Clinical trial NCT00144365: Comparison of Facility and Home-based ART Delivery Systems in Uganda
Official title: Comparison of Facility and Home-based ART Delivery Systems in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AIDS
Keywords: HIV
Africa
Adherence
HIV viral load
Sexual behavior
Voluntary counseling and testing
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: British Medical Research Council
name: The AIDS Support Organization
First posted: 2005-09-05
Enrollment: 1453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: HIV viral load
Secondary outcomes:
measure: Medication adherence
measure: Treatment failure
measure: Morbidity
measure: Survival
measure: Sexual behavior
measure: Family member HIV testing
measure: cost-effectiveness
Other outcomes:
Locations:
city: Jinja
country: Uganda
facility: The AIDS Support Organization
Study officials:
affiliation: British Medical Research Council
name: Heiner Grosskurth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Rebecca Bunnell, ScD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Tropical Medicine and Hygeine
name: Shabbar Jaffar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The AIDS Support Organization
name: Alex Coutinho, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References: