Bisexuality, HIV/AIDS, Substance Use
Conditions
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.
Interventions
BEHAVIORALHIV 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.
Sponsors
Rosalind Franklin University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B*SMART B\*SMART is an online HIV and substance use prevention intervention for self-identified bisexual adolescent men. It includes 90 minutes of content, which can be completed in a single session or across multiple sessions. Participants had one month to complete the intervention. It includes 4 modules that participants can navigate in their preferred order. Within each module, information is presented via text, audio, video, and activities. The modules cover topics related to (1) sexual orientation and gender identity (e.g., coming out, reducing internalized stigma, positive aspects of being bisexual), (2) sexual activity, pleasure, and consent, (3) HIV/STI (e.g., types, level of risk associated with different sexual activities, types of protection, the influence of substance use), and (4) healthy relationships (e.g., different relationship configurations, effective communication). | 31 |
| Waitlist The control condition was a waitlist. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Waitlist | Total | B*SMART |
|---|---|---|---|
| Age, Continuous | 15.93 years STANDARD_DEVIATION 0.96 | 15.93 years STANDARD_DEVIATION 0.99 | 15.94 years STANDARD_DEVIATION 1.03 |
| HIV status Negative | 5 Participants | 9 Participants | 4 Participants |
| HIV status Unknown | 24 Participants | 51 Participants | 27 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black (non-Hispanic) | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 7 Participants | 15 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other (non-Hispanic) | 5 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity White (non-Hispanic) | 16 Participants | 33 Participants | 17 Participants |
| Region of Enrollment United States | 29 participants | 60 participants | 31 participants |
| Sex/Gender, Customized Sex/gender Cisgender boys | 22 Participants | 45 Participants | 23 Participants |
| Sex/Gender, Customized Sex/gender Transgender boys | 7 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Acceptability
Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.
Time frame: Post-intervention
Population: Of the 31 participants in the intervention condition, 24 completed the intervention and 16 completed the post-intervention acceptability survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B*SMART | Acceptability | 3.62 score on a scale | Standard Deviation 0.36 |
Primary
Retention
Retention from enrollment through the 1-month follow-up assessment.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B*SMART | Retention | 25 Participants |
| Waitlist | Retention | 26 Participants |
Secondary
Condomless Sex
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).
Time frame: 1-month follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B*SMART | Condomless Sex | Engaged in condomless sex | 2 Participants |
| B*SMART | Condomless Sex | Did not engage in condomless sex | 23 Participants |
| Waitlist | Condomless Sex | Engaged in condomless sex | 2 Participants |
| Waitlist | Condomless Sex | Did not engage in condomless sex | 24 Participants |
Secondary
Condom Use Intentions
Participants were asked eight questions to assess their intentions to use condoms. Scores ranged from 1-4. Higher scores represent greater condom use intentions.
Time frame: 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B*SMART | Condom Use Intentions | 3.62 score on a scale | Standard Deviation 0.51 |
| Waitlist | Condom Use Intentions | 3.33 score on a scale | Standard Deviation 0.56 |
p-value: 0.029ANCOVA
Secondary
Condom Use Self-efficacy
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.
Time frame: 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B*SMART | Condom Use Self-efficacy | 6.08 score on a scale | Standard Deviation 1.08 |
| Waitlist | Condom Use Self-efficacy | 5.89 score on a scale | Standard Deviation 0.91 |
p-value: 0.542ANCOVA
Secondary
HIV Knowledge
Participants were asked 12 true/false questions to assess their HIV knowledge. Values ranged from 0-12. Higher scores represent greater HIV knowledge.
Time frame: 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B*SMART | HIV Knowledge | 9.32 score on a scale | Standard Deviation 1.07 |
| Waitlist | HIV Knowledge | 6.85 score on a scale | Standard Deviation 1.91 |
p-value: <0.001ANCOVA
Secondary
Internalized Stigma and Identity Affirmation
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.
Time frame: 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B*SMART | Internalized Stigma and Identity Affirmation | Internalized stigma | 2.56 score on a scale | Standard Deviation 1.53 |
| B*SMART | Internalized Stigma and Identity Affirmation | Identity affirmation | 5.47 score on a scale | Standard Deviation 1.54 |
| Waitlist | Internalized Stigma and Identity Affirmation | Internalized stigma | 2.86 score on a scale | Standard Deviation 1.32 |
| Waitlist | Internalized Stigma and Identity Affirmation | Identity affirmation | 5.50 score on a scale | Standard Deviation 0.96 |
Comparison: The outcome for this analysis is internalized stigma.p-value: 0.084ANCOVA
Comparison: The outcome for this analysis is identity affirmation.p-value: 0.417ANCOVA
Secondary
Sexually Transmitted Infection (STI) Knowledge
Participants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.
Time frame: 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B*SMART | Sexually Transmitted Infection (STI) Knowledge | 7.75 score on a scale | Standard Deviation 2.59 |
| Waitlist | Sexually Transmitted Infection (STI) Knowledge | 5.70 score on a scale | Standard Deviation 2.48 |
p-value: 0.013ANCOVA
Secondary
Substance Use
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).
Time frame: 1-month follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B*SMART | Substance Use | Binge drinking | 1 Participants |
| B*SMART | Substance Use | Marijuana use | 6 Participants |
| Waitlist | Substance Use | Binge drinking | 1 Participants |
| Waitlist | Substance Use | Marijuana use | 6 Participants |