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

NCT03409328 — Not applicable, Completed, 60 participants, Rosalind Franklin University of Medicine and Science

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RegistryNCT03409328
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment60 (Actual)
SponsorRosalind Franklin University of Medicine and Science (Other)
ConditionsHIV/AIDS, Substance Use, Bisexuality
InterventionsHIV and substance use prevention (Behavioral)
Datesstart 2021-06-11, primary completion 2022-01-31, completion 2022-01-31, first posted 2018-01-24, last updated 2024-08-22
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
HIV and substance use preventionExperimentalBehavioral: HIV and substance use preventionParticipants 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.
WaitlistNo interventionThe control condition will be a waitlist.
  • 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.

+Outcome measures

Primary outcomes

  • Retention [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).]: Retention from enrollment through the 1-month follow-up assessment.
  • Acceptability [Post-intervention]: Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.

Secondary outcomes

  • HIV Knowledge [1-month follow-up]: Participants were asked 12 true/false questions to assess their HIV knowledge. Values ranged from 0-12. Higher scores represent greater HIV knowledge.
  • Sexually Transmitted Infection (STI) Knowledge [1-month follow-up]: Participants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.
  • Condom Use Intentions [1-month follow-up]: Participants were asked eight questions to assess their intentions to use condoms. Scores ranged from 1-4. Higher scores represent greater condom use intentions.
  • Condom Use Self-efficacy [1-month follow-up]: 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.
  • Internalized Stigma and Identity Affirmation [1-month follow-up]: 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.
  • Condomless Sex [1-month follow-up]: 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).
  • Substance Use [1-month follow-up]: 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).

+Eligibility

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

+Posted results

Participant flow

MilestoneB*SMARTWaitlist
Started3129
Completed2526
Not completed63

Outcome results

  • Retention (Primary), Count of participants, Participants: B*SMART 25; Waitlist 26
  • Acceptability (Primary), Mean, score on a scale: B*SMART 3.62 +/- .36
  • HIV Knowledge (Secondary), Mean, score on a scale: B*SMART 9.32 +/- 1.07; Waitlist 6.85 +/- 1.91 (p <.001)
  • Sexually Transmitted Infection (STI) Knowledge (Secondary), Mean, score on a scale: B*SMART 7.75 +/- 2.59; Waitlist 5.70 +/- 2.48 (p .013)
  • Condom Use Intentions (Secondary), Mean, score on a scale: B*SMART 3.62 +/- .51; Waitlist 3.33 +/- .56 (p .029)
  • Condom Use Self-efficacy (Secondary), Mean, score on a scale: B*SMART 6.08 +/- 1.08; Waitlist 5.89 +/- .91 (p .542)
  • Internalized Stigma and Identity Affirmation (Secondary), Mean, score on a scale: B*SMART 2.56 +/- 1.53; Waitlist 2.86 +/- 1.32 (p .084)
  • Condomless Sex (Secondary), Count of participants, Participants: B*SMART 2; Waitlist 2
  • Substance Use (Secondary), Count of participants, Participants: B*SMART 1; Waitlist 1

Adverse events

Time frame: Adverse event data were collected for up to 2 months.

ArmDeathsSerious adverse eventsOther adverse events
B*SMART0/31 (0.0%)0/31 (0.0%)0/31 (0.0%)
Waitlist0/29 (0.0%)0/29 (0.0%)0/29 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Rosalind Franklin University of Medicine and ScienceNorth Chicago, IllinoisUnited States

+Study documents

+Investigators

My Notes