Influences on Risk Behaviors Among Young Men
Phase: NA
Conditions: Sexual Behavior
Sponsor: Boston University

Young Men and Media Study 
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Young Men and Media Study Protocol 
 
ClinicalTrials.gov number: NCT04109443 
Protocol Version Number: 1.1 
Protocol Version Date: 24 October 2019 
Funding Mechanism:  NIMH (K23MH109346) 
Principal Investigator: Kimberly M. Nelson, PhD, MPH 
 
Phone: 617-358-1482 
 
E-mail: knel@bu.edu 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston University. No part of it may be transmitted, reproduced, 
published, or used by other persons without prior written authorization from the study sponsor. 
 
 
 
 
Detailed Statistical Plan 
Section 4 pages 4-5 and Section 12 pages 14-15 
 
 

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TABLE OF CONTENTS 
1 List of Abbreviations .............................................................................................................. 3 
2 Protocol Summary .................................................................................................................. 3 
3 Background/Rationale & Purpose ....................................................................................... 3 
3.1 
Background Information .............................................................................................. 3 
3.2 
Rationale and Purpose ................................................................................................ 4 
4 Objectives ................................................................................................................................ 4 
4.1 
Study Objectives ........................................................................................................... 4 
4.2 
Study Outcome Measures ........................................................................................... 4 
4.2.1 
Primary Outcome Measures ......................................................................... 4 
4.2.2 
Secondary Outcome Measures ................................................................... 5 
5 Study Design ........................................................................................................................... 5 
6 Potential Risks and Benefits ................................................................................................. 5 
6.1 
Risks ............................................................................................................................... 5 
6.2 
Potential Benefits .......................................................................................................... 7 
6.3 
Analysis of Risks in Relation to Benefits ................................................................... 7 
7 Study Subject Selection ........................................................................................................ 7 
7.1 
Subject Inclusion Criteria ............................................................................................. 7 
7.2 
Subject Exclusion Criteria ........................................................................................... 7 
8 Study Intervention .................................................................................................................. 8 
9 Study Procedures ................................................................................................................... 8 
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) ................................ 10 
10.1 Definitions .................................................................................................................... 10 
10.2 Safety Review ............................................................................................................. 11 
10.3 Reporting Plans .......................................................................................................... 12 
10.4 Stopping Rules ............................................................................................................ 12 
11 Data Handling and Record Keeping .................................................................................. 12 
11.1 Confidentiality .............................................................................................................. 12 
11.2 Source Documents ..................................................................................................... 13 
11.3 Case Report Forms .................................................................................................... 14 
11.4 Study Records Retention .......................................................................................... 14 
12 Statistical Plan ...................................................................................................................... 14 
12.1 Study Hypotheses ...................................................................................................... 14 
12.2 Sample Size Determination ...................................................................................... 14 
12.3 Statistical Methods ..................................................................................................... 15 
13 Ethics/Protection of Human Subjects ................................................................................ 15 
14 Literature References .......................................................................................................... 15 
15 Appendix ................................................................................................................................ 20 
 
 

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1 
List of Abbreviations 
 
Abbreviation 
Abbreviation definition 
ASMM 
Adolescent sexual minority males 
CAI 
Condomless anal intercourse 
CBO 
Community Based Organization 
HIV 
Human Immunodeficiency Virus 
LGBT 
Lesbian, Gay, Bisexual, and Transgender 
LGBTQQ 
Lesbian, Gay, Bisexual, Transgender, Queer, and Questioning 
MSM 
Men who have Sex with Men 
PI 
Principal Investigator 
SEOM 
Sexually Explicit Online Media 
STI 
Sexual Transmitted Infection 
US 
United States 
YM&M 
Young Men & Media 
 
2 
Protocol Summary 
Title: 
Influences on risk behaviors among young men 
Population: 
Adolescent sexual minority males (N = 150, male sex, male gender 
identity, 14-17 years old; self-identify as gay/bisexual, report being 
sexually attracted to males, or report having voluntary sexual 
contact with a male partner in the past year) 
Intervention: 
Online sexual health media literacy intervention 
Objectives: 
The objective of this pilot study is to assess the acceptability, 
feasibility, and preliminary efficacy of an online sexual health media 
literacy intervention  
Design/Methodology: 
A RCT design with two conditions (i.e., online sexual health media 
literacy vs. control) and three assessments (i.e., baseline, post-
intervention, 3 month follow-up). See Appendix 1 for detailed study 
flow diagram. 
Total Study Duration: 
24 months 
Subject Participation Duration: 3 months 
 
3 
Background/Rationale & Purpose 
3.1 
Background Information 
Adolescent sexual minority males (ASMM), ages 14-17, are disproportionately affected by HIV in the United States 
(US).1 Racial and ethnic minority ASMM are particularly affected.2 The disproportionate incidence among ASMM is 
largely attributed to engagement in sexual risk behaviors, including condomless anal intercourse (CAI).3,4  
Despite increased risk, few HIV prevention interventions target ASMM < 18 years old.5,6 For ASMM, adolescence 
(ages 14-17) is a developmental period when significant biopsychosocial changes are coupled with negotiation of a 
same-sex attraction.4,7–11 Further, ASMM are particularly susceptible to perceived peer norms, including media-based 
perceived norms,12,13 which predict behavior.9–11,14 As most sexual risk behavior patterns are established during 
adolescence among ASMM,3,4,15,16 it is important for HIV prevention interventions to target ASMM during this vulnerable 
period. Intervening with ASMM will help them learn and establish healthy sexual behaviors,4 which will have both 
immediate and long-term health benefits.4,15,17,18  

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The CDC has highlighted the importance of addressing online media influences on HIV risk among adolescents.19 One 
Internet source that contributes to ASMMs’ HIV risk is their use of sexually explicit online media (SEOM; i.e., online 
pornography).20–26 With limited access to relevant sexual education in school27–29 or from parents,24 ASMM use SEOM20–
26,30 and adopt the behaviors they see.23,26  
The amount of male-male specific SEOM portraying CAI has increased substantially in recent years,31,32 raising 
concerns about the encouragement of risky sexual behaviors among consumers.33,34 105 These concerns are supported by 
five large-scale studies showing positive associations between exposure to CAI in sexually explicit media and 
engagement in CAI among adult MSM35–39 and one among ASMM.26 Further, ASMM report modeling their sexual 
experiences after what they view in SEOM, including engaging in CAI.23,26  
As SEOM triggers and maintains sexual risk-taking among ASMM, 20–26,30 it is critical for HIV prevention interventions 
to address the influence of this “super peer.”12,13,25 One way to address this influence is by developing a SEOM-targeted 
sexual health media literacy intervention.12,25,40 Media literacy interventions have positively impacted many health 
behaviors,41 including sexual health behaviors,42–44 and may be an effective means of addressing the influence of SEOM 
on the sexual risk of adolescent ASMM. As such, using information from an online survey of ASMM from across the 
US24,26,45,45–47 and the guidance of a youth advisory board, we developed an online sexual health media literacy 
intervention called the Young Men & Media (YM&M) intervention.  
The procedures involved in this research (i.e., online assessments, online intervention) are considered low-risk. Thus, 
participants will incur minimal risks due to their participation in this study. This study will be conducted in compliance 
with the protocol, applicable regulatory requirements, and BMC/BU Medical Campus Human Research Protection 
policies and procedures. 
3.2 
Rationale and Purpose  
Given ASMMs’ increased risk for HIV1 in combination with their decreased access to relevant sexual health 
education from traditional sources24,27–29 and reliance on SEOM for sexual health information,20–26,30 development of 
sexual health interventions for ASMM that address male-male sexual practices and SEOM are critical. To our knowledge, 
YM&M is the first intervention to specifically address SEOM use among ASMM. To ensure that this approach is both 
feasible and acceptable to ASMM we are proposing to pilot test the intervention.  
4 
Objectives 
4.1 
Study Objectives 
The goal of this study is to conduct an exploratory clinical trial to pilot test the online media literacy intervention for 
feasibility, acceptability, and preliminary efficacy.  
4.2 
Study Outcome Measures 
An overview of outcome measure 
timing is provided in Table 1. 
4.2.1 Primary Outcome Measures 
The primary outcomes will be 
feasibility and acceptability of the 
intervention.  
Feasibility measures. To assess study 
feasibility, banner ad click-through 
rate, number of individuals recruited 
per week, and the percentage of 
individuals who were eligible; 
assented; dropped out and lost to 
follow-up will be calculated. To assess 
the feasibility of the media literacy 
Table 1. Outcome Measures: Purpose and Timing of Administration 
Purpose 
Construct or Behavior 
Baseline 
Intervention 
Post 
Intervention 
Follow-
up 
Feasibility 
Study recruitment  
x 
 
 
 
Study retention  
 
 
x 
x 
Intervention metrics  
 
x 
x 
 
Acceptability 
Webpage ratings  
 
x 
 
 
Satisfaction survey  
 
 
x 
 
Preliminary 
Efficacy 
Sexual risk behaviors 
x 
 
 
x 
Antecedents to sexual 
risk 
x 
 
x 
x 
Media literacy  
x 
 
x 
x 
Sexual health 
knowledge  
x 
 
x 
x 

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intervention we will calculate intervention metrics (i.e., time spent on each piece of intervention content, percentage 
who complete all intervention content).  
Acceptability measures. To assess acceptability, media literacy intervention participants will be asked to complete 
content ratings on each piece of intervention content using a 5-star rating system. Participants will also be given the 
option of providing written feedback on each piece of content as well. All participants will also be asked to complete a 
satisfaction survey at the post-intervention follow-up.48 Participants will be asked to report on study procedure 
acceptability (e.g., acceptability of recruitment, consent, assessment procedures). Intervention participants will be asked 
to report how informative, interesting, and helpful the intervention was; how likely they would be to recommend it to 
friends; and if they have suggestions for how it could be improved. Participants in the control group will be asked which 
website they went to, if any, and to report how informative, interesting, and helpful the website was; as well as how 
likely they would be to recommend it to friends. The satisfaction survey will include a combination of likert scale and 
open-ended responses.   
4.2.2 Secondary Outcome Measures 
The secondary outcomes will measure preliminary efficacy (i.e., changes in sexual risk behaviors, media literacy skills, 
and sexual health knowledge). 
Sexual risk. Sexual risk behaviors and antecedents to sexual risk behaviors will be assessed. Participants will be asked 
about the number of sex partners, gender of partners, HIV-status of partners, romantic/primary partner status, sexual 
activities and condom use, and substance use with sex in the prior 3 months. Participants will be asked to report only on 
voluntary sexual behavior (i.e., not forced). To optimize the accuracy of these reports, counts of behaviors will be asked 
in an open response format.49–52 Antecedents to sexual risk-taking include intentions to have sex and for sexual 
communication (e.g., communication about HIV/STI status, condom use)44,53 as well as condom attitudes.54  
Media literacy skills will be assessed using questions adapted from the two previous sexual health media literacy 
interventions, including awareness of SEOM myths, awareness of SEOM influence, and SEOM skepticism.42–44  
Sexual health knowledge will be determined by assessing HIV55 and STI56 transmission knowledge; HIV/STI prevention 
method knowledge;57 and the levels of HIV/STI transmission risk (low, medium, high) associated with sexual behaviors 
(e.g., oral sex, anal sex).53 
5 
Study Design 
The study design is a pilot randomized controlled trial (RCT) with two conditions (i.e., YM&M intervention vs. control) 
and three online assessments (i.e., baseline, post-intervention, 3 month follow-up). Prior to randomization all 
participants (N = 150) will complete a baseline assessment. Participants will then be randomly assigned (1:1 
randomization) to the intervention or to the control group. The randomization schedule will be generated using a 
permuted block randomization procedure with small, random-sized blocks. Following receipt of the intervention or 
control, participants will be asked to complete a post-intervention assessment and a 3-month follow-up. Data will 
include self-report and usage data. See Appendix 1 for a schematic of the study design and participant flow and 
Appendix 2 for a schedule of events.  
6 
Potential Risks and Benefits 
6.1 
Risks 
The procedures involved in this research (i.e., online assessments, online intervention) are considered low-risk. Thus, 
participants will incur minimal risks due to their participation in this study. Potential untoward events that may occur 
include:  
 
Emotional discomfort. 
 
Breach of confidentiality. 
The level of risk for each of these events is minimal.   
Emotional discomfort. Some of the topics that are asked about or discussed (e.g., SEOM use, sexual behaviors) 
may cause discomfort or anxiety. There is also the potential for anxiety related to acknowledging behavior with potential 
legal implications (alcohol/drug use, condomless sex which placed someone at risk of contracting an infectious disease). 

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These risks are recognized. Nonetheless, recent research assessing the psychological impact of similar questions among 
LGBT adolescents found that 90% of the participants reported feeling “very comfortable” or “comfortable” with the 
questions they were asked and only 3% reported feeling “very uncomfortable,” which is similar to what has been found 
in other research assessing reactions to questions about sexuality and substance use.58,59  
To minimize the potential for participant psychological distress or discomfort during the online assessments and 
intervention participants will be notified that they can skip any questions or intervention content that they are 
uncomfortable with and stop the assessment or intervention at any time. Participants will also be invited to contact the 
PI should any discomfort arise. 
Breach of confidentiality. The study will take every precaution to ensure that the privacy of study participants is 
protected. To guard confidentiality, each participant will receive a unique ID number. All computer records will be 
protected by standard measures that limit data access to authorized personnel. Online data will be collected and 
managed using the REDCap60 electronic data capture tools managed by Boston University Medical Campus IT. REDCap is 
a secure, web-based application designed by network engineering and approved by IT Security. REDCap servers are 
backed up daily and monitored for hardware failures. Self-report and usage data will be collected from respondents, and 
likewise retrieved by the PI, over an SSL encrypted connection.  
The intervention website is designed and implemented by LongTek, Inc., a technology provider with extensive 
experience creating secure, encrypted websites for research projects.  All data (e.g., email addresses, content ratings, 
time spent on intervention content, number of log-ins) will be housed, monitored, and downloaded by the PI from the PI 
portal within the intervention website. The intervention website data is protected with SSL in transit via TLS 1.2 using 
256 bit RSA encryption. Certain fields within the intervention database (including participant and administration user's 
emails and passwords) are encrypted at rest using hashed and salted SHA256 bit encryption. Participant data can only be 
accessed by the specific participant by entering a username and password via the participant login page.  The PI login 
portal has a logically separated data table and dedicated login page that allows PI users access to a real-time view of 
aggregate data regarding time spent on intervention pages and number of log-ins. The log-in page will not indicate the 
content, purpose, or target population.  Website servers are housed in a highly secure environment, backed up daily 
(nightly backup of database and file system retained for at least 7 days), and monitored for hardware failures (99.9% 
uptime).  
Participants will be encouraged to go to a private location at the beginning of the survey, assessments, and when 
they log into the intervention. To mitigate the chance of another person seeing that the participant is in this study, a 
time limit will be set on the intervention such that if no movements have occurred on the participant’s screen within 20 
minutes the screen will be redirected to the log-in page. Lastly, all correspondence with participants will be devoid of 
any indication of the content, purpose, or target population of the study and participants will be encouraged to delete 
correspondence (e.g., emails) as soon as the participant decides they no longer need the contained information. 
In addition, because of the potentially sensitive nature of the data that are being collected, we have received a 
Certificate of Confidentiality to ensure that participants’ data cannot be subpoenaed with a court order. No individual 
identities will be used in any reports or publications.  
Other considerations: Mental health and substance use. As mental health and substance use issues are prevalent 
among ASMM, we will provide all participants with links and phone numbers for LGBT-specific services (e.g., the 
National Alliance on Mental Health LGBTQ website, PRIDE Institute Substance Use Treatment website, GLBT National 
Youth Talkline phone number, Trevor Helpline Crisis Intervention for LGBTQ Youth phone number). Although none of 
the proposed measures specifically ask about reportable issues, the satisfaction survey for the intervention will include 
open-ended responses. The PI will check these open-ended responses daily in the unlikely event that a participant 
reports any indication of current, ongoing abuse or neglect of children or elders and/or of imminent danger to self or a 
specified individual as these indications will have to be considered for clinical intervention and mandated reporting to 
the appropriate authorities. Daily checks will be documented via PI initials on a study calendar.  
Other considerations: Website developer training. To ensure the website developer is informed of research 
ethics and participant confidentiality they have completed on-line CITI Human Subjects Protection training and signed an 

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agreement to keep all participant information confidential. The developer has a background in designing/programming 
websites for research purposes, thus have completed these trainings and signed research confidentiality agreements 
before. 
6.2 
Potential Benefits 
The largest anticipated benefit is from participating in the YM&M intervention. We expect that individuals who 
complete the YM&M intervention will gain insight into their sexual health and SEOM consumption that could lead to 
sustained sexual behavior and attitude change.  
By participating in the research, participants will also benefit from knowing they may ultimately be helping others 
to reduce their risk behaviors. Possible risks are likely to be outweighed by the new knowledge gained regarding the 
potential of this approach to reduce HIV risk and increase the sexual well-being of ASMM. The risks of participating in 
the research will be minimized through our extensive efforts to maintain confidentiality and to reduce discomfort or 
distress. 
6.3 
Analysis of Risks in Relation to Benefits 
We expect the benefits will outweigh the risks of participating in this research. In previous research conducted by 
the PI many participants have reported that they enjoyed participating. In addition, some participants noted that 
completing self-report assessments, which ask them to reflect on their health behaviors, was a helpful experience; 
based on previous research, it is likely that the act of filling out detailed health behavior assessments can result in 
positive health behavior changes.   
7 
Study Subject Selection 
A convenience sample of ASMM (N = 150) from across the US will be recruited online through social media.  
7.1 
Subject Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
 
Be age 14 to 17. 
 
Report having been assigned male sex at birth and self-identify as male (i.e., be cisgender male). 
 
Self-identify as gay/bisexual, report being sexually attracted to males, or report having voluntary sexual contact 
with a male partner in the past year. 
 
Have intentionally accessed SEOM in their lifetime. 
 
Have a valid personal email address. 
 
Be a US resident. 
 
Be new to the study. 
 
All inclusion criteria will be determined via self-report except for having a valid email address. Having a valid email 
address will be determined by requiring participants to use a unique link sent to their personal email address to access 
the assessments.  
7.2 
Subject Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
Are unwilling or unable to provide informed assent, which would preclude meaningful participation in the 
research. 
 
Are unable to understand and read English. Participants who are unable to understand and read English will not 
be included because they would not be able to complete the assessments nor would they benefit from the 
intervention.  
 
Do not have the appropriate device and necessary software to allow them to experience all the intervention 
content. Because (a) 94% of sexual minority adolescents reporting at least daily Internet use61 and (b) 
participants will be recruited from websites that are likely to have similar device and software requirements, this 

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criterion should not limit our sample. A recent online sexual health education pilot intervention targeting LGBT 
adolescents (ages 16-20) had a similar requirement and found that only 4% of the 1,734 potential participants 
who completed their eligibility screener were ineligible due to the technology requirements.53  
8 
Study Intervention 
Four main topics areas were identified by youth in our previous survey24,26,45,45–47 and the youth advisory board as 
important foci for the intervention: (1) male anatomy, including information about how anal sex can be pleasurable and 
about anal health; (2) HIV/STI prevention information (e.g., transmission risks, accessing testing, condom use); (3) 
general sexual health information (e.g., types of male-male sex, consent, dating safety, partner communication); and (4) 
SEOM literacy (e.g., differences between porn and reality, what’s behind the scenes on a pornography set, normalization 
of porn use among male youth). Youth felt that intervention content should be interactive (e.g., games, videos, 
animations) and the website should have an interface that would be familiar to ASMM (e.g., similar to Netflix). Youth 
preferred a website with a responsive design (i.e., will work on a mobile device, tablet, or computer) as opposed to a 
downloadable phone application. Please see Appendix 3 for screen shots from the intervention website and a more 
detailed description of the content. 
9 
Study Procedures 
Overview 
 
Recruitment, screening, and assent (described in more detail below): Participants will be recruited via online 
advertisements. Once they click on an advertisement they will be presented with information about the study and a 
brief online screener to establish eligibility. If they are eligible they will be presented with assent materials and 
complete capacity to assent questions. If they agree to participate they will then be emailed a unique link to the 
baseline assessment.   
 
Baseline assessment: Participants will be sent an email with a link to a self-report online survey (N = 150; Approx. 
25-35 minutes); compensation for time ($15 electronic gift card via email). If participants do not complete the 
baseline assessment within three days of assenting, we will send them up to 3 reminder emails in a 10-day period.  
 
Randomization: immediately following the final question in the baseline assessment, REDCap60 will be programmed 
to randomly assign participants (1:1 randomization) to the YM&M intervention or to a control group. The 
randomization schedule will be generated using a permuted block randomization procedure with small, random-
sized blocks.  
o Participants randomized to the YM&M (n = 75) intervention will be sent an email with username (their email) 
and a temporary password and asked to complete all of the website content within three weeks of receiving 
the email. Participants will be asked at first log-in to set up their own password. If a participant has not logged 
into the website within one week of receiving the original email, they will be sent up to 3 reminder emails in a 
10-day period.  
o Participants in the control condition (n = 75) will be sent an email with links to various HIV prevention websites 
(e.g., the CDC HIV Prevention site, the National HIV and STD Testing Resource site) and encouraged to visit at 
least one site in the next three weeks.  
 
YM&M intervention exposure: Intervention content, language, and length was informed by a youth advisory board 
and a previously completed online survey.24,26,45,45–47 Although the intervention is designed to be completed in one 
sitting (i.e., < 90 minutes in length), participants will be given the option of logging out and logging in again to 
continue where they left off, should they need to. Intervention content is described in more detail above and in 
Appendix 3. 
 
Post-intervention assessment: Three weeks after the baseline survey participants will be sent an email to complete 
a second online survey (N = 150; Approx. 15-25 minutes); compensation for time ($25 electronic gift card via email). 
If participants do not complete the post-intervention assessment within three days of receiving the email, we will 
send them up to 3 reminder emails in a 10-day period. 
 
Follow-up assessment: Fifteen weeks after the baseline survey participants will be sent an email to complete a final 
online survey (N = 150; Approx. 20-30 minutes); compensation for time ($35 electronic gift card via email). If 

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participants do not complete the follow-up assessment within three days of receiving the email, we will send them 
up to 3 reminder emails in a 10-day period. 
 
All participants: Participants will be offered a bonus if they complete all assessments ($20 electronic gift card via 
email). All participants will receive a list of youth-oriented resources at the end of the survey or if they are inelegible 
(Appendix 4).  
Detailed description of recruitment, screening, assent, and retention procedures.  
Recruitment Processes. Participants will be recruited using advertisements and posts on social networking websites 
(e.g., Facebook, Instagram, Snapchat). Potential participants recruited via advertisements will be directed to the 
screening website which will assent them for screening and then ask potential participants to continue on for eligibility 
questions.  
Screening Procedures. Study eligibility will be determined via inclusion criteria questions (nested among foil 
questions so that these criteria are not obvious) and cross verified using additional questions throughout the survey. 
Eligibility screening will occur on the screening website, which will be hosted and created using REDCap,60 a highly 
secure online survey program. To protect against the possibility of multiple enrollment of the same participant, eligibility 
screening information will be cross-referenced against: date of birth, age, race/ethnicity, and geographic location.62,63 
Online advertisements and the eligibility screener will not indicate the necessary requirements for eligibility in order to 
minimize the potential for faking eligibility.64 To ensure ethnic and racial diversity, eligibility criteria and advertisements 
will be adjusted to oversample racial/ethnic minority participants, as needed.65 Screening data will be retained for 
eligible and ineligible individuals as described in the assent for screening.     
Assent Procedures. In line with ethical recommendations66–70 and standard practice5,6,15,24,26,45,53,59,71–75 for sexual 
health research with LGBT adolescents, a waiver of parental consent is being requested to decrease risk to participants 
and ensure validity of the results. Parental consent would decrease participation rates because some youth will fear that 
they may be “outed” (i.e., involuntary disclosure of their sexual minority status) as a result of participation. Specifically, 
disclosure of sexual preferences may place some participating youth at risk for parental disapproval leading, in some 
instances, to harassment, abuse, or even expulsion from the home.45,58,76–79 Recent research by the CDC reports that 
ASMM commonly experience homonegativity which leads to internalized homonegativity, HIV stigma, silence about 
homosexuality, and forced housing displacement due to their sexual orientation, which, in turn, leads to increased risk 
for HIV seroconversion. This is especially true for racial/ethnic minority ASMM.80 It is crucial that the proposed research 
reach these high-risk ASMM.   
The nature and scope of the proposed research does not pose more than “minimal risk” to participants (45 CFR Part 
46.102) (i.e., “that the probability and magnitude of harm or discomfort anticipated in the research are not greater in 
and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests”). Study measures and exposure to sexual health topics are standard in this 
population, as are waivers of parental permission.5,6,15,24,26,45,53,59,71–75 The majority of adolescents will have received 
some form of formal sexual education by the time they are 14 years old.81 Thus, the proposed intervention will most 
likely not be a participant’s first exposure to formal sexual health education and instead will be an ASMM-specific 
supplement to the sexual health education they have already received.  Additionally, only participants who self-report 
have voluntarily been exposed to SEOM will be included. Participants will not be exposed to SEOM as a part of this 
study. Further, all 50 states plus the District of Columbia allow most minors 14 years old or older to consent to STI 
services without parental permission.82 Similarly, youths of any age can buy condoms without parental consent.  
To compensate for waiver of parental consent, participants will receive a formal assessment of capacity to assent 
(described below) to ensure their understanding of study goals, procedures, and risks from disclosure of sensitive 
information. Further assent material will include a table clearly outlining the pros and cons of participation. Consistent 
with national policy recommendations from the Society for Adolescent Medicine and the American Psychological 
Association,83,84 requiring parental permission for the proposed study would have a number of possible negative effects, 
including: (1) reducing the validity of the findings by effectively eliminating potential participants unwilling to share 
permission forms with their parents/guardians; (2) increasing risk to youth whose parents would have a negative 

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response to the material in the permission forms that would correctly suggest their child has a minority sexual 
preference; and (3) adding little in the way of actual subject protection, given the minimal risk of study 
participation.45,58,76–79 The procedures for the waiver of parental consent are consistent with the guidelines provided by 
the Department of Health and Human Services (45 CFR Part 46, Subpart D). 
There will be two assent procedures as a part of the study: (1) assent for screening and (2) assent for the full study. 
Both of those assent procedures will occur online and affirmation of desire to take part in either the screening or full 
study will be shown by potential participants clicking acknowledgment that they would like to proceed. 
When a potential participant clicks on a study advertisement they will be portalled to the assent for screening 
materials. Those materials will describe screening procedures, confidentiality, and subject rights. At the end, potential 
participants will be asked to indicate whether they would like to move on to eligibility questions or not, which is the 
documentation of their decision to proceed with the screening.  
Assent procedures for the full study will describe the study, its risk and benefits, confidentiality, no deception, and 
how to contact the investigators. The assent process will highlight that potential participants have the option of refusing 
to participate in the study, withdrawing their participation at any time, and/or refusing to answer any questions that 
they feel uncomfortable responding to. Further, potential participants will be informed that their decision to participate 
or not participate in the study will not affect their relationship with any websites, LGBT youth-oriented CBOs, clinics, or 
Boston University. Capacity to assent will be further confirmed by administering multiple choice questions that will 
evaluate participants’ ability to: (1) name things they will be expected to do during the study, (2) explain how they will 
be assigned to their group, (3) explain what they would do if they experienced distress during the study, and (4) identify 
potential risks for participating in the study.85,86 Participants who are unable to accurately answer the multiple choice 
questions will be redirected to the relevant portions of the assent materials and asked the questions again. Capacity to 
assent questions and answers will be automatically re-ordered each time they are presented to reduce the chance of 
participants blindly choosing answers until they get the right ones. Participants will be given three chances to correctly 
answer capacity to assent materials. If after three chances they continue to answer questions incorrectly they will be 
considered ineligible. Potential participants will be given the option of contacting study staff (via e-mail, telephone 
number, and mailing address) to ask questions before enrolling. After potential participants have been determine to 
have capacity to assent they will be asked whether they would like to participate in the study or not, which is the 
documentation of their decision to enroll in the study. Once eligible participants have assented they will be sent an 
email containing a unique link to the baseline survey. To proceed to the main body of the survey, eligible participants 
will be required to click on that link. Participants will be reminded about assent parameters at the start of each follow-
up assessment. 
Retention Plan. Retention strategies include participant reminders, repeated contact, and compensation. Eligible 
participants who provide assent will be asked to provide an email address and phone number(s) for 
recontacting/tracking. REDCap will maintain an electronic system that will notify participants via email when they are 
due for an assessment and remind them up to 3 times within a 10-day period if they have missed an assessment. 
Participants will have the option to discontinue the study at any point by contacting study staff. Participants who wish to 
drop out of the study will be queried as to their reasons and attempts will be made to address their concerns. 
Participants will be compensated at the completion of the baseline survey ($15) and after each of the follow-up surveys 
($25 for post-intervention, $35 for follow-up). Participants will be offered a bonus for the completion of all surveys 
($20). Participants will be compensated via electronic gift cards.  
See the Appendix 2 for the schedule of events.  
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
10.1 Definitions 
The following definitions will be used in the assessment of safety: 
Adverse Events (AEs) include any abnormal or harmful behaviors, increasing risk behaviors (e.g., sexual risk behaviors), 
suicidal behaviors, breach in the protection of participant data or breach of confidentiality whether or not consider 
related to the subjects participation in the research.   

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Serious Adverse Event (SAE) is any adverse event that  
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or 
surgical intervention to prevent one of the other outcomes listed in this definition (examples of such events 
include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias 
or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse).  
Life-threatening means that the event places the subject at immediate risk of death from the event as it occurred.  
Unanticipated Problem is defined as an event, experience or outcome that meets all three of the following criteria:  
 
is unexpected; AND 
 
is related or possibly 
related to participation 
in the research; AND 
 
suggests that the 
research places subjects 
or others at a greater risk 
of harm (including 
physical, psychological, 
economic, or social 
harm) than was 
previously known or 
recognized.  
Possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused 
by the procedures involved in the research 
Unexpected means the nature, severity, or frequency of the event is not consistent with either: 
 
the known or foreseeable risk of adverse events associated with the procedures involved in the research that are 
described in (a) the protocol–related documents, such as the IRB-approved research protocol, any applicable 
investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources 
of information, such as product labeling and package inserts; or 
 
the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing 
the adverse event and the subject’s predisposing risk factor profile for the adverse event. 
10.2 Safety Review 
Both the risks listed in Section 4.1 and unknown risks will be monitored as follows:  
Study safety and progress will be monitored according to the schedule outlined in Table 2 (and more frequently, if 
needed). The PI (Dr. Nelson), will closely supervise all study activities on a day-to-day basis. The PI will personally 
monitor recruitment procedures, accrual and retention, and data integrity daily in order to take the necessary measures 
in a timely fashion. Participants will be instructed to notify the PI immediately if any symptoms occur during the online 
assessments or sexual health media literacy intervention. All AEs will be documented daily by the PI. AEs will be labeled 
according to severity, as ‘mild’ if the event does not have a major impact on the participant, ‘moderate’ if it causes the 
participant some minor inconvenience and ‘severe’ if it causes a substantial disruption to the participant’s well-being. All 
AEs and SAEs will be labeled as definitely, probably, possibly or unrelated to the study intervention.  
Table 2. Study Safety and Progress Monitoring  
Data Source / 
Frequency of Aggregation 
Frequency of Review 
Data Type 
Online Asessments/Website 
PI 
Accrual, Retention, and Attrition  
Daily 
Daily 
Adverse Events*  
Daily 
Daily 
Missing data/data integrity  
Twice a Week 
Twice a Week 
Intervention Integrity  
Daily 
Daily 
* Please note: serious adverse events will be reported within 24 hours to the IRB and to the sponsor 
(NIH) in accordance with their requirements.  

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10.3 Reporting Plans 
The Principal Investigator at BMC/BU Medical Campus will report Unanticipated Problems, safety monitors’ reports, and 
Adverse Events to the BMC/BU Medical Center IRB in accordance with IRB policies: 
 
Unanticipated Problems occurring at BMC/BU Medical Campus will be reported to the IRB within 7 days of the 
investigator learning of the event. 
 
Reports from safety monitors with recommended changes will be reported to the IRB within 7 days of the 
investigator receiving the report.  
 
Adverse Events (including Serious Adverse Events) will be reported in summary at the time of continuing review, 
along with a statement that the pattern of adverse events, in total, does not suggest that the research places 
subjects or others at a greater risk of harm than was previously known. 
 
Reports from safety monitors with no recommended changes will be reported to the IRB at the time of continuing 
review.  
The PI will promptly inform the NIH and the IRB of any changes in recruitment or in the protocol relevant to safety as the 
study is being performed.  She will additionally notify the NIH promptly of any unanticipated problems or any actions 
taken by the IRB during continuing study review and any major changes in the status of the ongoing protocol which 
would only occur with IRB approval.  Such changes would include but are not limited to: amendments to the protocol, 
temporary suspension of participant accrual, or of the protocol, any changes in informed consent or IRB approval status, 
termination of participant accrual or of the protocol, or other problems or issues that could affect the human subjects in 
the study. 
10.4 Stopping Rules 
Considering the low-risk of this study, no interim analyses are proposed and stopping rules have not been established. 
However, the study may be discontinued at any time by the IRB, the NIMH, the OHRP, or other government agencies as 
part of their duties to ensure that research participants are protected.  
11 Data Handling and Record Keeping 
11.1 Confidentiality 
Confidentiality of study data will be maintained by numerically coding all data, by disguising identifying information, 
and by keeping all data in password-protected, encrypted computer files. All information obtained from participants will 
be accessible only to research staff.  Study staff will maintain participant privacy by securing records using password-
protected, encrypted databases. In meetings when study procedures are reviewed and issues of compliance are raised, 
participants will not be identified by name unless necessary, and if necessary only by first name. Project meetings will be 
held in private conference rooms.  
Data will be obtained from electronic assessments completed by study participants and usage data from the study 
website. Personally identifiable information (PII), assessment responses, and usage data will be kept in separate 
datasets. They will be linked only with a randomly generated ID variable that is included in all data. Although the 
datasets will be housed on the same server (e.g., REDCap for assessment and self-report data, the intervention website 
for usage data and content review data), they will otherwise be completely separate. The PII dataset will be deleted 
upon completion of data collection and cleaning. AE reports and annual summaries will not include subject-identifiable 
material. Multiple levels of password protection will be utilized and access will be denied to non-study personnel. No 
identifiable information will be stored on laptops or transportable devices in this study. Further, REDCap and website 
servers will be physically stored in high security areas and study desktops will be located within a secured building. 
 
If it is discovered that despite security precautions electronic data has been hacked, or if someone has illegally 
gained access to any data, the PI will determine to what extent the hacking has been successful. The PI will promptly 
inform the appropriate authorities to the extent of the hacking (e.g., BU, the IRB, NIH project officer, and, if appropriate, 
the police department). The PI in collaboration with the above authorities will determine what action, if any, is 
appropriate. In the unlikely event that hacking occurs, an attempt will be made to contact every participant potentially 
affected by the hacking to inform them that their data may have been accessed. Legal recourse will also be sought to 

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prevent further use or distribution of the data if we are able to identify the individual or agency who hacked the data. 
Upon reasonable suspicion that the data has been hacked, all data collection will be suspended until the incident has 
been reviewed and a secure means of continuing to obtain and store data has been re-established. 
Because of the sensitive nature of the data we are collecting, we have received a Certificate of Confidentiality for 
this study to ensure that participants’ data cannot be subpoenaed with a court order. 
The study monitor or other authorized representatives of the sponsor may inspect all documents and records 
required to be maintained by the investigator. The study will permit access to such records. 
11.2 Source Documents 
There are two sources of data: (a) 
participant self-report and (b) usage data: 
 
Self-report data: will be collected via 
content ratings for each piece of 
intervention content and the 
assessments. Assessments for the pilot 
RCT will be conducted at baseline, 
post-intervention (3 week after 
baseline), and follow-up (15 weeks 
after baseline). Assessment data will be 
collected using a secure online survey 
software system, namely, REDCap.60 
Content ratings will be collected 
through the intervention website.  
 
Usage data: will include banner ad 
click-through rate, time spent on 
intervention content, and number of 
intervention website log-ins. Banner ad 
click-through rate will be acquired from 
the advertising websites. Time spent 
on each piece of intervention content 
and number of intervention website 
log-ins will be collected via the 
intervention website. 
Only authorized study personnel will have 
access to the data.  
Self-report measures. An overview of the 
constructs and assessed behaviors is 
provided in Table 3. 
Descriptive measures and moderators. 
Socio-demographics. Age, race/ethnicity, 
birth sex, gender identity, sexual 
orientation, education level, living 
situation, and zip code will be asked using 
standard formats. Legal Guardians. Participants will be asked questions about their legal guardians and how “out” they 
are about their sexual attraction to male partners.15 Outness. Participants will also be asked about their overall degree of 
“outness.”37,87 Healthcare access/use. Access and use of healthcare services, including HIV/STI testing.77 Substance use. 
The impact of participants’ use of alcohol and other drugs will be assessed using the CAGE Adapted to Include Drugs 
(CAGE-AID).88 Participants will also be asked about which drugs they used recreationally in their lifetime. Mental Health 
Table 3. Measures: Purpose and Timing of Administration 
Purpose 
Construct or Behavior 
Baseline 
Intervention 
Post 
Intervention 
Follow-
up 
Descriptors  / 
Moderators 
Socio-demographics  
x 
 
 
 
Legal Guardians 
x 
 
 
 
Outness  
x 
 
 
x 
Healthcare 
access/use 
x 
 
 
x 
Substance Use  
x 
 
 
x 
Mental Health  
x 
 
 
x 
Sexual Abuse History 
x 
 
 
x 
Sexual Education 
Exposure  
x 
 
 
x 
Feasibility 
Study recruitment  
x 
 
 
 
Study retention  
 
 
x 
x 
Intervention metrics  
 
x 
x 
 
Acceptability 
Webpage ratings  
 
x 
 
 
Satisfaction survey  
 
 
x 
 
Exposure 
SEOM exposure  
x 
 
 
x 
Mediators 
Identification with 
SEOM actors  
x 
 
x 
x 
Perceived  norms of 
SEOM behavior  
x 
 
x 
x 
Expectancies about  
SEOM behavior 
x 
 
x 
x 
Perceived  
consequences of 
SEOM behavior  
x 
 
x 
x 
Preliminary 
Efficacy 
Sexual risk behaviors 
x 
 
 
x 
Antecedents to sexual 
risk 
x 
 
x 
x 
Media literacy  
x 
 
x 
x 
Sexual health 
knowledge  
x 
 
x 
x 

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will be assessed using the PHQ-4. Sexual abuse history will be assessed using the sexual abuse subscale of the Childhood 
Trauma Questionnaire (CTQ). Sexual education exposure. Sources of sexual education (e.g., parents, school, online) and 
coverage male-male sexual health-related topics will be assessed.15  
Feasibility measures. To assess study feasibility, banner ad click-through rate, number of individuals recruited per week, 
and the percentage of individuals who were eligible; assented; dropped out and lost to follow-up will be calculated. To 
assess the feasibility of the media literacy intervention we will calculate intervention metrics (i.e., time spent on each 
piece of intervention content, percentage who complete all intervention content).  
Acceptability measures. To assess acceptability, media literacy intervention participants will be asked to complete 
content ratings on each piece of intervention content using a 5-star rating system and an open text field. Participants 
will also be given the option of providing written feedback on each piece of content as well. All participants will also be 
asked to complete a satisfaction survey at the post-intervention follow-up.48 Participants will be asked to report on study 
procedure acceptability (e.g., acceptability of recruitment, consent, assessment procedures). Intervention participants 
will be asked to report how informative, interesting, and helpful the intervention was; how likely they would be to 
recommend it to friends; and if they have suggestions for how it could be improved. Participants in the control group 
will be asked which website they went to, if any, and to report how informative, interesting, and helpful the website 
was; as well as how likely they would be to recommend it to friends. The satisfaction survey will include a combination 
of Likert scale and open-ended responses.   
Exposure measure and mediators. Sexually explicit online media (SEOM) use will be established through a measure 
developed in a previous study of SEOM use among adult MSM37 and adapted for use with ASMM.26 This measure cover 
topics including: frequency and timing of usage; prevalence of viewing portrayed behaviors in SEOM; preferences for 
condoms use in SEOM; arousal during use; identification with SEOM actors; perceived norms of SEOM behaviors; 
expectancies about portrayed behaviors; perceived consequences of portrayed behaviors; and beliefs about the 
influence of SEOM on behaviors within the participant and on other MSM (i.e., perceived norms).  
Preliminary Efficacy measures. To conduct exploratory assessments of intervention efficacy, we will measure three 
primary outcomes: sexual risk, media literacy, and sexual health knowledge. Sexual risk. Sexual risk behaviors and 
antecedents to sexual risk behaviors will be assessed. Participants will be asked aggregate information about the 
number of sex partners, gender of partners, HIV-status of partners, romantic/primary partner status, sexual activities 
and condom use, and substance use with sex in the prior 3 months. Participants will be asked to report only on voluntary 
sexual behavior (i.e., not forced). To optimize the accuracy of these reports, counts of behaviors will be asked in an open 
response format.49–52 Antecedents to sexual risk-taking include intentions to have sex and for sexual communication 
(e.g., communication about HIV/STI status, condom use)44,53 as well as condom attitudes.54 Media literacy skills will be 
assessed using questions adapted from the two previous sexual health media literacy interventions, including awareness 
of SEOM myths, awareness of SEOM influence, and SEOM skepticism.42–44 Sexual health knowledge will be determined 
by assessing HIV55 and STI56 transmission knowledge; HIV/STI prevention method knowledge;57 and the levels of HIV/STI 
transmission risk (low, medium, high) associated with sexual behaviors (e.g., oral sex, anal sex).53 
11.3 Case Report Forms 
N/A 
11.4 Study Records Retention 
All study records will be retained in electronic form for at least seven years after completion of the study.  
 
12 Statistical Plan 
12.1 Study Hypotheses 
We hypothesize that the YM&M intervention will be feasible and acceptable. We further hypothesize that sexual risk 
behaviors will decrease and media literacy skills and sexual health knowledge will increase by greater amounts in the 
intervention group compared to the control group at post-intervention and 3-month follow-up.  
12.2 Sample Size Determination 

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Sexual health media literacy interventions have an overall effect size of 0.21 - 0.38 on antecedents to sexual risk 
behaviors.42–44 For this exploratory study, we conservatively anticipate a Cohen’s d = 0.20 between 2 groups. With the 
current sample size (N = 150) and a two-sided α = 0.05, we have 52% power to determine an effect size 0.20. With a 
two-sided α = 0.05 and 80% power (β = 0.20) we would require retention of a total sample size of 192. Considering the 
scope of the award, recruitment and retention of this sample size is not feasible. The proposed sample size is adequate 
to evaluate feasibility and acceptability of the intervention and gauge whether the intervention effects are encouraging. 
12.3 Statistical Methods 
Because this is a small pilot study, analyses are not powered to detect intervention effects or formally test mediation or 
moderation. To determine feasibility of conducting a RCT, we will calculate the percentage of individuals who were: 
eligible; assented; were randomized; and completed the post-intervention and 3-month follow-up. To determine 
feasibility of the intervention, we will calculate the total time spent on each intervention page as well as the percentage 
of individuals who complete the intervention. To determine acceptability of the intervention, we will calculate mean 
content ratings for the intervention pages and satisfaction surveys as well as inspect open-ended responses. As a 
secondary goal and to obtain preliminary evidence of efficacy of the online media literacy intervention, we will examine 
the within- and between-group differences at each follow-up for all three efficacy measures (i.e., sexual risk, media 
literacy, sexual health knowledge) using a series of longitudinal mixed effects models, controlling for baseline values, as 
well as any group differences.  
13 Ethics/Protection of Human Subjects 
This study is to be conducted according to applicable US federal regulations and institutional policies (which are based in 
federal regulations, guidance, and ICH Good Clinical Practice guidelines). 
This protocol and any amendments will be submitted to the Boston Medical Center and Boston University Medical 
Campus IRB, for formal approval of the study conduct. The decision of the IRB concerning the conduct of the study will 
be made in writing to the investigator. A copy of the initial IRB approval letter will be provided to NIMH before 
commencement of this study.  
All subjects for this study will be provided assent material describing this study and providing sufficient information for 
subjects to make an informed decision about their participation in this study. The assent material will be submitted with 
the protocol for review and approval by the IRB. The assent of a subject, using the IRB-approved assent material, must 
be obtained before that subject is submitted to any study procedure. Assent will be documented as required by the IRB.   
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Parents:” Motivation to participate in oral and injectable PrEP clinical trials among adolescent men who have sex 
with men. PloS One 2018;13(7):e0200560.  
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15 Appendix 
 
 
DESCRIPTION 
1 Schematic of study design and participant flow  
2 Schedule of events 
3 Intervention website content 
4 Resource list 
 
 

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Appendix 1 
 
 Schematic of study design  
and participant flow

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Potential Participant Clicks 
on Online Advertisement 
Screening Assent 
Eligibility Screener 
Assent Information 
Capacity to Assent 
Questions 
Email unique link to 
Baseline Assessment 
Community Resource 
List 
Community Resource 
List 
Community Resource 
List 
Eligible 
Ineligible 
Capacity 
No Capacity 
Baseline Assessment 
Email online gift 
certificate 
Randomization 
Email Intervention 
Website Info 
 
Email with Control 
Group Links 
Email Link to 3-
week Assessment 
Email Link to 15-
week Assessment 
Community 
Resource List 
3-Week 
Assessment 
Email online gift 
certificate 
Community 
Resource List 
15-Week 
Assessment 
Email online gift 
certificate and 
bonus 
Community Resource 
List 
Agree to screening 
Does not 
agree to 
screening 

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Appendix 2 
 
 Schedule of events 
 
 
 

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Baseline
• 25-35 minute online survey
Randomization
Intervention or Control
Post-Intervention Assessment (3 weeks post-baseline)
• 15-25 minute online survey
3 Month Assessment (15 weeks post-baseline)
• 20-30 minute online survey

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Appendix 3 
  
Intervention Website Content 
 
 

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A. Website Address: 
a. www.youngmenandmedia.com 
 
B. Landing Page: 
a. Description: The landing page is basic with no information to indicate the target 
population or anyway to enter the page without a sign in.  
b. Screenshot: 
 
 
 
C. Sign in page: 
a. Description: The sign in page is basic with no information to indicate the target 
population or anyway to enter the page without an assigned sign in.  
b. Screenshot: 
 
 
 
D. Website Design: 
a. Description: The website is designed to mimic the flow and formatting of Netflix. It is 
adaptive so that it can be used on a mobile phone or a computer. There are tiles to 
represent the various parts of the intervention. There are three rows of tiles: 
recommended, completed, and locked. Once a participant has completed 

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recommended content, the tile for that content will move to the completed row and 
locked content will be unlocked and moved to recommended. Participants can complete 
pieces of content more than once and will be asked to rate each piece of content on a 5-
star scale and provide additional comments about content (that can only be seen by 
them and our staff) upon their completion. 
b. Screenshot of Site: 
 
 
 
c. Screenshot of Example Feedback Panel: 
 
 
 
 
 

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d. Intervention Content 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Topics 
Intervention Content (Detailed Descriptions Below) 
Male-Male Sex Ed 101 
  
Anatomy 
 
Penis 
Sexual Health/Anatomy Animation by Blue Seat Studios  
Anus/Prostate 
Sexual Health/Anatomy Animation by Blue Seat Studios  
HIV/AIDS and STIs Prevention 
 
HIV transmission 101 
HIV/STI Jeopardy 
STI transmission 101 
HIV/STI Jeopardy 
How to use a condom 
Sexual Health/Anatomy Animation by Blue Seat Studios  
How to talk with sexual partners about STIs/HIV 
Choose Your Own Dating Adventure Game 
How to access services (e.g., testing, doctors) 
HIV/STI Jeopardy 
General Sexual Health 
  
The types of sex you can have with a male partner  
Sex Menu 
How to pick partners 
Choose your own adventure communication overview 
Anal health 
Interview with Dr. Bryan Kutner 
Fiber/Anal douching 
Interview with Dr. Bryan Kutner  
How to safely and comfortably have anal sex 
Interview with Dr. Bryan Kutner  
How to use lubrication or lube (e.g., K-Y, bodyglide) 
Interview with Dr. Bryan Kutner 
Communication with partners 
Choose Your Own Dating Adventure Game 
Consent 
Tea Consent Animation by Blue Seat Studios 
How to talk with sexual partners about what you 
would/wound NOT like to do sexually 
Choose Your Own Dating Adventure Game 
Sex-seeking website/app etiquette/protection  
Choose Your Own Dating Adventure Game 
Porn Literacy 
 
What's omitted 
Porn Matching Game 
Behind the scenes 
  
Author and purpose 
Porn Set Scavenger Hunt Game 
Political/Economic Context 
Porn Set Scavenger Hunt Game 
Porn Addiction 
Porn by the Numbers Infographic  

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e. Sexual Health/Anatomy Animation by Blue Seat Studios 
i. Description: This animated video uses humor to cover basic anatomy of the 
penis, anus, and prostate as well as how to correctly put a condom on, the 
importance of talking with partners, and a brief introduction to anal health.  
ii. Screenshot: 
 
 
f. HIV/STI Jeopardy 
i. Description: This game is based on traditional jeopardy (5 columns with 5 
questions in each column). The five columns are: (1) HIV 101, (2) HIV Testing, (3) 
STI 101, (4) STI Testing & Symptoms, and (5) Final Review. Each question is given 
a dollar value and there is a “Daily Double” after all questions have been 
answered. The questions cover the basics of HIV/STI transmission, how to 
prevent HIV/STIs, and how to access services. Example questions include: “What 
does HIV stand for?” “What are ways you can protect yourself from getting HIV 
and other sexually transmitted infections?”  
ii. Screenshot: 
 
 
 

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g. Sex Menu 
i. Description: This infographic goal is to expand what participants consider male-
male sex. It covers a wide range of behaviors including hand holding, cuddling, 
licking, masturbation, oral sex, and anal sex. All images imply the sexual 
behaviors that are being highlighted in an artistic manner. They do not show 
anything that could be considered pornographic (e.g., no exposed genitalia, 
penetration) and are in accord with what youth would be able to see in 
standard magazine and TV advertisements.   
 
ii. Screenshot: 
 
 
h. Choose your own dating adventure game 
i. Description: In the tradition of choose your own adventure books, this game 
allows participants to play out different dating scenarios including choices 
related to where to meet partners, using alcohol or drugs on a date, whether to 
have sex or not, talking about HIV/STIs with partners, and talking about what 
you do and do not want to do sexually with partners. With each choice 
participants are given feedback about the pros and cons of the choice they have 
made. At the end participants are given a summary of their choices and how 
they choices relate to their HIV/STI risk and safety.   
ii. Screenshot: 
 
 
i. 
Interview with Dr. Bryan Kutner, anal health specialist 
i. Description: Dr. Bryan Kutner, an anal health specialist and clinical psychologist, 
is interviewed in this video and discusses topics related to anal health including 

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anatomy, fiber/douching, how to safely and comfortably have anal sex, how to 
use lube, and how to effectively communicate with partners.   
ii. Screenshot: 
 
 
j. 
Tea Consent Animation by Blue Seat Studios 
i. Description: This animated video uses humor to convey what does and does not 
constitute consent between sexual partners.   
ii. Screenshot: 
 
 
k. Porn Matching Game  
i. Description: Participants are given a list of sexual and relationship behaviors and 
asked to sort them into three buckets: (1) Shown in porn, but not very realistic 
(e.g., rapid/rough anal sex); (2) Shown in porn and realistic (e.g., mutual 
masturbation); (3) Not often shown in porn, but happens in real life sexual 
relationships (e.g., talking with partners, eye contact). 
ii. Screenshot: 
 
 
l. 
Porn Set Scavenger Hunt Game  
i. Description: In this game participants are asked to find all of the items that are 
“clickable” on an illustrated porn set (which does not depict any sexual acts). 
When they click on an item (e.g., the producer, STI test results, the lighting rig) 

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they are given a description of the item and why it is there. The goal of this 
game is to help participants to understand that what they see on the screen 
when they are viewing pornography is not representative of what is actually 
happening on the set and to illustrate the roles and motives of the people who 
are involved in making the porn.  
ii. Screenshot: 
 
 
m. Porn by the Numbers Infographic 
i. Description: To help youth understand the typical way porn is used by other 
ASMM their age, this infographic (using data from Phase 2 of this study) 
provides basic statistics about how many 14-17 year old ASMM report viewing 
porn, how often they view, how many are masturbating while they are viewing, 
and the top three reasons for viewing  
ii. Screenshot: 
 
 
 
 
 
 
 
 

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Appendix 4 
 
 Resource List 
 
 

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The Young Men & Media Study 
 
For those who are ineligible:  
 
Thank you for your time! Check out these youth-friendly national community resources. 
 
For those who are completed a baseline assessment:  
 
Thank you for completing the first survey!  
 
Once we have determined that you are eligible and have not taken the survey more than once, we will 
email you a $15 Amazon.com gift certificate code. You will also receive a second email with either a link, 
username, and temporary password for our developed website or some links to other HIV/STD related 
websites.  
 
For those who are completed a 3-week assessment:  
 
Thank you for completing the second survey!  
 
We will email you a $25 Amazon.com gift certificate code. Also, don’t forget that there is one more 
survey that will be sent to you in about three months.  
 
For those who are completed a 15-week assessment:  
 
Thank you for completing the last survey!  
 
We will email you a $35 Amazon.com gift certificate code. Also, if you completed all three surveys, we 
will email you an additional $20 Amazon.com gift certificate code.  
 
For everyone:  
 
If you have any questions or comments about our study or have experienced any distress as a result of 
this study, please feel free to contact the study investigator, Dr. Kimberly Nelson, 617-358-1482, 
ymnm@bu.edu. 
 
Additionally, we have compiled a list of youth-friendly national community resources below that you 
may find useful. 
 
 
 

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The Trevor Project 
The Trevor Project is the leading national organization providing crisis intervention and suicide 
prevention services to LGBTQ young people ages 13-24, including a 24-hour helpline. 
Address:PO Box 69232 West Hollywood, CA 90069  
Phone:(866) 488-7386 
Email:info@thetrevorproject.org  
Website:http://www.thetrevorproject.org/ 
 
GLBT National Youth Talkline 
The GLBT Youth Talkline provides telephone and online private, one-to-one chat and email peer-
support, as well as factual information and local resources for cities and towns across the United States. 
The talkline is open Monday - Friday from 4pm to 12am and Saturday 12pm to 5pm. 
Address: 511 East Pike Street Seattle, WA 98122 
Phone: (800) 246-7743 
Email: help@GLBThotline.org 
Website:http://www.glbthotline.org/talkline.html 
 
PRIDE Institute 
The PRIDE Institute specializes in treatment of substance abuse, sexual health, and co-occuring mental 
health issues for LGBTQ+ clients. Their phone line is open 24 hours a day. 
Phone: (800) 547-7433 
Website:https://pride-institute.com/ 
 
The National Alliance on Mental Illness 
The National Alliance on Mental illness (NAMI) provides information about how mental health 
conditions affect the LGBTQ community as well as ways to find LGBTQ-inclusive mental health 
treatment. 
Phone:(800) 950-NAMI 
Email: info@nami.org 
Website:https://www.nami.org/Find-Support/LGBTQ 
 
Genders & Sexualities Alliance (GSA) Network 
GSA Network operates the GSA Network of California, which connects over 900 clubs across the state, 
the National Association of GSA Networks, which unites 40 statewide networks of GSA clubs, and GSAs 
Unite (unite.gsanetwork.org), an online campaign and petition platform supporting youth organizers 
across the country. 
Phone:(415) 552-4229 
Email: info@gsanetwork.org 
Website:https://gsanetwork.org/