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NCT01439503 · ClinicalTrials.gov registry record · Phase 2
Safer Sex Program for Young African-American Men
A Phase 2 study, sponsored by Richard Crosby.
- Completed
- Registry status
- Phase 2
- Development phase
- 620
- Enrollment target
NCT01439503 is a Phase 2 study that has completed, run by Richard Crosby. The registered enrollment target is 620 participants.
The verdict
NCT01439503, a Phase 2 study, has completed, sponsored by Richard Crosby.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 620 participants
- Enrollment target
Study Summary
To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses: Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing. H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition. H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition. H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition. H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition. H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.
Interventions
- BEHAVIORAL Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2012-09 |
| Est. Completion | 2018-04-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01439503
The ClinicalTrials.gov registry entry for NCT01439503 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 620 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Richard Crosby, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intervention is the first listed.
NCT01439503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01439503 about?
NCT01439503 is a clinical study titled "Safer Sex Program for Young African-American Men". To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling fro...
What is the current status of trial NCT01439503?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 620 participants. The study started on 2012-09. Estimated completion is 2018-04-02.
What interventions are being tested in trial NCT01439503?
The interventions under investigation include: Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01439503?
This trial is sponsored by Richard Crosby, which has 3 total clinical trials registered on ClinicalTrials.gov.
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