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

Primary Purpose

HIV/AIDS, Substance Use, Bisexuality

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV and substance use prevention
Sponsored by
Rosalind Franklin University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rosalind Franklin University of Medicine and Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIV and substance use prevention

Waitlist

Arm Description

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.

The control condition will be a waitlist.

Outcomes

Primary Outcome Measures

Retention
Retention of at least 80% of the desired sample size throughout the course of the study will be used to measure feasibility.
Acceptability
Acceptability will be measured with 8-items from the Abbreviated Acceptability Rating Profile.

Secondary Outcome Measures

HIV knowledge
HIV knowledge will be measured with the Brief HIV Knowledge Questionnaire.
Sexually Transmitted Infection (STI) knowledge
STI knowledge will be measured with the STI Knowledge Questionnaire.
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.
Condom use self-efficacy
Condom use self-efficacy will be measured with 10-items referencing condom use self-efficacy with partners of different genders.
Bisexual stigma and pride
Bisexual stigma and pride will be measured with the Bisexual Identity Inventory.
Condon use
Condon use will be measured with the HIV-Risk Assessment for Sexual Partnerships.
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.

Full Information

First Posted
January 11, 2018
Last Updated
April 25, 2022
Sponsor
Rosalind Franklin University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT03409328
Brief Title
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Official Title
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rosalind Franklin University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Substance Use, Bisexuality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV and substance use prevention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
The control condition will be a waitlist.
Intervention Type
Behavioral
Intervention Name(s)
HIV and substance use prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention
Description
Retention of at least 80% of the desired sample size throughout the course of the study will be used to measure feasibility.
Time Frame
Through study completion, an average of two months
Title
Acceptability
Description
Acceptability will be measured with 8-items from the Abbreviated Acceptability Rating Profile.
Time Frame
Through completion of the intervention, an average of one month
Secondary Outcome Measure Information:
Title
HIV knowledge
Description
HIV knowledge will be measured with the Brief HIV Knowledge Questionnaire.
Time Frame
Baseline and 1-month follow-up
Title
Sexually Transmitted Infection (STI) knowledge
Description
STI knowledge will be measured with the STI Knowledge Questionnaire.
Time Frame
Baseline and 1-month follow-up
Title
Preventive behavior intentions
Description
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.
Time Frame
Baseline and 1-month follow-up
Title
Condom use self-efficacy
Description
Condom use self-efficacy will be measured with 10-items referencing condom use self-efficacy with partners of different genders.
Time Frame
Baseline and 1-month follow-up
Title
Bisexual stigma and pride
Description
Bisexual stigma and pride will be measured with the Bisexual Identity Inventory.
Time Frame
Baseline and 1-month follow-up
Title
Condon use
Description
Condon use will be measured with the HIV-Risk Assessment for Sexual Partnerships.
Time Frame
Baseline and 1-month follow-up
Title
Substance use
Description
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.
Time Frame
Baseline and 1-month follow-up

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants must self-identify as male regardless of their sex assigned at birth.
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian A Feinstein, PhD
Organizational Affiliation
Rosalind Franklin University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rosalind Franklin University of Medicine and Science
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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