Skip to content

Home-based AIDS Care Project

Home-based AIDS Care Project, Tororo, Uganda

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00119093
Enrollment
1000
Registered
2005-07-13
Start date
2003-05-31
Completion date
2009-03-31
Last updated
2012-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness

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.

Interventions

PROCEDURELaboratory and clinical monitoring regimens

Sponsors

The AIDS Support Organization
CollaboratorOTHER
Ministry of Health, Uganda
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Equivalence of 3 different monitoring regimens for ART

Secondary

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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026