Home-based AIDS Care Project, Tororo, Uganda
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Equivalence of 3 different monitoring regimens for ART
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Equivalence of 3 different monitoring regimens for ART
Secondary Outcomes
- medication adherence
- viral load
- quality of life
- depression
- cost-effectiveness
- CD4 cell count
- Sexual risk behavior