- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144365
Comparison of Facility and Home-based ART Delivery Systems in Uganda
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Jinja, Uganda
- The AIDS Support Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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HIV viral load
|
Secondary Outcome Measures
Outcome Measure |
---|
Treatment failure
|
Survival
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cost-effectiveness
|
Sexual behavior
|
Morbidity
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Medication adherence
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Family member HIV testing
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Collaborators and Investigators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-4371
- 1U01PS000065-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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