Home-based AIDS Care Project

Study Overview
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Brief Summary
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The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.

Detailed Description
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In Uganda, the high cost and complexity of administering antiretroviral therapy is an obstacle to full implementation country-wide. The Home-based AIDS care program (HBAC) pilot project was designed to deliver and monitor ARV and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. In addition, the cost and complexity of frequent laboratory monitoring of viral load and CD4 cell counts is a major impediment to widespread use of ARV therapies in Uganda and other resource-limited settings. Nested within the Home-Based AIDS Care (HBAC) project, is a randomized study of strategies for monitoring ARV therapy that involves 3 arms: 1) Quarterly CD4 cell counts, viral loads and home visits by trained lay persons; 2) Quarterly CD4 cell counts and home visits; and 3) Home visits alone.

Official Title
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Home-based AIDS Care Project, Tororo, Uganda

Conditions
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HIV Infections

Intervention / Treatment
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* Procedure: Laboratory and clinical monitoring regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection CD4 cell count <250 or symptomatic AIDS Age >13 years Karnofsky score >40% AST or ALT < 5 times normal values Creatinine clearance >25 ml/min

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laboratory and clinical monitoring regimens|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence of 3 different monitoring regimens for ART |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual risk behavior |  |  | 
| medication adherence |  |  | 
| quality of life |  |  | 
| depression |  |  | 
| cost-effectiveness |  |  | 
| viral load |  |  | 
| CD4 cell count |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness