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Clinical Trials/NCT03409328
NCT03409328
Completed
Not Applicable

Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men

Rosalind Franklin University of Medicine and Science1 site in 1 country60 target enrollmentJune 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Rosalind Franklin University of Medicine and Science
Enrollment
60
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
last year

Overview

Brief Summary

Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM (most of whom identify as gay) and heterosexual youth, creating an urgent need for interventions for gay and bisexual adolescents. Further, self-identified bisexual men, especially adolescents, have been neglected in research. Therefore, little is known about factors that drive engagement in risk behavior among self-identified bisexual adolescent men. The goals of this study are to: (1) examine factors that drive engagement in HIV risk behavior and substance use among self-identified bisexual adolescent men; and (2) develop and pilot test a tailored HIV and substance use prevention intervention for this population.

Detailed Description

Young gay, bisexual, and other men who have sex with men (MSM) are disproportionately affected by HIV. Despite this burden, most HIV prevention interventions target adult MSM (most of whom identify as gay) and heterosexual youth, creating an urgent need for interventions for gay and bisexual adolescents. Further, self-identified bisexual men, especially adolescents, have been neglected in research. This is a critical problem because: (1) there are as many, if not more, bisexual adolescent men than gay adolescent men; (2) bisexual adolescent men engage in several HIV risk behaviors more than their gay peers; (3) bisexual adolescent men are at increased risk for substance use-a robust risk factor for HIV; and (4) bisexual men face unique HIV prevention issues. Given that bisexual men are rarely included in research and most existing research on them focuses on "behaviorally bisexual" adult men, little is known about factors that drive engagement in risk behavior among self-identified bisexual adolescent men. Attending to bisexual identity is critical to reducing HIV and substance use, because bisexuality is highly stigmatized and stigma-related stressors (e.g., concerns about disclosing one's bisexual identity) impact sexual behavior, substance use, and healthcare utilization. Interventions are also more effective when tailored to populations, underscoring the need for an intervention for self-identified bisexual adolescent men. The goals of this study are to: (1) examine factors that drive engagement in HIV risk behavior and substance use among self-identified bisexual adolescent men; and (2) develop and pilot test a tailored HIV and substance use prevention intervention for this population. In Phase 1, interviews will be conducted with 60 diverse self-identified bisexual adolescent men ages 14-17 focused on sexual identity, sexual decision-making, substance use motivations, and intervention preferences/barriers. In Phase 2, a tailored intervention will be developed using findings from Phase 1. In Phase 3, feasibility, acceptability, and preliminary efficacy will be tested in a pilot randomized trial (N = 60) with a waitlist control and one-month follow-up. In sum, self-identified bisexual adolescent men are at increased risk for HIV and substance use, but little is known about factors that drive their engagement in risk behavior. By focusing on self-identified bisexual adolescent men-an underrepresented, health disparity population-this study can identify prevention targets and reduce disparities in HIV and substance use.

Registry
clinicaltrials.gov
Start Date
June 11, 2021
End Date
January 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian A. Feinstein

Associate Professor

Rosalind Franklin University of Medicine and Science

Eligibility Criteria

Inclusion Criteria

  • Age 14-17
  • Identifies as male
  • Identifies as bisexual or another non-monosexual identity (e.g., pansexual)
  • HIV-negative (self-report)
  • Fluent in English
  • Lives in United States

Exclusion Criteria

  • Does not meet inclusion criteria

Outcomes

Primary Outcomes

Acceptability

Time Frame: Post-intervention

Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.

Retention

Time Frame: Up to 2 months (participants in the intervention condition had 1-month to complete the intervention and the follow-up assessment was 1-month later; participants in the control condition waited for 1-month and then completed the follow-up assessment).

Retention from enrollment through the 1-month follow-up assessment.

Secondary Outcomes

  • HIV Knowledge(1-month follow-up)
  • Sexually Transmitted Infection (STI) Knowledge(1-month follow-up)
  • Condom Use Intentions(1-month follow-up)
  • Condomless Sex(1-month follow-up)
  • Condom Use Self-efficacy(1-month follow-up)
  • Internalized Stigma and Identity Affirmation(1-month follow-up)
  • Substance Use(1-month follow-up)

Study Sites (1)

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