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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Substance Use; Bisexuality
• Intervention / Treatment: Behavioral: HIV and substance use prevention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University of Medicine and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

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
Experimental: HIV and substance use prevention; Participants in the intervention condition will receive an HIV and substance use prevention program for self-identified bisexual adolescent men. The intervention content will be developed through formative research during the initial phase of the study.	Behavioral: HIV and substance use prevention; The intervention content will be developed through formative research during the initial phase of the study. However, the intervention will address: bisexual-inclusive sexual health education, unique influences of risk behavior among bisexual adolescents, and skills to cope with bisexual stigma and to increase acceptance of one's bisexual identity.
No Intervention: Waitlist; The control condition will be a waitlist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Retention from enrollment through the 1-month follow-up assessment.	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).
Acceptability	Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.	Post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Knowledge	Participants were asked 12 true/false questions to assess their HIV knowledge. Values ranged from 0-12. Higher scores represent greater HIV knowledge.	1-month follow-up
Sexually Transmitted Infection (STI) Knowledge	Participants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.	1-month follow-up
Condom Use Intentions	Participants were asked eight questions to assess their intentions to use condoms. Scores ranged from 1-4. Higher scores represent greater condom use intentions.	1-month follow-up
Condom Use Self-efficacy	Participants were asked eight or nine questions to assess their condom use self-efficacy (cisgender participants received one question that transgender participants did not receive). Scores ranged from 1-7. Higher scores represent greater condom use self-efficacy.	1-month follow-up
Internalized Stigma and Identity Affirmation	Internalized stigma and identity affirmation were measured with the Bisexual Identity Inventory. Scores ranged from 1-7. Higher scores represent greater internalized stigma or identity affirmation.	1-month follow-up
Condomless Sex	Participants were asked a series of questions about their sexual activity and condom use from the HIV-Risk Assessment for Sexual Partnerships. Condomless sex (anal or vaginal) was treated as a dichotomous variable (0 = none, 1 = any).	1-month follow-up
Substance Use	Participants were asked a series of questions about their alcohol and drug use. Outcomes included binge drinking and marijuana use. Outcomes were dichotomous (any vs. none).	1-month follow-up

Collaborators and Investigators

• Sponsor: Rosalind Franklin University of Medicine and Science
• Investigators: Principal Investigator: Brian A Feinstein, PhD, Rosalind Franklin University of Medicine and Science

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 9481383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators can contact the PI to discuss potential use of the data for purposes other than those specified in the specific aims. These requests will be considered by the PI on a case-by-case basis to ensure that all investigators are qualified and that the data will be used in a responsible and ethical manner. If the data are shared, a data sharing agreement will be developed and all shared data will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No