Trial no.:
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PACTR201602001460157 |
Date of Approval:
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06/02/2016 |
Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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TRIAL DESCRIPTION |
Public title
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Community versus Clinic-based Adherence Clubs |
Official scientific title |
Community Versus Clinic-based ART Adherence Clubs to Enhance Patient Long-term Retention-in-Care |
Brief summary describing the background
and objectives of the trial
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Adherence clubs are groups of 25-30 patients stable on antiretroviral treatment (ART) who meet once every two months with club facilitators (counselors, and nurses on dates of blood draws) for a one hour session during which counseling is provided and ART medication distributed. Clinic-based adherence clubs implemented in Khayelitsha, South Africa have demonstrated that patients participating in clubs have reduced loss to follow up and lower risk of viral load rebound compared to stable patients receiving routine clinic-based care. Key questions remain as to whether the effectiveness of adherence clubs differs when based at the clinic compared to those based in the community. This is an unblinded randomized controlled trial of community-based versus clinic-based adherence clubs for patients who are stable on ART. The overall goal of this study is to evaluate whether, compared to clinic-based adherence clubs, community-based clubs result in improved patient outcomes and greater retention in care without compromising overall quality of patient medical care. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Infections and Infestations |
Sub-Disease(s) or condition(s) being studied |
HIV/AIDS |
Purpose of the trial |
Other Interventions |
Anticipated trial start date |
01/02/2014 |
Actual trial start date |
12/02/2014 |
Anticipated date of last follow up |
31/07/2016 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
800 |
Actual target sample size (number of participants) |
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Recruitment status |
Closed to recruitment,follow-up continuing |
Publication URL |
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