Safer Sex Program for Young African-American Men

Completed · Phase 2

Conditions studied: Gonorrhea, Chlamydia, Trichomoniasis, Syphilis, HIV Infections

In brief

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.

Key facts

Study ID

NCT01439503

Run by

Richard Crosby

People needed

620

Starts

2012-09-01

Expected to finish

2018-04-02

Last updated by the study team

2019-02-21

Who can join

Age: 15 and older, up to 29. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 15-29 years of age
• Identifying as an African American Male
• Males must be presenting themselves for STD testing
• Males must report recently (past 3 months) engaging in penile-anal sex with other males as a "top" (meaning the insertive partner)

You may not qualify if…

• Males not identifying as African American
• Males older than 29 years of age
• Males that are not patients of the STD clinic
• Males who have not engaged in penile-anal sex with other males as a "top" within the past 3 months

Where it is running

• Mississippi State Department of Health STD Clinic — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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