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

NCT03409328 | Completed Results

• 1 other identifier: 9481383
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS; Substance Use; Bisexuality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• HIV Knowledge

  1-month follow-up

• Sexually Transmitted Infection (STI) Knowledge

  1-month follow-up

• Condom Use Intentions

  1-month follow-up

• Condom Use Self-efficacy

  1-month follow-up

• Internalized Stigma and Identity Affirmation

  1-month follow-up

Study Arms (2)

HIV and substance use prevention

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

The control condition will be a waitlist.

Interventions

HIV and substance use prevention BEHAVIORAL

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.

HIV and substance use prevention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Gender Eligibility Details: Participants must self-identify as male regardless of their sex assigned at birth.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Rosalind Franklin University of Medicine and Science: lead

Study Sites (1)

Rosalind Franklin University of Medicine and Science

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders; Bisexuality

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Results Point of Contact

• Title: Dr. Brian Feinstein
• Organization: Rosalind Franklin University

brian.feinstein@rosalindfranklin.edu

847-578-8736

Study Officials

• Brian A Feinstein, PhD

  Rosalind Franklin University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 24, 2018
• Study Start: June 11, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)