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

AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144365
• Other study ID #: CDC-NCHSTP-4371
• Secondary ID: 1U01PS000065-01
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: September 10, 2012
• Start date: February 2005
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1453
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• AIDS

Intervention

Drug:
• Antiretroviral therapy

Locations

Country	Name	City	State
Uganda	The AIDS Support Organization	Jinja

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	British Medical Research Council, The AIDS Support Organization

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral load
Secondary	Medication adherence
Secondary	Treatment failure
Secondary	Morbidity
Secondary	Survival
Secondary	Sexual behavior
Secondary	Family member HIV testing
Secondary	cost-effectiveness