Home-based AIDS Care Project

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT00119093

Collaborator

The AIDS Support Organization (Other), Ministry of Health, Uganda (Other)

1,000

Enrollment

Location

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Procedure: Laboratory and clinical monitoring regimens	N/A

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

Actual Enrollment :

1000 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Home-based AIDS Care Project, Tororo, Uganda

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Outcome Measures

Primary Outcome Measures

Equivalence of 3 different monitoring regimens for ART []

Secondary Outcome Measures

Sexual risk behavior []
medication adherence []
quality of life []
depression []
cost-effectiveness []
viral load []
CD4 cell count []

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tororo Hospital/CDC-Uganda	Tororo		Uganda

Sponsors and Collaborators

Centers for Disease Control and Prevention
The AIDS Support Organization
Ministry of Health, Uganda

Investigators

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