Trial Outcomes & Findings for Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men (NCT NCT03409328)
NCT ID: NCT03409328
Last Updated: 2024-08-22
Results Overview
Retention from enrollment through the 1-month follow-up assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
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).
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
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).
|
Waitlist
The control condition was a waitlist.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
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).
|
Waitlist
The control condition was a waitlist.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
Baseline Characteristics
Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Baseline characteristics by cohort
| Measure |
B*SMART
n=31 Participants
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).
|
Waitlist
n=29 Participants
The control condition was a waitlist.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.94 years
STANDARD_DEVIATION 1.03 • n=5 Participants
|
15.93 years
STANDARD_DEVIATION .96 • n=7 Participants
|
15.93 years
STANDARD_DEVIATION .99 • n=5 Participants
|
|
Sex/Gender, Customized
Sex/gender · Cisgender boys
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex/gender · Transgender boys
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White (non-Hispanic)
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black (non-Hispanic)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other (non-Hispanic)
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
HIV status
Negative
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
HIV status
Unknown
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
B*SMART
n=31 Participants
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).
|
Waitlist
n=29 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Retention
|
25 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Post-interventionPopulation: Of the 31 participants in the intervention condition, 24 completed the intervention and 16 completed the post-intervention acceptability survey.
Acceptability was measured with an adapted version of the Abbreviated Acceptability Rating Profile. Scores ranged from 0-4. Higher scores represent greater acceptability.
Outcome measures
| Measure |
B*SMART
n=16 Participants
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).
|
Waitlist
The control condition was a waitlist.
|
|---|---|---|
|
Acceptability
|
3.62 score on a scale
Standard Deviation .36
|
—
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants were asked 12 true/false questions to assess their HIV knowledge. Values ranged from 0-12. Higher scores represent greater HIV knowledge.
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
HIV Knowledge
|
9.32 score on a scale
Standard Deviation 1.07
|
6.85 score on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants were asked 12 true/false questions to assess their STI knowledge. Scores ranged from 0-12. Higher scores represent greater STI knowledge.
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Sexually Transmitted Infection (STI) Knowledge
|
7.75 score on a scale
Standard Deviation 2.59
|
5.70 score on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants were asked eight questions to assess their intentions to use condoms. Scores ranged from 1-4. Higher scores represent greater condom use intentions.
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Condom Use Intentions
|
3.62 score on a scale
Standard Deviation .51
|
3.33 score on a scale
Standard Deviation .56
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants 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.
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Condom Use Self-efficacy
|
6.08 score on a scale
Standard Deviation 1.08
|
5.89 score on a scale
Standard Deviation .91
|
SECONDARY outcome
Timeframe: 1-month follow-upInternalized 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.
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Internalized Stigma and Identity Affirmation
Internalized stigma
|
2.56 score on a scale
Standard Deviation 1.53
|
2.86 score on a scale
Standard Deviation 1.32
|
|
Internalized Stigma and Identity Affirmation
Identity affirmation
|
5.47 score on a scale
Standard Deviation 1.54
|
5.50 score on a scale
Standard Deviation .96
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants 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).
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Condomless Sex
Engaged in condomless sex
|
2 Participants
|
2 Participants
|
|
Condomless Sex
Did not engage in condomless sex
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 1-month follow-upParticipants 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).
Outcome measures
| Measure |
B*SMART
n=25 Participants
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).
|
Waitlist
n=26 Participants
The control condition was a waitlist.
|
|---|---|---|
|
Substance Use
Binge drinking
|
1 Participants
|
1 Participants
|
|
Substance Use
Marijuana use
|
6 Participants
|
6 Participants
|
Adverse Events
B*SMART
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place