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

September 2, 2005
September 10, 2012
February 2005
December 2008   (final data collection date for primary outcome measure)
HIV viral load
Same as current
Complete list of historical versions of study NCT00144365 on ClinicalTrials.gov Archive Site
  • Medication adherence
  • Treatment failure
  • Morbidity
  • Survival
  • Sexual behavior
  • Family member HIV testing
  • cost-effectiveness
Same as current
Not Provided
Not Provided
 
Comparison of Facility and Home-based ART Delivery Systems in Uganda
Comparison of Facility and Home-based ART Delivery Systems in Uganda

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
AIDS
Drug: Antiretroviral therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1453
December 2010
December 2008   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00144365
CDC-NCHSTP-4371, 1U01 PS00065-01
No
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • British Medical Research Council
  • The AIDS Support Organization
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
Centers for Disease Control and Prevention
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP