Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-identified Bisexual Adolescent Men
Phase: NA
Conditions: HIV/AIDS, Substance Use, Bisexuality
Sponsor: Rosalind Franklin University of Medicine and Science

Title: Understanding and Reducing HIV Risk Behavior and Substance Use Among Self-
identified Bisexual Adolescent Men 
 
Identifiers: NCT03409328 
 
Date: 03/15/24 

Study Protocol 
Participants were recruited via paid advertisements on social media (Facebook and 
Instagram). Advertisements directed potential participants to an online eligibility survey. 
Eligibility criteria included: (1) age 14-17; (2) identify as bisexual, pansexual, or queer; (3) 
report attraction to more than one gender or regardless of their gender; (4) identify as male; (5) 
live in the US; and (6) have access to the internet. 
Eligibility survey responses were reviewed by study staff and eligible participants were 
contacted using their preferred method of communication. At this time, they were provided with 
a link to an online assent form and assessment of decisional capacity. After reading the assent 
form, they were asked a series of questions about the study procedures and risks. If they got any 
of the questions wrong, they were given one additional chance to re-read the assent form and re-
answer the questions. If they got any of the questions wrong the second time, they were 
ineligible to participate. If they got all of the questions right, they were asked if they agreed to 
participate in the study. If they agreed to participate in the study, they were automatically 
directed to the baseline survey. 
After completing the baseline survey, participants were randomized to the intervention 
group or the control group. Participants in the intervention group were immediately provided 
with access to the online intervention (described below). They had one month to complete the 
intervention. As soon as they completed the intervention, they were sent a link to an online post-
intervention survey to assess intervention acceptability. After one month, regardless of whether 
or not they completed the intervention, they were sent a link to an online one-month follow-up 
survey to re-assess intervention outcomes. They had one month to complete the one-month 
follow-up survey. Participants in the control group were not asked to do anything for one month. 
After one month, they were sent a link to an online post-waitlist survey to re-assess intervention 
outcomes. Participants could earn up to $90 for completing the study tasks. This study was 
approved by the Institutional Review Board at Rosalind Franklin University. 
Intervention. The online intervention (B*SMART) included 90 minutes of content, which 
could be completed in a single session or across multiple sessions. B*SMART was adapted from 
two previous sex education programs for LGBTQ youth—Queer Sex Ed (QSE; Mustanski et al., 
2015) and SMART Sex Ed (Mustanski et al., 2020). The goal of the adaptation was to tailor the 
content to the unique needs of bisexual, pansexual, and queer male youth. B*SMART included 4 
modules that participants could navigate in their preferred order. Within each module, 
information was presented via text, audio, video, and activities. 
The first module (“Your guide to sexual orientation and gender identity”) covered topics 
such as: differences between sexual orientation and gender identity; differences between specific 
sexual orientations and gender identities; coming out (including unique challenges for bisexual, 
pansexual, and queer male youth and tips for how to do so safely); strategies for reducing 
internalized stigma; and positive aspects of being bisexual, pansexual, or queer. 
The second module (“Unfiltered sex ed: Sexual activity, pleasure, and consent”) covered 
topics such as: specific sexual behaviors; how to minimize discomfort and maximize pleasure 
during sex; the importance of consent; and adolescents’ rights related to sex and sexual health 
(including a state-by-state map depicting laws related to accessing HIV/STI testing/care without 
parental/guardian consent). 
The third module (“Sex ed in the real world”) covered topics such as: different types of 
STIs; different types of protection (e.g., external condoms, internal condoms, birth control, pre-
exposure prophylaxis); the level of risk associated with different sexual behaviors (demonstrated 

via an interactive activity where participants could see the risk associated with specific sexual 
behaviors and how it changes when different types of protection are used); the influence of 
substance use on sex and sexual health (including an activity where participants could see how 
their own substance use compared to other bisexual, pansexual, and queer male youth’s 
substance use based on data from a nationally representative sample); and how to find an 
HIV/STI testing site (including an activity where participants could identify HIV/STI testing 
centers near where they live). 
The fourth module (“Single? Taken? It’s complicated? Healthy relationships”) covered 
topics such as: healthy relationships; different relationship configurations; the importance of 
relationship expectations; and using effective communication to promote healthy relationships. 
 
Statistical Analysis Plan 
Statistical analyses were performed in R Version 4.2.1 (R Core Team, 2022). Chi-squared 
tests and independent samples t-tests were used to evaluate data missingness across critical study 
variables (i.e., condition, demographics, baseline levels of outcomes). Similarly, to assess 
randomization success, chi-squared tests and independent samples t-tests were used to compare 
the intervention and control groups on demographics and baseline levels of outcomes. 
To assess intervention acceptability, we computed the mean and standard deviation of the scale 
score. Between group differences in intervention efficacy were modeled using ANCOVAs, 
whereby intervention effects controlled for baseline levels of outcomes.