Safer Sex Program for Young African-American Men

NCT ID: NCT01439503

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2018-04-02

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.

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.

Conditions

Gonorrhea; Chlamydia; Trichomoniasis; Syphilis; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Richard Crosby

OTHER

Sponsor Role: lead

Responsible Party

Richard Crosby

PhD/DDI Endowed Professor and Chair

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard A Crosby, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Leandro A Mena, MD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Health Care

Locations

Mississippi State Department of Health STD Clinic

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

1R01MH092226-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-0204-F3R

Identifier Type: -

Identifier Source: org_study_id