Comparison of Facility and Home-based ART Delivery Systems in Uganda

This study has been completed.

Sponsor:

Collaborators:

British Medical Research Council

The AIDS Support Organization

Information provided by (Responsible Party):

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00144365

First received: September 2, 2005

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Purpose

The study is a 3-year, randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

Condition	Intervention	Phase
AIDS	Drug: Antiretroviral therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Comparison of Facility and Home-based ART Delivery Systems in Uganda

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

Primary Outcome Measures:

HIV viral load

Secondary Outcome Measures:

Medication adherence
Treatment failure
Morbidity
Survival
Sexual behavior
Family member HIV testing
cost-effectiveness


Enrollment:	1453
Study Start Date:	February 2005
Study Completion Date:	December 2010
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

The study is a randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on plasma HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

The trial is conducted with The AIDS Support Organization (TASO) clinic in Jinja, Uganda. Randomization is conducted through geographic clusters, defined using sub-counties in the district, and stratified by distance from fixed health facilities, and urban/rural. Just over 800 participants, living in 40 clusters, will be recruited over a period of 3-6 months and followed-up over a period of 3 years.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infection Plan to remain resident in the area for at least 12 months CD4 cell count <200 cells/mm3 or severe symptomatic HIV (WHO stage 3 or 4) Identify a medicine companion who will assist in adherence to ART treatment Age 18 years or above.

Exclusion Criteria:

Abnormal liver and renal function test results (AST or ALT ≥ 5x upper limit of normal Calculated creatinine clearance < 25 ml/min). The tests are conducted only in individuals in whom they are clinically indicated

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: NCT00144365

Locations


Uganda
The AIDS Support Organization
Jinja, Uganda

Sponsors and Collaborators

Centers for Disease Control and Prevention

British Medical Research Council

The AIDS Support Organization

Investigators


Principal Investigator:	Heiner Grosskurth, MD, PhD	British Medical Research Council
Principal Investigator:	Rebecca Bunnell, ScD, MEd	Centers for Disease Control and Prevention
Principal Investigator:	Shabbar Jaffar, PhD	London School of Tropical Medicine and Hygeine
Principal Investigator:	Alex Coutinho, MBChB, MSc	The AIDS Support Organization

More Information


Responsible Party:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00144365 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-4371 1U01PS000065-01
Study First Received:	September 2, 2005
Last Updated:	September 10, 2012
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:


HIV Africa Adherence	HIV viral load Sexual behavior Voluntary counseling and testing

ClinicalTrials.gov processed this record on September 26, 2016

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