Home-based AIDS Care Project

This study has been terminated.
(Terminated by IRB for non-compliance with human subject regulations.)
Sponsor:
Collaborators:
The AIDS Support Organization
Ministry of Health, Uganda
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00119093
First received: July 8, 2005
Last updated: September 10, 2012
Last verified: September 2012

July 8, 2005
September 10, 2012
May 2003
March 2009   (final data collection date for primary outcome measure)
Equivalence of 3 different monitoring regimens for ART
Same as current
Complete list of historical versions of study NCT00119093 on ClinicalTrials.gov Archive Site
  • Sexual risk behavior
  • medication adherence
  • quality of life
  • depression
  • cost-effectiveness
  • viral load
  • CD4 cell count
Same as current
Not Provided
Not Provided
 
Home-based AIDS Care Project
Home-based AIDS Care Project, Tororo, Uganda

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Procedure: Laboratory and clinical monitoring regimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1000
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00119093
CDC-NCHSTP-3666
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • The AIDS Support Organization
  • Ministry of Health, Uganda
Principal Investigator: Rebecca E Bunnell, ScD, MEd Centers for Disease Control and Prevention
Principal Investigator: Jonathan H Mermin, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Alex Coutinho, MBChB, MPH The AIDS Support Organization
Principal Investigator: David Moore, MD CDC-Uganda and University of British Columbia
Principal Investigator: Jordan Tappero, MD, MPH Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP