Safer Sex Program for Young African-American Men

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Kentucky
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Crosby, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01439503
First received: September 20, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Gonorrhea
Chlamydia
Trichomoniasis
Syphilis
HIV Infections
Behavioral: Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Brief, Clinic-Based, Safer Sex Program for Young African-American Men

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 620
Study Start Date: September 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Kentucky
Investigators
Principal Investigator: Richard A Crosby, PhD University of Kentucky
Principal Investigator: Leandro A Mena, MD University of Mississippi Health Care
  More Information

No publications provided

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
Study First Received: September 20, 2011
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chlamydia 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
Slow Virus Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections
Treponemal Infections
Spirochaetales Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 23, 2014