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NCT01033942 · ClinicalTrials.gov registry record · Phase 2
Pre-Exposure Prophylaxis in YMSM
A Phase 2 study of HIV, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT01033942 is a Phase 2 study of HIV that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 68 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01033942, a Phase 2 study of HIV, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.
Conditions Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Many Men, Many Voices (3MV)
- DRUG coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Study Locations (2)
Illinois
- Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital - Chicago
- Childrens Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01033942
The ClinicalTrials.gov registry entry for NCT01033942 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (85% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01033942 reports 2 study locations spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01033942 about?
NCT01033942 is a clinical study titled "Pre-Exposure Prophylaxis in YMSM". This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be ran...
What is the current status of trial NCT01033942?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2009-08. Estimated completion is 2011-09.
What conditions does trial NCT01033942 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01033942?
The interventions under investigation include: Placebo (DRUG), Many Men, Many Voices (3MV) (BEHAVIORAL), coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP (DRUG).
Who is sponsoring clinical trial NCT01033942?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01033942 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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