Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men
Phase: NA
Conditions: Human Papillomavirus
Sponsor: Northwestern University

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PROTOCOL TITLE:
Using Text Messaging to Increase HPV Vaccination among Young Sexual 
Minority Men 
SHORT TITLE:
txt2protect 
PRINCIPAL INVESTIGATORS:
Mary Gerend, PhD
Medical Social Sciences, Feinberg School of Medicine 
312-503-7716
mary.gerend@northwestern.edu 
Brian Mustanski, PhD 
Medical Social Sciences, Feinberg School of Medicine 
312-503-5421
brian@northwestern.edu 
VERSION NUMBER:
Version 16
VERSION DATE:
10.12.2018
IRB #: STU00202705-MOD0016 Approved by NU IRB for use on or after 11/5/2018 through 2/27/2019.

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Table of Contents
1.0
Objectives ...............................................................................................................3
2.0
Background.............................................................................................................3
3.0
Inclusion and Exclusion Criteria..............................................................................6
4.0
Study-Wide Number of Subjects.............................................................................7
5.0
Study-Wide Recruitment Methods ..........................................................................7
6.0
Multi-Site Research ................................................................................................7
7.0
Study Timelines ......................................................................................................7
8.0
Study Endpoints......................................................................................................7
9.0
Procedures Involved ...............................................................................................8
10.0
Data and Specimen Banking ................................................................................11
11.0
Data and Specimen Management ........................................................................12
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects .........................13
13.0
Withdrawal of Subjects*........................................................................................13
14.0
Risks to Subjects*.................................................................................................13
15.0
Potential Benefits to Subjects ...............................................................................13
16.0
Vulnerable Populations.........................................................................................14
17.0
Community-Based Participatory Research...........................................................14
18.0
Sharing of Results with Subjects ..........................................................................14
19.0
Setting...................................................................................................................14
20.0
Resources Available .............................................................................................14
21.0
Prior Approvals .....................................................................................................15
22.0
Recruitment Methods............................................................................................15
23.0
Local Number of Subjects.....................................................................................15
24.0
Confidentiality .......................................................................................................16
25.0
Provisions to Protect the Privacy Interests of Subjects ........................................16
26.0
Compensation for Research-Related Injury..........................................................16
27.0
Economic Burden to Subjects...............................................................................17
28.0
Consent Process ..................................................................................................17
29.0
Process to Document Consent in Writing .............................................................17
30.0
Drugs or Devices ..................................................................................................17
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1.0
Objectives
Objectives and Aims 
The objective of this project is to develop and pilot test a text messaging intervention to 
increase human papillomavirus (HPV) vaccination in young adult men who self-identify 
as gay, bisexual, or queer (which for the sake of brevity, will be referred to as MSM 
throughout this application, although some men will be sexually inexperienced).
Specific Aim 1: Develop, iteratively refine, and pre-test messages using a 5-step 
formative research procedure. To achieve this aim we will use a well-established 
formative approach for designing targeted health interventions. The procedure consists 
of 5 steps: 1) conduct online focus groups, an online survey, and in-depth interviews to 
inform message content, 2) draft initial messages based on focus group findings and 
pilot data, 3) refine message content and assess acceptability using content advisory 
teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test 
the protocol. Intended users of the program (i.e., MSM aged 18-26 years old from the 
Chicago metro area) will be recruited to assist with this process. 
Specific Aim 2: Test the feasibility, acceptability, and preliminary efficacy of the 
txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial 
(RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-26) who live in the 
Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. 
The treatment condition will receive a culturally appropriate text messaging-based HPV 
vaccination intervention based on the IMB model, whereas the control condition will 
receive a text messaging-based sexual health intervention that includes basic facts 
about HPV vaccination readily accessible online. Primary outcome measures include 
intervention feasibility (recruitment and retention in the trial), acceptability (satisfaction 
with the intervention), and preliminary efficacy as determined by initiation (receipt of the 
first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month 
trial. Vaccination status will be verified by participants’ medical records and the Illinois 
Immunization Registry. 
Hypotheses
Specific Aim 2: Participants in the t2p condition (vs. control) will report greater 
acceptability of the intervention and will be significantly more likely to initiate and 
complete the 3-dose HPV vaccine series by the end of the trial. 
2.0
Background
Significance and Innovation 
HPV is a common STI that can cause cancer (anal, penile, oropharyngeal cancer) and 
genital warts in men.1 Due to their sexual practices (e.g., receptive anal intercourse), 
MSM are at particularly high risk for HPV infection and are disproportionately 
affected by HPV-related cancers. Over a 1-year study, for example, oncogenic HPV 
types 16 and/or 18 were detected in 37% of MSM aged 16-30 years.2 Rates of anal 
cancer are over 17 times higher among MSM relative to heterosexual men,3 and the 
burden of anal cancer is exceptionally high among HIV-positive MSM.4 In addition to 
cancer, HPV causes genital warts, which are costly to treat and negatively impact quality 
of life.5 A safe and effective vaccine is available to prevent HPV infection, yet HPV 
vaccination rates in the U.S. have been disappointingly low, particularly among 
males. The quadrivalent HPV vaccine (for types 6, 11, 16, 18) and more recently, the 9-
valent HPV vaccine (plus types 31, 33, 45, 52, 58) are extremely effective in preventing 
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HPV infection.1, 6 The HPV vaccine is given as a 3-dose series, with the 2nd and 3rd 
doses administered 1-2 and 6 months after the 1st dose, respectively. The Advisory 
Committee on Immunization Practices (ACIP) recommends routine HPV vaccination in 
11- and 12-year-old girls and boys, and catch-up vaccination among 13-26 year-old 
females and 13-21 year-old males not previously vaccinated, although males aged 22-
26 may also be vaccinated.1 Although HPV vaccine is most effective in sexually naïve 
youth, given their high-risk status, ACIP recommends HPV vaccine for all MSM up to 
age 26 regardless of whether they have been sexually active, as it is unlikely they have 
been exposed to all HPV types covered by the vaccine.1, 6 Nationally, HPV vaccine 
uptake in males lags far behind females: About 60% of adolescent females have 
received at least one dose of the vaccine compared to only 41.7% of males.7 A similar 
disparity holds for completion of the 3-dose series (39.7% of females vs. 21.6% of 
males).7 Although HPV vaccine is recommended for all MSM though age 26 years, 
relatively few have been vaccinated. Recent studies with national samples of gay and 
bisexual men aged 18-26 found that only 13-21% had initiated the series.8, 9 Our pilot 
work suggests that many MSM are simply unaware of the vaccine or perceive other 
important barriers to getting vaccinated. To remedy this gap, the goal of the proposed 
research is to develop and pilot test a text messaging intervention to increase 
HPV vaccination in young MSM. This contribution is significant because it will identify 
new strategies for promoting HPV vaccination among a high-risk population. Beyond 
these more immediate outcomes, the ultimate goal of this research is to reduce 
morbidity, mortality, and disparities associated with HPV-related cancers among MSM. 
This work will also shed light on factors that affect use of other health services for young 
MSM that, like vaccination, typically involve interaction with the health care system (e.g., 
HIV testing, mental health screening and treatment).
Although MSM are disproportionately affected by HPV-related cancers, this group has 
been neglected in previous HPV vaccination research. Research has centered 
largely on parents and young adult women.10-18 While such work has identified important 
factors that promote and/or discourage HPV vaccination, it falls short of recognizing 
factors that may be unique to young MSM. Existing research suggests relatively high 
acceptance of HPV vaccine among MSM;19-28 nevertheless many of these studies 
have significant limitations: 1) they were conducted prior to ACIP’s 2011 
recommendation for routine HPV vaccination among boys and men and thus were 
hypothetical in nature, 2) involved MSM older than age 26 years, and 3) lacked a strong 
theoretical framework.29 To our knowledge, only two studies (one by our team) have 
been conducted with young adult gay and bisexual men since HPV vaccination became 
routine for males in 2011.8, 9 As the HPV vaccination intervention field is still in its 
relative infancy, no known HPV vaccination interventions have been designed 
specifically for MSM. In addition to its focus on young MSM, the proposed research is 
innovative in several ways: 1) Our intervention will target young adults directly rather 
than indirectly through their parents. 2) We will build on and further strengthen an 
existing evidence-based intervention for vaccination (“reminder-recall”) by including 
messages that address barriers to HPV vaccine uptake with special emphasis on 
barriers unique to MSM. 3) Because our pilot data identified provider recommendation 
as the strongest predictor of HPV vaccination,8 several messages will come directly from 
a physician specializing in sexual minority health. To facilitate this objective we have 
partnered with one of the largest LGBT health care centers in Chicago, Howard Brown 
Health Center (HBHC). 4) We will encourage participants to receive HPV vaccine in 
primary care clinics as well as at pharmacies. Pharmacies have been identified as a 
promising alternative setting for increasing HPV vaccination rates, particularly for 
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promoting completion of the 3-dose series due to their convenient locations and longer 
hours of operation.30, 31 5) We will be recruiting participants directly from the community 
and thus will be able to extend the reach of the intervention to those individuals who 
might not normally see a physician.32, 33 Together, these elements reflect a novel 
approach to promoting HPV vaccination among young MSM.
Preliminary Data
HPV vaccination among young MSM. To inform the proposed project, Drs. 
Gerend, Phillips, and Mustanski conducted a pilot study to identify barriers and 
facilitators to HPV vaccine uptake among young MSM.8 We recruited a national sample 
of 336 MSM aged 18-26 to complete an online survey. 21% had received ≥1 dose of 
HPV vaccine. Provider recommendation was the strongest predictor of uptake such that 
MSM with a recommendation were over 40 times more likely to have been vaccinated. 
We also observed disparities in uptake, with lower rates among 21-26 year-olds (vs. 18-
20), Latinos (vs. Whites), and HIV-negative (vs. HIV-positive) men. Primary barriers to 
uptake included lack of information about HPV and the vaccine, lack of provider 
recommendation, and not having disclosed their sexual identify to their provider. 
Reducing barriers to HPV vaccination. In previous work (R03CA138069), Dr. 
Gerend identified primary barriers to HPV vaccine uptake among young adult women 
aged 18-2634 and demonstrated that tailoring intervention materials to women’s 
perceived barriers increased their intentions to receive HPV vaccine.35 Intervention 
materials addressed common barriers to uptake including lack of information about HPV 
and the vaccine, concerns about side effects and vaccine safety, low perceived need 
due to not being sexually active or in a committed relationship, disliking shots, and 
vaccine cost. In the proposed RCT, we will use a targeted approach36, 37 such that 
treatment messages will be specifically designed for MSM (e.g., provide tips to address 
common and unique barriers to HPV vaccine uptake among young MSM).
Guy2Guy (G2G): A text messaging intervention for young MSM. To design 
our messages we will follow the 5-step procedure used to develop Guy2Guy38 (G2G; 
R01MH096660, Mustanski & Ybarra, Multiple PIs), a text messaging-based HIV 
prevention intervention for adolescent gay, bisexual and queer men. MSM were 
randomly assigned to the treatment (a culturally appropriate HIV prevention and healthy 
sexuality intervention that was informed by the target population and guided by the IMB 
model39) or control arm (that provided basic HIV prevention facts plus healthy lifestyle 
information). Participants received 5-10 text messages daily for 5 weeks. In addition to 
being highly feasible and acceptable,38, 40 short-term outcome analyses found that the 
rate of condomless sex acts over the course of the intervention was 61% lower in 
treatment vs. control (although long term effects were more modest). Of particular 
relevance to the proposed study, participants in the treatment group were over twice as 
likely to get tested for HIV relative to control.
Rationale 
Reminder-recall and text messaging interventions. Reminder-recall 
interventions are a well-established evidence-based approach to increasing vaccination 
that are endorsed by the US Task Force on Community Preventive Services.41, 42 The 
goal of these interventions is to both educate and notify individuals that they are due (or 
overdue) for a vaccine. Historically, reminder-recall interventions used letters, postcards, 
or telephone calls, but have recently transitioned to electronic formats such as text 
messages and email. Text messages (or short-message service, SMS) serve as 
particularly effective reminders in that, relative to a letter or postcard, they are more 
likely to grab attention, reach the intended recipient, and because they can be stored on 
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a cellular phone, can be easily accessed almost any time.42 Beyond providing basic 
education and a cue to action, text messages can be tailored to address barriers to 
vaccine uptake. Although research is still accumulating, text messaging-based 
interventions appear to be a promising, cost-effective strategy for promoting health 
behaviors.43-45 Such interventions may be particularly effective for young adults, as 
nearly all young adults in the U.S. own a cell phone (mainly a smartphone) and 97% use 
text messaging.46 We chose to create a text messaging intervention rather than a 
smartphone application because text messages can be sent proactively and are 
routinely used by the target age group.   
Theoretical framework. The theoretical framework guiding the proposed project 
is the Information, Motivation, and Behavioral Skills (IMB) model.39 This model, originally 
developed for HIV prevention, proposes that individuals will engage in a given health 
behavior when they are adequately informed, motivated to act, and have the appropriate 
behavioral skills and self-efficacy do to so. Text messages can provide basic information 
(e.g., about HPV and the vaccine; 
convenient locations to get 
vaccinated such as a pharmacy) 
and serve as a reminder (e.g., to 
schedule an appointment, to receive 
the 2nd or 3rd dose). They can also 
boost motivation (e.g., by promoting 
favorable attitudes and norms; by 
addressing barriers like safety 
concerns) and improve necessary 
skills (e.g., talking with one’s doctor 
about the vaccine, verifying health 
insurance coverage). 
3.0
Inclusion and Exclusion Criteria
Specific Aim 1 
Participants for this project will be self-identified gay, bisexual, and queer males between 
the ages of 18-26 years who provide informed consent to participate. (Please note that 
the upper age limit will be reduced to age 25 for the beta test and RCT so participants 
will continue to remain eligible for HPV vaccination throughout the length of the study.) 
Participants will be recruited online through ads placed on websites and dating apps 
such as Facebook, Twitter, Grindr, Craigslist, and Jack’d, a strategy that has been 
extremely successful by the current team across multiple NIH-funded projects and in a 
number of metropolitan areas across the U.S. including Chicago.40, 47-49 
ResearchMatch.org will also be utilized as a recruitment tool. ResearchMatch.org is a 
national electronic, web-based recruitment tool that was created through the Clinical & 
Translational Science Awards Consortium in 2009 and is maintained at Vanderbilt 
University as an IRB-approved data repository (see IRB #090207). Participants may also 
be recruited from existing participant registries (e.g., Institute for Sexual and Gender 
Minority Health and Wellbeing [ISGMH]; Third Coast Center for AIDS Research [CFAR]). 
Interested participants will be directed to a screening survey where eligibility will be 
assessed. The inclusion criteria will closely match that of the intended users of the 
eventually designed program and be consistent with the latest CDC guidelines for HPV 
vaccination. Participants must:
1) be male (sex at birth and gender identity)
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2) be 18-26 (*Upper age limit will be age 25 for the beta and RCT) years old 
3) self-identify as gay, bisexual, or queer; ever had sex with a man; or be 
physically attracted to men
4) be English speaking 
5) live in the Chicago metro area
6) be the exclusive owner of a cell phone 
7) have used text messaging for at least 6 months
8) plan to have the same cell phone number for the next 9 months
9) be enrolled in an unlimited text messaging plan
The screener will also assess HPV vaccination status, which will be confirmed by 
consulting the Illinois Immunization Registry before enrollment. Vaccinated and 
unvaccinated participants will take part in Step 1, but Steps 3 and 5 will be limited to 
unvaccinated participants. Participants will be selected using a purposive sampling 
strategy to ensure a sample that is diverse in age, race, ethnicity, and sexual identity. 
Individuals meeting inclusion criteria will be contacted by telephone to complete the 
enrollment process (e.g., confirm eligibility, describe the study). 
Specific Aim 2 
Inclusion criteria will be identical to Aim 1 except that enrollment will be limited to 
individuals who have not been previously vaccinated for HPV. HPV vaccination status 
will be assessed twice – once in the screener and again in the baseline survey – before 
participants are randomized and enrolled into the study. Participants’ self-reported 
vaccination status in the screener and baseline survey will be confirmed by consulting 
the Illinois Immunization Registry before enrollment. 
Special Populations 
We will not be recruiting any special populations (e.g., adults unable to consent, 
individuals who are not yet adults, pregnant women, or prisoners) for this project. 
4.0
Study-Wide Number of Subjects
N/A
5.0
Study-Wide Recruitment Methods
N/A
6.0
Multi-Site Research
N/A
7.0
Study Timelines
Participants who take part in Aim 1 will be involved with the study for the length of the 
focus group (2 days). We anticipate using the first 10 months of the 24-month project to 
complete Aim 1. Participants who take part in Aim 2 will be involved with the study for 
the length of pilot RCT (9 months). We plan to begin recruiting for the pilot RCT in month 
11 and expect recruitment to take approximately 3 months.
We anticipate that the duration required to enroll all study subjects will be approximately 
one year and a half. 
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We anticipate completing the study approximately 4-6 months after the pilot RCT. The 
funding period for this project is 2 years; however, we suspect that we may need to 
request a no-cost extension to wrap up the study. 
8.0
Study Endpoints
Primary Outcomes – Aim 2 
Feasibility. Intervention feasibility will be evaluated by recruitment and retention 
in the RCT. We will record recruitment and enrollment statistics at every step (e.g., 
number of clicks on online ads, number who complete the screener, number of eligible 
participants, number randomized). Retention rates will be computed for each 
assessment period. An 80% 9-month retention rate will be used to indicate a feasible 
intervention. 
Acceptability. Intervention acceptability will be assessed at the end of Phases 1 
and 2 with an adapted version of a scale used in G2G38 and KIU! (an online HIV 
prevention intervention; R34MH079714, Mustanski PI).49 The scale includes both open- 
(“What did you like about the program? What could be improved?”) and closed-ended 
questions (e.g., “I would recommend a program like this to my friends” 1=strongly 
disagree to 5=strongly agree). Average scores ≥4 will be used to indicate an acceptable 
intervention. 
Vaccination Status. A final confirmatory assessment of HPV vaccination status 
will be conducted at the 9-month follow-up. Participants will be asked whether they 
received any doses of HPV vaccine (yes/no) since baseline and if yes, the number of 
doses and where they were received. Vaccination status will be confirmed by consulting 
the Illinois Comprehensive Automated Immunization Registry (I-CARE). Pharmacies in 
Illinois are required to report all vaccinations to the registry,50 thus any HPV vaccines 
administered at a local pharmacy over the trial will be documented in I-CARE. Medical 
chart data will be sought from those participants who report receiving any doses from 
their primary care physician over the 9-month trial and those doses are not found in I-
CARE. Medical chart data will only be sought for those participants who sign the medical 
release form (see supporting documents). 
Vaccination status will be checked in I-CARE at the beginning and end of the 
trial. Please see supporting documents and below for additional detail. 
9.0
Procedures Involved
Note: Version 2 of this IRB application was associated with a Just-in-Time request from 
NIH for this project. Since that time, this project was funded and officially began on July 
1, 2016. Some of the attachments associated with the approved (Version 2) IRB 
application are in draft form. We will be sure to submit updated versions of all study-
related documents and report any changes regarding study procedures or personnel as 
appropriate.  
Research Design for Aim 1
Overview. The primary goal of Aim 1 is to develop content for the text 
messaging intervention and conduct initial pre-testing using a 5-step formative approach 
developed by Mustanski and Ybarra:38 (1) Conduct 4 online focus groups to inform 
message content, (2) Draft initial messages based on focus group findings and our pilot 
data, (3) Further refine message content and assess acceptability using 3 content 
advisory teams, (4) Conduct internal alpha testing to ensure software functionality, and 
(5) beta test the protocol. 
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Step 1: Develop message content. We will conduct online focus groups (FGs) 
using a password-protected message board to inform message content and delivery 
preferences. This approach has been used by Mustanski and colleagues and proven to 
be a rich source for intervention development by allowing participants to identify barriers 
and potential solutions and make suggestions on how to frame intervention content.38, 47, 
48 Relative to traditional in-person FGs, online FGs can accommodate a larger number of 
participants who can participate throughout the day from any location at their 
convenience. FG participants will be required to visit the message board 2-3 times per 
day for 2 days to respond to the moderators’ questions and comments from other 
participants. We will conduct 4 FGs total, 2 with vaccinated and 2 with unvaccinated 
participants. See Appendix 1 for a sample moderator script. 
To complement the online FGs, we will also conduct an online survey and in-
depth interviews. Our pilot data for this project focused on a national sample of YMSM. 
As the current project specifically targets YMSM in the Chicago area, we would like to 
gain a better understanding of facilitators and barriers to HPV vaccination for our local 
population. Although these factors will be assessed in the online focus groups, we 
believe that these additional data collection formats will allow for a richer understanding 
of men’s knowledge, attitudes, and beliefs regarding HPV vaccination than could be 
supplied in a focus group alone. See Appendix 8 and 9 for the online survey and 
interview guide. 
Step 2: Draft initial messages. Transcripts from the FGs will be imported into 
Dedoose,51 a mixed-methods analysis program. Two rounds of constant comparison 
analysis will be conducted to create and refine the codebook, which will be followed by a 
thematic content analysis.52, 53 Using these themes in conjunction with results from our 
pilot work,8 Dr. Gerend will draft an initial pool of messages. Treatment condition 
messages will be written to directly address IMB components, with special emphasis on 
barriers relevant to each component. Messages will take into account unique socio-
cultural and developmental factors relevant to gay, bisexual, and queer men to ensure 
that content is appealing and culturally appropriate. Control condition messages will 
include basic facts about HPV vaccination currently available online plus general sexual 
health content adapted from G2G. Control messages will be largely informational yet, to 
ensure a blinded control group, will be aligned with what young MSM might expect in a 
sexual health program. Messages will be reviewed by Drs. Phillips, Mustanski, and 
Houlberg and subjected to further edits and review, as necessary.
Step 3: Refine messages and assess acceptability. We will use content 
advisory teams (CATs) to further refine the messages. CAT1 and CAT2 will focus on 
treatment condition messages and CAT3 will focus on control condition messages. CAT 
members will receive an email link to the list of initial messages hosted on a secure web-
based application called REDCap and will be asked to provide feedback on their overall 
tone, clarity, and appeal, and to identity their favorite and least favorite messages (See 
Appendix 2 for draft survey). Several days later, CAT members will take part in a 2-day 
online FG (similar to Step 1) to discuss the messages as a group and provide 
suggestions for improvement. Feedback from CAT1 will be used to further refine the 
messages. This process will then be repeated with another team (CAT2). CAT3 will 
complete this process for control condition messages. See Appendix 3 for a sample FG 
guide.
Step 4: Test software functionality. We will conduct alpha testing with the 
study team to ensure that the text messaging software is functioning correctly. In 
addition, we will verify the enrollment process and randomization procedure, assess 
message delivery and display, and correct any programming bugs.
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Step 5: Beta-test the protocol. To identify opportunities for improving program 
usability and to ensure functionality we will beta test the protocol. Twenty participants will 
be recruited for the beta test. Participants will complete a baseline survey and then 
receive 5-10 messages daily (similar to the number sent in G2G) for 3 weeks (similar to 
Phase 1 of the pilot RCT described below). At the end of week 1 and 2, participants will 
receive a brief check-in survey to provide open-ended feedback on the program. After 
the final week of messages (week 3), participants will complete a final check-in survey 
plus additional items to assess intervention acceptability and immediate outcomes of 
interest (e.g., HPV/HPV vaccine knowledge, IMB constructs, intentions to get 
vaccinated). See Appendix 4 for draft surveys associated with the Beta-test.  
Research Design for Aim 2 
Overview. The primary goal of Aim 2 is to pilot test the intervention to establish 
feasibility, acceptability, and preliminary efficacy. Young MSM in the Chicago metro area 
will be recruited primarily online as well as from Howard Brown Health Center, and 
randomly assigned to the treatment or control condition. The intervention will be divided 
into two phases: During Phase 1 (weeks 1 through 3) participants will receive about 10 
messages per day (similar to G2G). During Phase 2 (weeks 4 through 36) message 
frequency will decrease to monthly messages. The precise number of messages sent 
per day and delivery schedule may be altered based on feedback from participants in 
Aim 1. To give participants sufficient time to get vaccinated and because HPV 
vaccination is currently achieved with 3 doses administered over a 6-month period, 
participants will be followed for 9 months. Participants will complete assessments at 
baseline, immediately after Phase 1, and at the end of the 9-month trial (in order to 
observe all doses). Upon study completion, vaccination status will be verified by 
participants’ medical records and the Illinois Immunization Registry, which tracks 
pharmacy-delivered vaccines.
Pilot RCT. Participants will be randomized 1:1 to the treatment or control 
condition using the REDCap (Research Electronic Data Capture) randomization module. 
Intervention content will be delivered in two phases over a 36-week period. During 
Phase 1 (weeks 1 through 3), participants will receive about 10 messages daily. During 
Phase 2 (weeks 4 through 36), message frequency will decrease to monthly messages. 
To match for attention, message frequency will be equal across the treatment and 
control conditions. During Phase 2, participants  will receive up to three “pop-up” surveys 
where they will be able to inform us if/when they receive a/each dose of HPV vaccine so 
messages can be appropriately tailored (e.g., switch from promoting initiation to 
completion of the 3-dose series). Participants with a primary care provider will be 
instructed to contact their provider about receiving the vaccine. If their provider does not 
carry the vaccine, participants will be directed to seek the vaccine at a local pharmacy 
(e.g., Walgreens, CVS). Uninsured and underinsured participants will be directed to 
HBHC, a FQHC that provides care on a sliding fee scale. 
Treatment condition. Phase 1 content will be presented in 3 modules (1 per 
week), each reflecting a component of the IMB: Module 1 will address information 
about HPV infection and the HPV vaccine. It will also include a “doctor’s blog” to capture 
the important influence providers have in promoting HPV vaccination and to further 
legitimize the information. Module 2 will address motivations to receive HPV vaccine. 
Content will address attitudes and social norms about HPV vaccination, vulnerability to 
HPV infection, and vaccination intentions. Module 3 will focus on behavioral skills and 
self-efficacy for initiating and completing the 3-dose series such as scheduling an 
appointment, talking with their doctor about the vaccine (and possibly their sexual 
identity), verifying whether their health insurance covers the vaccine, and finding 
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alternative locations to receive the vaccine (such as a pharmacy) if it is not carried by 
their physician. Each module will include tips that address potential barriers relevant to 
each IMB component. Phase 2 “booster” messages will largely reinforce Phase 1 
content to foster continued engagement with the program, although some new content 
will also be introduced. For example, messages will shift to encourage vaccine 
completion when a participant initiates the series. 
Control condition. Phase 1 content will be presented in 3 modules; however, 
unlike the treatment group, content will be topic-based rather than theory-based and will 
focus on general sexual health. Module 1 will address basic facts about HIV and STIs, 
including HPV. Module 2 will address HIV/STI prevention (e.g., condom use) and will 
include basic facts about HPV vaccination that are currently available online. Module 3 
will address healthy relationships. Phase 2 messages will reinforce Phase 1 content to 
maintain engagement. 
Text Messaging and Data Collection Platform. With the exception of screening 
survey data (which will be collected using Limesurvey for the Beta test and RCT), study 
data will be collected and managed using REDCap (Research Electronic Data Capture) 
an electronic data capture system hosted at Northwestern University. REDCap is a 
secure, web-based application designed to support data capture for research studies. 
REDCap added the functionality to send SMS and phone surveys in the 6.6.0 release. 
This functionality is enabled through the cloud-based telephony service provider Twilio 
(www.twilio.com). In accordance with the defined text-messaging schedule of the pilot 
RCT, we will use REDCap to send text messages to participants. We will also use 
REDCap to inform participants about online assessments. Participants will receive the 
link to the survey via text message. This will provide consistency for participants in that 
all messages will be coming from one source. We chose REDCap as our platform 
because it is cost-effective, user friendly, open source, and scalable, features that will be 
particularly important in future implementation of the t2p intervention.
Assessments. Participants will complete the screener plus three assessments at 
baseline, end of Phase 1 (end of week 3), and end of Phase 2 (end of the 9-month trial), 
with participants initially receiving $10, $10, and $30 for each respective survey. 
Beginning in June 2018, the incentives were increased so that participants received $15 
each at baseline and the end of Phase 1, and $45 at the end of Phase 2. The study 
team hopes that the increase in incentives will help with meeting recruitment and 
enrollment scopes. The changes to the incentive dollar amounts will be updated on all 
study materials (e.g. online screener, recruitment materials, intervention/control text 
messages, surveys, etc.).
For participants enrolled with the original payment structure and still active in 
June 2018, we will make up the difference at their next scheduled payment. For 
example, if a participant is in Week 2 when the change in payment is instituted, they 
would receive the new Phase 1 payment ($15) plus an extra $5 for baseline (total $20) 
after completing the Phase 1 survey. If a participant is in Month 6 when the change is 
instituted, they would receive the new Phase 2 payment ($45) plus an extra $10 ($5 
each) for baseline and Phase 1 (total $55) after completing the Phase 2 survey. 
Participants who are difficult to reach and are out of window for completing their 
Phase 2 survey will be offered the option to complete a shorter version of the survey. 
This survey will take approximately 5 minutes to complete and have an emphasis on the 
primary outcomes of the study. This will be a last resort option, as we want most 
participants to complete the full Phase 2 survey.  Participants will also have the option to 
complete this shorter survey online on their own or over the phone with the Project 
Coordinator. Participants who complete the shorter version of the Phase 2 survey will be 
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paid $20 instead of the standard $45 received by participants who complete the full 
Phase 2 survey.
During Phase 2, participants may also receive up to three “pop-up” surveys, 
depending on their vaccination status at the end of Phase 1. Participants who complete 
a pop-up survey within the designated time frame will be eligible for a monthly $50 e-
raffle. Surveys will be brief and configured for easy completion on multiple platforms (cell 
phone, tablet). Participants will receive special data collection text messages with the 
link to each survey. Participants who do not respond will receive up to 3 reminders by 
text and email. See Appendix 5 for draft surveys for the pilot RCT.
Sources of Materials
Participants enrolled in Steps 1 and 3 will take part in an online focus group. 
Some participants enrolled in Step 1 will take part in an online survey or an in-depth 
interview. Participants enrolled in Step 3 (CATs) will also complete a survey to provide 
feedback on the initial messages. Participants enrolled in Step 5 (beta test) will complete 
assessments at baseline and immediate post-test (3 week follow-up). Participants 
enrolled in the pilot RCT will complete assessments at baseline, immediately after Phase 
1, and at the end of the 9-month trial. RCT participants may also receive up to three 
“pop-up” surveys during Phase 2. 
Data for the focus groups will be collected using a secure online message board 
that members of our team have used successfully in previous research. All survey data 
will be collected online through REDCap, a secure, web-based application designed to 
support data capture for research studies. 
Data for the in-depth interviews will be collected in person or by phone. 
Interviews will take place in the privacy of the PI’s (Dr. Gerend’s) office and will last 
approximately 45-60 minutes. Participants will be able to skip any questions they are not 
comfortable answering. 
Surveys will include sensitive questions such as questions about sexual 
behavior. The benefits to collecting data online include increased self-disclosure 
compared to interviewer-based data collection; convenience for the participant, as he 
can decide when to complete it; and increased safety, as he can decide when and where 
it is best to answer these questions. Participants will also be able to skip any questions 
that make them uncomfortable.
We are sensitive to how the survey experience can affect the validity of the data. 
All online surveys will be as brief as possible and configured for easy completion on 
multiple platforms (e.g., cell phone, tablet, laptop). Based on previous research, we 
estimate that the Step 1 online survey will take approximately 10-15 minutes, the 
baseline survey will take approximately 15-20 minutes, the immediate post-test survey 
(end of Phase 1) will take approximately 25-30 minutes, and the end of trial survey will 
take about 15-20 minutes. The shorter version of the end of trial survey offered to 
participants who are difficult to reach and out of window will take about 5 minutes. Pop-
up surveys (during Phase 2) will take less than one minute to complete. 
HPV vaccination status will be verified via the Illinois Comprehensive Automated 
Immunization Registry (I-CARE) and participants’ medical chart. Vaccination status will 
be confirmed in I-CARE for all RCT participants both before participants begin receiving 
messages and at the end of the 9-month trial. Pharmacies in the state of Illinois are 
required to report all vaccinations to the registry,57 thus any HPV vaccines administered 
to participants at a local pharmacy over the course of the 9-month trial will be 
documented in I-CARE. 
Additionally, medical chart data will be sought from those participants who report 
receiving any doses of HPV vaccine from their primary care physician over the 9-month 
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trial and those doses are not found in I-CARE. The project coordinator will contact these 
participants at the end of the trial and ask them to complete the medical release form 
(see supporting documents). Upon receipt of the signed form, the project coordinator will 
contact the participant’s primary care doctor to verify the number and timing of any HPV 
vaccine doses that were received during the trial. Medical chart data will only be sought 
for those participants who sign the medical release form. 
10.0
Data and Specimen Banking
Specimen Banking 
No specimens will be banked for future use. 
Data Banking 
The research team agrees to develop a transportable de-identified database, codebook, 
and mechanism by which data could be shared with other investigators upon approval of 
the CO-PIs. Data will be stored in the secure Feinberg School of Medicine managed 
storage system. 
Interested investigators will be asked to complete a standardized request form stating 
the specific aims of the analysis, the analytic plans, resources the requestors have to 
carry out the project, the proposed timeline, and distribution goals (manuscripts and/or 
grant application). The CO-PIs will review these requests to determine whether the 
proposed analyses constitute an innovative and significant exploration of the data, 
whether the proposed team has sufficient resources to undertake the request, how data 
will be protected/managed, and whether there are sufficient resources to honor the 
request. If any of these issues are problematic, the CO-PIs will attempt to negotiate a fair 
resolution with the interested parties and/or with NIH program staff. The CO-PIs will 
keep a record of all individuals/research teams who receive a copy of the data.  
11.0
Data and Specimen Management
Analysis Strategy 
Intervention feasibility will be computed as outlined above and summarized in a 
CONSORT map. Acceptability of the intervention will be assessed with descriptive 
statistics for the closed-ended items and with the same qualitative approach used for the 
online FG data for the open-ended items. Intervention efficacy will be assessed using an 
intent-to-treat approach. T-tests and chi-square analyses will be used to compare 
baseline characteristics of participants in the treatment vs. control condition. Separate 
chi-square analyses will be conducted for HPV vaccine initiation (receipt of ≥1 dose) and 
completion (receipt of 3 doses) to assess effects of treatment. Secondary analyses will 
examine potential differences in IMB constructs at the end of Phase 1 by treatment arm 
and assess whether they mediate effects of t2p on vaccine uptake. Following Gerend,34 
we will also conduct a detailed analysis of barriers to vaccine uptake among participants 
who did not get vaccinated over the course of the study to inform additional 
modifications for the large-scale trial.  
Power Analysis 
Based on previous studies,14, 41, 43, 54 we hypothesize that 18-21% of treatment arm 
participants will receive their 1st dose of HPV vaccine, compared to 6-8% of control arm 
participants. The comparison of outcomes between arms, with two-sided alpha = 0.05, 
will have > 80% power for all scenarios with N=192 per condition. Based on previous 
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studies with similar samples (G2G, Keep It Up! [KIU!])38, 49 and retention rates as high as 
85-95% with follow-ups as long as one year, we anticipate an attrition rate of 5-20%. 
Using the most conservative estimate (20%) we will enroll 230 participants per arm to 
account for attrition.
Steps to Maintain Data Security and Confidentiality 
Participant privacy and data will be carefully protected. Online surveys will be 
conducted online using a secure web-based application (REDCap). 
To maintain privacy in the online focus groups, all participants will be asked to 
use pseudonyms rather than their real names, and to refrain from mentioning others by 
name. This will help to ensure openness. If any personal information is inadvertently 
disclosed, names or other identifying information will be redacted from the focus group 
transcripts.
Each participant will be given a unique identifier in the data set which will be 
stripped of all personal information to protect confidentiality. Data sets used for analysis 
will contain participant identification numbers but neither names nor other identifying 
information such as home address. Identification information will be retained by the PI 
for the duration of the study and stored separately from the responses provided by 
subjects. 
Collaborators will receive data stripped of personal identifiers (de-identified data). 
To ensure complete confidentiality, access to the “key” linking personal identifiers to 
usernames and passwords will be restricted to the CO-PIs. Reports will not identify 
individual participants. Drs. Gerend and Mustanski will oversee the data storage and 
reporting procedures. De-identified data will be stored into perpetuity. The “key” linking 
personally identifiable information to the participant’s ID in the data set will be destroyed 
at the end of the study. Reports will only use aggregated data. All study staff will be 
trained in security and confidentiality procedures before receiving access to any 
participant data.
Data will be stored on a dedicated secure server at the Feinberg School of 
Medicine. All data will be transmitted securely by connecting to the SFTP server using 
the encrypted SSH protocol. Users initiate that connection using a client application like 
Filezilla. The connection uses a non-standard port to further obscure the connection. A 
username and strong password will be assigned to each user and each username is 
unique to an individual. User accounts on the server can only access data folders that 
have been assigned to them. The CO-PIs are responsible for telling the system 
administer if there are new users or users that should be deleted. The CO-PIs are 
responsible for all additions, edits, or deletion of data during the study. 
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects
N/A
13.0
Withdrawal of Subjects*
The CO-PIs do not anticipate having to a) withdraw subjects from this research without 
their consent or b) terminate the study early. 
Participants may decide to withdraw from the study at any time. No additional data will 
be collected after a participant withdraws. When a participant shares his intent to 
withdraw, the investigator will ask if the information already collected can be used or 
whether it should be destroyed. 
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14.0
Risks to Subjects*
There are minimal risks to participants in this study. The greatest risk is the potential loss 
of confidentiality if someone were to see a participant’s survey responses or other online 
material that would disclose their sexual orientation. Some of the sensitive topics 
covered in the text messaging intervention could cause discomfort for some participants. 
Further, a participant could feel uncomfortable answering some of the survey questions 
about their sexual behaviors.
15.0
Potential Benefits to Subjects
Participants will learn about steps they can take to reduce their risk of HPV infection, 
genital warts, and HPV-related cancers (e.g., anal cancer, oral cancer, and penile 
cancer) through HPV vaccination.
16.0
Vulnerable Populations
N/A
17.0
Community-Based Participatory Research
N/Aa
18.0
Sharing of Results with Subjects
N/A
19.0
Setting
The primary location where this research will take place is the Feinberg School of 
Medicine, within the Department of Medical Social Sciences. 
We have also partnered with one of the largest LGBT health care centers in Chicago, 
Howard Brown Health Center (HBHC), which will serve as a consortium site contributing 
to the project. Magda Houlberg, M.D., Chief Clinical Officer at HBHC, will serve as site 
Principal Investigator and will be responsible for supervising all aspects of the proposed 
research associated with HBHC. Dr. Houlberg will review intervention messages for 
medical accuracy, tone and clarity. Lastly, HBHC has agreed to serve as a referral clinic 
for the pilot randomized controlled trial associated with this project. Participants who are 
uninsured or underinsured will be directed to HBHC—a Federally Qualified Health 
Center (FQHC) specializing in LGBTQ care—to receive HPV vaccine. Dr. Houlberg will 
oversee the patient referral process. 
Participants for this project will be recruited online, from HBHC clinics, and from 
participant registries (explained in further detail below), and most research procedures 
will largely take place online as well. For example, the focus groups for Aim 1 will take 
place online and the intervention associated with the pilot RCT (Aim 2) will be delivered 
via text messages. Participant assessments will also take place online. The in-depth 
interviews will be conducted in person or by phone in the PI’s (Dr. Gerend’s) office (FSM 
Department of Medical Social Sciences).
20.0
Resources Available
Investigative Team 
The investigative team has the skills, experience, and resources to successfully carry 
out the proposed project. Dr. Gerend is one of the leading experts on HPV vaccination 
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and has been PI of two NCI-funded projects on HPV vaccination. Dr. Phillips brings 
expertise in conducting HIV/STI epidemiological research with MSM. Mr. Bass is a 
software architect with years of experience in programming, systems integration, and 
information technology. Dr. Mustanski directs a program focused on the health of LGBT 
youth and has been PI of multiple NIH-funded studies. Dr. Houlberg, Chief Medical 
Officer at our partner clinic (HBHC), brings expertise in infectious diseases and patient-
centered care for sexual minorities. 
The CO-PIs will provide close monitoring of the study to ensure steady progress 
of the pilot trial and the safety of its participants. The CO-PIs will also train all 
study personnel about the protocol, the research procedures, and their duties 
and functions. The CO-PIs will be in daily contact with study personnel and will 
actively oversee participant recruitment and enrollment, intervention administra-
tion, and all data collection activities. The research team will hold regular 
meetings to monitor and discuss study progress. 
21.0
Prior Approvals
Howard Brown Health Center will be relying on the NU IRB for this study and thus has 
completed the required IRB Authorization Agreement form. 
22.0
Recruitment Methods
Participants will be recruited online through ads placed on websites and dating apps 
such as Facebook, Twitter, Grindr, Craigslist, and Jack’d. ResearchMatch.org will also 
be utilized as a recruitment tool.  ResearchMatch.org is a national electronic, web-based 
recruitment tool that was created through the Clinical & Translational Science Awards 
Consortium in 2009 and is maintained at Vanderbilt University as an IRB-approved data 
repository (see IRB #090207). Participants may also be recruited from existing 
participant registries (e.g., Institute for Sexual and Gender Minority Health and Wellbeing 
[ISGMH]; Third Coast Center for AIDS Research [CFAR]). Participants may also be 
recruited from Howard Brown Health clinics through passive recruitment. Howard Brown 
staff will post flyers with txt2protect study information, including a link to the online 
eligibility screener, in clinic waiting areas and other spaces deemed appropriate. 
Interested candidates will be directed to complete the screening survey, which will 
assess eligibility criteria. All eligible candidates will then be directed to complete an 
online informed consent form. Eligible candidates will be informed that they will be 
contacted by the Study Manager with information about next steps for taking part in the 
study. 
Interested candidates recruited from paid dating app ad campaigns (e.g. Grindr and 
Jack’d) who screen as ineligible will be directed to an optional, online survey on smoking 
and e-cigarettes. The study team has added this supplemental survey because of the 
high cost of dating app ad campaigns and the anticipated large number of participants 
who will screen as ineligible. This will allow us to make the most of the large reach of the 
dating app ad campaigns and collect data that can help inform future research studies 
on smoking and e-cigarettes, and cancer risk.
Please see supporting documents for sample recruitment ads and the smoking and e-
cigarette survey. 
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Participant Payments 
Aim 1 
Focus group members taking part in Step 1 will receive $25 for their participation. 
Participants who complete the Step 1 online survey will receive $10 for their 
participation. Participants who complete the Step 1 in-depth interview will receive $40. 
Individuals who serve on the content advisory teams in Step 3 will receive $50 for 
providing initial feedback and their focus group participation. Participants who take part 
in the beta test (Step 5) will receive $75 for their participation. Given the nature of the 
study (online), payments will be in the form of an electronic gift card.
Aim 2 
Participants will be asked to complete the screener plus three assessments at 
baseline, end of Phase 1 (end of week 3), and end of Phase 2 (end of the 9-month trial), 
with participants initially receiving $10, $10, and $30 for each respective survey. 
Beginning in June 2018, the incentives were increased so that participants received $15 
each at baseline and the end of Phase 1, and $45 at the end of Phase 2. The study 
team hopes that the increase in incentives will help with meeting recruitment and 
enrollment scopes. The changes to the incentive dollar amounts will be updated on all 
study materials (e.g. online screener, recruitment materials, intervention/control text 
messages, etc.).
For participants enrolled with the original payment structure and still active in 
June 2018, we will make up the difference at their next scheduled payment. For 
example, if a participant is in Week 2 when the change in payment is instituted, they 
would receive the new Phase 1 payment ($15) plus an extra $5 for baseline (total $20) 
after completing the Phase 1 survey. If a participant is in Month 6 when the change is 
instituted, they would receive the new Phase 2 payment ($45) plus an extra $10 ($5 
each) for baseline and Phase 1 (total $55) after completing the Phase 2 survey. 
Participants who are difficult to reach and are out of window for completing their 
Phase 2 survey will be offered the option to complete a shorter version of the survey. 
This survey will take approximately 5 minutes to complete and have an emphasis on the 
primary outcomes of the study. This will be a last resort option, as we want most 
participants to complete the full Phase 2 survey.  Participants will also have the option to 
complete this shorter survey online on their own or over the phone with the Project 
Coordinator. Participants who complete the shorter version of the Phase 2 survey will be 
paid $20 instead of the standard $45 received by participants who complete the full 
Phase 2 survey.
During Phase 2, participants who complete a pop-up survey within the 
designated time frame will be eligible for a monthly $50 e-raffle. Given the nature of the 
study (online), payments will be in the form of an electronic gift card. 
23.0
Local Number of Subjects
We plan to enroll 950 participants total. 
Aim 1 participants will be recruited to assist with the development of the intervention 
messages: 
Step 1: Four online focus groups with 20 participants per group = 80 
Online survey with 250-300 participants = 300
In-depth interviews with 25-30 participants = 30
Step 3: Three content advisory teams with 20 participants per team = 60 
Step 5: Beta test will include 20 participants total = 20 
Aim 2, participants will be recruited to pilot test the text messaging-based intervention: 
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Pilot RCT: We will recruit 230 participants per arm (treatment vs. control) = 460 
24.0
Confidentiality
N/A
25.0
Provisions to Protect the Privacy Interests of Subjects
Participant Privacy and Study Experience 
Participant privacy and data will be carefully protected. Online surveys will be 
conducted online using a secure web-based application (REDCap). Surveys will include 
sensitive questions such as questions about sexual behavior. The benefits to collecting 
data online include increased self-disclosure compared to interviewer-based data 
collection; convenience for the participant, as he can decide when to complete it; and 
increased safety, as he can decide when and where it is best to answer these questions. 
Participants will also be able to skip any questions that make them uncomfortable.
We are sensitive to how the survey experience can affect the validity of the data. 
All online surveys will be as brief as possible and configured for easy completion on 
multiple platforms (e.g., cell phone, tablet, laptop). Based on previous research, we 
estimate that the Step 1 online survey will take approximately 10-15 minutes, the 
baseline survey will take approximately 15-20 minutes, the immediate post-test survey 
(end of Phase 1) will take approximately 25-30 minutes, and the end of trial survey will 
take about 15-20 minutes. The shorter version of the end of trial survey offered to 
participants who are difficult to reach and out of window will take about 5 minutes. Pop-
up surveys (during Phase 2) will take less than one minute to complete. 
To maintain privacy in the online focus groups, all participants will be asked to 
use pseudonyms rather than their real names, and to refrain from mentioning others by 
name. This will help to ensure openness. If any personal information is inadvertently 
disclosed, names or other identifying information will be redacted from the focus group 
transcripts.
Accessing Participant Information (e.g., Medical Records)
On the eligibility screener, participants will be asked whether they have been 
vaccinated against HPV. It is possible that some participants will not know their status. 
Although Step 1 will involve participants who have and have not been vaccinated against 
HPV, enrollment for Steps 3 and 5 as well as the pilot RCT will be limited to 
unvaccinated participants, thus it will be important to confirm vaccination status before 
participants are enrolled in the study. Before enrollment begins, we will consult the 
Illinois Immunization Registry (I-CARE) to assess HPV vaccination status for all 
participants who have provided consent and meet eligibility criteria for the study. 
Vaccination status will be confirmed in I-CARE for all RCT participants both 
before participants begin receiving messages and at the end of the 9-month trial. 
Additionally, medical chart data will be sought from those participants who report 
receiving any doses of HPV vaccine from their primary care physician over the 9-month 
trial and those doses are not found in I-CARE. The project coordinator will contact these 
participants at the end of the trial and ask them to complete the medical release form 
(see supporting documents). Upon receipt of the signed form, the project coordinator will 
contact the participant’s primary care doctor to verify number and timing of any HPV 
vaccine doses that were received during the trial. Medical chart data will only be sought 
for those participants who sign the medical release form. 
26.0
Compensation for Research-Related Injury
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N/A
27.0
Economic Burden to Subjects
N/A
28.0
Consent Process
Participants will be recruited online through ads placed on websites and dating apps 
such as Facebook, Twitter, Grindr, Craigslist, and Jack’d. ResearchMatch.org will also 
be utilized as a recruitment tool.  ResearchMatch.org is a national electronic, web-based 
recruitment tool that was created through the Clinical & Translational Science Awards 
Consortium in 2009 and is maintained at Vanderbilt University as an IRB-approved data 
repository (see IRB #090207). Participants may also be recruited from existing 
participant registries (e.g., Institute for Sexual and Gender Minority Health and Wellbeing 
[ISGMH]; Third Coast Center for AIDS Research [CFAR]). Participants may also be 
recruited from Howard Brown Health clinics through passive recruitment. Howard Brown 
staff will post flyers with txt2protect study information, including a link to the online 
eligibility screener, in clinic waiting areas and other spaces deemed appropriate.
Interested candidates will be directed to complete the screening survey, which will 
assess eligibility criteria. All eligible candidates will then be directed to complete an 
online informed consent form. Please see attached consent forms for further details. 
Please note that we will be using different consent forms for each separate step of the 
study (Aim 1: Steps 1, 3 and 5; Aim 2). 
Eligible candidates who have provided informed consent will be informed that they will 
be contacted by the Study Manager with information about next steps for taking part in 
the study. 
Ineligible candidates or individuals who do not provide informed consent will be thanked 
for their interest in the study and directed to relevant resources (e.g., the IMPACT 
Program’s website). 
To enroll in the study, all participants (with the exception of those participants who take 
part in the online survey for Step 1) will talk by telephone with the Study Manager. The 
Study Manager will re-confirm the candidate’s eligibility and then describe the study. The 
next step in the enrollment process will depend on the activity for which we are currently 
recruiting. For the in-depth interviews, online FGs, and content advisory teams, 
participants will be given information about next steps (e.g., scheduling the interview, 
scheduling the online focus group, reviewing the initial pool of messages, etc). 
For the beta test and pilot RCT, participants deemed to be eligible (based on their 
screening survey responses) will be sent a text message welcoming them into the study. 
The text message will also contain a link to the consent form, which will be followed by 
the baseline survey. The project coordinator will direct and oversee the consent and 
enrollment process. Before participants are randomized, the project coordinator will 
confirm that participants have received no doses of HPV vaccine since screening by 
checking their self-reported vaccination status in the baseline survey as well as the I-
CARE registry. 
29.0
Process to Document Consent in Writing
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As the research activities for this project will largely take place online, we will not be 
obtaining written documentation of consent for most participants. Instead, participants 
who take part in this project will be required to provide online consent (by selecting “I 
agree” to participate in this study). The one exception will be those participants who take 
part in the in person interview (Step 1) in Dr. Gerend’s office. For those participants, we 
will obtain written consent prior to conducting the interview (see attached consent form: 
Aim 1 Step 1 Interview hard copy version). Participants who complete the interview by 
phone will be asked to complete an online version of the consent form prior to beginning 
the interview (see attached consent form: Aim 1 Step 1 Interview online version). This 
research presents no more than minimal risk of harm to participants and does not 
involve procedures for which written documentation of consent is normally required 
outside the research context. 
30.0
Drugs or Devices
N/A
References
1.
Markowitz LE, Dunne EF, Saraiya M, et al. Human papillomavirus vaccination: 
recommendations of the Advisory Committee on Immunization Practices (ACIP). 
MMWR Recomm Rep 2014;63(RR-05):1-30.
2.
Glick SN, Feng Q, Popov V, Koutsky LA, Golden MR. High rates of incident and 
prevalent anal human papillomavirus infection among young men who have sex 
with men. J Infect Dis 2014;209(3):369-76.
3.
Daling JR, Madeleine MM, Johnson LG, et al. Human papillomavirus, smoking, 
and sexual practices in the etiology of anal cancer. Cancer 2004;101(2):270-80.
4.
Silverberg MJ, Lau B, Justice AC, et al. Risk of anal cancer in HIV-infected and 
HIV-uninfected individuals in North America. Clin Infect Dis 2012;54(7):1026-34.
5.
Dinh TH, Sternberg M, Dunne EF, Markowitz LE. Genital warts among 18- to 59-
year-olds in the United States, national health and nutrition examination survey, 
1999--2004. Sex Transm Dis 2008;35(4):357-60.
6.
Petrosky E, Bocchini JA, Jr., Hariri S, et al. Use of 9-valent human papillomavirus 
(HPV) vaccine: updated HPV vaccination recommendations of the advisory 
committee on immunization practices. MMWR Morb Mortal Wkly Rep 
2015;64(11):300-4.
7.
Reagan-Steiner S, Yankey D, Jeyarajah J, et al. National, Regional, State, and 
Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 
Years - United States, 2014. MMWR Morb Mortal Wkly Rep 2015;64(29):784-92.
8.
Gerend MA, Madkins K, Philips GL, 2nd, Mustanski B. Predictors of human 
papillomavirus vaccination among young men who have sex with men.  under 
review.
9.
Reiter PL, McRee AL, Katz ML, Paskett ED. Human Papillomavirus Vaccination 
Among Young Adult Gay and Bisexual Men in the United States. Am J Public 
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