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

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ClinicalTrials.gov Identifier: NCT00144365
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 11, 2012
Sponsor:
Collaborators:
British Medical Research Council
The AIDS Support Organization
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Description
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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.

Condition or disease Intervention/treatment Phase
AIDS Drug: Antiretroviral therapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of Facility and Home-based ART Delivery Systems in Uganda
Study Start Date : February 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HIV viral load

Secondary Outcome Measures :
  1. Medication adherence
  2. Treatment failure
  3. Morbidity
  4. Survival
  5. Sexual behavior
  6. Family member HIV testing
  7. cost-effectiveness

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144365


Locations
Uganda
The AIDS Support Organization
Jinja, Uganda
Sponsors and Collaborators
Centers for Disease Control and Prevention
British Medical Research Council
The AIDS Support Organization
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
More Information
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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00144365     History of Changes
Other Study ID Numbers: CDC-NCHSTP-4371
1U01PS000065-01 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Centers for Disease Control and Prevention:
HIV
Africa
Adherence
 HIV viral load
Sexual behavior
Voluntary counseling and testing