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Safer Sex Program for Young African-American Men

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ClinicalTrials.gov Identifier: NCT01439503
Recruitment Status : Recruiting
First Posted : September 23, 2011
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Richard Crosby, University of Kentucky

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Gonorrhea Chlamydia Trichomoniasis Syphilis HIV Infections Behavioral: Intervention Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Brief, Clinic-Based, Safer Sex Program for Young African-American Men
Study Start Date : September 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Men receiving the control condition will be comprised of standard of care counseling from the clinic plus a variety of free condoms and water-based lubricants. They will also provide a specimen for STD testing, and receive text message questions for 12 weeks. The text messaging system will be used to collect self-reported dependent variables from men on a weekly basis. Texting will also serve as a constant method of contact between the PD and the enrolled men to remind them of follow-up assessments. In addition, the participants will complete the ACASI questionnaire to assess their sexual behavior, as well as demonstrate their condom application ability.
Experimental: Treatment
Men receiving the treatment condition will receive text messages each week after their enrollment date and this will continue for 12 weeks to collect self-reported dependent variables. Text messaging will also be used to confirm and remind men about the day of each follow-up assessment. Each participant will also provide a specimen for STD testing, as well complete the ACASI questionnaire to assess sexual behavior and demonstrate their condom application ability. These participants will also be provided with a variety of free condoms and water-based lubricants. In addition, men in the treatment condition will also be enrolled in an education program.
 Behavioral: Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  1. The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure. [ Time Frame: 12 months (per participant) ]
    This will be achieved through the use of a centralized text messaging service. Once each week (throughout the 12-month observation period) men will receive questions, via text. The data from these weekly questions will be cumulated to form "3-month" variables that correspond with the STD-testing intervals between baseline and the first follow-up assessment and between the first follow-up assessment and the second one (at 6 months), as well as the "6-month" variables corresponding to the STD-testing interval between the 6-month assessment and the final assessment at 12 months.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439503


Contacts
Contact: Richard A Crosby, PhD 859-257-5620 rcros2@email.uky.edu
Contact: Leandro A Mena, MD 601-984-5560 lmena@umc.edu

Locations
United States, Mississippi
Mississippi State Department of Health STD Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Leandro A Mena, MD    601-984-5560    lmena@umc.edu   
Sponsors and Collaborators
Richard Crosby
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Richard A Crosby, PhD University of Kentucky
Principal Investigator: Leandro A Mena, MD University of Mississippi Health Care
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Richard Crosby, PhD/DDI Endowed Professor and Chair, University of Kentucky
ClinicalTrials.gov Identifier: NCT01439503     History of Changes
Other Study ID Numbers: 11-0204-F3R
1R01MH092226-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
HIV Infections
Gonorrhea
Syphilis
Trichomonas Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Treponemal Infections
Spirochaetales Infections
Protozoan Infections
Parasitic Diseases