Safer Sex Program for Young African-American Men
Condition: Gonorrhea; Chlamydia; Trichomoniasis; Syphilis; HIV Infections
MeSH terms: Gonorrhea; Syphilis; Trichomonas Infections
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for
      African Americans and has called for a heightened national response. The crisis is especially
      dramatic in the South and it is now apparent that young African American men who have sex
      with men (MSM) are exceedingly likely to be infected. Unfortunately, the ever-expanding HIV
      epidemic experienced by this population has not been matched by equal attention to the
      development of efficacious prevention programs. The proposed project expands upon an
      NIMH-funded study (R21 MH066682-01A1) conducted by Dr. Crosby. His study of young African
      American males found that a brief, clinic-based intervention reduced incidence of subsequent
      STDs by about 50%. This brief, one-on-one, intervention program, known as Focus on the Future
      (FOF), is a practical alternative to group-based safer sex programs that can be difficult to
      translate from science into practice. The program is now classified as a "Best Practice"
      intervention by CDC. This project will begin with an extensive formative phase designed to
      adapt FOF to MSM. The adapted program will seek to "sexualize" condoms to promote their
      consistent and correct use to better prevent STD/HIV. The program is uniquely flexible in
      that it can be applied to MSM regardless of their HIV serostatus. The adapted program will be
      tested by a two-arm efficacy trail. We will recruit 620 MSM (15-29 years of age) from a
      publicly-funded STD clinic in Jackson MS. 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 ditty bag of supplies from the "condom and lube buffet" (condom/lube
      distribution). The trial will test four hypotheses: 1) Men randomized to receive the
      intervention will have a lower incidence rate of laboratory-confirmed STDs (by urine assay
      and rectal swab) at a 6-month and a 12-month follow-up assessment) compared to controls. 2)
      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 controls. 3) Men randomized to receive the intervention will report having
      significantly fewer unprotected penetrative (penile-vaginal or penile-anal) sex partners
      between follow-up assessments compared to controls. 4) Men randomized to receive the
      intervention will report having significantly fewer negative experiences with condom use
      between follow-up assessments compared to controls. Given the dearth of evidence-based
      options for intervening with this vulnerable population in clinical settings, demonstrated
      efficacy of the adapted program has important implications for U.S. public health efforts
      directed towards the prevention of STD/HIV.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of an education program. The education program includes providing the ability to enjoy condom use through improved skills related to finding the right "fit and feel" of condoms, using lubricants that are compatible with latex, negotiating condom use, negotiating sex, and talking with new and existing sex partners about ways to "sexualize" condoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention