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

History of Changes

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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

Locations

Uganda
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

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):

Ekwaru JP, Campbell J, Malamba S, Moore DM, Were W, Mermin J. The effect of opportunistic illness on HIV RNA viral load and CD4+ T cell count among HIV-positive adults taking antiretroviral therapy. J Int AIDS Soc. 2013 Apr 1;16:17355. doi: 10.7448/IAS.16.1.17355.

Campbell JD, Moore D, Degerman R, Kaharuza F, Were W, Muramuzi E, Odongo G, Wetaka M, Mermin J, Tappero JW. HIV-infected ugandan adults taking antiretroviral therapy with CD4 counts >200 cells/μL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. Epub 2012 Mar 14.

Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, Downing R, Coutinho A, Solberg P, Alexander LN, Tappero J, Campbell J, Moore DM. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011 Nov 9;343:d6792.

Weidle PJ, Moore D, Mermin J, Buchacz K, Were W, Downing R, Kigozi A, Ndazima V, Peters P, Brooks JT. Liver enzymes improve over twenty-four months of first-line non-nucleoside reverse transcriptase inhibitor-based therapy in rural Uganda. AIDS Patient Care STDS. 2008 Oct;22(10):787-95.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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