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.

Condition	Intervention
HIV Infections	Procedure: Laboratory and clinical monitoring regimens

Further Study Details: 

Primary Outcomes: Equivalence of 3 different monitoring regimens for ART
Secondary Outcomes: Sexual risk behavior; medication adherence; quality of life; depression; cost-effectiveness; viral load; CD4 cell count
Expected Total Enrollment:  1000

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Uganda
      Tororo Hospital/CDC-Uganda, Tororo,  Uganda

Study chairs or principal investigators

Rebecca E Bunnell, ScD, MEd,  Principal Investigator,  Centers for Disease Control and Prevention   
Jonathan H Mermin, MD, MPH,  Principal Investigator,  Centers for Disease Control and Prevention   
Alex Coutinho, MBChB, MPH,  Principal Investigator,  The AIDS Support Organization   
David Moore, MD,  Principal Investigator,  CDC-Uganda and University of British Columbia   

Study ID Numbers:  CDC-NCHSTP-3666
Last Updated:  July 25, 2005
Record first received:  July 12, 2005
ClinicalTrials.gov Identifier:  NCT00119093
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02