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NCT01632397 · ClinicalTrials.gov registry record · Phase 4
Pre-exposure Prophylaxis Adherence Intervention for MSM
A Phase 4 study of Medication Adherence, sponsored by Fenway Community Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
- 1
- Study location
NCT01632397: Completed Phase 4 study of Medication Adherence, sponsored by Fenway Community Health.
NCT01632397 is a Phase 4 study of Medication Adherence that has completed, run by Fenway Community Health. The registered enrollment target is 103 participants, below the 1,655-participant average among 52 other Medication Adherence trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01632397, a Phase 4 study of Medication Adherence, has completed, sponsored by Fenway Community Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
- 1
- Study location
Study Summary
Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.
Primary Outcome
This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).
Conditions Studied
Interventions
- BEHAVIORAL CBT-based counseling
- BEHAVIORAL Health education and supportive counseling
Study Locations (1)
Massachusetts
- The Fenway Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT01632397 record still lists
NCT01632397 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,655-participant average among 52 other Medication Adherence trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Medication Adherence appearing as the primary indexed condition, and to 2 interventions - of which CBT-based counseling is the first listed.
NCT01632397 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01632397 about?
NCT01632397 is a clinical study titled "Pre-exposure Prophylaxis Adherence Intervention for MSM". Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.
What is the current status of trial NCT01632397?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2011-08. Estimated completion is 2014-02.
What conditions does trial NCT01632397 study?
This clinical trial studies the following conditions: Medication Adherence.
What interventions are being tested in trial NCT01632397?
The interventions under investigation include: CBT-based counseling (BEHAVIORAL), Health education and supportive counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01632397?
This trial is sponsored by Fenway Community Health, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01632397 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Medication Adherence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01632397's enrollment target sits among peer trials
103 31st of 52 higher than 22 of 52 other Medication Adherence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Medication Adherence 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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