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NCT03256435 · ClinicalTrials.gov registry record · NA
Retention in PrEP Care for African American MSM in Mississippi
A NA study, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT03256435: Completed NA study, sponsored by Brown University.
NCT03256435 is a NA study that has completed, run by Brown University. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03256435, a NA study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
Innovative and novel HIV prevention interventions are urgently needed for African American (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk individuals. Although acceptability studies have demonstrated high interested in PrEP in the US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in real world settings are likely more complex, since payment for PrEP can be a substantial financial burden. The ADAPT\_ITT approach (an approach to adapting behavioral interventions to new populations: Assessment, Decision, Administration, Production, Topical Experts - Integration, Training, Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP) intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the country. This study will include formative research to understand the cultural and social contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from these qualitative interviews will inform the study intervention which will be tested and refined in a dynamic open pilot evaluation.
Primary Outcome
Blood samples will be collected from participants at 3- and 6-month assessments to test for the presence of detectable levels of Emtricitabine/Tenofovir (FTC/TDF). Samples will be processed and shipped to Dr. Peter Anderson's lab at the University of Colorado Anschutz for analysis of the quantification (drug levels) of detectable serum levels of FTC and TDF.
Interventions
- BEHAVIORAL RAMP PrEP initiation, adherence, and retention intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-09-07 |
| Est. Completion | 2021-05-31 |
| Phase | NA |
What the finished NCT03256435 record still lists
NCT03256435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which RAMP PrEP initiation, adherence, and retention intervention is the first listed.
NCT03256435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03256435 about?
NCT03256435 is a clinical study titled "Retention in PrEP Care for African American MSM in Mississippi". Innovative and novel HIV prevention interventions are urgently needed for African American (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a daily oral antiretroviral p...
What is the current status of trial NCT03256435?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2016-09-07. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03256435?
The interventions under investigation include: RAMP PrEP initiation, adherence, and retention intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03256435?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03256435's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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