Home-based AIDS Care Project

HIV Infections Clinical Trial

Official title:

Home-based AIDS Care Project, Tororo, Uganda

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00119093
• Other study ID #: CDC-NCHSTP-3666
• Status: Terminated
• Phase: N/A
• First received: July 8, 2005
• Last updated: September 10, 2012
• Start date: May 2003
• Est. completion date: March 2009

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Laboratory and clinical monitoring regimens

Locations

Country	Name	City	State
Uganda	Tororo Hospital/CDC-Uganda	Tororo

Sponsors (3)

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

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of 3 different monitoring regimens for ART
Secondary	Sexual risk behavior
Secondary	medication adherence
Secondary	quality of life
Secondary	depression
Secondary	cost-effectiveness
Secondary	viral load
Secondary	CD4 cell count