Pre-Exposure Prophylaxis in YMSM
Public ClinicalTrials.gov record NCT01033942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01033942
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Interventions
- coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP Drug
- Placebo Drug
- Many Men, Many Voices (3MV) Behavioral
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 22 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2009
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
- Last update posted
- Apr 16, 2017
2009 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital | Chicago | Illinois | 60612 | — |
| Childrens Memorial Hospital | Chicago | Illinois | 60614 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01033942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01033942 live on ClinicalTrials.gov.