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NCT01291589 · ClinicalTrials.gov registry record · Phase 1
HIV Prevention in Very High Risk Men Who Have Sex With Men
A Phase 1 study, sponsored by Fenway Community Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01291589: Completed Phase 1 study, sponsored by Fenway Community Health.
NCT01291589 is a Phase 1 study that has completed, run by Fenway Community Health. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01291589, a Phase 1 study, has completed, sponsored by Fenway Community Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners).
Primary Outcome
The potential for an effect will determine the magnitude of the change in self-reported unprotected anal intercourse acts with HIV-uninfected and HIV-unknown status partners in the previous 3 months from baseline assessment to post treatment and follow-up.
Interventions
- BEHAVIORAL Cognitive-behavioral therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01291589 record still lists
NCT01291589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive-behavioral therapy is the first listed.
NCT01291589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01291589 about?
NCT01291589 is a clinical study titled "HIV Prevention in Very High Risk Men Who Have Sex With Men". The purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) HIV-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmissio...
What is the current status of trial NCT01291589?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01291589?
The interventions under investigation include: Cognitive-behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01291589?
This trial is sponsored by Fenway Community Health, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01291589's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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