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Home-based AIDS Care Project

Primary Purpose

HIV Infections

Status
Terminated
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Laboratory and clinical monitoring regimens
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tororo Hospital/CDC-Uganda

Outcomes

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

Full Information

First Posted
July 8, 2005
Last Updated
September 10, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
The AIDS Support Organization, Ministry of Health, Uganda
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1. Study Identification

Unique Protocol Identification Number
NCT00119093
Brief Title
Home-based AIDS Care Project
Official Title
Home-based AIDS Care Project, Tororo, Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated by IRB for non-compliance with human subject regulations.
Study Start Date
May 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
The AIDS Support Organization, Ministry of Health, Uganda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiretroviral therapy, HIV, Adherence, Viral Load, Opportunistic illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laboratory and clinical monitoring regimens
Primary Outcome Measure Information:
Title
Equivalence of 3 different monitoring regimens for ART
Secondary Outcome Measure Information:
Title
Sexual risk behavior
Title
medication adherence
Title
quality of life
Title
depression
Title
cost-effectiveness
Title
viral load
Title
CD4 cell count

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Bunnell, ScD, MEd
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan H Mermin, MD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Coutinho, MBChB, MPH
Organizational Affiliation
The AIDS Support Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Moore, MD
Organizational Affiliation
CDC-Uganda and University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jordan Tappero, MD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tororo Hospital/CDC-Uganda
City
Tororo
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
23547778
Citation
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.
Results Reference
derived
PubMed Identifier
22423133
Citation
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.
Results Reference
derived
PubMed Identifier
22074711
Citation
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.
Results Reference
derived
PubMed Identifier
18778241
Citation
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.
Results Reference
derived

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Home-based AIDS Care Project

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