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
  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:


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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144365

Locations
Uganda
The AIDS Support Organization
Jinja, Uganda
Sponsors and Collaborators
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

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00144365     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4371, 1U01 PS00065-01
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 April 23, 2014