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Home-based AIDS Care Project

NCT ID: NCT00119093

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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Antiretroviral therapy HIV Adherence Viral Load Opportunistic illness

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Laboratory and clinical monitoring regimens

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The AIDS Support Organization

OTHER

Sponsor Role collaborator

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca E Bunnell, ScD, MEd

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Jonathan H Mermin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Alex Coutinho, MBChB, MPH

Role: PRINCIPAL_INVESTIGATOR

The AIDS Support Organization

David Moore, MD

Role: PRINCIPAL_INVESTIGATOR

CDC-Uganda and University of British Columbia

Jordan Tappero, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

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Tororo Hospital/CDC-Uganda

Tororo, Tororo, Uganda

Site Status

Countries

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Uganda

References

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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(1):17355. doi: 10.7448/IAS.16.1.17355.

Reference Type DERIVED
PMID: 23547778 (View on PubMed)

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/muL who discontinue cotrimoxazole prophylaxis have increased risk of malaria and diarrhea. Clin Infect Dis. 2012 Apr;54(8):1204-11. doi: 10.1093/cid/cis013. Epub 2012 Mar 14.

Reference Type DERIVED
PMID: 22423133 (View on PubMed)

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. doi: 10.1136/bmj.d6792.

Reference Type DERIVED
PMID: 22074711 (View on PubMed)

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. doi: 10.1089/apc.2008.0020.

Reference Type DERIVED
PMID: 18778241 (View on PubMed)

Other Identifiers

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CDC-NCHSTP-3666

Identifier Type: -

Identifier Source: org_study_id