An interventional study of HIV and substance use prevention in HIV/AIDS, Substance Use and Bisexuality, sponsored by Rosalind Franklin University of Medicine and Science. Completed at 1 site in United States. Open to participants aged 14 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Rosalind Franklin University of Medicine and Science · Not applicable, Interventional, and 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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 60 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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Exclusion Criteria:
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.
Behavioral: HIV and substance use prevention
The control condition will be a waitlist.
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.
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).
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
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
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
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
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
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
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
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
| Milestone | B*SMART | Waitlist |
|---|---|---|
| Started | 31 | 29 |
| Completed | 25 | 26 |
| Not completed | 6 | 3 |
| Withdrew: Lost to follow-up | 6 | 3 |
Retention from enrollment through the 1-month follow-up assessment.
| Participants | B*SMART | Waitlist |
|---|---|---|
| Retention | 25 | 26 |
Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.
| score on a scale | B*SMART |
|---|---|
| Acceptability | 3.62 ± .36 |
Participants were asked 12 true/false questions to assess their HIV knowledge. Values ranged from 0-12. Higher scores represent greater HIV knowledge.
| score on a scale | B*SMART | Waitlist |
|---|---|---|
| HIV Knowledge | 9.32 ± 1.07 | 6.85 ± 1.91 |
Participants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.
| score on a scale | B*SMART | Waitlist |
|---|---|---|
| Sexually Transmitted Infection (STI) Knowledge | 7.75 ± 2.59 | 5.70 ± 2.48 |
Participants were asked eight questions to assess their intentions to use condoms. Scores ranged from 1-4. Higher scores represent greater condom use intentions.
| score on a scale | B*SMART | Waitlist |
|---|---|---|
| Condom Use Intentions | 3.62 ± .51 | 3.33 ± .56 |
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.
| score on a scale | B*SMART | Waitlist |
|---|---|---|
| Condom Use Self-efficacy | 6.08 ± 1.08 | 5.89 ± .91 |
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.
| score on a scale | B*SMART | Waitlist |
|---|---|---|
| Internalized stigma | 2.56 ± 1.53 | 2.86 ± 1.32 |
| Identity affirmation | 5.47 ± 1.54 | 5.50 ± .96 |
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).
| Participants | B*SMART | Waitlist |
|---|---|---|
| Engaged in condomless sex | 2 | 2 |
| Did not engage in condomless sex | 23 | 24 |
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).
| Participants | B*SMART | Waitlist |
|---|---|---|
| Binge drinking | 1 | 1 |
| Marijuana use | 6 | 6 |
Collected over Adverse event data were collected for up to 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| B*SMART | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Waitlist | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | B*SMART | Waitlist | Total |
|---|---|---|---|
| Mean | 15.94 ± 1.03 | 15.93 ± .96 | 15.93 ± .99 |
| Sex/Gender, Customized(Participants) | B*SMART | Waitlist | Total |
|---|---|---|---|
| Sex/gender — Cisgender boys | 23 | 22 | 45 |
| Sex/gender — Transgender boys | 8 | 7 | 15 |
| Race/Ethnicity, Customized(Participants) | B*SMART | Waitlist | Total |
|---|---|---|---|
| Race/ethnicity — White (non-Hispanic) | 17 | 16 | 33 |
| Race/ethnicity — Black (non-Hispanic) | 1 | 1 | 2 |
| Race/ethnicity — Hispanic | 8 | 7 | 15 |
| Race/ethnicity — Other (non-Hispanic) | 5 | 5 | 10 |
| Region of Enrollment(participants) | B*SMART | Waitlist | Total |
|---|---|---|---|
| United States | 31 | 29 | 60 |
| HIV status(Participants) | B*SMART | Waitlist | Total |
|---|---|---|---|
| Negative | 4 | 5 | 9 |
| Unknown | 27 | 24 | 51 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Rosalind Franklin University of Medicine and Science