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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409328
• Other study ID #: 9481383
• Status: Completed
• Phase: N/A
• Start date: June 11, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Rosalind Franklin University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bisexuality
• HIV/AIDS
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Rosalind Franklin University of Medicine and Science	North Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Retention of at least 80% of the desired sample size throughout the course of the study will be used to measure feasibility.	Through study completion, an average of two months
Primary	Acceptability	Acceptability will be measured with 8-items from the Abbreviated Acceptability Rating Profile.	Through completion of the intervention, an average of one month
Secondary	HIV knowledge	HIV knowledge will be measured with the Brief HIV Knowledge Questionnaire.	Baseline and 1-month follow-up
Secondary	Sexually Transmitted Infection (STI) knowledge	STI knowledge will be measured with the STI Knowledge Questionnaire.	Baseline and 1-month follow-up
Secondary	Preventive behavior intentions	Preventive behavior intentions will be measured with 8-items referencing condom use intentions with partners of different genders; items will also be adapted to reference HIV testing intentions and pre-exposure prophylaxis (PrEP) use intentions.	Baseline and 1-month follow-up
Secondary	Condom use self-efficacy	Condom use self-efficacy will be measured with 10-items referencing condom use self-efficacy with partners of different genders.	Baseline and 1-month follow-up
Secondary	Bisexual stigma and pride	Bisexual stigma and pride will be measured with the Bisexual Identity Inventory.	Baseline and 1-month follow-up
Secondary	Condon use	Condon use will be measured with the HIV-Risk Assessment for Sexual Partnerships.	Baseline and 1-month follow-up
Secondary	Substance use	Participants will report on their past-month alcohol and drug use; the HIV-Risk Assessment for Sexual Partnerships will also be used to measure alcohol and drug use before/during sex.	Baseline and 1-month follow-up