HIV Prevention Program for African American Teen Males

A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males

The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: Male Sexual Health Program; Behavioral: Focus on the Future Program

Detailed Description

Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), 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 to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).

The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.

• Study Type: Interventional
• Enrollment (Anticipated): 840
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Adolescent Medicine Program, LSU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• at least 15, but not more than 23 years of age
• attending the clinic for the expressed purpose of being tested for sexually transmitted infections
• engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
• willingness to return for the two planned follow-up assessments

Exclusion Criteria:

• self-report of being HIV positive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Male Sexual Health Program	Behavioral: Male Sexual Health Program; An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex.
Experimental: Focus on the Future Program	Behavioral: Focus on the Future Program; A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of laboratory-confirmed STIs	2- and 6-month follow-up, as well as 12-month follow-up medical records review
Self-report of unprotected penetrative sex (past 30 days)	2- and 6-month follow-up
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)	2 and 6-month follow-up
Self-report of negative experiences with the correct use of condoms (past 30 days)	2- and 6-month follow-up

Collaborators and Investigators

• Sponsor: Richard Crosby
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Ryan Pasternak, MD, MPH, Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

General Publications

• Crosby RA, Mena L, Smith RV. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention. Health Educ Res. 2018 Jun 1;33(3):197-204. doi: 10.1093/her/cyy010.
• Crosby RA, Mena L, Salazar LF, Hardin JW, Brown T, Vickers Smith R. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. Sex Transm Dis. 2018 Mar;45(3):169-176. doi: 10.1097/OLQ.0000000000000721.
• Crosby R, Salazar LF. Reduction of condom use errors from a brief, clinic-based intervention: a secondary analysis of data from a randomised, controlled trial of young black males. Sex Transm Infect. 2015 Mar;91(2):111-5. doi: 10.1136/sextrans-2013-051492. Epub 2014 Jun 4.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 24, 2009

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV; Randomization; African American; Brief Intervention; Men; Condoms
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 080666; NIH Grant # 1R01MH083621