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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention British Medical Research Council The AIDS Support Organization |
|---|---|
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00144365 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Facility and Home-Based ART Delivery Systems in Uganda |
| Estimated Enrollment: | 800 |
| Study Start Date: | February 2005 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Shabbar Jaffar, MD | Shabbar.Jaffar@lshtm.ac.uk | |
| Contact: Rebecca Bunnell, DSc, MEd | rrb7@cdc.gov |
| Uganda | |
| The AIDS Support Organization | Recruiting |
| Jinja, Uganda | |
| Contact: Alex Coutinho, MBChB coutinhoa@tasouganda.org | |
| Principal Investigator: Alex Coutinho, MBChB, MSc | |
| 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 |
More Information
| Study ID Numbers: | CDC-NCHSTP-4371, 1U01 PS00065-01 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 2, 2005 |
| ClinicalTrials.gov Identifier: | NCT00144365 |
| Health Authority: | United States: Federal Government |
|
HIV Africa Adherence |
HIV viral load Sexual behavior Voluntary counseling and testing |
|
HIV Infections Acquired Immunodeficiency Syndrome |
