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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Waitlist | No Intervention | The control condition will be a waitlist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-month follow-up |
| Sexually Transmitted Infection (STI) Knowledge |
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Inclusion Criteria:
Exclusion Criteria:
Participants must self-identify as male regardless of their sex assigned at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Brian A Feinstein, PhD | Rosalind Franklin University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosalind Franklin University of Medicine and Science | North Chicago | Illinois | 60064 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Waitlist | The control condition was a waitlist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Retention from enrollment through the 1-month follow-up assessment. | Posted | Count of Participants | Participants | 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). |
|
Adverse event data were collected for up to 2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Feinstein | Rosalind Franklin University | 847-578-8736 | brian.feinstein@rosalindfranklin.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2024 | Mar 15, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| D001727 | Bisexuality |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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|
Participants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.
| 1-month follow-up |
| 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. | 1-month follow-up |
| 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. | 1-month follow-up |
| 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. | 1-month follow-up |
| 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). | 1-month follow-up |
| 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). | 1-month follow-up |
| BG001 | Waitlist | The control condition was a waitlist. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HIV status | Count of Participants | Participants |
|
| OG001 | Waitlist | The control condition was a waitlist. |
|
|
| 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. | Of the 31 participants in the intervention condition, 24 completed the intervention and 16 completed the post-intervention acceptability survey. | Posted | Mean | Standard Deviation | score on a scale | Post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
|
|
|
|
| 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). | Posted | Count of Participants | Participants | 1-month follow-up |
|
|
|
| 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). | Posted | Count of Participants | Participants | 1-month follow-up |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Waitlist | The control condition was a waitlist. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| ANCOVA |
The ANCOVA controlled for baseline levels of the outcome. |
| .417 |
| F |
| 0.67 |
| 2-Sided |
| Other |