The HIV Program UNIT 2 HIV CURRICULUM PARTICIPANT S MANUAL

Transcription

1 T F A R D UNIT 2 The HIV Program

2 UNIT 2 BACKGROUND The HIV Program Poverty and lack of access to basic human rights such as adequate nutrition compound the devastating effects of HIV on communities. Comprehensive HIV care addresses these factors by combining effective diagnosis and treatment of HIV with patient education, daily accompaniment and adherence support, and nutritional and other social support. GOAL OF THE UNIT In this unit, participants will learn how to provide comprehensive HIV care to non-pregnant adult HIV-positive patients by conducting an initial evaluation of newly diagnosed HIVpositive patients, by determining when they should start antiretroviral therapy (ART), and by providing continuous patient monitoring. Consult Unit 5 for more information about caring for HIV-positive pregnant patients. Participants will also examine the roles of clinicians, social workers and community health workers in helping the patient adhere to treatment and obtain nutritional and other social support. 1

3 GENERAL OBJECTIVES By the end of the unit, you will be able to: 1. Describe the epidemiology of HIV/AIDS in the country. 2. Describe the different components of the HIV Program. 3. Describe the roles of the clinician, social worker, and community health worker in the HIV Program. 4. Conduct an initial medical evaluation of a new HIV-positive patient. 5. Initiate cotrimoxazole prophylaxis. 6. Use CD4 cell counts and WHO Clinical Staging to determine if ART should be started. 7. Choose an appropriate ART regimen. 8. Conduct monitoring visits for patients on ART and not yet on ART, and describe the monitoring visit schedule. 9. Evaluate patient adherence to ART and describe strategies for increasing adherence to ART and clinic visits. 10. Monitor a patient s response to ART. 11. Identify and manage side effects caused by antiretroviral drugs (ARVs). 12. Complete the enrollment form, follow-up form, and summary form accurately. When you see this icon, check the information to make sure it is up to date. (This includes all protocols, algorithms, treatments, and statistics which are subject to change.) 2

4 PART 1 Introduction to Unit 2 Review of Epidemiology In 2008, according to data published by WHO, UNAIDS, and UNICEF, HIV/AIDS was affecting the population of Rwanda (9.7 million inhabitants in total) in the following ways: Adults Estimated prevalence in adults aged 15 to 49: 2.8% [2.4% - 3.2%] Estimated number of adults aged 15 and up living with HIV: Estimated number of women aged 15 and up living with HIV: Estimated number of men aged 15 and up living with HIV: Children Estimated number of children aged 0 to 14 living with HIV: Estimated number of orphans due to AIDS aged 0 to 17: Treatment Estimated percentage of people who need antiretroviral therapy who are receiving it: 71% Source: WHO, UNAIDS, UNICEF. Epidemiological Fact Sheet on HIV and AIDS. Rwanda. October 2008 KEY POINT HIV/AIDS is a common disease in the country that affects people of all ages. 3

5 Overview of the HIV Program The HIV Program ensures that HIV-positive patients receive the care they need to lead healthy and productive lives. Clinicians, social workers, and community health workers must work together to ensure that HIV-positive patients enrolled in the HIV Program STAY in the program long-term. The HIV Program provides: 1. Effective management of HIV infection and opportunistic infections 2. Daily accompaniment and adherence support 3. Nutrition and other social support 4. Patient education and prevention counseling The clinical team provides these services through three central activities: 1. Initial evaluation of the new HIV-positive patient 2. Early introduction of antiretroviral therapy and other therapies 3. Continuous monitoring of HIV-positive patients The HIV Program chart below shows the services offered in the HIV Program and the different roles of health care providers. Once a patient is diagnosed with HIV and enrolled in the program, the first step is to conduct an initial evaluation. An important part of this step is to determine whether the patient should start ART. The second step consists of starting ART (and other therapies) for those who require it. The third step is to provide continuous monitoring of the patient. Different health care providers play complimentary roles within each step: The clinician provides regular medical care to the patient from the initial evaluation onwards according to a specific schedule and coordinates the care of the patient with other health care providers. The community health worker ensures that the patient adheres to the system of care by delivering the patient s medication every day and tracking patients who do not show up for their regular appointments at the clinic, by monitoring the patient s health, and by providing psychological support. The social worker is responsible to initially evaluate the potential psychosocial barriers that might affect the patient s capacity to adhere to the system of care and to provide ongoing psychosocial support through individual counseling, support groups, and referrals to social programs. One of the aims of the HIV Program is to provide psychosocial support to patients so they can lead a productive and dignified life. It is the responsibility of all members of the clinical team: the clinician, the community health worker, and the social worker, to assess and monitor for changes in the patient s psychosocial situation so assistance can be provided when it is needed. 4

6 HIV Program Chart (For Non-Pregnant Adults) CLINICIAN COMMUNITY HEALTH WORKER SOCIAL WORKER Initial Evaluation Starting ART Continuous Monitoring for patients on ART Perform a thorough patient history and physical exam Order baseline laboratory tests Determine whether ART and other therapies should be started Provide patient education and prevention counseling Fill out enrollment form, patient visit card, and community health worker treatment form Complete a psychosocial evaluation to ensure that the patient has social support before starting ART Evaluate nutritional status and initiate nutritional support if indicated Initiate cotrimoxazole prophylaxis Provide pre-art education Order and analyze pre-art laboratory tests Initiate ART Conduct regular visits with patient to monitor clinical status and adherence level Regular laboratory monitoring: CD4 cell count every 6 months and viral load every year (or more often if treatment failure is suspected/as clinically indicated) Provide patient education and prevention counseling during every visit Community health workers do not perform the inital evaluation Patient chooses a CHW Provide directly observed treatment (DOT) daily Ensure adherence to the system of care Monitor for side effects and refer to health center where initial assessment was conducted Provide education and psychological support Perform a thorough initial psychosocial evaluation, including a home visit Determine whether ongoing psychosocial support is needed Provide patient education and counseling Fill out the psychosocial form Provide pre-art education and counseling Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support Continuous Monitoring for patients NOT on ART Conduct visits with patient every 3 months to monitor clinical status Regular laboratory monitoring: CD4 cell count every 6 months and viral load every year (and as clinically indicated) If the CD4 count is less than 500, clinicians should monitor the CD4 count every 3 months Provide patient education and prevention counseling during every visit Ensure adherence to system of care, such as appointments and prophylaxis Monitor for health problems Provide education and psychological support Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support 5

7 KEY POINTS 1. The HIV Program provides: Effective management of HIV infection and opportunistic infections Daily accompaniment and adherence support Nutrition and other psychosocial support Patient education and prevention counseling 2. The clinical team provides these services through three central activities: Initial evaluation of the new HIV-positive patient Early introduction of antiretroviral therapy and other therapies Continuous monitoring of HIV-positive patients 3. Clinicians, social workers, and community health workers must work together to ensure that HIV-positive patients enrolled in the HIV Program STAY in the program long-term. 6

8 Initial Evaluation of the PART 2 New HIV-Positive Patient Initial Evaluation HIV Program Chart (For Non-Pregnant Adults) CLINICIAN Perform a thorough patient history and physical exam Order baseline laboratory tests Determine whether ART and other therapies should be started Provide patient education and prevention counseling Fill out enrollment form, patient visit card, and community health worker treatment form Complete a psychosocial evaluation to ensure that the patient has social support before starting ART Evaluate nutritional status and initiate nutritional support if indicated Initiate cotrimoxazole prophylaxis COMMUNITY HEALTH WORKER Community health workers do not perform the inital evaluation SOCIAL WORKER Perform a thorough initial psychosocial evaluation, including a home visit Determine whether ongoing psychosocial support is needed Provide patient education and counseling Fill out the psychosocial form 7

9 Elements of the Initial Medical Evaluation The goal of the initial evaluation of a new HIV-positive patient is to assess the patient s health status, to identify what type of treatment s/he requires, and to evaluate her/his psychosocial needs. The clinician and the social worker both play an important role in the initial evaluation. The clinician conducts a detailed medical evaluation and the social worker conducts a detailed psychosocial evaluation. Together, the clinician s and the social worker s evaluations make up the complete initial evaluation. Below is a checklist of elements that clinicians must perform during the initial medical evaluation: ELEMENTS OF THE INITIAL MEDICAL EVALUATION Take a thorough patient history: History of HIV diagnosis and HIV status of family members and partners Medical History: Prior opportunistic infections or other illnesses Prior hospitalizations Prior surgeries History of ART or anti-tb medication: Prior ART (including ART to prevent HIV transmission from mother to child and postexposure prophylaxis) and level of adherence Prior anti-tb treatment Prior prophylaxis (cotrimoxazole, dapsone, fluconazole, isoniazid) Other medication, including traditional medicines RATIONALE It is important to document when and where the patient was diagnosed with HIV and whether children and partners have been tested because HIV spreads between sexual partners and during childbirth. Untested children and partners MUST be offered HIV testing and those positive enrolled in the HIV Program. HIV education and prevention counseling should also be provided to family members and partners. Learning about the patient s medical history, particularly opportunistic infections, can give an indication of the stage, or severity, of a patient s illness. Evaluating whether ART and/or anti-tb treatment was taken in the past, when it was started and stopped, and the level of adherence during treatment is important as poor adherence increases the risk of resistance to these drugs. History of allergies or side effects to medications Allergic reactions and side effects to medications can be serious and past reactions should be well understood before prescribing any new treatment. 8

10 ELEMENTS OF THE INITIAL MEDICAL EVALUATION Psychosocial situation RATIONALE To provide comprehensive care, the clinician must understand the patient s psychosocial circumstances. Identify current illnesses: Current complaints Screen for tuberculosis Screen for sexually transmitted infections Screen for pregnancy Screen for malnutrition Evaluate use of condoms and family planning: Use of condoms Current contraceptive methods used Perform a thorough physical exam Determine WHO Clinical Stage Symptoms the patient is currently experiencing should be closely evaluated as they may represent a new opportunistic infection and influence treatment decisions. Patients should be screened for tuberculosis and sexually transmitted infections. Untreated sexually transmitted infections increase the risk HIV transmission. HIV-positive women should be screened for pregnancy and those who are pregnant referred to the program for the prevention of mother to child transmission. Patients should be screened for malnutrition to determine if nutritional support is needed. All patients should receive counseling on use of family planning methods during their initial consultation. All HIV-positive patients and their partner(s) should be educated on the importance of using condoms during every sexual encounter to prevent transmission of HIV and other sexually transmitted infections. A thorough physical exam can reveal signs or symptoms of disease that the patient may not have identified. It is important to measure the baseline weight and height to follow weight and body mass index (BMI) trends over time. Information gathered in the history and physical exam helps to determine the stage, or severity, of a patient s HIV infection. The World Health Organization (WHO) has created a tool called WHO Clinical Staging that helps clinicians determine the patient s clinical stage. 9

11 ELEMENTS OF THE INITIAL MEDICAL EVALUATION Order laboratory tests: CD4 cell count RPR if syphilis is suspected If tuberculosis screening is positive, order sputum smear microscopy x3 and chest x-ray (if available) Pregnancy test if indicated RATIONALE Some laboratory tests are done automatically when a patient is enrolled in the HIV Program: CD4 cell count; RPR (to screen for syphilis); sputum smear microscopy x 3 and a chest x-ray (if available) if the tuberculosis screening is positive. Women who might be pregnant should undergo a pregnancy test. Other tests are done based on patient complaints, physical exam findings, or when ART is started. Decide which treatments need to be started: ART Cotrimoxazole prophylaxis (for all HIV-positive patients); other prophylaxis as appropriate Anti-tuberculosis treatment Other medications Provide patient education and prevention counseling Information from the patient s medical history and physical exam will determine what new therapies are needed. Education and prevention work together: as patients understand their HIV infection better, they can take actions that will help them stay healthy and prevent transmission of HIV to others. It is important to do a thorough initial medical evaluation. Every item included in the checklist is essential to provide effective HIV care. Missing information can lead to sub-optimal treatment. This checklist may seem long, but clinicians use a tool called the enrollment form to help them remember all these elements. This form has to be completed for each patient undergoing an initial evaluation and it stays in the patient s chart. The second part of the initial evaluation is an in-depth psychosocial evaluation conducted by the social worker. The information gathered is recorded on the psychosocial evaluation form. As you learned about the social worker s role in the previous unit, we will not review this today. However, you can find the psychosocial evaluation form on page 111 of your Participant s Manual. It is important to remember that, even if clinicians are not primarily responsible for the initial psychosocial evaluation, they must be aware of patients psychosocial situation. Clinicians should ask patients about their social circumstances in the initial medical evaluation and discuss complicated cases in-depth with social workers and community health workers. 10 Cotrimoxazole Prophylaxis All HIV-positive patients should also receive cotrimoxazole prophylaxis to prevent certain opportunistic infections, such as Pneumocystis pneumonia and toxoplasmosis, from occurring. When taken daily, cotrimoxazole prophylaxis has been shown to reduce morbidity and mortality in HIV-positive adults and is the most commonly prescribed prophylactic drug. Dapsone is given to patients who cannot take cotrimoxazole (e.g. allergies).

12 Because it is the most commonly used prophylaxis, how and when to prescribe cotrimoxazole is described here. Other prophylactic therapies, such as fluconazole for recurrent fungal infections, should be prescribed by an experienced clinician. Criteria for starting cotrimoxazole prophylaxis in non-pregnant adults: If HIV-positive, start cotrimoxazole Dosage prescribed: 960mg orally once a day KEY POINTS 1. The goal of the initial evaluation is to assess the patient s health status, to identify what type of treatment s/he requires, and to evaluate her/his psychosocial needs. 2. While the social worker is responsible for the formal psychosocial evaluation, it is important for the clinician to understand the patient s psychosocial situation to determine the best treatment options. 3. All HIV-positive patients should receive cotrimoxazole prophylaxis. 11

13 When to Start ART: CD4 Cell Count A key tasks in the initial medical evaluation is to determine whether or not a patient should begin ART. The decision to start ART is based on: 1. The patient s CD4 cell count 2. The patient s WHO clinical stage What is a CD4 cell? The immune system consists mainly of white blood cells that fight harmful organisms such as bacteria, viruses, and parasites. One subtype of white blood cells are CD4 T lymphocytes. The human immunodeficiency virus, or HIV, weakens the immune system by targeting and destroying the CD4 T lymphocytes. We will refer to CD4 T lymphocytes as CD4 cells. Life Cycle of HIV This diagram shows the life cycle of HIV and how it affects the CD4 cell. The virus enters the patient s bloodstream when s/he is infected and circulates in the blood. In Step 1, the virus attaches to a receptor and co-receptor on the surface of the CD4 cell. The virus fuses with the CD4 cell, and its genetic material enters the CD4 cell. In Step 2, the genetic material of the virus is replicated in the CD4 cell through the process of reverse transcription, integration and transcription. In Step 3, the newly replicated genetic material assembles into new viruses that are released into the blood. The CD4 cell dies after the replication process is completed. In Step 4, the newly released viruses mature and go on to infect other CD4 cells. 12

14 CD4 Cell Count Without ART A CD4 cell count is a laboratory test that measures the number of CD4 cells present in a sample of the patient s blood. When the CD4 cell count is high, the immune system is still strong. As the number of CD4 cells decreases, the immune system becomes weak, and the patient becomes at risk for infections. The normal CD4 cell count for individuals without HIV is greater than 500cells/mm 3 (500 CD4 cells per cubic millimeter of blood). After a person is first infected with HIV, the virus replicates quickly, and the CD4 cell count rapidly declines in the first few weeks. At this point, some people get sick with flu-like symptoms, a syndrome that is called Acute Retroviral Syndrome. However, the body s immune system will mount an initial response to HIV, and viral load, the number of HIV present in a sample of the patient s blood, will decrease to a level that is temporarily controlled by the immune system. The person then enters into a latent clinical state with no symptoms of infection. This latent period, which varies widely between patients, can last between 2 and 15 years. During that time, the viral load gradually increases, resulting in a corresponding slow decrease in CD4 cell counts. When CD4 cell counts fall below 500 cells/mm 3, the person can start to develop opportunistic infections (OIs) - infections that take advantage of a body s weakened immunity to proliferate and that do not usually develop in a healthy person. Without ART, a person progresses over time from having an HIV infection to having Acquired Immunodeficiency Syndrome (AIDS), the most advanced stage of HIV infection. 13

15 Infectious Complications and CD4 Cell Count CD4 CELL COUNT >500/mm 3 INFECTIOUS COMPLICATIONS Acute retroviral syndrome Candidal vaginitis /mm 3 <200/mm 3 <100/mm 3 Pneumococcal and other bacterial pneumonia Pulmonary tuberculosis Herpes Zoster Oropharyngeal candidiasis (thrush) Kaposi s sarcoma Oral hairy leukoplakia Some infections such as tuberculosis, herpes, bacterial infections, and candidiasis begin to affect the patient at higher CD4 cell counts, while other infections such as cytomegalovirus and toxoplasmosis usually affect patients with a CD4 cell count below 200 cells/mm 3. CD4 Cell Count and the HIV Program Pneumocystis pneumonia Disseminated histoplasmosis and coccidiomycosis Miliary/extrapulmonary TB Progressive multifocal leukoencephalopathy (PML) Disseminated herpes simplex Toxoplasmosis Cryptococcosis Cryptosporidiosis, chronic Microsporidiosis Candidal esophagitis <50/mm 3 Disseminated cytomegalovirus (CMV) Disseminated Mycobacterium avium complex Adapted from: Bartlett, J. G. Gallant, J. E. Pham, P. (2009) Medical Management of HIV Infection. In the HIV Program, ART is started when the CD4 cell count falls below 350 cells/mm 3 because this is the level at which serious opportunistic infections present. Starting ART at this level will increase the CD4 cell count and prevent complications from developing. If the patient s CD4 cell count is above 350 cells/mm 3, the patient is followed regularly at the clinic, and the CD4 cell count is checked every 6 months. If the CD4 cell count is less than 500, check the CD4 count every 3 months. If the CD4 cell count falls below 350 cells/mm 3, ART is started. 14

16 KEY POINTS 1. CD4 cells are lymphocytes that fight harmful organisms in the body such as bacteria, viruses, and parasites. HIV destroys CD4 cells and weakens the body s immune system. 2. A CD4 cell count less than 350 cells/mm 3 is an indication to start ART. When to Start ART: WHO Clinical Staging Although the CD4 cell count is an important tool in determining treatment for an HIV-positive patient, clinicians must also consider the patient s clinical condition. The WHO has created a tool to determine the clinical stage of HIV-positive patients. It is called WHO Clinical Staging. Clinicians should use WHO Clinical Staging with every patient, regardless of CD4 cell count, because in certain situations it may provide even more important information than the CD4 cell count. In situations where CD4 cell counts are not available, clinicians should use WHO Clinical Staging to determine whether a patient requires ART. WHO Clinical Staging of HIV in Adults and Adolescents Clinical Stage 1 Asymptomatic* CLINICAL NAME Persistent generalized lymphadenopathy* DESCRIPTION No HIV-related symptoms reported and no signs on examination Painless enlarged lymph nodes >1 cm, in two or more noncontiguous sites (excluding inguinal), with no known cause and persisting for three months or longer Source: Adapted from Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO 2006 revision. *Diseases that are more commonly seen in the clinics 15

17 Clinical Stage 2 CLINICAL NAME Moderate unexplained weight loss (under 10% of body weight)* DESCRIPTION Unexplained weight loss. In pregnancy, failure to gain weight. Recurrent bacterial upper respiratory infections (current infection plus one or more in the last six months)* Unilateral face pain with nasal discharge (sinusitis), painful inflamed eardrum (otitis media), or throat infection without cough or nasal discharge (pharyngitis) Herpes zoster* Angular cheilitis Recurrent oral ulcerations (two or more episodes in last six months) Papular pruritic eruption Seborrheic dermatitis Fungal nail infections Painful, blistered rash in a well-defined area on one side of the body not crossing the midline Splits or cracks at the angle of the mouth, usually responding to antifungal treatment Painful ulcers in the mouth, typically yellow-grey surrounded by a halo of inflammation Itchy small red bumps on the skin Itchy scaly skin particularly affecting hairy areas (scalp, axillae, upper trunk, and groin) Painful red and swollen nail bed or white discoloration of nail with thickening and separation of nail from nail bed Source: Adapted from Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO 2006 revision. *Diseases that are more commonly seen in the clinics 16

18 Clinical Stage 3 CLINICAL NAME Unexplained severe weight loss (more than 10% of body weight)* DESCRIPTION Unexplained weight loss (over 10% of body weight) and visible thinning of face, waist, and extremities or BMI below In pregnancy, weight loss may be masked. Unexplained chronic diarrhea for longer than one month* Loose or watery stools three or more times daily reported for longer than one month Unexplained persistent fever (intermittent or constant and lasting longer than one month)* Pulmonary tuberculosis (current)* Severe bacterial infections (such as pneumonia, meningitis, bone or joint infection or severe pelvic inflammatory disease)* Persistent oral candidiasis* Oral hairy leukoplakia Acute necrotizing ulcerative gingivitis or periodontitis Reported constant or intermittent fever or night sweats for more than one month without obvious cause and not responding to antibiotics or antimalarials Cough, blood in sputum, shortness of breath, chest pain, weight loss, fever or night sweats lasting at least two to three weeks, PLUS a positive sputum test or a negative sputum test but a chest x-ray suggestive of tuberculosis Fever accompanied by specific symptoms or signs that localize the infection, and infection responds to appropriate antibiotic Persistent or recurring white plaques in the mouth that can be scraped off, or red patches on tongue, palate, or lining of mouth, usually painful or tender White patches on the sides of the tongue that look hairy or rough and cannot be scraped off Severe infection of the gums with severe pain, ulcerated gums, loosening of teeth, spontaneous bleeding, bad odor Unexplained anemia (below 8g/dL), neutropenia (below 0.5 x 10 9 /L), or chronic (more than one month) thrombocyotopenia (below 50 x 10 9 /L)* Low level of red blood cells, white blood cells, or platelets. May present as pale conjunctiva, low energy, or unexplained bruising or bleeding Source: Adapted from Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO 2006 revision. *Diseases that are more commonly seen in the clinics 17

19 Clinical Stage 4 CLINICAL NAME HIV wasting syndrome* DESCRIPTION Unexplained weight loss (over 10% of body weight) with obvious wasting or BMI below 18.5, PLUS either unexplained chronic diarrhea OR unexplained persistent fever Pneumocystis pneumonia* Severe pneumonia caused by the bacteria Pneumocystis jiroveci presenting as rapid breathing on exertion or at rest, nonproductive cough and fever (slow onset within the last three months) Recurrent severe bacterial pneumonia (current infection plus one or more episodes in last six months)* Chronic herpes simplex infection* Oesophageal candidiasis* Extrapulmonary tuberculosis* Kaposi s sarcoma* Acute onset (under two weeks) of symptoms (fever, cough, rapid breathing, and chest pain) that respond to antibiotics Recurrent infection caused by herpes simplex virus presenting as open sores in mouth, genitals, or anus for more than one month Fungal infection of the esophagus presenting as recent onset of difficult and/or painful swallowing together with oral candidiasis Lymphoma Tuberculosis infection outside of the lung tissue (e.g. in abdomen, bones, etc.), presenting with systemic symptoms of tuberculosis (fever, night sweats, weight loss) and often other localizing signs Type of cancer presenting as blue, brown, or black patches or nodules on skin or inside mouth Cancer of the lymphatic system presenting as persistent swollen lymph nodes, and/or general symptoms like fatigue and weight loss Invasive cervical cancer Advanced cancer of the cervix in female patients HIV-associated nephropathy or cardiomyopathy Kidney and heart disease developing with HIV infection that can cause fluid in the lungs and difficulty breathing and swollen legs and feet Source: Adapted from Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO 2006 revision. *Diseases that are more commonly seen in the clinics 18

20 Clinical Stage 4 (cont.) HIV encephalopathy CLINICAL NAME DESCRIPTION Disease of the brain caused by HIV presenting as disorientation, confusion, agitation, motor dysfunction that progress over weeks or months and that cannot be explained by other conditions or illnesses Progressive multifocal leukoencephalopathy Viral infection in the brain causing severe progressive neurological deterioration (e.g. gait/speech disorder, visual loss, limb weakness) Toxoplasmosis of the central nervous system Extrapulmonary cryptococcosis (including meningitis) Chronic cryptosporidiosis or isosporiasis Recurrent septicaemia Cytomegalovirus infection Atypical disseminated leishmaniasis Disseminated mycosis (histoplasmosis, coccidiomycosis) Disseminated non-tuberculous mycobacteria infection Parasitic infection in the brain presenting as recent onset of focal neurological signs (e.g. visual changes) or reduced level of consciousness Fungal infection that often presents as meningitis Parasitic infections causing watery diarrhea and stomach cramps Repeated blood infections Viral infection that often affects the retina Parasitic infection transmitted by sand flies that causes skin sores and damage to organs Rare fungal infections usually occurring in the lungs that has spread to other sites in the body Mycobacteria infection (other than Mycobacterium tuberculosis) that has spread to different sites in the body Source: Adapted from Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach. WHO 2006 revision. *Diseases that are more commonly seen in the clinics 19

21 According to the Guidelines for the provision of comprehensive care to persons infected by HIV in Rwanda (Version 2009), the criteria for initiating ART in non-pregnant adults are: Any patient with WHO clinical stage 4, regardless of CD4 count. Any patient with WHO clinical stage 1, 2, or 3, whose CD4 count is < 350/mm 3. It is important to evaluate your patient s overall health in the context of all their symptoms, even if their symptoms do not match exactly the classic WHO clinical stages. KEY POINTS 1. CD4 cell count and WHO Clinical Staging are critical tools to determine whether an HIV-positive patient should start ART. 2. Patients with a WHO clinical stage 4, or patients with a WHO clinical stage 1, 2, or 3, whose CD4 count is < 350/mm 3, should start ART. 3. Consult more experienced clinicians for cases where indications for ART are unclear. 20

22 Case Studies Task: Read the case studies and answer the related questions. CASE STUDY #1 A 36-year-old woman was diagnosed with HIV 2 weeks ago and comes to see you for her initial medical evaluation. She does not have any symptoms, and the physical exam is normal. Her CD4 cell count is 338 cells/mm 3. What is her WHO clinical stage? Would you start her on ART? Why? 21

23 CASE STUDY #2 A 28-year-old male patient has come to the clinic several times over the past 6 months with recurring sinusitis. He has lost about 5% of his body weight over this time. His previous CD4 cell counts were between of cells/mm 3. His CD4 count is now 361cells/mm 3. What is his WHO clinical stage? Would you start him on ART? Why? Have you had a complex or borderline case like this one? How did you deal with the case? 22

24 CASE STUDY #3 A 30-year-old woman was diagnosed with HIV 6 months ago. She has been admitted to the hospital three times in the last 4 months: twice for bacterial pneumonia and once for severe pelvic inflammatory disease. Her weight has decreased from 52 kg to 46 kg in the last 6 months. Her CD4 cell count was 405 cells/mm 3 6 months ago, and it is currently 345 cells/mm 3. What is her WHO clinical stage? Would you start her on ART? Why? 23

25 CASE STUDY #4 A 26-year-old man was diagnosed with HIV 4 months ago. He complains of a rash on his right lower limb for the last month. The CD4 cell count is not available as the machine has broken down and is awaiting repair. Partners In Health, Malawi What is your diagnosis of the rash? What is his WHO clinical stage? Would you start him on ART? Why? 24

26 Nutritional Support Providing nutritional support is a vital part of HIV care for a number of reasons: HIV and malnutrition form a vicious cycle. HIV causes malnutrition and HIV immune suppression is made worse by poor nutritional status. Studies have shown that malnutrition at the time of starting ART is significantly associated with decreased survival. Lack of access to adequate nutrition can be associated with decreased adherence to ART (side effects can be exacerbated with lack of food, etc.). The clinician must determine the patient s nutritional status during the initial medical evaluation and during every visit thereafter, to determine whether the patient needs nutritional support. This is done by calculating the patient s Body Mass Index (BMI). The BMI is calculated by dividing the weight of a patient in kilograms by their height in meters squared. Body Mass Index (BMI) = Weight in kg/height in meters 2 BODY MASS INDEX 18.5 NUTRITIONAL STATUS Normal Mild malnutrition Moderate malnutrition < 16.0 Severe malnutrition Patients with a BMI below 18.5 or patients diagnosed with tuberculosis and HIV co-infection receive food packages (beans, flour, oil, sugar) once a month for 6 months. Where available, they are also referred to the agricultural program where they learn to grow small gardens at home. 25

27 ACTIVITY Task: Calculate the BMI for each sample. Weight Height BMI kg 180 cm kg 178 cm kg 182 cm kg 170 cm kg 172 cm kg 167 cm KEY POINTS 1. Providing nutritional support is a vital part of HIV care. 2. Clinicians must determine the patient s nutritional status during the initial evaluation and during every visit thereafter, to see whether the patient needs nutritional support. 3. Patients with a BMI below 18.5 or patients diagnosed with tuberculosis and HIV co-infection receive food packages once a month for 6 months. 26

28 PART 3 Starting Antiretroviral Therapy Starting ART HIV Program Chart (For Non-Pregnant Adults) CLINICIAN Provide pre-art education Order and analyze pre-art laboratory tests Initiate ART COMMUNITY HEALTH WORKER Patient chooses a CHW SOCIAL WORKER Provide pre-art education and counseling 27

29 How ART Works Antiretroviral drugs work by inhibiting, or stopping, various parts of the HIV replication cycle. There are four classes of antiretroviral drugs: Fusion inhibitors block the fusion of the virus with the CD4 cell. Reverse transcriptase inhibitors block the replication of the viral genetic material in the CD4 cell. There are 2 types of reverse transcriptase inhibitors: 1. Nucleoside reverse transcriptase inhibitors 2. Non-nucleoside reverse transcriptase inhibitors Integrase inhibitors also block the replication of the viral genetic material in the CD4 cell. Protease inhibitors block the final assembly of the new viral genetic material into a virus. In Rwanda, only reverse transcriptase inhibitors and protease inhibitors (highlighted on next page) are used in treatment regimens. Fusion and Integrase inhibitors are relatively new drugs and are not used in the country. 28

30 Classes of Antiretroviral Drugs* REVERSE TRANSCRIPTASE INHIBITORS NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS) NON- NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIS) PROTEASE INHIBITORS (PIS) FUSION INHIBITORS INTEGRASE INHIBITORS Abacavir (ABC) Efavirenz (EFV) Atazanavir (ATV) Enfuvirtide (ENF) Didanosine (ddi) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4t) Tenofovir (TDF) Zidovudine (AZT) Nevirapine (NVP) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Lopinavir/Ritonavir (LPV/r) Nelfinavir (NFV) Ritonavir (RTV) Saquinavir (SQV) Tipranavir (TPV) Maraviroc (MVC) entry inhibitor Raltegravir (RAL) Source: *Classes of ARVs used in Rwanda appear in the first three columns. 29

31 To effectively suppress the HIV replication cycle, a combination of three antiretroviral drugs from at least two different classes must always be used. For patients who have never received ART before (treatment-naïve patients), a first-line treatment regimen is recommended. In Rwanda, first-line regimens contain 2 NRTIs and 1 NNRTI. Patients who are failing to respond to first-line treatment are given second-line treatment. In Rwanda, second-line regimens contain 2 NRTIs and 1 PI, a potent class of antiretroviral drugs. Recommended ART Regimen Compositions REGIMEN COMPOSITION EXAMPLE First-line regimen (for treatment-naïve patients) Second-line regimen (only for patients no longer responding to their first-line regimen) KEY POINTS 2NRTIs + 1NNRTI Tenofovir + Lamivudine + Efavirenz 2NRTIs + 1 PI Zidovudine + Lamivudine + Lopinavir/ritonavir 1. A combination of three antiretroviral drugs from at least two different classes must always be used to effectively suppress the HIV replication cycle. 2. First-line regimens contain 2NRTIs + 1NNRTI and second-line regimens contain 2NRTIs + 1PI. 30

32 Choosing ART Regimens and Baseline Laboratory Tests The table below shows the recommended first-line ART regimens for treatment-naïve patients. ART Regimens Chart For Non-Pregnant, Treatment-Naive Adults* RECOMMENDATION ART REGIMEN DOSAGE Preferred regimens Alternative regimens Replace NVP with EFV if concomitant anti-tuberculosis treatment is used or if the patient has a known allergy to NVP TDF / 3TC / NVP TDF / FTC / NVP TDF / 3TC / EFV TDF / FTC / EFV Initial phase (first 15 days): TDF 300 mg 1x/day 3TC 300 mg 1x/day NVP 200 mg 1x/day Maintenance phase (after 15 days): TDF 300 mg 1x/day 3TC 300 mg 1x/day NVP 200 mg 2x/day Initial phase (first 15 days): TDF 300 mg 1x/day FTC 200 mg 1x/day NVP 200 mg 1x/day Maintenance phase (after 15 days): TDF 300 mg 1x/day FTC 200 mg 1x/day NVP 200 mg 2x/day Alternative regimens Replace TDF with ABC if TDF is contraindicated (ex: renal insufficiency) ABC / 3TC / NVP TDF 300 mg 1x/day 3TC 300 mg 1x/day EFV 600 mg 1x/day (in evening) TDF 300 mg 1x/day FTC 200 mg 1x/day EFV 600 mg 1x/day (in evening) Initial phase (first 15 days): ABC 600 mg 1x/day 3TC 300 mg 1x/day NVP 200 mg 1x/day Maintenance phase (after 15 days): ABC 600 mg 1x/day 3TC 300 mg 1x/day NVP 200 mg 2x/day ABC / 3TC / EFV ABC 600 mg 1x/day 3TC 300 mg 1x/day EFV 600 mg 1x/day (in evening) * EFV is contraindicated in the 1st trimester of pregnancy. For more information on HIV and pregnancy, see Unit 5. For all women of reproductive age initiating ART, ensure access to effective contraception and discuss their plans for future pregnancy. 31

33 The preferred regimens are TDF/3TC/NVP or TDF/FTC/NVP. If a patient is currently taking or will start anti-tuberculosis treatment, do not use NVP; use EFV instead. If the patient has renal insufficiency, do not use TDF; use ABC instead. Many of patients will have started ART before 2009, when these new recommended regimens were released, and will be taking older regimens that are not listed on this table. If the patient is responding well to that regimen, her/his current regimen should not be changed. If a patient starting ART has received ART in the past and stopped, an experienced clinician should be consulted before starting ART, as the first-line regimens recommended in this table might not be appropriate. In the initial evaluation, an HIV-positive patient undergoes a CD4 cell count, complete blood count, ALT, creatinine, RPR screening for syphilis (if syphilis is suspected), sputum smear microscopy x 3 and a chest x-ray if the tuberculosis screening is positive, and, if relevant, a pregnancy test. If a patient starting ART has abnormal tests, consult an experienced colleague before starting ART. 32

34 Laboratory Tests For Patients Starting ART TEST REASON NORMAL VALUES* Complete blood count AZT should not be prescribed if a patient s hemoglobin is <9 g/dl.** A baseline measurement of CBC helps to monitor for bone marrow suppression after initiation of ART (especially with AZT). Hemoglobin: Men: g/dl Women: g/dl White Blood Cells: 4 10 x 10 9 /L ALT (also known as SGPT) (liver enzymes) Creatinine NVP and the AZT/3TC combination should not be prescribed if a patient has moderate to severe liver disease. A baseline measurement of liver enzymes helps to monitor for liver toxicity after initiation of ART (particularly NVP). Repeat 2-4 weeks after initiation of NVP-based regimen. A baseline measurement helps to monitor for kidney toxicity after initiation of ART. Dosage adjustments have to be made for AZT, 3TC, D4T, and TDF if patient has kidney disease. ALT: 5 60 IU/L Creatinine: Men: μmol/l Women: μmol/l * Normal values may vary based on reference lab. ** If pregnant and anemic, aggressively treat anemia and determine, in consultation with infectious disease specialist, whether an ART regimen change is needed. Anemia should be monitored closely and treated in all patients. NVP contraindicated in pregnant women with CD4 > 250 cells/mm 3. See Unit 5 for more information on ART in pregnancy. Just as with any drug combination, antiretroviral drugs can interfere with the way the body processes other drugs, and other drugs can affect how the body processes antiretroviral drugs. Before starting ART, it is important to always check whether patients are taking other medications (including traditional herbs and tonics), and, in patients already taking ART, check for interactions before prescribing a new medication. A more experienced clinician should be consulted in these cases until common drug interactions well understood. 33

35 Selected Drug Interactions* AGENTS ANTIRETROVIRAL DRUGS THAT INTERACT WITH AGENTS RECOMMENDATIONS Oral contraceptives NVP, EFV, PIs Use alternative methods. DMPA is an effective alternative to combined oral contraceptives. Patients should always use condoms during every sexual encounter to avoid transmitting HIV and acquiring STIs. Antibiotics: Clarithromycin Rifampicin Antifungals: EFV NVP, PIs Use alternative antibiotic. Avoid NVP with rifampicin and use EFV instead. When co-administered with rifampicin, use EFV dose of 600 mg/day. Avoid PIs with rifampicin and consult an experienced clinician. Ketoconazole EFV, NVP, LPV/r Ketoconazole levels are very decreased with NVP and may be decreased by EFV. Ketoconazole levels are increased by LPV/r; do not use high dose ketoconazole with LPV/r. Consult with an experienced clinician for co-administration. Anticonvulsants: Carbamazepine Phenytoin Phenobarbital GI Agents: Proton-pump inhibitors (i.e. omeprazole) Limited data available on interaction between these drugs and antiretroviral drugs. saquinavir, atazanavir, nelfinavir Use with caution. In particular, administration of carbamazepine, phenytoin, and phenobarbital should be avoided for patients receiving NNRTIs and PIs. Consult an experienced clinician for co-administration. Avoid co-administration. For other drugs, including indinavir and tipranavir, use caution with coadministration and consult with an experienced clinician. Cisapride Antacids (e.g. aluminum hydroxide) H2 antagonists (e.g. ranitidine, cimetidine, famotidine) PIs, EFV, delavirdine Many drugs atazanavir, fosamprenavir, tipranavir, delavirdine, raltegravir Avoid co-administration. In general, it is good practice to separate antacid dose by two hours before or after ART administration. Consult an expert clinician; potential interaction may require close monitoring, alteration of drug dosage or timing of administration, or choice of alternative drug. In addition, use these same precautions regarding the use of cimetidine with tenofovir. Herbal therapies Limited data available. In general, herbal products should be used with caution. Specifically, St. John s Wort and supplemental garlic are contraindicated. *Note: This table shows common drug interactions - other less common drug interactions can occur. Consult a more experienced clinician when antiretroviral drugs and other medication are to be co-administered. 34

36 KEY POINTS 1. Treatment-naïve patients requiring ART should be started on a first-line treatment regimen. 2. Cotrimoxazole prophylaxis should be started in all HIV-positive patients. 3. The following baseline laboratory tests should be ordered in patients starting ART: CD4 count, complete blood count, ALT, and creatinine. 4. Clinicians should consult a more experienced clinician whenever ART is to be co-administered with other medications until all the common drug interactions are well understood. Completing The Enrollment Form, The Patient Visit Card, And The Community Worker Treatment Form When conducting the initial medical evaluation and when starting ART, clinicians must complete an enrollment form for each patient. It is important to fill out the form accurately and legibly. The form will be kept in the patient s chart, and the information contained in the form will also be stored in a database called the Electronic Medical Records (EMR) System, which helps monitor patients in the HIV Program. In addition to the enrollment form, clinicians must fill the patient visit card and the community health worker treatment form. Each patient receives a visit card to help remind them of the date of their next clinic visit. When the patient is enrolled in the HIV Program, the clinician must fill out the front portion (name, clinic, community health worker s name, date, regimen, and HIV Program group) and then, at every visit, uses the visit spaces on the card to record the date of the patient s next visit. When the patient comes to that visit, a check mark is written in the column next to the date. The card also contains a space for food distributions for patients receiving nutritional support. The food distributions are done once a month after the patient has come to her/his medical visit with the clinician; if a patient does not come for the medical visit, s/he does not receive the food package for that month. This motivates patients to come to their monthly medical visits. When a patient is starting ART, the clinician must also fill out the top portion of the community health worker treatment form (patient name, community health worker name, and medicines/dosages) and give the form to the community health worker, who will record on it every time s/he directly observes the patient taking a dose of medication. It is a tool used to monitor adherence to treatment. 35

37 ROLE PLAY Tasks: You will now practice filling out the enrollment forms by doing a role play with a partner. First decide who will play the role of the patient and who will play the role of the clinician. The person playing the patient should read scenario #1 below. The person playing the clinician SHOULD NOT read the scenario but can prepare by reviewing the enrollment form. During the role play, the clinician will interview the patient and the patient will provide the information from the scenario, including the results of the physical exam (the clinician does not have to perform the exam). The clinician will complete the enrollment form, using the information provided by the patient. Then, switch roles and do the second role play, with the former patient now playing the clinician, and vice versa. Scenario #1 Your name is Jean, and you are a 26-year-old male. You went to the primary care outpatient clinic in Cyarubare health center four days ago because you have had a productive cough and night sweats for more than one month. You were tested for tuberculosis and HIV that same day. The results came back positive for tuberculosis, and you were started on anti-tb treatment (RHZE) the following day. Your HIV test was also positive, and you were enrolled in the HIV Program in the same health center. You are not married and do not have any children. You work as a farmer on your land and sometimes have enough vegetables to sell in the market. You have not had any allergies or side effects to medications in the past. You have never received ART or prophylaxis in the past and this is the first time you are treated for tuberculosis. The only medicine you take occasionally is a traditional medicine for headaches. Besides the symptoms that developed one month ago, you have always been healthy. You have never been hospitalized, had surgery, or been sick with other major illnesses. Today, you are still complaining of a productive cough and night sweats. You don t know your weight, but your pants are fitting looser now than they used to. You don t think you have had fever or that you have been in contact with somebody who has tuberculosis. You don t have diarrhea. You have had one regular sexual partner for the last 4 months. She is your girlfriend, and her name is Marie. She is 19 years old, and you hope to get married soon. You have vaginal intercourse but do not use condoms as you don t like how they feel. You have not told her your HIV status. Before you met Marie, you had sex with a woman who lives in your village who is 2 years older than you. Her name is Françoise, and she is also a farmer. You had vaginal sex a few times a month for five or six months, and you stopped seeing her 4 months ago. You only used condoms sometimes because you couldn t always buy them. You don t know her HIV status, and she doesn t know yours. You have never had sexually transmitted infections (STIs) in the past and have 36

38 no current signs or symptoms of STIs (pain on urination, genital lesions, or scrotal swelling). You do not pay or trade for sexual favors. You drink beer when you have money to pay for it, about three beers a week. You are not a victim of sexual or domestic violence. If the clinician asks whether you give the health center permission to communicate your diagnosis with your community health worker, you answer yes. Jean s Physical Exam Findings Weight = 57 kg Height = 169 cm Temp 37.7 C, pulse 88/min, RR 16/minute, BP 11/6 Good general state, but with white spots inside the mouth that can be wiped off when scraped. All other parts of the exam are normal. Laboratory tests CD4 cell count 290 cells/mm 3 Scenario #2 Your name is Claudine and you are a 32-year-old female. You went to the primary care outpatient clinic in Rusumo health center two days ago because you have had a painful, blistered rash on one side of your back for two weeks. The nurse prescribed treatment for herpes zoster and suggested you be tested for HIV in the primary health care clinic that same day. Your HIV test was positive, and you were enrolled in the HIV Program in that same clinic. You are married and have 2 children, a 7-year-old boy named Désiré and a 4-year-old girl named Robertine. They have not been tested for HIV. You own a small shop near your house. You have not had any allergies or side effects to medications in the past. You have never received ART, prophylaxis or anti-tb treatment in the past. Prior to this episode, you had never had this type of rash. You do not take any medication regularly. Besides the rash that developed two weeks ago, you have always been healthy. The only times you have been in the hospital was when your children were born, which were both normal vaginal births. You have never had surgery or ever been sick with other major illnesses. Today, you are still complaining of a painful, blistered rash on one side of your back, but it has become drier and less blistered since starting your medication two days ago. You don t know your weight, but you don t think it has changed significantly in the past year. You do not have a cough or night sweats. You don t think you have had fever or that you have been in contact with somebody who has tuberculosis. You don t have diarrhea. You have had one regular sexual partner for the last 8 years. He is your husband, and his name is Bernard. He is 36 years old and he is a farmer. You have vaginal intercourse but do not use condoms as you are married and they are not necessary. You have not told him your HIV status. Before you were married, you had no sexual partners. Your husband has never told you whether or not he was sexually active 37

39 before you were married. You are not aware of any other women he is having sex with. You have never had sexually transmitted infections (STIs) in the past and have no current signs or symptoms of STIs (pain on urination, vaginal discharge, genital lesions, or lower abdominal pain). You had your last period two weeks ago. For contraception, you receive Depo-Provera at the family planning clinic. You do not pay or trade for sexual favors. You do not drink alcohol. You are not a victim of sexual or domestic violence. If the clinician asks whether you give the health center permission to communicate your diagnosis with your community health worker, you answer yes. Claudine s Physical Exam Findings Weight = 48 kg Height = 153 cm Temp 37.4 C, pulse 76/min, RR 14/minute, BP 10/5 Generally well-appearing, but with cervical lymphadenopathy All other parts of her exam are normal Laboratory tests CD4 cell count 324 cells/mm 3 KEY POINTS 1. When conducting the initial medical evaluation and starting ART, clinicians must complete an enrollment form, a patient visit card and a community health worker treatment form for each patient. 2. The information recorded on the enrollment form helps monitor patients in the HIV Program. It is important that enrollment forms are filled out accurately and legibly. 38

40 Continuous Monitoring PART 4 of HIV-Positive Patients Continuous Monitoring for patients on ART Continuous Monitoring for patients NOT on ART HIV Program Chart (for Non-Pregnant Adults) CLINICIAN Conduct regular visits with patient to monitor clinical status and adherence level Regular laboratory monitoring: CD4 count every 6 months and viral load every year (or more often if treatment failure is suspected/as clinically indicated) Provide patient education and prevention counseling during every visit Conduct visits with patient every 3 months to monitor clinical status Regular laboratory monitoring: CD4 count every 6 months and viral load every year (and as clinically indicated) If the CD4 count is less than 500, clinicians should monitor the CD4 count every 3 months Provide patient education and prevention counseling during every visit COMMUNITY HEALTH WORKER Provide directly observed treatment (DOT) daily Ensure adherence to the system of care Monitor for side effects and refer to health center where initial assessment was conducted Provide education and psychological support Ensure adherence to system of care, such as appointments and prophylaxis Monitor for health problems Provide education and psychological support SOCIAL WORKER Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support 39

41 Monitoring Visits The final step of the HIV Program is to regularly monitor patients according to a defined schedule. The timing of visits and laboratory tests depends on whether the patient is receiving ART or not: Patients on ART: Patients return for a monitoring visit 14 days after the start of ART to ensure that they are tolerating the medication. After this visit, they are seen every month for clinical follow-up. Regular laboratory monitoring includes a CD4 count every 6 months and viral load every year (or more often if treatment failure is suspected/as clinically indicated). Patients not on ART: Patients return for clinical follow-up every 3 months. Regular laboratory monitoring includes a CD4 count every 6 months and viral load every year (and as clinically indicated). Continuous Monitoring for patients on ART Continuous Monitoring for patients NOT on ART CLINICIAN Conduct regular visits with patient to monitor clinical status and adherence level Regular laboratory monitoring: CD4 every 6 months and viral load every year (or more often if treatment failure is suspected/as clinically indicated) Provide patient education and prevention counseling during every visit Conduct visits with patient every 3 months to monitor clinical status COMMUNITY HEALTH WORKER Provide directly observed treatment (DOT) daily Ensure adherence to the system of care Monitor for side effects and refer to health center where initial assessment was conducted Provide education and psychological support SOCIAL WORKER Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support Regular laboratory monitoring: CD4 count every 6 months and viral load every year (and as clinically indicated) If the CD4 count is less than 500, clinicians should monitor the CD4 count every 3 months Provide patient education and prevention counseling during every visit Ensure adherence to system of care, such as appointments and prophylaxis Monitor for health problems Provide education and psychological support Evaluate psychosocial needs Coordinate and provide ongoing psychosocial support 40

42 Below is a checklist of elements that clinicians must perform during regular monitoring visits with patients on ART and not on ART. Clinicians must complete a follow-up form and summary form for each patient during every monitoring visit. Checklist for Monitoring Visits for Non-Pregnant Adults PATIENTS ON ART* PATIENTS NOT ON ART* Ask about current complaints, especially new signs/symptoms of opportunistic infections Perform a physical exam, including weight Document vital signs (blood pressure, heart rate, respiratory rate, and temperature) Monitor CD4 levels and WHO clinical stage over time Monitor weight over time Calculate and interpret BMI Ask about adherence Ask about side effects Ask about hospitalizations since last visit Screen for tuberculosis Screen for STIs Screen for pregnancy Ask about condom use and current family planning method Perform a basic psychosocial assessment to identify urgent needs Order lab tests according to schedule or as indicated Perform patient education and prevention counseling Fill out the Follow-up Form and the Patient Summary Form Ask about current complaints, especially new signs/symptoms of opportunistic infections Perform a physical exam, including weight Monitor CD4 levels and WHO staging to determine whether ART is indicated Monitor weight over time Calculate and interpret BMI Ask about hospitalizations since last visit Screen for tuberculosis Screen for STIs Screen for pregnancy Ask about condom use and current family planning method Perform a basic psychosocial assessment to identify urgent needs Order lab tests according to schedule or as indicated Perform patient education and prevention counseling Fill out the Follow-up Form and the Patient Summary Form *The items in bold are the elements of the monitoring visit that differ between patients on ART and patients not on ART. 41

43 KEY POINTS 1. Patients on ART return for a monitoring visit 14 days after the start of ART to ensure that they are tolerating the medicine. After this visit, they are seen every month for clinical follow-up. Regular laboratory monitoring includes a CD4 count every 6 months and a viral load every year (or more often if treatment failure is suspected/as clinically indicated). 2. Patients not on ART return for clinical follow-up every 3 months. Regular laboratory monitoring includes a CD4 count every 6 months and viral load every year (and as clinically indicated). 42

44 Monitoring Adherence Adherence means that the patient follows treatment as prescribed. Non-adherence means that the patient is not following treatment as prescribed. There are many ways in which patients can be non-adherent: they can fail to take medications as prescribed (dose, schedule); they can miss appointments at the clinic; they can fail to follow advice about living a healthy lifestyle, like decreasing alcohol consumption, avoiding smoking. The community health worker, social worker and clinician all play an important role in ensuring adherence to treatment. The community health worker helps ensure adherence: delivering the drugs to the patient and observes that s/he takes them reporting to the clinician any problems with adherence tracking patients who miss their clinic visits educating patients on the importance of adherence evaluating patients psychosocial situation and lifestyle, providing support, watching for side effects and referring to the clinic if needed The social worker helps ensure adherence by: evaluating patients who are non-adherent to determine the source of the problem providing the psychosocial services/counseling necessary to mitigate the problems that lead to non-adherence educating the patient on the importance of adherence The clinician helps ensure adherence by: evaluating the patients adherence to ART during every clinic visit identifying patients who miss clinic visits determining the cause of non-adherence coordinating with the community health worker and social worker to find strategies to improve adherence The clinician, community health worker (including the community health worker leaders), and social worker work as a team to ensure adherence in patients. Clinicians evaluate adherence during every clinic visit by asking: In the last 30 days or since your last visit, how many doses have you missed? Why? Does the community health worker deliver your drugs every day and watch you swallow them? How many times a day does s/he deliver your drugs? Non-adherence to ART will prevent the patient from suppressing HIV replication. This will lead to disease progression and can also lead to the development of drug resistance, a process by which the HIV mutates and no longer responds to the antiretroviral drugs. 43

45 CASE STUDIES Tasks: In your group, read the case that corresponds to the number on the chart paper that your group received. Discuss these questions and write your responses on the chart paper. What is the challenge in this case? What are possible solutions to this adherence challenge? After 5 minutes, pass your chart paper to a different group, so that each group gets a new case. Read your new case (that corresponds to the number on the new chart paper), look over the responses the other group wrote on the paper already, and decide whether to add anything. Then pass that case on to another group and receive another case. Circulate the cases in this manner until each group has worked on all cases. Adherence Case Study #1 Marie is a 14-year-old girl who attends boarding school. Each day her community health worker, who is her teacher, stands at the front of the class and asks Marie to come take her medicine. This embarrasses Marie and she does not like being different from her friends, so she stopped coming to class one week ago. What is the challenge in this case? What are possible solutions to this adherence challenge? Adherence Case Study #2 Joseph is a 32-year-old man who has been taking ART for three years. His community health worker informs you that Joseph is often not at home in the morning when he delivers his medicines. His wife says he is out cultivating the new land they received from a family member. What is the challenge in this case? What are possible solutions to this adherence challenge? 44

46 Adherence Case Study #3 Charles is a 21-year-old man who just started taking ART three months ago. Whenever his community health worker goes to his house to deliver his medicines, Charles tells him that he no longer needs to take it because he is feeling much better. The community health worker helps him understand why it is important to continue taking the medicines, but sometimes Charles refuses to take it. He has missed 2 doses since his last visit at the clinic three weeks ago. What is the challenge in this case? What are possible solutions to this adherence challenge? Adherence Case Study #4 Beatrice is a 29-year-old widow who just moved to the area and recently started ART. She does not know her neighbors and does not want them to know she has HIV. For a couple of days, she walked to meet the community health worker outside of the village to take her medicines, but recently, she has missed all of her appointments with the community health worker and clinic. She comes to the clinic today because of a new health complaint. What is the challenge in this case? What are possible solutions to this adherence challenge? Adherence Case Study #5 William is a 36-year-old man who has been in the HIV Program for 5 years. He knows that he is supposed to take his morning and nighttime doses, but his community health worker does not always show up for nighttime visits. What is the challenge in this case? What are possible solutions to this adherence challenge? KEY POINT Addressing adherence issues can be challenging. Clinicians, social workers, and community health workers must work as a team to understand the problem and to find creative solutions to help patients adhere to their treatment and clinic visits. 45

47 Monitoring The Response To ART Once a patient starts ART, the clinician must monitor whether s/he is responding well to treatment and what actions to take when s/he is not responding as expected. A patient s response to treatment can be monitored by: Assessing her/his clinical status at every follow-up visit for symptoms of new opportunistic infections and changes in weight. In general, the absence of new opportunistic infections and weight gain are good indicators that the patient is responding well to treatment. Assessing her/his immunological status by measuring the CD4 cell count every 6 months. A patient should improve clinically within 3 months of starting ART. For example, s/he should gain weight, opportunistic infections should diminish, etc. The CD4 cell count should increase by at least 50 cells/mm 3 in the first six months of ART. On average, an increase of about 150 cells/mm 3 in the first year of treatment can be expected to occur in treatmentnaïve patients. However, patients with a very low baseline CD4 cell count might have a slower build up of CD4 cells. Treatment failure is the term used to describe when a patient s health fails to improve or worsens despite ART. Treatment failure can occur at 3 levels: Clinical failure when the patient s clinical status deteriorates despite taking ART. Disease progression should be considered in the patient presenting with a new infection, recurrent infection, or malignancy. Immunological failure the patient s CD4 cell count decreases despite taking ART. Virological failure the patient s viral load (amount of HIV in a sample of blood) increases despite taking ART. It is important to note that a deterioration of the patient s clinical status can occur a few weeks to 6 months after starting ART because of Immune Reconstitution Inflammatory Syndrome (IRIS). IRIS is an inflammatory response to a previously unrecognized subclinical opportunistic infection (like tuberculosis, for example). This should NOT be considered as clinical failure, but rather that the patient s immune system is getting stronger with ART and is now capable of combating opportunistic infections that were already present in the body. The patient can become quite ill, but rarely should ART be discontinued. IRIS should be treated by an experienced clinician. 46

48 Criteria For Treatment Failure CLINICAL FAILURE When the patient s clinical status deteriorates despite taking ART. Disease progression should be considered in the patient presenting with a new infection, recurrent infection, or malignancy. IMMUNOLOGIC FAILURE (CD4 CELL COUNT) VIROLOGIC FAILURE (VIRAL LOAD) A return of CD4 counts to the pre-treatment baseline or below (in the absence of any concomitant infection that is liable to cause a transient reduction in CD4) or A fall of more than 50% in the CD4 cell count below the peak value ever obtained after initiating ART (in the absence of any concomitant infection that is liable to cause a transient reduction in CD4) Detectable viral load (VL > 1,000) after 6 months of treatment in a patient with good adherence to ART If a patient meets any of these criteria, treatment failure must be suspected and its causes investigated. The viral load can, however, be used to confirm treatment failure in a patient who presents clinical or immunological failure. Possible Causes of Treatment Failure in a Patient Receiving ART DRUG INTERACTIONS: E.G. NVP WITH ANTI-TB POOR ADHERENCE TO TREATMENT BY THE PATIENT CAUSES OF ARV TREATMENT FAILURE OPPORTUNISTIC INFECTIONS E.G. TB RESISTANCE OFTHE VIRUS TO THE DRUGS PRESCRIPTION ERROR OR POOR ABSORPTION Adapted from: Guidelines for the provision of comprehensive care to persons infected by HIV in Rwanda. Ministry of Health. Republic of Rwanda

49 The factors that can cause treatment failure include: Levels of antiretroviral drugs in the blood are too low to suppress HIV replication because of: Poor adherence to ART (most common cause and first thing to investigate in a patient with treatment failure) Prescription errors (dose of medication too low) Poor absorption of medication (e.g., vomiting, diarrhea) Drug interactions Particular attention has to be paid to this as drug resistance can develop quickly in these circumstances. Drug resistance when the levels of antiretroviral drugs in the blood are not adequate to suppress HIV replication, a change in the genetic material of the HIV virus, known as a mutation, can occur. HIV can then multiply even in the presence of these antiretroviral drugs. New opportunistic infection or other major illness - an opportunistic infection or other illness such as major surgery may cause a transient decline in a CD4 cell count (e.g. tuberculosis). If you suspect treatment failure in a patient: Verify the patient s adherence in a precise manner; always involve the community health worker and social worker in these discussions. Rule out any drug interactions or poor absorption. Verify that ART doses are correct. Verify whether a current opportunistic infection may be causing a transient decline in CD4s. If there is tuberculosis, treat it and check the CD4 cell count after the intensive phase and at the end of tuberculosis treatment and decide accordingly. Repeat a CD4 cell count in 3-4 weeks to rule out lab errors. Provide counseling to ensure optimal adherence during the waiting period before the next test. Do not allow more than 4 weeks to pass in case the failure is real. If treatment failure is highly suspected, order a viral load. A viral load >1,000 copies/ ml after 6 months of treatment with good adherence is an indication to change to second-line therapy. Discuss all cases of suspected treatment failure with an experienced clinician. The decision to change ART from a first-line regimen to a second-line regimen should always be taken by a team of clinicians. If treatment failure is confirmed, the regimen must be changed. Work very closely with the community health worker to ensure adherence to the second-line regimen. Treatment failure is very serious and needs to be diagnosed quickly and managed effectively. If you suspect treatment failure, DO NOT WAIT AND CONSULT AN EXPERIENCED CLINICIAN IMMEDIATELY. 48

50 Recommendations For Switching From a First-Line Regimen to a Second-Line Regimen in Non-Pregnant Adults* FIRST-LINE REGIMENS RECOMMENDED SECOND-LINE REGIMEN TDF /3TC / NVP or TDF / 3TC / EFV or TDF / FTC / NVP or TDF / FTC / EFV ABC / 3TC / NVP or ABC / 3TC / EFV AZT / 3TC / NVP or AZT / 3TC / EFV or D4T / 3TC / NVP or D4T / 3TC / EFV A clinician should never take the decision to change a patient from a first-line regimen to a second-line regimen alone. A team of experienced clinicians should review the case and take the decision as a group. KEY POINTS AZT / 3TC / Lop/r AZT / 3TC / Lop/r TDF / 3TC / Lop/r * Consider drug-drug interactions with the new ART regimen, especially as it relates to treatment of new opportunistic infections. 1. Once a patient starts ART, response to treatment is monitored by assessing her/ his clinical status at every follow-up visit and assessing her/his immunological status by measuring the CD4 cell count every 6 months. 2. If a patient s health fails to improve or worsens despite ART (s/he has symptoms of HIV disease, her/his CD4 count decreases, or the viral load increases), treatment failure must be suspected and investigated. 3. As poor adherence is a common cause of treatment failure, the community health worker and social worker must be involved when discussing treatment failure cases. 4. Treatment failure is very serious and needs to be diagnosed quickly and managed effectively. Experienced clinicians must be consulted immediately, and the decision to switch to a second-line regimen must be taken as a group. 49

51 Monitoring Side Effects of ART The most common side effects are usually not life-threatening, but they may prevent patients from adhering to treatment, so they must be managed aggressively. Although rare, some side effects can be dangerous and life-threatening. Clinicians must be able to recognize these side effects immediately and manage them appropriately. A clinician must always: Know what side effects to expect from the antiretroviral drugs s/he is prescribing. Explain the potential side effects of antiretroviral drugs to patients so they can recognize them early and come to the clinic. Ask patients during each visit whether they are experiencing side effects to their medication. The side effects chart is divided into three major sections that indicate the severity of a side effect. Minor: minor side effects are often seen at the start of treatment; if other serious causes are ruled out, a minor side effect rarely requires changing a medication, and clinicians can provide reassurance to the patient. Serious: serious side effects may require a change in medication, and always require careful assessments. Urgent: urgent side effects require clinicians to stop the patient s current treatment immediately, consult an experienced clinician. 50

52 Minor SIDE EFFECT OFFENDING AGENTS FREQUENCY AND TIME OF PRESENTATION, DIFFERENTIAL DIAGNOSIS MANAGEMENT Gastrointestinal intolerance: nausea, vomiting, diarrhea, anorexia AZT, ddi PIs (particularly ritonavir) Common in first weeks of treatment Differential diagnosis: hepatotoxicity Usually self-limiting after a few weeks. Offer symptomatic treatment. Discolored nails: black or blue nails Headache Fatigue Strange dreams (without adverse neurological or psychiatric effects) NVP AZT AZT, TDF PIs AZT, TDF PIs Rare; occurs 2 to 6 weeks after starting treatment Differential diagnosis: none Common in first weeks of treatment Differential diagnosis: IRIS Common in first weeks of treatment Differential diagnosis: anemia, opportunistic infections EFV Common in the first 2 to 3 weeks Reassure the patient. Changing ART is not indicated. Usually self-limiting after a few weeks. Rule out other causes. Offer symptomatic treatment (e.g. paracetamol). Usually self-limiting after a few weeks. Rule out other causes. Usually self-limiting after a few weeks, although vivid dreams may continue in some patients. Differentiate between strange dreams and insomnia, and rule out other causes. If persistent and bothersome, consult an experienced clinician. 51

53 Serious SIDE EFFECT OFFENDING AGENTS FREQUENCY AND TIME OF PRESENTATION, DIFFERENTIAL DIAGNOSIS MANAGEMENT Central nervous system disturbance: impaired concentration, nightmares, and depression (risk of suicide) Peripheral neuropathy: numbness, pain, or tingling in extremities Lipoatrophy: loss of fat in buttocks, face, arms, or legs Fat accumulation: fat accumulation on upper back, breasts, or abdomen Dyslipidemia, hyperglycemia: alterations in blood lipids or glucose levels Myopathy: muscle wasting, weakness, cramping EFV d4t, ddi d4t, ddi PIs EFV d4t, ddi, AZT Common; usually occurs immediately after starting treatment Differential diagnosis: cerebral malaria, chronic meningitis (tuberculosis, cryptococcal, neurosyphilis), HIV-related dementia, nutritional deficiencies (especially niacin) Common; occurs during the first year of treatment Differential diagnosis: HIVassociated neuropathy, vitamin deficiencies (B1, B6, B12), diabetes mellitus Common with long-term use; gradually appears months after start of treatment Differential diagnosis: weight loss related to HIV progression Variable frequency; occurs late in therapy Differential diagnosis: new onset of diabetes mellitus Rare; occurs late in therapy Differential diagnosis: HIVassociated myopathy Usually self-limiting after a few weeks. Warn the patient of this potential side effect before treatment starts. Switch EFV for NVP if symptoms persist. Switch offending agent for a less neurotoxic NRTI (e.g. switch d4t/ddi for TDF). Switch offending agent (e.g. switch d4t/ddi for TDF or ABC). May slow or halt progression, but effects may be irreversible. Diet and exercise. Consult experienced clinician for appropriate treatment of dyslipidemia and hyperglycemia. Switch offending agent if symptoms are intolerable and cannot be attributed to another cause. Bone marrow suppression: anemia, leukopenia AZT Rare; occurs during first year of therapy Differential diagnosis: malaria, nutritional deficiencies, chronic parasitic infection Switch AZT for TDF. Consider blood transfusion. Nephrotoxicity, renal calculi TDF IDV Rare; more common with impaired baseline renal function; usually occurs after weeks or months of treatment Differential diagnosis: HIVrelated renal insufficiency, pyelonephritis Switch offending agent (e.g. switch TDF for AZT). Consult experienced clinician for appropriate treatment of nephrotoxicity and renal calculi. 52

54 Urgent SIDE EFFECT OFFENDING AGENTS FREQUENCY AND TIME OF PRESENTATION, DIFFERENTIAL DIAGNOSIS MANAGEMENT Hepatotoxicity: jaundice, abdominal pain Pancreatitis: severe abdominal pain Rash: can range from mild rash with or without itching to severe, painful rash with fever, mucous membrane ulcers, edema, or shock NVP PIs TMP/SMX d4t, ddi (especially when used in combination) NVP PIs TMP/SMX ABC (see below) Rare; hepatotoxicity related to NVP usually occurs in the first 12 weeks of treatment; hepatotoxicity related to PIs and TMP/SMX can occur anytime during therapy Differential diagnosis: viral hepatitis, cytomegalovirus infection Rare; occurs late in therapy Differential diagnosis: gallstones, cholecystitis, alcoholic pancreatitis, gastroduodenal ulcers Rare; usually occurs early in therapy Differential diagnosis: hypersensitivity to ABC If liver function tests > 3x normal value, stop ART and TMP/SMX. After resolution of symptoms and laboratory abnormalities, resume ART but avoid most likely offending agent (e.g. switch NVP for EFV). Stop ART and give supportive treatment. After resolution of symptoms and laboratory abnormalities, resume ART but switch most likely offending agent (e.g. switch d4t/ddi for TDF). In mild cases, give antihistamines and observe. In moderate cases with no mucosal involvement, switch offending agent (eg. switch NVP for EFV). In severe cases with mucosal involvement (called Stevens-Johnson Syndrome), stop ART and give supportive treatment. After resolution, resume ART but avoid most likely offending agents (e.g. switch NVP for LPV/r). To resume PCP prophylaxis, switch TMP/ SMX for dapsone. Hypersensitivity to ABC: rash, fever, fatigue, cough, or dyspnea while taking ABC ABC Rare; usually occurs within 2 months of starting treatment Differential diagnosis: anaphylaxis to other drugs Stop ABC and give symptomatic treatment. Do not restart ABC (e.g. switch ABC for AZT). Re-exposure could lead to life threatening allergic reaction. Lactic acidosis: fatigue, weakness, myalgias, nausea, vomiting, abdominal pain, weight loss d4t, ddi Rare; occurs late in therapy Differential diagnosis: hepatitis Stop ART and give supportive treatment. After resolution of symptoms, restart ART and replace most likely offending agents. 53

55 Side effects in the Serious and Urgent charts often require a substitution of the offending agent. The final decision to change a drug should be made in consultation with an experienced clinician. The side effect and its management must be well documented in the patient s file so that the patient is not given this drug again in the future. KEY POINTS 1. Know what side effects to expect from the antiretroviral drugs you are prescribing. 2. Explain the potential side effects of antiretroviral drugs to patients so they can recognize them early and come to the clinic. 3. Ask your patients during each visit whether they are experiencing side effects to their medication. 4. Keep the Side Effects Chart in a place where you can access and refer to them easily. 5. The final decision to change a drug should be made in consultation with an experienced clinician. 6. The side effect and its management must be well documented in the patient s file. Completing the Follow-Up Form and Summary Form Clinicians must complete the follow-up and summary forms to document patient s status during every monitoring visit. As with the enrollment form, it is important to fill out the follow-up and summary forms accurately and legibly. The forms will be kept in the patient s chart, and the information contained in the form will also be stored in the EMR System. These forms can be found in the Annex at the back of the manual. 54

56 ROLE PLAY Tasks: You will now practice filling out the follow-up and summary forms by doing a role play with a partner. First decide who will play the role of the patient and who will play the role of the clinician. The person playing the patient should read scenario #1 below. The person playing the clinician SHOULD NOT read the scenario but can prepare by reviewing the enrollment form. During the role play, the clinician will interview the patient and the patient will provide the information from the scenario, including the results of the physical exam (the clinician does not have to perform the exam). The clinician will complete the follow-up form, using the information provided by the patient. After the interview, fill out the summary form together based on the information gathered on the follow-up form. Then, switch roles and do the second role play, with the former patient now playing the clinician, and vice versa. Scenario #1 Your name is Jean, and you are a 26-year-old male. You have been in the HIV Program for 7 months and you return to the clinic today for a regular monitoring visit. You have been on the same ART regimen since entering the program. You are also continuing cotrimoxizole prophylaxis. You don t have any side effects to your medication. You still have the same community health worker and things are going well with her. You are still living at the same address. Your community health worker comes to your house twice a day to deliver your drugs (early in the morning and around 6 o clock at night) and watches you take them. You have not missed any doses since your last visit. Your six-month CD4 cell count was done during your last monitoring visit and the result was 340cells/mm 3. You are sexually active with your new wife and you are not using condoms consistently nor any other type of contraception. You successfully completed your anti-tb treatment last month. Since then, you have not had any coughing, night sweats, fever, weight loss or had any contact with a known tuberculosis patient. You are not presenting any symptoms of sexually transmitted infections (pain on urination, genital lesions, or scrotal swelling) or any diarrhea. You do not have any other symptoms. You have not been hospitalized since your last visit. Jean s Physical Exam Findings Weight = 59 kg Height = 169 cm Temp 37.0 C, pulse 80/min, RR 16/minute, TA 11/8 Good general state All other parts of the exam are normal Scenario #2 55

57 Your name is Claudine, and you are a 32-year-old female. You have been in the HIV Program for 7 months and you return to the clinic today for a regular monitoring visit. You have been on the same ART regimen since entering the program. You are also continuing cotrimoxizole prophylaxis. You don t have any side effects to your medication. You still have the same community health worker and things are going well with her. You are still living at the same address. Your community health worker comes to your house twice a day to deliver your drugs (early in the morning and around 6 o clock at night) and watches you take them. You have not missed any doses since your last visit. Your six-month CD4 cell count was done during your last monitoring visit and the result was 367cells/mm 3. You are sexually active with your husband and you are using condoms consistently. You are not taking any other medication. You do not have any coughing, night sweats, fever, weight loss or had any contact with a known tuberculosis patient. You are not presenting any symptoms of sexually transmitted infections (pain with urination, vaginal discharge, genital lesions, or lower abdominal pain) or any diarrhea. You do not have any other symptoms. You have not been hospitalized since your last visit. Claudine s Physical Exam Findings Weight = 49 kg Height = 153 cm Temp 37.2 C, pulse 84/min, RR 16/minute, TA 10/6 Good general state All other parts of the exam are normal KEY POINTS 1. Just like the enrollment form, the follow-up form is an important tool to help the clinician perform a thorough monitoring visit. 2. The summary form is important to help monitor the patient s progress from one visit to the next. 3. The follow-up and summary forms must be filled out correctly and legibly so the patient s progress can be tracked accurately. 56

58 Case Studies Clinicians must recognize when a patient s HIV infection or treatment is not progressing the way it should, examine possibilities for responding, and find a solution to the problem. In complex cases, clinicians should always consult an experienced clinician before making any treatment decisions. Tasks: Read each case and discuss the related questions. CASE STUDY #1 Josephine is a 23-year-old woman who was diagnosed with HIV 1 month ago. Her CD4 count was 287 cells/mm 3 so ART and cotrimoxazole were started 2 weeks ago. She is back today, 2 weeks later, for a follow-up visit. She complains of nausea and vomiting. She says that since her new boyfriend is also HIV-positive, they haven t been using condoms. She says that she would like children in the future, but not right now. What facts about Josephine make you worried about her case? What are possible causes of Josephine s symptoms? What next steps should you take with this patient? What advice should you give Josephine about managing the nausea and vomiting? 57

59 CASE STUDY #2 Charles is a 37-year-old man who has been in the HIV Program since He started ART in March He is followed at the HIV clinic every 2 months, but he missed is last appointment. He is back today for a regular visit and said that he missed his last visit because he was visiting relatives in another district. He is unsure about how many doses of medication he missed in the past month. His last CD4 cell count 5 months ago was 417 cells/mm 3. Today his CD4 count is 400 cells/ mm 3. When asked about his condom use, he says he uses them occasionally. What facts about Charles make you worried about his case? What are possible causes of Charles decrease in CD4 cells? What next steps should you take with this patient? When do you want to see Charles at the clinic again? CASE STUDY #3 Claudine is a 42-year-old woman who has been in the HIV Program since She started ART in April 2007 when her CD4 cell count fell below 350 cells/mm 3 for the first time. She has been on the same regimen since then. During her regular follow-up visit today, she complains of general fatigue. She had the same complaint during her last follow-up visit, but she says it has gotten worse since then. She looks unwell and tired. She says that she sometimes uses condoms, but hasn t used them at all in the past 2 months. Her pregnancy test today is negative. She hasn t noticed any significant weight loss, but you chart her weight today in comparison to previous visits and notice the downward trend over the last 8 months with a total weight loss of 13% of her body weight. She denies problems taking ART. She reports 2 missed doses in the last month. What facts about Claudine make you worried about her case? What could explain Claudine s condition? What next steps should you take with this patient? 58

60 Patient Education PART 5 and Prevention Counseling Patient Education and Prevention Counseling Education and prevention work together: as patients understand their disease better, they can take actions that will help them stay healthy and prevent transmission of HIV to others. Before starting ART, patients attend an education session on HIV. A nurse teaches the medical aspects of the disease, such as how HIV is transmitted, how to take ART correctly, and how to recognize side effects, and the social worker educates on adherence, nutrition, and healthy living. Patients often find it hard to absorb all the information shared with them during this initial education session. To reinforce these messages, clinicians should provide education and prevention counseling to patients during every visit. There are two main components to education and prevention counseling: WHAT to discuss and HOW to discuss it. 59

61 WHAT to discuss: Key education and prevention messages Sexual partners and prevention of HIV transmission (and other STIs): Ask about any new sexual partners; ask if they use condoms during every sexual encounter; ask if they told their sexual partners about their HIV status and if their sexual partners been tested; ask how their partners can be encouraged to be tested; discuss methods to prevent HIV transmission to partners and to protect themselves against other STIs; distribute condoms. Adherence to ART and clinic visits: Explain that taking medication keeps them healthy and prevents their disease from progressing; visiting the clinic is vital to ensure proper follow-up and treatment. Side effects of ART: Remind patients of side effects and symptoms that should prompt coming to the clinic. Healthy living: Advise them to avoid alcohol and smoking; practice good hygiene and nutrition; avoid isolation. Family planning: Ask if they want children; explain what they can do to prevent an unwanted pregnancy; refer them to the family planning clinic; discuss the different options when HIV-positive couples want to conceive. HOW to discuss it: Good communication techniques Use direct eye contact Show a nonjudgmental attitude Use simple language that the patient will understand Conduct the visit in a private space Ensure confidentiality Ask the patient to bring a family member with them if possible so more than one person is learning the information Ask the patient to explain back to you what you have just said (this is sometimes called the talk-back method) to make sure s/he understands Repeat the messages during every visit 60

62 Tasks: ROLE PLAY Choose one person to play the role of Robertine and one to play the role of the clinician. Perform the role play (no more than 5 minutes). The clinician should use the key education and prevention messages and the communication techniques, including the talk-back method. Switch roles and repeat the steps. Scenario Robertine is a 36-year-old HIV-positive patient who has been in the HIV Program for several years. She comes to the clinic today for a regular monitoring visit, but you notice in her medical chart that she missed her last appointment at the clinic. She is married with five children. She does not use any birth control methods and she and her husband do not use condoms regularly. KEY POINTS 1. To reinforce education and prevention messages, clinicians should provide education and prevention counseling to patients during every visit. 2. Education and prevention counseling should include discussions about sexual partners and prevention of HIV transmission (and other STIs), adherence to treatment and clinic visits, side effects of ART, healthy living, and family planning. 3. Use good communication techniques to make patients feel more comfortable and able to ask questions and absorb the information. 61

63 Condom Review Both male and female condoms provide a barrier between the two people so sperm, vaginal secretions, and the HIV virus cannot pass between them. Clinicians should always have condoms at hand when seeing patients and they should distribute an adequate supply to the patient to last until her/his next appointment. Sometimes patients are shy when taught about condoms. Males are often reluctant to use them. Women are often reluctant to ask their partners to use them. However, they are the best defense against HIV/AIDS except for abstinence, so it is important to educate patients about them. How to Use a Male Condom How to Use a Male Condom FAMILY PLANNING

64 How to Use a Female Condom KEY POINTS 1. Condoms effectively protect against HIV and other sexually transmitted infections. 2. Clinicians should always have condoms at hand when seeing patients and they should distribute an adequate supply to the patient to last until her/his next appointment. 63

65 Conclusion Task: Reflect silently on how you can use what you have learned in this unit to improve your work when you return to your clinic. When you have reflected for a minute or two, write down three things you will CHANGE in your practice to use what you have learned. These will be your three resolutions. Resolutions: 64

66 Glossary Bone marrow suppression: Decreased production of one or more of the types of blood cells produced in the bone marrow (i.e. red blood cells, white blood cells, and platelets), which could result in clinical manifestations such as anemia, decreased immunity, and increased bleeding or bruising. Epidemiology: The study of factors which affect the health of a population. Hepatotoxicity: Damage to the liver caused by infection or drugs (i.e. prescription drugs, illicit drugs, or alcohol abuse). Evidence of hepatotoxicity can include abnormal liver function tests and clinical signs such as jaundice, abdominal pain, nausea, vomiting, diarrhea, weakness, and liver enlargement. Initial phase: The first 15 days of antiretroviral therapy. Maintenance phase: The second and long-term phase of antiretroviral therapy that follows the initial phase. Post-Exposure Prophylaxis: Antitretroviral therapy that is given to a person who is HIV-negative or of unknown HIV status immediately after exposure to the HIV virus (for example, after a needle stick injury or rape). Prevalence: The total number of cases of a disease that exist in a particular location and population. Renal toxicity: Damage to the kidneys caused by a medication or toxin with subsequent abnormal kidney function labs. Rapid Plasma Reagin (RPR): A blood test used to screen for syphilis. Stevens-Johnson Syndrome: A rare, severe, and potentially life-threatening problem generally characterized by flu-like symptoms and painful rash that involves the skin and mucous membranes followed by the skin shedding off. Stevens-Johnson Syndrome has been linked to various stressors as: drugs, infection, or malignancy. Common drug associations include NNRTIs such as NVP and sulfonamide drugs such as SMP-TMZ. Patients with sulfonamide reactions may also cross react to PIs such as amprenavir. 65

67 Abbreviations AIDS: Acquired Immunodeficiency Syndrome ART: Antiretroviral Therapy ARV: Antiretrovirals BMI: Body Mass Index DOT: Directly Observed Therapy HIV: Human Immunodeficiency Virus RPR: Rapid Plasma Reagin Key References 1. Guidelines for the Provision of Comprehensive Care to Persons Infected by HIV in Rwanda. Ministry of Health. Republic of Rwanda The PIH Guide to the Community-Based Treatment of HIV in Resource-Poor Settings. Revised 2 nd edition. Partners In Health. Boston Antiretroviral Therapy for HIV Infection in Adults and Adolescents in Resource-limited Settings: Towards Universal Access. Recommendations for a Public Health Approach. World Health Organization Rapid Advice. Antiretroviral Therapy for HIV Infection in Adults and Adolescents. World Health Organization. November NOTE: Revised WHO guidelines on antiretroviral therapy for HIV infection in adults and adolescents are expected in Pocket Guide. Adult HIV/AIDS Treatment. John G. Bartlett, MD. The John Hopkins University, School of Medicine Bartlett, J.G. Gallant, J.E. Pham, P. (2009) Medical Management of HIV Infection. 66

68 Pre-Test 1. Which of the following is NOT a central activity of the HIV Program: A. Continuous monitoring of HIV-positive patients B. Early introduction of antiretroviral therapy and other therapies C. Provision of prenatal care to HIV-positive pregnant patients D. Initial evaluation of a new HIV-positive patient 2. Which of these team members is involved in assessing the psychosocial situation of patients in the HIV Program: A. Social workers B. Clinicians C. Community health workers D. All of the above 3. Fill in the blank: A CD4 cell count less than cells/mm 3 is an indication to start antiretroviral therapy. 4. Which of the following WHO clinical stage(s) require(s) starting antiretroviral therapy regardless of the CD4 cell count: A. 2 B. 4 C. 1 and 2 D. 3 and 4 5. Fill in the blank: An HIV-positive patient comes to clinic with a cough and fever. You determine he has pulmonary tuberculosis. What is this patient s WHO clinical stage? 6. In the HIV Program, nutritional support is provided for 6 months to which of the following group of patients: A. All patients newly enrolled in the HIV Program B. All patients with a BMI between 18.5 and 20 C. Patients diagnosed with tuberculosis and HIV co-infection and/or have a BMI below 18.5 D. Only patients with a CD4 cell count below 100 cells/mm 3 7. True or False: To effectively suppress the HIV replication cycle, a combination of two antiretroviral drugs must be used. A. True B. False 67

69 8. Which of the following antiretroviral drug classes are used to treat HIV infection in Rwanda: 1. Reverse transcriptase inhibitors 2. Protease inhibitors 3. Fusion inhibitors 4. Integrase inhibitors Choose A, B, C, or D A. #1 only B. #3 only C. #1 and #2 D. #3 and #4 9. Cotrimoxazole prophylaxis is given to HIV-positive patients to prevent: A. Treatment failure B. Dangerous infections, such as toxoplasmosis or Pneumocystis pneumonia C. Tuberculosis D. Urgent side effects to antiretroviral therapy 10. Fill in the blank: For HIV-positive patients, the CD4 cell count is measured every months to monitor their immunological status. 11. Which of the following are ways in which community health workers help patients adhere to their treatment? A. They provide Directly Observed Therapy (DOT) B. They deliver drugs to the patient every day C. They visit the patient twice a week and do a pill count D. A & B E. A & C 12. True or False: Treatment failure can occur at three levels: clinical failure (as evidenced by a new or recurrent WHO stage 4 illness while on ART); immunological failure (as evidenced by a return of the CD4 cell count below the pre-art baseline or a fall of more than 50% below the peak value ever obtained after initiating ART); virological failure (as evidenced by a detectable viral load after 6 months of ART). A. True B. False 13. A decrease in the CD4 cell count of a patient on antiretroviral therapy is: A. Serious and always caused by non-adherence to treatment B. Serious and can be caused by non-adherence to treatment, HIV resistance to antiretroviral drugs, or a new opportunistic infection C. Not serious and can be reversed by providing nutritional support D. Not serious and almost always a laboratory error 68

70 14. True or False: When starting antiretroviral therapy, minor side effects such as nausea and fatigue are common and often disappear spontaneously after a few weeks of treatment. A. True B. False 15. Which of the following is NOT an urgent side effect of antiretroviral drugs: A. Hypersensitivity to ABC B. Lactic acidosis C. Blue or black discoloration of nails D. Pancreatitis 16. Which of the following antiretroviral drugs can cause anxiety, depression and nightmares shortly after starting antiretroviral therapy: A. ABC B. NVP C. AZT D. EFV 17. Which of the following communication techniques used by clinicians are effective at helping patients understand and remember information about their disease or treatment: A. Ask the patient to explain back in their own words the information that was given to them (talk-back method) B. Repeat the same messages at every visit C. Use simple language D. All of the above 18. True or False: Both male and female condoms provide a barrier between the two people during sexual intercourse so sperm, vaginal secretions, and the HIV virus cannot pass between them. A. True B. False 69

71 Post-Test 1. Which of the following is NOT a central activity of the HIV Program: A. Continuous monitoring of HIV-positive patients B. Early introduction of antiretroviral therapy and other therapies C. Provision of prenatal care to HIV-positive pregnant patients D. Initial evaluation of a new HIV-positive patient 2. Which of these team members is involved in assessing the psychosocial situation of patients in the HIV Program: A. Social workers B. Clinicians C. Community health workers D. All of the above 3. Fill in the blank: A CD4 cell count less than cells/mm 3 is an indication to start antiretroviral therapy. 4. Which of the following WHO clinical stage(s) require(s) starting antiretroviral therapy regardless of the CD4 cell count: A. 2 B. 4 C. 1 and 2 D. 3 and 4 5. Fill in the blank: An HIV-positive patient comes to clinic with a cough and fever. You determine he has pulmonary tuberculosis. What is this patient s WHO clinical stage? 6. In the HIV Program, nutritional support is provided for 6 months to which of the following group of patients: A. All patients newly enrolled in the HIV Program B. All patients with a BMI between 18.5 and 20 C. Patients diagnosed with tuberculosis and HIV co-infection and/or have a BMI below 18.5 D. Only patients with a CD4 cell count below 100 cells/mm 3 7. True or False: To effectively suppress the HIV replication cycle, a combination of two antiretroviral drugs must be used. A. True B. False 70

72 8. Which of the following antiretroviral drug classes are used to treat HIV infection in Rwanda: 1. Reverse transcriptase inhibitors 2. Protease inhibitors 3. Fusion inhibitors 4. Integrase inhibitors Choose A, B, C, or D A. #1 only B. #3 only C. #1 and #2 D. #3 and #4 9. Cotrimoxazole prophylaxis is given to HIV-positive patients to prevent: A. Treatment failure B. Dangerous infections, such as toxoplasmosis or Pneumocystis pneumonia C. Tuberculosis D. Urgent side effects to antiretroviral therapy 10. Fill in the blank: For HIV-positive patients, the CD4 cell count is measured every months to monitor their immunological status. 11. Which of the following are ways in which community health workers help patients adhere to their treatment? A. They provide Directly Observed Therapy (DOT) B. They deliver drugs to the patient every day C. They visit the patient twice a week and do a pill count D. A & B E. A & C 12. True or False: Treatment failure can occur at three levels: clinical failure (as evidenced by a new or recurrent WHO stage 4 illness while on ART); immunological failure (as evidenced by a return of the CD4 cell count below the pre-art baseline or a fall of more than 50% below the peak value ever obtained after initiating ART); virological failure (as evidenced by a detectable viral load after 6 months of ART). A. True B. False 13. A decrease in the CD4 cell count of a patient on antiretroviral therapy is: A. Serious and always caused by non-adherence to treatment B. Serious and can be caused by non-adherence to treatment, HIV resistance to antiretroviral drugs, a new opportunistic infection, or acute illness C. Not serious and can be reversed by providing nutritional support D. Not serious and almost always a laboratory error 71

73 14. True or False: When starting antiretroviral therapy, minor side effects such as nausea and fatigue are common and often disappear spontaneously after a few weeks of treatment. A. True B. False 15. Which of the following is NOT an urgent side effect of antiretroviral drugs: A. Hypersensitivity to ABC B. Lactic acidosis C. Blue or black discoloration of nails D. Pancreatitis 16. Which of the following antiretroviral drugs can cause anxiety, depression and nightmares shortly after starting antiretroviral therapy: A. ABC B. NVP C. AZT D. EFV 17. Which of the following communication techniques used by clinicians are effective at helping patients understand and remember information about their disease or treatment: A. Ask the patient to explain back in their own words the information that was given to them (talk-back method) B. Repeat the same messages at every visit C. Use simple language D. All of the above 18. True or False: Both male and female condoms provide a barrier between the two people during sexual intercourse so sperm, vaginal secretions, and the HIV virus cannot pass between them. A. True B. False 72

74 ANNEX 1 Patient Visit Card Partners In Health Name: Clinic: Accompagnateur: TRACnet Number: Treatment Plan: Group: Clinical Appointment Schedule Scheduled Appointment Date/Time Appointment Respected Food Program Schedule Scheduled Appointment Date/Time Appointment Respected 73

75 ANNEX 1 Community Health Worker Treatment Form Patient Name Accompagnateur Name Medicine and Dosage Times (AM) Medicine and Dosage Times (PM) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec A A A A A A A A A A A A 74

76 REPUBLIC OF RWANDA TRACnet N o MINISTRY OF HEALTH Health Center: ADULT MEDICAL CHART ( 15 YEARS) Exit from program Date of exit : / / Reason for exit : Transferred to : Deceased : Date / / Lost to follow-up Date of exit : / / Reason for exit : Transferred to : Deceased : Date / / Lost to follow-up Date of exit : / / Reason for exit : Transferred to : Deceased : Date / / Lost to follow-up 75

77 Form for important medical appointments according to the protocol of care EMR Date Reason for appointment EMR Actual appoint- Scheduled visit scheduled ment date Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Monthly appt Other: Yes No, reason: Date lost to follow-up Date of return Comments / / / / / / / / / / / / / / / / / / / / / / / / 76

78 PATIENT SUMMARY FORM 77

79 PATIENT SUMMARY - ADULT LAST NAME: FIRST NAME: TRACnet#: Name of the health center: Date of birth: / / Height: cm Date of enrollment: / / (dd/mm/yyyy) Date started ARV: / / (dd/mm/yyyy) EMR LIFETIME ANTIRETROVIRAL TREATMENT EMR INITIAL TREATMENT: D4T + 3TC +NVP D4T + 3TC + EFV AZT + 3TC + EFV TDF + 3TC + NVP TDF + 3TC + EFV Other (specify and include dose): CHANGE OF TREATMENT REGIMEN (1): DATE / / AZT + 3TC + NVP AZT + 3TC + EFV TDF + 3TC + Kaletra ABC + 3TC + Kaletra DDI + ABC + Kaletra AZT + 3TC + Kaletra Other: CHANGE OF TREATMENT REGIMEN (2): DATE / / AZT + 3TC + NVP AZT + 3TC + EFV TDF + 3TC + Kaletra ABC + 3TC + Kaletra DDI + ABC + Kaletra AZT + 3TC + Kaletra Other: EMR ANTITUBERCULOSIS TREATMENT EMR EMR Start date: / / Sputum smear: Positive Negative Continuation Type of regimen: First Retreatment MDR-TB phase Write the Anti-TB treatment: / / (See the treatment form for treatment changes) Start date: / / Sputum smear: Positive Negative Type of treatment: Retreatment MDR-TB Write the Anti-TB treatment: EMR PROPHYLACTIC TREATMENT EMR Medication: Cotrimoxazole Fluconazole Dapsone Start date: Other: / / Medication: Cotrimoxazole Fluconazole Dapsone Start date: Other: / / Medication: Cotrimoxazole Fluconazole Dapsone Other: Start date: / / Continuation phase / / Stop date: / / Stop date: / / Stop date: / / Stop date / / REASON: Failure Interaction with TB medication Toxicity Pregnancy Stopped taking (non-compliance) Out of stock Death Other: Stop date / / REASON: Failure Interaction with TB medication Toxicity Pregnancy Stopped taking (non-compliance) Out of stock Death Other: Stop date / / REASON: Failure Interaction with TB medication Toxicity Pregnancy Stopped taking (non-compliance) Out of stock Death Other: Stop date: / / AFTER TREATMENT: Cured (sputum smear positive at beginning, date sputum smear negative: / / ) Treatment failure Treatment completed Treatment stopped Transferred Deceased Stop date: / / AFTER TREATMENT: Cured (sputum smear positive at beginning, date sputum smear negative: / / ) Treatment failure Treatment completed Treatment stopped Transferred Deceased Reason for stopping: Toxicity Stopped taking (non-compliance) Out of stock CD4 improvement Other: Reason for stopping: Toxicity Stopped taking (non-compliance) Out of stock CD4 improvement Other: Reason for stopping: Toxicity Stopped taking (non-compliance) Out of stock CD4 improvement Other: OTHER MEDICATIONS TAKEN CHRONICALLY > 1 MOS. EMR Medication Start date EMR Stop date Comments / / / / / / / / / / / / / / / / 78

80 ALLERGIES & SIDE EFFECTS EMR Date Drug suspected Effect Action taken / / / / / / HOSPITALIZATIONS: OPPORTUNISTIC INFECTIONS Anaphylaxis Mild rash Moderate rash Severe rash (peeling) Nausea Vomiting Jaundice Neuropathy Anemia Lactic acidosis Hepatitis Nightmares Lipodystrophy Other (specify): Anaphylaxis Mild rash Moderate rash Severe rash (peeling) Nausea Vomiting Jaundice Neuropathy Anemia Lactic acidosis Hepatitis Nightmares Lipodystrophy Other (specify): Anaphylaxis Mild rash Moderate rash Severe rash (peeling) Nausea Vomiting Jaundice Neuropathy Anemia Lactic acidosis Hepatitis Nightmares Lipodystrophy Other (specify): EMR Diagnosis Date Duration Comments Malaria Pneumonia Gastroenteritis / / days weeks Malaria Pneumonia Gastroenteritis / / days weeks Malaria Pneumonia Gastroenteritis / / days weeks Malaria Pneumonia Gastroenteritis / / days weeks Malaria Pneumonia Gastroenteritis / / days weeks EMR Diagnosis: Date WHO Stage Comments Stopped medication Dose change Symptomatic treatment Other: Stopped medication Dose change Symptomatic treatment Other: Stopped medication Dose change Symptomatic treatment Other: Malaria Pneumonia Gastroenteritis / / days weeks Malaria Pneumonia Gastroenteritis / / days weeks EMR Diagnosis: Date: Comments Asthma Diabetes Epilepsy Heart disease Renal insufficiency Other: / / Asthma Diabetes Epilepsy Heart disease Renal insufficiency Other: / / 79

81 SUMMARY OF VISITS EMR Date of visit dd/mm/yyyy Weight kg Patient condition A=normal activities B=performs activities with help C=bedridden Current opportunistic infection (If new infection, enter into the table below) Current STI (If yes, see codes below) TB Screening Contraception A=abstinence C=condoms FP=family planning N=nothing Pregnant yes/no # of missed doses / 30 days ARV Adherence Explanation for missing doses 3=>95%=very good 4-8=85-94%=good 9=<85%=poor (codes below) E.g. 15/05/ B No Yes: No Yes: pos neg C + FP No Yes 2 G Kaposi s Sarcoma Urethral discharge / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes 80

82 / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes / / No Yes: No Yes: pos neg No Yes STI codes: UD = urethral discharge; VD = vaginal discharge; GU = genital ulcers; PPW = pelvic pain in a woman; IB = inguinal bubo; PSS = painful swelling of the scrotum; GW = genital warts; CN = conjunctivitis in a newborn Codes for explanation of missed doses: 1. Toxicity side effects 2. Pregnant 3. Non-compliance 4. Illness/hospitalization 5. Out of stock 6. Other LAB TEST MONITORING: EMR Date of exam Hb Ht WBC Neutro Lympho Plt SGOT SGPT Creat. Glucose RPR (annual) Other lab test CD4 (cells/mm 3 ) Viral load (copies/ml) (g/dl) (%) (x10 9 /l) (x10 9 /l) (x10 9 /l) (x10 9 /l) (iu/l) (iu/l) (µmol./l) (mg/dl) / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done / / neg pos not done IMAGING MONITORING: EMR Image type Date Clinical finding Chest X-RAY CT Head Other (specify): / / Chest X-RAY CT Head Other (specify): / / Chest X-RAY CT Head Other (specify): / / Chest X-RAY CT Head Other (specify): / / 81

83 CD4 (cells/mm 3 ) CD4 CURVE CHARTING HIV- / / / / / / / / / / / / / / / / / / / / / / / / / / 1RNA (Copies/ml) Date (dd/mm/yyyy) VIRAL LOAD CURVE CHART / / / / / / / / / / / / / / / / / / / / / / / / / / Date (dd/mm/yyyy) 82

84 BMI = weight in kilograms (kg/m 2 ) height in meters 2 BMI Height (cm) Weight (kg) BMI Curve Height cm BMI Weight (kg) Date (dd/mm/yyyy) Instructions to draw curves: 1. Measure the height of the patient during the first visit. 2. Find the weight corresponding to this height in the table column title BMI Draw a horizontal line across the BMI chart at the weight level found in step 2 above. Write BMI 16 at the end of this line 4. Repeat steps 2 and 3 for the BMI 18.5 column. 5. The two lines drawn should be of different colors. 6. At each visit, measure the patient s weight and write the result on the BMI chart along with the date of the visit. 7. Using the two lines indicating the patient s BMI 16 and BMI 18.5 as a reference, you are able to see if the patient s BMI for that visit is above 18.5 or 16, or if it is below these values 8. BMI < 18.5 nutritional support needed, BMI < 16 severe malnutrition, requires hospitalization and nutritional support. 83

85 PATIENT ENROLLMENT FORM 84

86 ENROLLMENT FORM FOR HIV+ PATIENTS Date of admission (day/month/year): / / HEALTH CENTER: EMR EMR Demographic information: Last name: First name: Father: Mother: Gender F M Date of birth: / / Place of birth: Profession: Civil status: Unmarried Married Widowed Common-law Separated Divorced Place of residence: Province: District: Sector: Unit: Village: Identity card: Telephone: Contact person: Last name: First name: Telephone: The contact person knows the HIV status of the patient? Yes No EMR Community health worker: Yes No Change of community health worker: Yes Date / / Last name: First name: Telephone: Relationship to patient: Last name: First name: Telephone: The patient has given consent to the health center to disclose his/her HIV status to his/her community health worker? Yes Date / / (Check only when consent is given) 85

87 HIV Diagnosis: New case: Yes No If yes, location of first HIV test: External consultation: VCT PMTCT Hospitalization Consultation TB Service Other: Date of HIV test: / / Transferred: Yes No If yes, transferred from where?: Patient category: ARV Pre-ARV PMTCT TB Nutrition HIV STATUS OF THE FAMILY Last name First name Relationship to patient Date of birth Date deceased HIV Test Result Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / Partner Child / / / / Yes No Neg Pos: Date / / KNOWN ALLERGIES/SIDE EFFECTS TO MEDICATIONS No Yes Medication: Side effects (e.g. rash, anaphylaxis, hepatitis) Date of side effect: / / / / / / / / PROPHYLACTIC TREATMENT No Yes Medication: Start date Treatment Stop date Reason for stop: Cotrimoxazole / / Current Intermittent / / Toxicity Non-compliance Out of stock Stopped Other: Dapsone / / Current Intermittent / / Toxicity Non-compliance Out of stock Stopped Other: Fluconazole / / Current Intermittent / / Toxicity Non-compliance Out of stock Stopped Other: Isoniazid / / Current Intermittent / / Toxicity Non-compliance Out of stock Stopped Other: 86

88 ANTI TB TREATMENT No Yes Type of treatment Sputum smear Start date: Stop date: Treatment status: First treatment: pos / / / / Cured Failure Treatment completed Abandoned RHEZE/ 4RH neg Transferred Ongoing unknown Retreatment: pos / / / / Cured Failure Treatment completed Abandoned 2S+RHZE / 1 RHZE / 5RHE neg Transferred Ongoing unknown Treatment for MDR-TB: pos / / / / Cured Failure Treatment completed Abandoned neg Transferred Ongoing unknown PREVENTION OF MOTHER TO CHILD TRANSMISSION (PMTCT) No Yes Regimen: Start date: Stop date: Reason for stopping: AZT NVP AZT+3TC+NVP / / / / End of pregnancy Toxicity Abandoned Transferred AZT+3TC+EFV Other Ongoing Other: AZT NVP AZT+3TC+NVP / / / / End of pregnancy Toxicity Abandoned Transferred AZT+3TC+EFV Other Ongoing Other: AZT NVP AZT+3TC+NVP / / / / End of pregnancy Toxicity Abandoned Transferred AZT+3TC+EFV Other Ongoing Other: AZT NVP AZT+3TC+NVP / / / / End of pregnancy Toxicity Abandoned Transferred AZT+3TC+EFV Other Ongoing Other: POST EXPOSURE PROPHYLAXIS (PEP) No Yes Regimen: Start date: Stop date: Reason for stopping: AZT+3TC+EFV AZT+3TC+Kaletra / / / / Toxicity Treatment complete Seropositive Abandoned TDF+3TC+Kaletra Other Transferred Other: AZT+3TC+EFV AZT+3TC+Kaletra / / / / Toxicity Treatment complete Seropositive Abandoned TDF+3TC+Kaletra Other Transferred Other: ANTIRETROVIRAL TREATMENT (ARV) No Yes Regimen: Start date: Stop date: Reason for stopping: D4T+3TC+NVP D4T+3TC+EFV / / / / Failure Interaction with other Anti-TB medications AZT+3TC+NVP AZT+3TC+EFV Toxicity Pregnancy Abandoned Out of stock TDF+3TC+NVP TDF+3TC+EFV Other: Other: AZT+3TC+NVP AZT+3TC+EFV / / / / Failure Interaction with other Anti-TB medications TDF+3TC+Kaletra ABC+3TC+Kaletra Toxicity Pregnancy Abandoned Out of stock DDI+ABC+Kaletra AZT+3TC+Kaletra Other: Other: OTHER MEDICATIONS TAKEN CHRONICALLY (INCLUDING TRADITIONAL TREATMENTS AND HERBAL MEDICATION) No Yes Medication: Start date: Stop date: Comments: / / / / / / / / / / / / / / / / 87

89 OPPORTUNISTIC INFECTIONS No Yes Diagnosis: Start date: Stop date: Result of treatment: / / / / / / / / / / / / / / / / OTHER DIAGNOSES No Yes Diagnosis: Date: Comments: Asthma Diabetes Epilepsy Hypertension / / Cardiac insufficiency Renal insufficiency Other: Asthma Diabetes Epilepsy Hypertension / / Cardiac insufficiency Renal insufficiency Other: HOSPITALIZATIONS No Yes Diagnosis: Date: Duration of hospitalization: Malaria Pneumonia Gastroenteritis Anemia / / days weeks months Meningitis Other: Malaria Pneumonia Gastroenteritis Anemia / / days weeks months Meningitis Other: Malaria Pneumonia Gastroenteritis Anemia / / days weeks months Meningitis Other: SURGICAL HISTORY No Yes CURRENT COMPLAINTS: CURRENT SIGNS & SYMPTOMS HISTORY OF ILLNESS & TB SCREENING No problems Date: / / / / Cough: No Yes: duration days weeks months Dry Bloody sputum Productive Dyspnea Chest pain Comments: Night sweats: No Yes: duration days weeks months Fever: No Yes: duration days weeks months Weight loss: No Yes Contact with a TB+ person: No Yes Results of TB screening: Neg Pos Diarrhea: No Yes Number of stools /day <1 month >1 month bloody 88

90 SEXUAL BEHAVIOR RISK ASSESSMENT SEXUAL PARTNERS IN THE LAST 6 MONTHS Gender: Type of partner Time elapsed Age: Profession: Frequent trips: Type of Condom use: HIV status HIV status of and duration of since last sexual of partner: of the client relationship: sexual activity: is known? contact: M Regular y/o No Vaginal No Neg No F Occasional Yes Oral Yes Post Yes Duration: Anal Unknown M Regular y/o No Vaginal No Neg No F Occasional Yes Oral Yes Post Yes Duration: Anal Unknown M Regular y/o No Vaginal No Neg No F Occasional Yes Oral Yes Post Yes Duration: Anal Unknown History of sexually transmitted infections in the client? No Yes If yes, specify: SEXUALLY TRANSMITTED INFECTIONS SCREENING NEGATIVE POSITIVE 01 Have you had a risky sexual contact recently? Yes No 02 Do you have pain when you urinate? Yes No 03 Do you have vaginal discharge that is unusual? Yes No 04 Do you have ulcerations in your genital area? Yes No 05 Do you have pain in your lower abdomen? Yes No 06 Do you have vaginal itching? Yes No 07 Have you noticed that your newborn baby has discharge from his/her eyes? Yes No 08 Have you noticed scrotal swelling? Yes No 09 Do you have rough growths (warts) around your anus or genitals? Yes No 10 Have you had painful sex? Yes No 89

91 FAMILY PLANNING AND REVIEW OF SEXUAL BEHAVIORS Sexually active: No Yes Date of last menses (LMP): / / Family planning: Is the patient using a family planning method? Yes No Abstinence Oral contraceptives Male condoms Female condoms Spermicides Depo-provera Date / / Sterilization/tubal ligation Date / / Norplant Date / / IUD Date / / Other (specify): Pregnant: No Yes Estimated delivery date / / Previous pregnancies: Number of pregnancies Number of living children Number of deceased children Abortions/miscarriages? No Yes: Number Ectopic pregnancies? No Yes: Number Condom use: Always Usually Sometimes Rarely Never If not always, why? Lack of experience/knowledge of how to use condoms Condoms too expensive Partner doesn t like to use condoms RISK FACTORS: Has the client paid for sexual favors? No Yes Has the client exchanged sexual favors for No Yes food/money/other things? Does the client use drugs/alcohol? No Yes PHYSICAL EXAM Weight kg Height cm BMI (kg/m 2 ) Heart rate /min Temp C Respiratory Rate /min B/P / Comments Is the client a victim of sexual assault/abuse? No Yes Client has risk factors Client does not have risk factors Has the client experienced domestic violence? No Yes Refer for counseling No Yes General state: Normal Abnormal: Skin: Normal Lesions consistent with Kaposi s Sarcoma Rash Lymph nodes: Normal Lymphadenopathy Other: Extremities: Normal Edema Swelling Pain Effusion Eyes: Normal Jaundiced Pale Other: Oropharynx: Normal Oral candidiasis Mouth ulcerations Tonsilitis Ears: Normal Discharge Hearing loss Other: Lungs: Normal Crackles Dullness Decreased/absent breath sounds Other: Cardiovascular: Normal Murmur: Other: Gastrointestinal: Normal Acites Hepatomegaly Splenomegaly Pain Bowel sounds Neurologic Normal Hypoaesthesia Hyperaesthesia Areflexia Hyperflexia Hypertonia Other: Urogenital: Normal Discharge Ulcerations Warts Adenopathies Tumor/masses Localized pain Not done Other: 90

92 WHO STAGE AND OPPORTUNISTIC INFECTIONS Does the patient have an opportunistic infection currently? No Yes (write S for suspected/c for confirmed) if yes, is this a new opportunistic infection? No Yes (enter in the summary form) STAGE 1 Persistent generalized lymphadenopathy Asymptomatic HIV infection STAGE 2 Unexplained weight loss < 10% of body weight Minor mucocutaneous manifestations Herpes zoster (in the last 2 years) Upper respiratory tract infections ( 2 in 6 mos.) STAGE 3 Oral candidiasis Oral hairy leukoplakia Acute ulcerative stomatitis, gingivitis or periodontitis Severe bacterial infections Pulmonary tuberculosis Unexplained chronic diarrhea > 1 month Unexplained persistent fever > 1 month Unexplained anemia/thrombocytopenia/neutropenia > 1 month PRESENT WHO STAGE: OTHER DIAGNOSES None STAGE 4 Wasting syndrome (unexplained weight loss of > 10% of presumed or measured total body weight) Pneumocystis jirovecii pneumonia (PCP) Severe recurrent pneumonia ( 2 in one year confirmed by x-ray) Herpes simplex (mucocutaneous > 1 month, or visceral at any site) Candidiasis (Esophagus, trachea, bronchi, or lungs) Cryptosporidiosis or isoporiasis with diarrhea (> 1 month) Disseminated mycoses (histoplasmosis, coccidiomycoses) Lymphoma (cerebral or B cell non-hodgkin) Disseminated non-tuberculosis mycobacteria infection Recurrent septicaemia (including non-typhoidal Salmonella > 2 episodes in one year) Cytomegalovirus infection (retinitis or infection of other organs, except for liver, spleen, or lymph nodes Progressive multifocal leukoencephalopathy (PML) Cerebral Toxoplasmosis Extrapulmonary TB Kaposi s Sarcoma HIV encephalopathy Extrapulmonary Cryptococcicosis Atypical disseminated Leishmaniasis (visceral) Invasive cervical cancer Unknown In bed > 50% of the day during the last month Asthma Diabetes Epilepsy Hypertension Cardiac insufficiency Renal insufficiency Other: TESTS TO BE DONE CD4 Sputum CBC SGOT/SGPT Blood glucose Date: / / Urea Creatinine Sedimentation rate Blood smear RPR Viral load Stool sample Urine sample Vaginal smear Urethral smear Chest x-ray Ultrasound PROPHYLAXIS Not indicated Cotrimoxazole Start Continue Stop: REASON Toxicity Refused by the patient Out of stock Other: Dapsone Start Continue Stop: REASON Toxicity Refused by the patient Out of stock Other: Fluconazole Start Continue Stop: REASON Toxicity Refused by the patient Out of stock Other: Isoniazid Start Continue Stop: REASON Toxicity Refused by the patient Out of stock Other: ANTITUBERCULOSIS TREATMENT Not indicated Continue without change Started Change of medication Change of dose Stopped 91

93 None RHZ number of pills given RHZE number of pills given RH number of pills given S g E g Other: If changed or interrupted, indicate reason Failure Out of stock Toxicity (specify) Continuation phase Treatment ended Other: ANTIRETROVIRAL TREATMENT Not indicated Continue without change Started Change of medication Change of dose Stopped D4T+3TC+NVP D4T+3TC+EFV AZT+3TC+NVP AZT+3TC+EFV TDF+3TC+NVP TDF+3TC+EFV ABC+3TC+EFV ABC+3TC+NVP AZT+3TC+Kaletra Other: OTHER MEDICATIONS CONCLUSION AND PLAN None Next appointment: / / Healthcare provider: Signature: GO TO THE PATIENT SUMMARY FORM TO ENTER INFORMATION ABOUT MEDICATIONS, OPPORTUNISTIC INFECTIONS, AND CHRONIC ILLNESSES IN THE CHARTS AND COMPLETE THE VISIT SUMMARY CHART. If changed or interrupted, indicate reason Failure Out of stock Toxicity (specify) Interaction with anti-tb medications Other: ELECTRONIC INFORMATION ENTERED BY Date / / 92

94 PSYCHOSOCIAL FORM 93

95 PSYCHOSOCIAL SUPPORT A. PSYCHOSOCIAL EVALUATION (FIRST VISIT) Date: / / Name of counselor: I. LOCATION 1. Does the patient have a permanent home? Yes No 2. Is the patient s home in the area of the health center? Yes No Provide special follow up if the answer is no II. SOCIO-ECONOMIC INFORMATION 1. How does the patient travel to the clinic? Walk Bicycle Car Bus Other: 2. How much time does it take for the patient to get to the clinic on foot? hours 3. Home: Number of people living in the house: Number of room: Roofing: Tile Straw Concrete Sheeting Other Floor: Concrete Clay/rammed earth Toilet/latrine: No Yes SOCIOECONOMIC ASSISTANCE: Already received Recommended Financial aid Agricultural assistance Scholarships Help with transportation Assistance with building or repairing the house 94

96 III. DISCLOSURE OF HIV STATUS TO OTHERS 1. Have you told your family your HIV status? Yes No Provide special follow up if the answer is no If yes, what were their reactions? Anger Crying Promise of support Silence/indifference Other (specify): IV. ADHERENCE 1. What do you know of antiretroviral treatment? (Explain the principles of ARV treatment) 2. Have you already received ARV services at another health center? Yes No If yes, discuss why s/he wants to change to your health center. 3. Do you think you will have any difficulties taking the ARV treatment as required? Yes No If yes, what kind of difficulties? 4. Have you consulted with other healthcare providers or traditional healers? Yes No If yes, special follow up is needed to make sure the patient understands the dangers related to poor adherence and drug interactions. 5. Do you authorize home visits? (Explain the importance and process of home visits) Yes No If the response is no, why? V. PREVENTION, COUPLE AND FAMILY 1. Do you have unprotected sex? Yes No 2. Would you like to have children? Yes No If yes, discuss the possibility that the patient could have an HIV+ baby. 3. What are the difficulties or misunderstandings that you experience with your partner/spouse? 4. Is your partner/spouse aware of your HIV status? Yes No 5. Do you use condoms when you have sex with your partner/spouse? Never Rarely Sometimes Regularly Always If not always, special follow up and counseling regarding the importance. 6. Do you have occasional/non-steady partners? Yes No 95

97 7. Do you use condoms during sexual activity with your occasional partners? Never Rarely Sometimes Regularly Always Provide further counseling if the answer is not always. VI. COMMUNITY BASED SUPPORT 1. Do you belong to an association for HIV positive persons? Yes No If yes, name and address of the association: 2. Do you receive social and economic assistance? Yes No If yes, which ones? 3. What other community support do you receive? Discuss possible opportunities in the community Guidance given to patient: Ask the patient if s/he has any questions. VII. CONCLUSIONS OF THE PSYCHOSOCIAL EVALUATION Schedule the next counseling session in 2 weeks to verify if the patient is eligible and schedule pre-arv education. Write notes directly following the evaluation: General conclusions of the session: Counselor note all observations from this session Anticipated barriers to adherence Specific questions or problems to monitor with the patient and plan for future guidance B. PRE-ARV COUNSELING Pre-ARV counselling is an individual session that takes place after the educational session (group session) and before the selection committee. The objective is to evaluate the patient s knowledge of the treatment and whether he/she is ready to begin treatment. NOTE: You must also review the conclusions of the first meeting. 1. Topics: (Patient knowledge: does the patient understand the difference between HIV and AIDS?) 2. Does s/he understand the principles and mode of action of antiretroviral treatment? 3. Does the patient understand the importance of adherence to treatment (attending all appointments, taking doses at the correct times, and not missing any doses?) 4. Does the patient have information about positive behaviors for good health? 5. Does the patient understand the concepts of a balanced diet and hygiene? Conclusion: (Is the patient ready to begin treatment?) 96

98 PATIENT FOLLOW-UP FORM 97

99 FOLLOW-UP APPTS. - ADULT DATE / / Scheduled visit Unscheduled visit 1. DEMOGRAPHIC INFORMATION: Change in Community Health Worker? No Yes, reason Go to the admission card to change Change of address or telephone number? No Yes: Go to the admission card to change 2. LATEST RESULTS: LAST CD4 DATE / / : Enter into the laboratory test monitoring section and repeat if > 6 months ago 3. HISTORY OF ILLNESS: Physical exam: Symptoms: Routine visit, no Weight kg: (enter into the BMI curve) problems Pulse/heart rate Temp C Resp. /min B/P / General: Normal Abnormal: Skin: Normal Lesions compatible with KS Rash: Lymph nodes: Normal Lymphodenopathy Extremities & appendages: Normal Edema Other: Eyes: Normal Jaundiced Pale Other: Oropharynx: Normal Oral candida Mouth ulcers Tonsilitis Other: Ears: Normal Exudate Other: Lungs: Normal Crepitus Dullness Rattling, loud Diminished breath sounds CV: Normal Murmur Other: Gastrointestinal: Normal Acites Hepatomegaly Splenomegaly Pain Dull Other systems (urogenital, neurologic): 4. HISTORY OF ILLNESS AND TB SCREENING: Result of TB screening: Neg Pos STI SCREENING POSITIVE NEGATIVE DIAGNOSIS/SYNDROME: NEXT STEPS: Diarrhea No Yes Number of times: /day < 1 month > 1 month Bloody Sexually active No Yes LMP: / / 98

100 Family planning: Is the patient using family planning? No Yes Abstinence Oral contraceptive Condoms Depo-Provera Other (specify): Pregnant: No Yes Estimated date of delivery / / HOSPITALIZATIONS: Hospitalization since last visit? No Yes SIDE EFFECTS: Is the patient experiencing side effects? No Yes: EFFECT OPPORTUNISTIC INFECTIONS: OTHER DIAGNOSIS: WHO STAGE: ADDITIONAL TESTS: DIAGNOSIS AND ACTION TO TAKE: ENTER INTO THE PATIENT SUMMARY Does the patient have a new opportunistic infection? No Yes: DIAGNOSIS: Does the patient have a chronic illness? No Yes: DIAGNOSIS: Current WHO stage: Unknown Are there signs of treatment failure? No Yes: Clinical failure Immunologic failure Viral failure Date: / / ENTER INTO THE PATIENT SUMMARY ENTER INTO THE PATIENT SUMMARY CD4 Urea Creatinine Sedimentation rate Viral load Stool sample Chest x-ray Ultrasound Sputum smear Blood smear RPR Urine sample Vaginal smear CBC Urethral smear IF CHANGING THE DRUG REGIMEN, ENTER INFORMATION IN THE PATIENT SUMMARY FORM. Conclusion: SGOT/SGPT Blood glucose ARVs: Not indicated Continuing Anti-TBC: Not indicated Continuing Prophylaxis: Not indicated Continuing Other medications? Start Change Stop Start Change Stop Start Change Stop No Yes: Next scheduled visit: / / HEALTHCARE PROVIDER: SIGNATURE: PSYCHOSOCIAL MONITORING This part must be filled in every time a patient presents for psychosocial or other consultation DATE Issue discussed Problem Plan of action Next scheduled visit 1. Psychosocial experience with regards Yes or no, if yes, describe: to infection/illness 2. Positive behavior Yes or no, if yes, describe: 3. Adherence with ARVs/ Yes or no, if yes describe: Treatment schedule 99

101 T F A R D UNIT 2 VERSION 1 The HIV Program Partners In Health 888 Commonwealth Avenue, 3rd Floor, Boston, MA DISTRIBUTION OR EDITING. PA R T N E R S I N H E A LT H H I V C U R R I C U L U M PA R TNOT I C I PAFOR NT S M ANUAL