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 III

Further Study Details: 

Primary Outcomes: HIV viral load
Secondary Outcomes: Medication adherence; Treatment failure; Morbidity; Survival; Sexual behavior; Family member HIV testing; cost-effectiveness
Expected Total Enrollment:  800

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00144365

Shabbar Jaffar, MD       Shabbar.Jaffar@lshtm.ac.uk
Rebecca Bunnell, DSc, MEd       rrb7@cdc.gov

Uganda
      The AIDS Support Organization, Jinja,  Uganda; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  CDC-NCHSTP-4371; 1U01 PS00065-01
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144365
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06