Safer Sex Program for Young African-American Men

NCT01439503 | Completed Phase 2

• 2 other identifiers: 11-0204-F3R1R01MH092226-01A1
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonorrhea; Chlamydia; Trichomoniasis; Syphilis; HIV Infections

Outcome Measures

Primary Outcomes (1)

• The frequency of unprotected sex rather than frequency of condom use will be used as the primary outcome measure.

  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.

  12 months (per participant)

Study Arms (2)

Control

NO INTERVENTION

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.

Treatment

EXPERIMENTAL

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

Interventions

Intervention BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Richard Crosby: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mississippi State Department of Health STD Clinic

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Trichomonas Infections; Syphilis; HIV Infections

Interventions

Methods

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Protozoan Infections; Parasitic Diseases; Treponemal Infections; Spirochaetales Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Richard A Crosby, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Leandro A Mena, MD

  University of Mississippi Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD/DDI Endowed Professor and Chair

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2012
• Primary Completion: November 25, 2017
• Study Completion: April 2, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-01

Locations

US (1)