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
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-based AIDS Care Project, Tororo, Uganda

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

Enrollment: 1000
Study Start Date: May 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119093

Locations
Uganda
Tororo Hospital/CDC-Uganda
Tororo, Uganda
Sponsors and Collaborators
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
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00119093     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3666
Study First Received: July 8, 2005
Last Updated: September 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Antiretroviral therapy
HIV
Adherence
Viral Load
Opportunistic illness

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014