Clinical trial NCT00119093: Home-based AIDS Care Project
Official title: Home-based AIDS Care Project, Tororo, Uganda
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
Keywords: Antiretroviral therapy
HIV
Adherence
Viral Load
Opportunistic illness
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: The AIDS Support Organization
name: Ministry of Health, Uganda
First posted: 2005-07-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Equivalence of 3 different monitoring regimens for ART
Secondary outcomes:
measure: Sexual risk behavior
measure: medication adherence
measure: quality of life
measure: depression
measure: cost-effectiveness
measure: viral load
measure: CD4 cell count
Other outcomes:
Locations:
city: Tororo
country: Uganda
facility: Tororo Hospital/CDC-Uganda
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Rebecca E Bunnell, ScD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Jonathan H Mermin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The AIDS Support Organization
name: Alex Coutinho, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: CDC-Uganda and University of British Columbia
name: David Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Jordan Tappero, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.