| Registry | NCT03409328 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 60 (Actual) |
| Sponsor | Rosalind Franklin University of Medicine and Science (Other) |
| Conditions | HIV/AIDS, Substance Use, Bisexuality |
| Interventions | HIV and substance use prevention (Behavioral) |
| Dates | start 2021-06-11, primary completion 2022-01-31, completion 2022-01-31, first posted 2018-01-24, last updated 2024-08-22 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for HIV/AIDS All trials for Substance Use All trials of HIV and substance use prevention
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HIV and substance use prevention | Experimental | Behavioral: 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. |
| Waitlist | No intervention | The control condition will be a waitlist. |
Sex: All, ages: 14 Years to 17 Years
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
| Milestone | B*SMART | Waitlist |
|---|---|---|
| Started | 31 | 29 |
| Completed | 25 | 26 |
| Not completed | 6 | 3 |
Time frame: Adverse event data were collected for up to 2 months.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| B*SMART | 0/31 (0.0%) | 0/31 (0.0%) | 0/31 (0.0%) |
| Waitlist | 0/29 (0.0%) | 0/29 (0.0%) | 0/29 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Rosalind Franklin University of Medicine and Science | North Chicago, Illinois | United States |