Home-based AIDS Care Project

Not Applicable

Terminated

• Conditions: HIV Infections

• Registration Number: NCT00119093
• Lead Sponsor: Centers for Disease Control and Prevention

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-07-08
• Study First Submitted QC: 2005-07-11
• Study First Posted: 2005-07-13
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Equivalence of 3 different monitoring regimens for ART

Secondary Outcome Measures

Name	Time	Method
medication adherence
viral load
quality of life
depression
cost-effectiveness
CD4 cell count
Sexual risk behavior

Trial Locations

Locations (1)

Tororo Hospital/CDC-Uganda; 🇺🇬 Tororo, Uganda