should not be a barrier to providing IPT. 8. Children living with HIV who do not have any one of the following symptoms: poor weight gain, fever, or current cough is unlikely to have active TB. 9. Children living with HIV who have any one of the following symptoms: poor weight gain, fever, current cough or contact history with a TB case may have TB. These children should be evaluated for TB and other conditions. If the evaluation shows no TB, such children should be offered IPT regardless of age. 10. Children living with HIV who are more than 12 months of age: For those who are unlikely to have active TB and have no contact with a TB case should receive six months of IPT (10 mg/kg/day). 9

10 11. Children living with HIV who are less than 12 months of age (infants): This group should only receive IPT if there is a history of contact with a TB case and they have no active TB. 12. All children living with HIV who have successfully completed treatment for TB disease should receive Isoniazid for an additional six months. 13. All HIV negative children under five years: Those who have a history of contact with a TB case should be screened for active TB using the Intensified TB Case Finding Guide. Those who have no symptoms and signs suggestive of active TB should receive six months of IPT. 10

11 2.0 INTRODUCTION TO THIS GUIDE 2.1 BACKGROUND The dramatic spread of the HIV epidemic throughout Sub-Saharan Africa in the past decades has been accompanied by up to a fourfold increase in the number of TB cases registered by national TB programs, including Uganda. It is estimated that 50 % of new adult cases of tuberculosis in Uganda are co-infected with HIV 1. Strategies to control tuberculosis must now include interventions to reduce HIV infection. Globally, children under 15 years of age account for approximately 6 % of all TB cases and children under five years are particularly at risk of developing TB disease following exposure to a person with active TB. HIV is the strongest risk factor for developing TB disease in those with a latent or new Mycobacterium tuberculosis infection. The risk of developing TB is between 20 to 37 times greater in people living with HIV (PLHIV) than among those who do not have HIV infection 2 ; TB is responsible for 30 percent of deaths among PLHIV in Uganda 3. Preventing tuberculosis among HIV infected persons and children under five years of age with a history of contact with a TB case should include Isoniazid Preventive Therapy (IPT). Isoniazid Preventive Therapy is the administration of a medicine called Isoniazid to individuals with latent infection of Mycobacterium tuberculosis in order to prevent progression to an active TB disease. In People Living with HIV and children under 15 years of age, the risk of developing tuberculosis is reduced by approximately 60 percent and the chance of survival is also increased. 2.2 Why this Guide? The Ministry of Health (MoH) adopted four key interventions as part of the core components of TB prevention among PLHIV. These include: 1. Intensified case finding (ICF) and treatment of TB among PLHIV as it interrupts transmission by infectious cases, 2. Isoniazid preventive therapy, 3. Infection control for TB, and 4. Initiation of anti-retroviral therapy (ART) early in PLHIV. The Uganda national guidelines on collaborative TB/HIV activities for 2013 provide for Isoniazid preventive therapy. The manual of the National Tuberculosis and Leprosy Program recommends IPT for children under five years of age who have had contact with a person with active TB and in whom active TB has been excluded. There is, however, no guide to enable health care workers to offer IPT to PLHIV and children under five years of age who are eligible. 1 Global Tuberculosis Report WHO Guidelines for intensified tuberculosis case-finding and Isoniazid preventive therapy for PLHIV in resource constrained settings 3 Uganda national guidelines on collaborative TB/HIV activities

12 Therefore, this guide has been developed to enable health care workers to offer IPT to: People living with HIV, and Children under five years of age with a history of contact with a patient with active TB disease. 2.3 What is the Purpose of this Guide? The purpose of this guide is to provide step-by-step guidance for health workers on the use of Isoniazid preventive therapy. 2.4 What are the Objectives of this Guide? The guide focuses on five specific objectives: 1. To provide guidance to health workers on how to screen for active TB among PLHIV 2. To help health workers assess for contraindications to IPT 3. To help health workers assess patients willingness and readiness to take IPT 4. To help the health workers initiate IPT to PLHIV without active TB 5. To guide health workers on how to initiate IPT for children under five years of age with a history of contact with a patient with active TB disease. 6. To guide the health workers on how to monitor patients on IPT 2.5 Who Can Use this Guide? This guide has been designed for medical officers, clinical officers, nurses, midwives, pharmacists and dispensers, and any other health care worker providing care for PLHIV and eligible HIV negative children under five years of age. 2.6 What is the Use of this Guide? This guide can be used as a job aide or reference guide for training, health education, and research. 2.7 What is the Structure of this Guide? The guide is divided into the following four sections: 1) Summary Action Points of this Guide, 2) Introduction to the Guide, 3) Isoniazid Preventive Therapy and Health Services, and 4) Annexes. 12

13 3.0 ISONIAZID PREVENTIVE THERAPY Isoniazid preventive therapy has become part of the package of care for PLHIV. Isoniazid preventive therapy among PLHIV should only be offered if the following prerequisites have been met: HIV counseling and rapid testing is available, Patients are screened for active TB disease before initiation of IPT, Providers follow-up and monitor patients monthly to encourage adherence, address side effects, and ensure active TB disease is not present, Providers use quality improvement approaches to initiate and roll out IPT, The HIV clinical team takes responsibility for implementing IPT, and There is strong collaboration between HIV and TB clinical teams in the facility. 3.1 Exclusion of Active Tuberculosis Who is eligible for TB screening in order to receive Isoniazid Preventive Therapy? All PLHIV should be regularly screened for TB wherever and whenever they receive care using the screening tool for TB in PLHIV (Annex 1). Children under five years of age with a history of close or household contact with a TB patient should be screened for TB using the Intensified TB Case Finding Guide (Annex 4). Screening for TB Is important regardless of whether patients have received or are receiving IPT. Is important regardless of whether or not patients are receiving ART. Is essential in order to exclude active tuberculosis in every PLHIV or child under five years with a history of contact with a TB patient prior to starting preventive therapy. Is critical in order to avoid giving one anti-tuberculosis drug to patients with TB disease who require a full treatment regimen Isoniazid Preventive Therapy screening in PLHIV IPT screening in adolescents and adults living with HIV Prior to initiation of IPT, adults and adolescents living with HIV (including pregnant women) should be screened for the following signs and symptoms of active TB disease: Current cough (cough within 24 hours or more) Fever Weight loss Profuse night sweats (more than usual sweating) 13

14 Isoniazid preventive therapy screening in children living with HIV For children living with HIV, only those who are more than 12 months of age should be routinely given IPT after excluding active TB disease. For children living with HIV who are below 12 months of age, only those with a history of household or close contact with a TB patient should be given IPT after excluding active TB disease. Children living with HIV should be screened for active TB disease with any one of the following symptoms: Poor weight gain (reported weight loss, very low weight for age, underweight, confirmed weight loss of more than five% since the last visit, growth curve flattened, or mid-upper arm circumference [yellow or red measurements]) Fever Current cough Contact history with an active TB case or a person with a chronic cough (cough lasting for more than two weeks) Screening in HIV negative children under five years of age with a history of contact with a patient with active TB disease HIV negative children under five years of age with a history of contact with a patient with active TB should be screened for active TB looking for any one of the following symptoms: Poor weight gain in the last one month (reported weight loss, very low weight for age, underweight for age, confirmed weight loss more than five percent since the last visit, or growth curve flattened, mid-upper arm circumference [yellow or red measurements]) Fever for two or more weeks Cough for two or more weeks 3.2 Eligibility for Isoniazid Preventive Therapy People living with HIV People living with HIV showing no symptoms suggestive of active TB are eligible for IPT. This is because of the high prevalence of TB infection in Uganda. Children living with HIV who are less than 12 months of age should not be given IPT unless there is a history of contact with a TB case and active TB disease has been ruled out HIV negative children under five years of age with a history of contact with a patient with active TB disease All HIV negative children under five years of age who have a history of contact with a patient with active TB disease should receive IPT for six months. Active TB disease should be excluded before giving them IPT. 14

15 Tuberculin Skin Test (TST) Tuberculin skin test is not a requirement for initiating IPT in Uganda. However, where TST s are feasible and can be performed, the test results should guide provision of IPT; PLHIV who have a positive TST benefit more from IPT. Key message All PLHIV with no symptoms suggestive of active TB disease are eligible for IPT Children living with HIV who are less than 12 months of age are eligible to receive IPT only when they have a history of contact with a TB case and active TB has been ruled out. All HIV negative children under five years of age with a history of contact with a patient with active TB are eligible for IPT (once active TB disease has been excluded) Isoniazid Preventive Therapy in HIV Positive Pregnant Women The benefits of TB preventive therapy for eligible pregnant women outweigh the risks. Active TB during pregnancy is associated with spontaneous abortions, and adverse peri-natal outcomes. Ten percent of maternal deaths in Africa are due to TB/HIV co-infection. Isoniazid Preventive Therapy is not contraindicated in pregnancy and it can be given during any trimester. Isoniazid Preventive Therapy should be completed even if the woman becomes pregnant while on the medicine. Key message Isoniazid preventive therapy is not contraindicated in pregnancy. It can be given during any trimester Isoniazid Preventive Therapy and ART ART dramatically reduces the risk of TB. However, patients on ART are still at increased risk of developing TB compared to HIV-negative people. The risk of developing TB is highest in the first six months after initiating ART. It often manifests itself as an immune reconstitution inflammatory syndrome (IRIS). It is therefore important to screen for TB before initiating ART and to assess for TB at every clinic visit. Isoniazid preventive therapy can be provided to PLHIV together with ART and this therapyshould not be stopped because the patient has been started on ART. Key message IPT can be provided to PLHIV together with ART after excluding active TB disease. 15

16 3.2.5 Isoniazid Preventive Therapy in Patients Previously Treated for TB People living HIV who successfully complete their TB treatment should immediately receive IPT for six months. It has been shown that PLHIV who receive IPT immediately after completion of TB treatment have less risk of TB recurrence and mortality. Key message PLHIV who successfully complete their TB treatment should immediately receive IPT for six months 3.3 What are the Contraindications for Isoniazid Preventive Therapy? Patients with symptoms of TB and those with active TB Patients on TB treatment PLHIV previously treated for MDR-TB Known or suspected hypersensitivity to Isoniazid Self-reported chronic liver disease or symptoms suggesting active hepatitis (jaundice, right upper quadrant pain, dark urine, pale stools) Alcoholic (regular or heavy alcohol consumption) History of convulsions (excludes febrile convulsions in children) History of psychosis Moderately severe peripheral neuropathy (burning sensations of the limbs) Concomitant medication: phenytoin, carbamazepine, warfarin, theophylline, disulfiram, selective serotonin re-uptake inhibitor, antidepressants (e.g. citalopram, fluoxetine, paroxetine, sertraline), oral ketoconazole, or itraconazole. Key message PLHIV who have: active TB, hypersensitivity to Isoniazid, liver disease, chronic alcohol use, mental disease, peripheral neuropathy, and drugs that cause liver toxicity should not be given IPT 3.4 Recommended Dose The recommended dose for IPT is: Adults: Isoniazid 5 mg/kg/day (maximum 300 mg per day) Children: Isoniazid 10 mg/kg/day (maximum 300 mg per day). Refer to annex 5 Vitamin B6 (pyridoxine): 25 mg per day should be given concomitantly with Isoniazid for the duration of therapy, to prevent the occurrence of peripheral neuropathy. 3.5 Duration The recommended duration of IPT is six months of continuous treatment. 16

17 Note IPT should be given as one six month course. 3.6 What are the Side Effects of Isoniazid Preventive Therapy? Common side effects: dizziness, dark urine, loss of appetite, nausea and vomiting, numbness, tingling and burning sensation, unusual fatigue, yellow eyes or skin Uncommon side effects: blurred vision, loss of vision, convulsions, fever and sore throat, joint pain, mood changes, skin rash, unusual bleeding or bruising 3.7 When and How to Start Isoniazid Preventive Therapy? When to start Isoniazid Preventive Therapy? When a patient has been screened and active TB disease has been ruled out Key message When contraindications to Isoniazid have been ruled out When the patient is well counseled and ready to start Isoniazid Preventive Therapy Start IPT only when active TB disease and contraindications to Isoniazid have been ruled out How to Start Isoniazid Preventive Therapy General preparation for all patients starting on Isoniazid Preventive Therapy The health workers should use the five A's to prepare patients for IPT: o o o o Assess for: signs and symptoms of active TB other medications signs and symptoms of chronic liver disease, peripheral neuropathy, or mental disease heavy and regular alcohol use Advise Give information about benefits of IPT, side effects, and regimen and duration of Isoniazid in preparation for self-management. This includes treatment advice and counseling Agree Ensure patient understands, wants, and agrees to IPT treatment plan. This is the basis for forming a partnership with the patient and supporting good patient self-management while on IPT. Assist Support the patient to adhere to IPT and overcome barriers; however, patients on ART already have treatment supporters who will offer added benefit for adherence. 17

18 o Arrange Prepare follow-up visits once every month Record initiation date in the HIV care/art card, pre-art and ART registers, as well as IPT register for HIV negative children under five years of age Record appointments in the appointment book Necessary linkages and referrals 3.8 Follow-Up Frequency Patients on IPT will be reviewed after two weeks of initiating treatment to assess for any side effects and reinforce adherence Thereafter, patients on IPT should be followed up with on a monthly basis What to do during follow-up visits? Assess for any contraindications to IPT Screen for symptoms of TB disease Look out for adverse effects of Isoniazid Assess adherence and categorize as good, fair, or poor Record prescription and dispensing at every visit Reinforce adherence messages 3.9 Isoniazid Preventive Therapy Interruptions Patients who interrupt IPT should be handled according to the duration of interruption. If the patient interrupts treatment for one month or less, then counsel and reassure the patient to continue IPT. If the patient interrupts treatment for more than one month, then reassess, rule out active TB, and seek patient s consent and cooperation before restarting treatment When to Stop Isoniazid Preventive Therapy? IPT should be discontinued when: Symptoms of TB are present. In such a situation, investigate to rule out active TB Patient develops active TB Severe adverse effects: yellow eyes, fever, severe tingling and burning sensation, blurred vision, loss of vision, convulsions, or unusual bleeding 3.11 What Should be Done When a Patient is on Isoniazid Preventive Therapy and is Suspected of Having or is Diagnosed with TB Disease Stop IPT Evaluate for TB disease If the patient is confirmed to have TB disease, then counsel and initiate on standard first line TB regimen as recommended by the National TB and Leprosy Program 18

19 3.12 Indicators for Monitoring Implementation of IPT The following indicators will be used for monitoring implementation of IPT: 1. Proportion of PLHIV who are eligible for IPT and are receiving it. Data source: HIV care card and register 2. Proportion of children under five years of age who are contacts of TB patients on treatment that are screened for active TB. Data source: Health unit TB register 3. Proportion of children under five years of age who are contacts of TB patients that are eligible for IPT and are receiving it. Data source: IPT register for under five year old children 19

20 4.0 Annexes Annex 1: Screening tool for TB in PLHIV Ministry of Health SOP: SCREENING TOOL FOR TB IN PLHIV This SOP guides health workers on how to: screen for active TB in PLHIV offer Isoniazid preventive therapy to those without symptoms of active TB STEP 1: The health care worker conducting the assessment asks the patient the following questions: A). FOR ADOLESCENTS AND ADULTS S/n Symptoms Yes (tick) No (tick) 1. Have you been coughing within the last 24 hours or more? 2. Do you have fever? 3. Have you lost weight? 4. Have you experienced profuse night sweats (sweating more than usual)? B) FOR CHILDREN UP TO 15 YEARS S/n Symptoms Yes (tick) No (tick) 1. Has the child been coughing within the last 24 hours or more? 2. Does the child have history of fever? 3. Does the child have weight loss or poor weight gain? Has the child had contact with an adult with active TB disease or chronic cough 4. (cough more than 2 weeks)? *The health care worker is encouraged to always conduct both physical examination and investigations for TB 20

21 ACTION POINTS: If the answer is Yes to any of the questions above, then: DO NOT GIVE Isoniazid preventive therapy. investigate further for possible active TB disease If the answer is No to all of the questions above, then go to Step 2 STEP 2: Assess for contraindications to Isoniazid preventive therapy S/n Contraindication Yes 1. Has the patient got known or suspected hypersensitivity reaction to Isoniazid? Symptoms may include: difficulty in breathing, swelling of the lips, tongue or face (tick) No (tick) 2. Has the patient got any symptoms of active hepatitis? Symptoms may include: jaundice, nausea, vomiting, right upper abdominal pain, dark urine, pale stools 3. Is the patient an alcoholic (regular or heavy alcohol consumption)? 4. Does the patient have history of convulsions? (excluding febrile convulsions) 5. Does the patient have history of mental illness? 6. Does the patient have peripheral neuropathy (burning sensation in the limbs)? 7. Is the patient currently taking any of the following medications: oral Ketoconazole, Itraconazole. Phenytoin, Carbamazepine, Warfarin, Theophylline, Disulfiram, selective serotonin re-uptake inhibitor antidepressants (e.g. Citalopram, Fluoxetine, Paroxetine, Sertraline) ACTION POINT: If the answer is Yes to any of the questions above, then: DO NOT GIVE Isoniazid preventive therapy, re-assess patient after 3 months. Investigate further for cause where feasible or refer If the answer is No to all the questions above then go to Step 3. STEP 3: Assess patient's readiness to start Isoniazid preventive therapy S/N Question Yes (tick) No (tick) 1. Does the patient show readiness to start Isoniazid preventive therapy? 21

22 ACTION POINT: Initiate If the answer is Yes to the above question, then start the patient on Isoniazid preventive therapy If the answer is No to the above question, then reassess patient during the next visit (starting from STEP 1). STEP 4: Recording of information above Record this information in the HIV/ART care card; this information should then be transferred to the pre- ART or ART register. 22

23 Annex 2: TB screening and Isoniazid Preventive Therapy Algorithm for Adults and Adolescents TB Screening and Isoniazid Preventive Therapy algorithm for Adults and Adolescents Adults and adolescents living with HIV Screen for TB with any one of the following symptoms: current cough, fever, weight loss, profuse night sweats (sweating more than usual) NO YES Assess for contraindications to Isoniazid preventive therapy* Investigate for TB and other diseases NO YES Other Diseases Not TB TB Give Isoniazid preventive therapy Defer Isoniazid preventive therapy Appropriate Rx & consider Isoniazid preventive therapy Follow up and consider Isoniazid preventive therapy Treat for TB Screen for TB at every clinic visit * refer to section 3.3 on contraindications for Isoniazid preventive therapy 23

24 Annex 3: TB screening and Isoniazid Preventive Therapy Algorithm for Children 12 Months and Above TB screening and Isoniazid preventive therapy algorithm for children 12 months and above Children 12 months old and above, living with HIV Screen for TB with any one of the following symptoms: current cough, fever, poor weight gain, contact history with a TB case, or a person with a chronic cough (cough more than two weeks) Yes No Assess Isoniazid preventive therapy Contraindications* Investigate for TB and other diseases NO YES Other diseases Not TB TB Give Isoniazid preventive therapy Defer Isoniazid preventive therapy Appropriate Rx & consider Isoniazid preventive therapy Follow up and consider Isoniazid preventive therapy Treat for TB Screen for TB at every clinic visit 24

25 Annex 4: Intensified Case Finding Form Ministry of Health Intensified TB Case Finding Guide Use the guide to identify presumptive TB: In HIV Clinic, OPD, IPD and Congregate settings This guide should be administered by either a health care provider or lay provider at the health facility. STEP 1: The person conducting the assessment asks the following questions: 1. Has the patient been coughing for 2 weeks or more? (for known HIV patients assess cough regardless of duration) 2. Has the patient had persistent fevers for 2 weeks or more? Yes No 3. Has the patient had noticeable weight loss (more than 3 kg) Yes No 4. Has the patient had night sweats for 3 weeks or more? Yes No Has the child had poor weight gain in the last one month *? (ask for children < 5 years) Has the child had contact with an adult with Pulmonary Tuberculosis or chronic cough? (ask for children < 5 years) *poor weight gain (weight loss, or very low weight (weight-for-age less than 3 z-score), or underweight (weight-for age less than 2 z-score), or confirmed weight loss (>5%) since the last visit, or growth curve flattening) Yes Yes Yes No No No STEP 2: Guide for actions to take If yes to question 1, request for sputum test and refer to clinician for further investigations. Direct the patient to a designated area for people with chronic cough. If no to question 1 and yes to any other question, refer to clinician for further investigations If no to all questions: repeat TB assessment at subsequent visits *For children who are unable to produce sputum, refer to clinician for further investigations STEP 3: Record of information at health facility level 1. If you are in a clinic attending to patients enrolled in HIV care, record this information on the comprehensive ART card; this information should then be transferred to the pre-art or ART register. 2. If you are in any HIV care setting (not attending to patients enrolled in HIV care, e.g. OPD) and presumptive TB case is found, record the information in a presumptive TB register. 25

26 Annex 5: INH dosing by weight band kg kg kg kg kg 25 INH 100 mg (tablet) INH 300 mg (tablet) 1 26

27 5.0 BIBLIOGRAPHY 1. Global Tuberculosis Report WHO Guidelines for Intensified Tuberculosis Case-Finding and Isoniazid Preventive Therapy for PLHIV in Resource Constrained Settings, Uganda National Guidelines on Collaborative TB/HIV Activities, Uganda Health Policy Manual of the National Tuberculosis and Leprosy Control. Second edition, WHO Guidance for National Tuberculosis Programs on the Management of Tuberculosis in Children. Second edition,