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

- HIV viral load
- Medication adherence
- Treatment failure
- Morbidity
- Survival
- Sexual behavior
- Family member HIV testing
- cost-effectiveness

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Uganda | |
The AIDS Support Organization | |
Jinja, Uganda |
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 |
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 |