HIV/AIDSNCT03409328
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
A study testing HIV and substance use prevention in people with HIV/AIDS and Substance Use, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- HIV/AIDS, Substance Use, Bisexuality
- What is being tested?
- HIV and substance use prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064
About this study
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.
Read the 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.
- Conditions
- HIV/AIDS, Substance Use, Bisexuality
- Being tested
- HIV and substance use prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Bisexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV and substance use preventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HIV and substance use prevention |
| Waitlist | No intervention | The control condition will be a waitlist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention from enrollment through the 1-month follow-up assessment.
Measured: 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.
Measured: Post-intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start11 Jun 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian A. Feinstein, Rosalind Franklin University of Medicine and Science
- Investigators
- Brian A Feinstein, PhD, Principal investigator, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409328
- Sponsor's protocol ID
- 9481383
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2018
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
- ClinicalTrials.gov ID
- NCT03409328
- Acronym / sponsor ID
- 9481383
- Conditions
- HIV/AIDS, Substance Use, Bisexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV and substance use prevention | Experimental | Behavioral: 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. |
| Waitlist | No intervention | –The control condition will be a waitlist. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 14-17
- Identifies as male
- Identifies as bisexual or another non-monosexual identity (e.g., pansexual)
- HIV-negative (self-report)
- Fluent in English
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV and substance use preventionThe 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. | Behavioural | HIV and substance use prevention |
Primary outcome
Retention
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).
Retention from enrollment through the 1-month follow-up assessment.
Acceptability
Time frame: 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.
7 secondary outcomes
HIV Knowledge
Time frame: 1-month follow-up
Sexually Transmitted Infection (STI) Knowledge
Time frame: 1-month follow-up
Condom Use Intentions
Time frame: 1-month follow-up
Condom Use Self-efficacy
Time frame: 1-month follow-up
Internalized Stigma and Identity Affirmation
Time frame: 1-month follow-up
Condomless Sex
Time frame: 1-month follow-up
Substance Use
Time frame: 1-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian A Feinstein, PhD principal investigator
Rosalind Franklin University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV and substance use prevention in people with HIV/AIDS and Substance Use, run by Rosalind Franklin University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.