Clinical trial NCT03409328: Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Official title: Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Substance Use
Bisexuality
Lead sponsor: Rosalind Franklin University of Medicine and Science
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Retention
timeFrame: 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).
measure: Acceptability
timeFrame: Post-intervention
Secondary outcomes:
measure: HIV Knowledge
timeFrame: 1-month follow-up
measure: Sexually Transmitted Infection (STI) Knowledge
timeFrame: 1-month follow-up
measure: Condom Use Intentions
timeFrame: 1-month follow-up
measure: Condom Use Self-efficacy
timeFrame: 1-month follow-up
measure: Internalized Stigma and Identity Affirmation
timeFrame: 1-month follow-up
measure: Condomless Sex
timeFrame: 1-month follow-up
measure: Substance Use
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Rosalind Franklin University of Medicine and Science
state: Illinois
Study officials:
affiliation: Rosalind Franklin University of Medicine and Science
name: Brian A Feinstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: