ATN 157 -We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples
Phase: NA
Conditions: HIV/AIDS
Sponsor: University of Michigan

 
We Prevent: A Dyadic Approach to HIV Prevention and Care Among Young Male Couples 
 
Protocol ID: FWA00004801 
ClinicalTrials.gov ID: NCT03551938 
Date: November 23, 2020 

ATN 157 – Phase III – Protocol 
 
23Nov2020 
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ATN 157 – We Prevent: A dyadic approach to HIV prevention and care 
 among young male couples 
 
 
Funded by: 
The Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD) 
 
 
 
 
Protocol Co-Chairs:   
Rob Stephenson, PhD, MSc, MA 
Department of Systems, Populations, and Leadership 
University of Michigan School of Nursing 
400 North Ingalls Building, Room 4170A 
Ann Arbor, MI 48109-5482 
734-615-0149 
rbsteph@umich.edu 
 
Kristi Gamarel, PhD, EdM 
Department of Health Behavior and Health Education 
University of Michigan School of Public Health 
1415 Washington Heights, SPH 1, Room 3826 
Ann Arbor, MI 48109 
734-647-3178 
kgamarel@umich.edu 
 
 
 
 
 

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ATN 157 – We Prevent: A dyadic approach to HIV prevention and care 
 among young male couples 
  
 
 
 
 
 
SIGNATURE PAGE 
 
 
I will conduct the study in accordance with the provisions of this protocol and all applicable 
protocol-related documents. I agree to conduct this study in compliance with United States (US) 
Health and Human Service regulations (45 CFR 46); applicable U.S. Food and Drug 
Administration regulations; standards of the International Conference on Harmonization 
Guideline for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee 
determinations; all applicable in-country, state, and local laws and regulations; and other 
applicable requirements (e.g., US National Institutes of Health, Division of AIDS) and 
institutional policies. 
 
 
Investigator of Record: _______________________________________________ 
Print/Type 
 
 
 
 
 
Signed: ___________________________________ Date: ____________________ 
 
 
Title: _____________________________________ 
 
 
 
 
 
 
 

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Table of Contents 
 
Table of Contents .......................................................................................................................................... 3 
Protocol Team Roster ................................................................................................................................... 5 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .................................................................................. 6 
STUDY ABSTRACT .......................................................................................................................................... 7 
1.0 INTRODUCTION ....................................................................................................................................... 9 
1.1 Background ......................................................................................................................................... 9 
1.2 Rationale ........................................................................................................................................... 10 
2.0 STUDY OBJECTIVES ................................................................................................................................ 11 
3.0 STUDY DESIGN....................................................................................................................................... 11 
3.1 Study Population ............................................................................................................................... 11 
3.2 Sample Size ....................................................................................................................................... 12 
4.0 ELIGIBILITY AND SCREENING ................................................................................................................. 12 
4.1 Inclusion Criteria for Phase I, II, and III ............................................................................................. 12 
4.2 Exclusion Criteria for Phase I, II, III .................................................................................................... 13 
4.4 Recruitment ...................................................................................................................................... 14 
4.5 Informed Consent ............................................................................................................................. 14 
4.6 Screening and Registration ............................................................................................................... 16 
5.0 STUDY PROCEDURES ............................................................................................................................. 16 
5.1 Enrollment Procedures ..................................................................................................................... 16 
5.2 Contact Information .......................................................................................................................... 17 
5.3 Counselor Training and Intervention Fidelity ................................................................................... 17 
5.4 Intervention Condition (Phase II and III) ........................................................................................... 18 
5.5 Registration & Randomization (Phase III RCT) .................................................................................. 19 
5.6 Control Condition .............................................................................................................................. 20 
6.0 SURVEYS AND COUNSELING SESSIONS ................................................................................................. 20 
6.1 Phase II and III Survey Measures ...................................................................................................... 20 
6.2 Phase I In-Depth Interviews (IDI) ...................................................................................................... 21 
6.3 Phase I Cognitive Interviews ............................................................................................................. 22 
6.4 Phase II and III Measures .................................................................................................................. 23 
6.5 Phase II Relationship-Skills Session ................................................................................................... 24 
6.6 Phase II CHTC Session ....................................................................................................................... 25 

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6.7 Phase II Exit Interview ....................................................................................................................... 25 
    6.8 Phase III Exit Interview………………………………………………………………………………………………………… ………25 
 
7.0 TECHNICAL EXPERTS ............................................................................................................................. 27 
8.0 DATA COLLECTION ................................................................................................................................ 27 
8.1 Development of Protocol and Case Report Forms ........................................................................... 27 
8.2 Data Records ..................................................................................................................................... 28 
8.3 CRFs ................................................................................................................................................... 28 
8.4 Self-Administered Surveys ................................................................................................................ 28 
8.6 VSee Platform Description (Phase I) ................................................................................................. 29 
8.8 Data Management ............................................................................................................................ 30 
8.8.1 CRFs ........................................................................................................................................ 31 
8.8.2 Audiotape Data ....................................................................................................................... 31 
8.8.3 Self-Administered Survey Data Transmission ................................................................... 31 
8.9 Data Quality Assurance ..................................................................................................................... 31 
8.10 Study Site Monitoring and Record Availability ............................................................................... 31 
9.0 PARTICIPANT MANAGEMENT ............................................................................................................... 32 
9.1 Tracking Participants ......................................................................................................................... 32 
9.2 Compensation ................................................................................................................................... 33 
9.3 Intervening on “Social Harms" .......................................................................................................... 33 
9.4 Criteria for Premature Study Discontinuation .................................................................................. 33 
10. MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING FROM THE STUDY ............... 34 
11. PHASE I DATA ANALYSIS ........................................................................................................................ 34 
11.1. Phase II DATA ANALYSIS ..................................................................................................................... 34 
11.2 Phase III DATA ANALYSIS ..................................................................................................................... 35 
12. HUMAN SUBJECTS ................................................................................................................................. 36 
12.1 Participants’ Confidentiality ............................................................................................................ 36 
12.2 Certificate of Confidentiality ........................................................................................................... 36 
12.3 Risks and Benefits ........................................................................................................................... 37 
12.3.1 Benefits ........................................................................................................................................ 39 
12.4 Institutional Review Board (IRB) Review and Informed Consent ................................................... 39 
12.5 Waiver of the Requirement for Parental Permission for Special Circumstances ........................... 39 
12.6 Waiver of the Requirement for Signed Consent Form ................................................................... 40 

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12.6.1 For Study Participation ........................................................................................................ 40 
12.6.2 For Eligibility Screening ....................................................................................................... 40 
12.7 Prisoner Participation ..................................................................................................................... 40 
12.8 45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health Information 
("Privacy Rule" Pursuant to the Health Insurance Portability and Accountability Act - HIPAA) ............. 41 
12.9 Study Discontinuation ..................................................................................................................... 41 
13.0 PUBLICATION OF RESEARCH FINDINGS .............................................................................................. 41 
Any presentation, abstract, or manuscript will be made available for review by the study sponsor(s) prior 
to submission.14.0 REFERENCES ................................................................................................................. 41 
 
Protocol Team Roster 
 
Lynae Darbes, PhD 
Co-Investigator 
Health Behavior and Biological Sciences 
University of Michigan School of Nursing 
400 North Ingalls, Rm 3341 
Ann Arbor, MI   48109 
(734) 763-7265 
Lynaed@umich.edu 
 
 
Matthew Rosso, MPH 
Project Manager 
University of North Carolina at Chapel Hill 
matthew_rosso@med.unc.edu 
919-966-3537 
 
Catherine Washington 
Research Associate 
University of Michigan School of Nursing 
400 North Ingalls 
Ann Arbor, MI 48109 
washicat@umich.edu 
734-647-7260 
 
 
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
AC  
 
 
 
Analytic Core 
AIDS   
 
 
Acquired Immunodeficiency Syndrome 
ART   
 
 
Antiretroviral Therapy 
ASO   
 
 
AIDS Service Organization 
ATN   
 
 
Adolescent Medicine Trials Network for HIV/AIDS Interventions 
CASI   
 
 
Computer Assisted Self Interview 
CDC   
 
 
Centers for Disease Control and Prevention 
CFR   
 
 
Code of Federal Regulations 
CHTC  
 
 
Couples HIV Testing and Counseling 
CRF   
 
 
Case Report Form 
CTR 
 
 
 
Counseling, Testing, Referral  
DCF   
 
 
Data Collection Form 
DHHS   
 
 
U.S. Department of Health and Human Services 
EC  
 
 
 
Ethics Committee 
GCP   
 
 
Good Clinical Practices 
HIPAA  
 
 
Health Insurance Portability and Accountability Act 
HIV  
 
 
 
Human Immunodeficiency Virus 
ICH  
 
 
 
International Conference on Harmonization 
IRB  
 
 
 
Institutional Review Board 
LGBTQ  
 
 
Lesbian, Gay, Bisexual, Transgender, Queer 
MC  
 
 
 
Management Core 
MTS   
 
 
Michigan Tailoring System, a platform for eHealth interventions 
NICHD  
 
 
National Institute of Child Health and Development 
NIDA   
 
 
National Institute on Drug Abuse 
NIH  
 
 
 
National Institutes of Health 
OHRP   
 
 
Office for Human Research Protections 
PI  
 
 
 
Principal Investigator 
PrEP   
 
 
Pre-Exposure Prophylaxis 
QNS   
 
 
Query and Notification System 
RDC   
 
 
Remote Data Capture 
SRV   
 
 
Subject Recruitment Venue 
STI  
 
 
 
Sexually Transmitted Infection 
TC  
 
 
 
Technology Core 
YGBMSM 
 
 
Young Gay, Bisexual, and other Men who have Sex with Men 
YMSM  
 
 
Young Men who have Sex with Men 
 
 
 
 

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STUDY ABSTRACT 
 
DESIGN: 
This project seeks to develop and pilot test a developmentally-
appropriate HIV prevention intervention that includes relationship 
skills for young gay, bisexual and other men who have sex with 
men (YGBMSM). This project involves three phases to develop 
and pilot test the intervention. Phase I collects brief quantitative 
survey data, in-depth qualitative and cognitive interview data from 
YGBMSM, and feedback from a technical expert group (TEG) to 
develop and refine the intervention that comprises the We Prevent 
study. Phase II involves conducting a one-arm pilot of the 
intervention condition to further refine the intervention content with 
a sample of 24 YGBMSM (12 dyads).The final phase of We 
Prevent, Phase III, involves conducting a randomized controlled 
trial (RCT) comparing the relationship-focused intervention to a 
control condition, which is HIV Counseling, Testing, and Referrals 
(CTR) alone with a sample of 320 YGBMSM. This protocol is for 
Phase III of the proposed activities..  
 
 
DURATION: 
Phase I is expected to take 7 months to complete. It includes data 
collection from two groups of participants: 1) 30 YGBMSM in in-
depth interviews and 8 YGBMSM in cognitive interviews and 2) 7 
Technical Experts, for a total sample of 45 research participants. 
Phase I is split into three tasks. For Task 1, 30 YGBMSM will be 
recruited through online banner advertisements and once 
consented and screened will complete a brief online survey which 
will take approximately 15-20 minutes to complete. Participants 
will then be invited to participate in an in-depth interview with a 
study staff member, which will take approximately 1-2 hours to 
complete. The data generated from Task 1 will be used to design 
the intervention manual. For Task 2, a technical expert group 
(TEG) of 7 individuals will be identified to participate in virtual 
meetings to review and provide feedback on the intervention 
content. For Task 3, an additional group of YGBMSM (n = 8), 
excluding those included in Task 1, will be recruited to complete 
cognitive interviews which will last approximately 1 hour to further 
refine the intervention. Phase II will consist of a one-arm pilot test 
of the intervention condition with 12 YGBMSM and their partners 
(total 24 participants). Each participant will complete baseline and 
1-month follow-up surveys and all will get mailed STI testing kits at 
baseline. Phase III involves a two-arm prospective RCT in which 
320 YGBMSM will complete surveys at Baseline, 3-month, 6-
month, and 9-month follow-up. They will only be mailed STI kits at 
Baseline and 6-month follow-up. Participants randomized to the 
intervention arm will have the option to participate with their 
partner, though it is not required or necessary. 
 
SAMPLE SIZE: 
Participants will be recruited online with potential representation 
from all 50 states. The sample size for Phase 1 is 45: this is 
comprised of 38 YGBMSM: 30 took part in in-depth interviews for 

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Task 1, and 8 took part in cognitive interviews for Task 3. For 
Task 2, 7 technical expert group members (TEG) were recruited to 
provide feedback on the intervention content. The sample size for 
Phase II is 24 participants (12 dyads), and the Phase III sample 
size is 320 participants. 
 
POPULATION: 
For phases I and II of the project, participants and their partners 
must be: (1) between the ages of 15 and 19 years (inclusive); (2) 
must meet the age of sexual consent in their states of residence 
(3) identify that they are in an emotional and/or sexual relationship 
with another male (assessed through multiple questions), (4)  
cisgender men (assigned male at birth and identifies as male) and 
transgender men (assigned female at birth and identifies as male 
or transgender man) who report intention to have sex with men; 
(5) report that they have engaged in any sex (oral, vaginal, anal) 
in their lifetime, (6) have access to personal device with internet 
access within their home, (7) self-report being HIV negative or 
unknown serostatus, and (8) speak or read English. A Technical 
Expert Group was  formed in Phase I and consisted of members 
who engage with diverse communities of YGBMSM and have 
experience in the provision of HIV and LGBTQ clinical and social 
services. Phase III participants must (1) be between the ages of 
15 and 24 years (inclusive); (2)  meet the age of sexual consent in 
their states of residence (3) identify that they are in an emotional 
and/or sexual relationship with another male (assessed through 
multiple questions), (4) be a cisgender man (assigned male at 
birth and identifies as male)  or transgender men (assigned female 
at birth and identifies as male or transgender man) who report 
intention to have sex with men; (5) report that they have engaged 
in any sex (oral, vaginal, anal) in their lifetime, (6) have access to 
a personal device with internet access within their home, (7) self-
report being HIV negative or unknown serostatus, and (8) speak 
or read English. 
 
Recruitment: 
For all phases, we aim to recruit at least 50% racial and ethnic 
minority participants in all phases. In Phase III, we will stratify by 
race and ethnicity. 
 
DATA COLLECTION: 
For all study phases, YGBMSM will be recruited via online banner 
advertisements on social media (Instagram, Facebook, Snapchat) 
and will be connected to a screener survey via Alchemer. When a 
participant screens eligible in Phase II, they will provide their and 
their partners’ contact information. After email and phone 
validation, they will be able to register for an account with the and 
will be enrolled in the study. Study staff will then send them each a 
link to complete the baseline survey. Once both partners have 
completed the baseline survey, the couple will schedule a 
relationship skills session that will be conducted via Zoom video-
chat software. Zoom is a HIPAA-secure video-conferencing 
program. Once they have completed the relationship skills 
session, they will be mailed at-home HIV test kits and scheduled 

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for their CHTC session. Surveys will be completed at Baseline and 
1-month follow-up. At-home STI testing kits will be offered at 
Baseline. Qualitative data will be audio-recorded, with participant 
consent, to allow for verbatim transcription of the interview and 
checked for accuracy and completion. A select number of 
participants (n=6) will be asked to complete an exit interview with 
study staff via Zoom. When a participant screens eligible for 
Phase III, they will be directed to a SMART registration page 
where they will complete the Baseline survey and be randomized. 
Those in the control condition will participate alone in a CTR 
session; those in the intervention arm will have the option to 
participate alone or with their partner in CTR + Relationship Skills 
and/or CHTC + Relationship Skills session(s). The HIV testing 
session will be conducted via Zoom, and the participant will 
complete follow-up surveys (3, 6, and 9 months) via Alchemer. 
 
 
OBJECTIVES:  
1) To develop and refine a developmentally appropriate 
relationship skills session as an additional session to the current 
CHTC and CTR interventions for 15-24-year-old YGBMSM.  
 
 
2) To conduct a randomized controlled trial (RCT) comparing the 
efficacy of the adapted intervention for YGBMSM versus a control 
condition, which is CTR alone. 
 
1.0 INTRODUCTION 
 
1.1 Background 
 
Young (15-24 years old) gay, bisexual and other men who have sex with men (YMSM) continue 
to be the group most heavily impacted by HIV in the US, despite stable or declining rates of 
infection among other groups.1,2 More than four decades into the epidemic, HIV prevention and 
research efforts in the US have continued to target MSM as individuals, largely focusing on 
messages that encourage the uptake of prevention efforts (traditionally condoms, and more 
recently PrEP) and reducing sexual risk. Recently, there has been growing interest in structural 
interventions to reduce HIV risk, tackling social, economic and cultural factors that place MSM in 
contexts of risk.3 However, despite socio-ecological theory postulating the importance of 
individual, dyadic and social influences on HIV risk, there has been a dearth of intervention 
efforts focused at the dyadic level. Substantial evidence indicates that one- to two-thirds of MSM 
acquire HIV from their main partners, and that the proportion of new infections attributable to 
main partners is higher (84%) among YMSM.4,5 Male couples’ increase in HIV risk is attributed 
to a combination of a lack of knowledge of both partners’ HIV status before engaging in 
condomless anal sex (CAS), higher number of anal sex acts between main partners, and more 
frequent receptive roles during anal sex acts.6-11 CAS within relationships often occurs 
concurrently to CAS outside of the relationship, often as part of a mutual sexual agreement, 
potentially increasing the couples’ risk for HIV and other sexually transmitted infections 
(STIs).7,8,12,13  
 

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Although a number of evidence-based biomedical HIV preventive strategies exist for YMSM, 
uptake of these strategies within relationships remains low. Studies with HIV-negative male 
couples have found strong evidence that partnered men test less frequently for HIV and other 
STIs,14-16 and are less likely to adopt biomedical prevention strategies15, 28 and that their use is 
contingent upon their perception of risk.15 There has also been low awareness and uptake of 
PrEP which may be reflective of limited dissemination efforts of biomedical prevention strategies 
for young male couples,17 compounded with low perception of their HIV risk,18 and the 
uncertainty of how using a strategy may affect their relationship.19 Furthermore, many YMSM 
report increased fatigue with safer sex messages and practices but express a need for services 
that address health more generally,20,21 including relationship education services.22 Integrating 
relationship skills with HIV prevention is an important and necessary means to curb HIV 
incidence amongst those at highest risk for infection. 
 
1.2 Rationale 
 
To date, there are few scalable dyadic HIV prevention interventions exist for YMSM in 
relationships.3,23 Couples HIV Testing and Counseling (CHTC) has been shown to be as 
acceptable as individual HIV testing.24 Despite widespread acceptability and utility,25 there has 
been limited dissemination and scaling up of couples-based HIV prevention interventions for 
YMSM, including CHTC. Qualitative evidence suggests that YMSM have CAS with serious 
partners to express trust and intimacy, and they stop using condoms without initiating pre-
exposure prophylaxis (PrEP) because they perceive that they are in a monogamous 
relationship.26,27 Young male couples also report infrequent HIV testing, even when CAS has 
occurred with outside partners.14,15 Because most existing prevention strategies focus in large 
part on reducing CAS with casual partners,28 many YMSM do not have the skills to navigate the 
complexities of HIV prevention in romantic relationships, such as timing of HIV testing, condom 
use, and use of biomedical prevention strategies. Thus, incorporating relationship skills into 
existing the CHTC intervention delivered via video-counseling has the potential to empower 
YMSM with the skills necessary to communicate and protect themselves from HIV in their current 
and future relationships.  
 
1.2.1 Telemedicine may provide an opportunity to address barriers to HIV testing for 
partnered YMSM.  
 
YMSM often rely on online technologies to build their social and sexual networks, receive social 
support, and obtain relevant health information. In general, Internet use among young adults aged 
15-29 is nearly universal, at 99% in 2016.29,30 Thus, telemedicine offers the opportunity to 
disseminate HIV prevention strategies to YMSM who might otherwise not have this opportunity. 
Telemedicine aims to circumvent traditional impediments to healthcare access.  Over the past 
decade, telemedicine formats have been adapted for use in MSM populations where stigma and 
a lack of LGBT-friendly healthcare providers contribute to reduced access to care.31 Online 
interventions are seen as convenient for youth users and allow for home-based access to health 
messaging, thereby reducing fears of embarrassment or ‘outing’ by connecting with local 
resources.32,3334 
 
1.2.2 Theoretical framework for We Prevent: Dyadic Intervention 
 
We-Prevent draws on the Relationship-Orientation Information-Motivation-Behavioral Skills 
(RELO-IMB) model,35 premised on the IMB model36 and developed for YMSM communities.37 The 
RELO-IMB model entails “Information” by addressing YMSM-specific knowledge (e.g., risk within 

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dyads and with outside partners), “Motivation” by addressing attitudes and peers norms about 
prevention in relationships, and “Behavioral Skills” by addressing risk reduction skills relevant to 
YMSM and their partners (e.g., discussion about safer sex, HIV testing, and negotiating safety in 
one’s sexual agreement). This study uses the RELO-IMB model, but with variations on specific 
measures in an effort to harmonize our metrics with other ATN studies. We Prevent includes two 
sessions: session one, a motivational interviewing guided session which provides a facilitated 
discussion between two YMSM in which they explore and understand their own HIV risk and learn 
behavioral skills to improve communication, and session two, a CHTC session between two 
YMSM which facilitates the development of a prevention plan that meets the goals of both 
partners. We hypothesize that YMSM and their partners who engage in We Prevent will 
demonstrate greater information about different prevention options (e.g., knowledge of PrEP and 
the importance of STI and repeat HIV testing). Furthermore, YMSM who engage in We Prevent 
will demonstrate greater communication skills to use in their relationship, which will provide them 
with greater self-efficacy for developing a HIV prevention plan with their partner. The use of 
motivational interviewing techniques will allow couples to realize areas where they are doing well 
in their communication and HIV prevention plan while highlighting areas for improvement. These 
skills will facilitate engaging in CHTC in the second session in which the two partners test together 
and develop a prevention plan. Thus, We Prevent will increase the uptake of HIV prevention 
strategies by exploring YMSM’s desires, goals and behaviors within their relationship and 
teaching YMSM models of communication and problem-solving strategies to help them enact 
effective communication towards HIV prevention planning and uptake. YMSM exposed to the 
intervention will learn about HIV prevention options (Information), HIV prevention and risk within 
relationships (Information and Motivation), and will practice communication and negotiation 
techniques towards the discussion of sex, sexual risk and HIV prevention and planning 
(Behavior). 
 
2.0 STUDY OBJECTIVES 
The overall objective of our program of research is to develop and test We Prevent (ATN 
Protocol #157), as part of the U19HD089881-02S2 UNC/Emory Center for Innovative 
Technology (iTech) across the prevention and care continuum project. Phase I and Phase II 
have already been approved by the UNC IRB and the objective of this proposal is to obtain 
approval for Phase III, which is the two-armed randomized control trial. For this application, we 
are requesting approval for Phase III procedures and materials only. The procedures and 
materials for Phase III rely on the findings from Phase II.  
 
3.0 STUDY DESIGN 
 
This four-year study consists of three phases to develop and test the “We Prevent” intervention 
for YMSM and their partners. Phase II and III protocols and procedures are premised on the 
formative data collected in Phase I; and Phase III has been further informed by the data 
collected in Phase II. 
 
 
3.1 Study Population 
 
For Phase I and II of this project, we  recruited a diverse sample of 15-19-year-olds. For Phase 
III of the project, we will recruit a diverse sample of 15-24 year-olds. Age of recruitment will vary 
state-by-state due to variations in state sexual consent laws. Therefore, in some states we will 

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not be able to recruit participants who are as young as 15, and this state-by-state logic will be 
built into the screener.. We will  exclude those who report a recent (6 month) history of intimate 
partner violence, using methods specifically designed for use with male couples. To ensure 
representation of racial/ethnic minorities, we have a target of 50% in all phases of the study be 
racial/ethnic minority participants. If enrollment of racial/ethnic participants drops below 50%, we 
will explore additional recruitment strategies.  
 
Eligibility for both the participant and their partner will include the following: (1) between the ages 
of 15 and 24 years; (2) participants must meet the age of sexual consent in their states of 
residence; (3) identify that they are in an emotional and/or sexual relationship with another male 
(assessed through multiple questions, both at the individual and dyadic level), () born male or  
female and currently identify as male or transgender man, with an intention to have sex with men 
(5) report that they have engaged in any sex (oral, anal, vaginal) in their lifetime, (6) have access 
to personal device with internet access within their home, (7) self-report being HIV negative or 
unknown serostatus, and (8) speak and read English. 
 
3.2 Sample Size 
 
Phase I  involved three Tasks, with separate samples for each Task. For Task 1 we have 
enrolled 30 YGBMSM (ages 15-19) who completed a brief online survey and an in-depth 
interview, in order to gather the necessary data for developing the intervention manual. For 
Task 2, we  enrolled 7 technical experts to undergo interviews to provide feedback on the 
intervention manual developed from the data in Task 1. For Task 3, we  enrolled 8 YGBMSM 
(ages 15-19) to complete a brief online survey and then cognitive interviews to refine the 
intervention manual. The 8 YGBMSM enrolled for Task 3 are independent to those enrolled in 
Task 1: it is important that those involved in the cognitive interviewing (Task 3) have had no 
prior contact with the study. In Phase II, we enrolled  12 YGBMSM (ages 15-19) and their 
partners (6 couples) in a one-arm pilot of the intervention to further refine the intervention. No 
participants completed sessions in Phase II, and the design for Phase III is modified based on 
this result. Only participants randomized to the intervention arm will have the option to 
participate alone or with their partner. Phase III involves conducting an RCT of the We Prevent 
intervention (CTR + relationship skills, or CHTC + relationship skills) compared to CTR alone 
with 320 YGBMSM ages 15-24. 
 
4.0 ELIGIBILITY AND SCREENING 
4.1.a Inclusion Criteria for Phase I and II 
 
*Below inclusion criteria must be satisfied by both participants within a dyad (i.e., both partners 
report that they are in an emotional and/or sexual relationship with each other).  
• 
Ages 15 to 19 years (inclusive) at time of screening  
• 
Current US resident 
• 
Sufficient age for sexual consent in the current state of residence  
• 
Self-identify that they are in an emotional and/or sexual relationship with another male  
• 
Cisgender men (assigned male at birth and identifies as male) and transgender men 
(assigned female at birth and identifies as male or transgender man) who report intention 
to have sex with men  
• 
Self-reports that they engaged in some form of sex (oral, vaginal, anal) in their lifetime 
• 
Has access to computer/personal device/smart phone with internet access  
• 
Self-report being HIV negative or unknown serostatus 

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• 
Speak and read English 
 
 
4.2 Exclusion Criteria for Phase I and II 
 
*Below exclusion criteria applies to both participants within a dyad 
• 
Younger than age for consent without parental permission in the current state of 
residence  
• 
Assigned female sex at birth and currently identifies as something other than male or 
transgender male 
• 
Assigned male sex at birth but identifies as gender other than male or transgender male 
• 
Aged 14 years or younger or 20 or older at the time of screening  
• 
HIV-positive 
• 
Not currently in an emotional and/or sexual relationship with another male 
• 
Does not speak or read English 
• 
Reports intimate partner violence in the past 6 months 
 
4.3 Inclusion Criteria for Phase I, Task 2 (Technical Expert Group) 
• 
The individual has published in a peer-reviewed journal in the following domains in the 
past 4 years: HIV interventions for YMSM, online HIV interventions for YMSM, or dyadic 
HIV interventions.  
• 
A list of potential participants will be identified through a review of the recent (4 year) 
literature.  
 
4.4 Inclusion Criteria for Phase III 
*Below inclusion criteria must be satisfied by individual participants (or both participants within a dyad if 
they choose to participate as a couple, only in the intervention arm)   
• 
Ages 15 to 24 years (inclusive)  
• 
Current US resident 
• 
Sufficient age for sexual consent in the current state of residence (both at the individual 
and dyadic level) 
• 
Self-identify that they are in an emotional and/or sexual relationship with another male  
• 
Cisgender men (assigned male at birth and identifies as male) and transgender men 
(assigned female at birth and identifies as male or transgender man) who report intention 
to have sex with men  
• 
Self-reports that they engaged in some form of sex (oral, vaginal, anal) in their lifetime 
• 
Has access to computer/personal device/smart phone with internet access  
• 
Self-report being HIV negative or unknown serostatus 
• 
Speak and read English 
 
 
4.5 Exclusion Criteria for Phase III 
 
*Below exclusion criteria applies to both participants within a dyad 
• 
Younger than age for consent without parental permission in the current state of 
residence  

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• 
Assigned female sex at birth and currently identifies as something other than male or 
transgender male 
• 
Assigned male sex at birth but identifies as gender other than male or transgender male 
• 
Aged 14 years or younger or 25 or older at the time of screening 
• 
HIV-positive 
• 
Not currently in an emotional and/or sexual relationship with another male 
• 
Does not speak or read English 
• 
Reports intimate partner violence in the past 6 months 
 
4.6 Recruitment 
 
All recruitment will be completed online: this protocol does not involve SRV engagement in 
recruitment or intervention delivery. Participants will be recruited via online ads placed on key 
social media websites (e.g., Facebook, Instagram, Snapchat, Grindr, etc.). The online ads will 
show visual representations of young male couples, in a range of race/ethnicities and will be 
titled: “We Prevent.” People who click on the advertisement will be taken to the Survey Gizmo 
screener webpage that provides basic information on the study: this will be referred to 
throughout the protocol as the ‘landing page’. On the landing page will be basic information on 
the study processes and a “do you consent to be screened?” question; if participants click “yes” 
they will be screened for eligibility.. All recruitment will be tracked in the screener with the 
question “How were you directed to the study website?”  
 
This study will also use Cameo as part of its online recruitment strategy. Cameo is a website 
that allows users to pay celebrities to create short 20-second videos and deliver a particular 
message of the user’s choice. Once the video is created and paid for, Cameo delivers the video 
file to the user. Study staff will upload the video to the social media sites already being used for 
recruitment. The script will only contain information about the study: “Hi, this is (insert celebrity 
name) and I want to tell you about an HIV prevention study from the University of Michigan. This 
study is aimed at young gay and bisexual men who are in their first relationships. If you are 
eligible, you will take a few surveys and get mailed an at-home HIV testing kit. Click on the link 
to see if you’re eligible!”  
 
4.7 Informed Consent 
 
For all phases of the study, there are two points of consent: 1) consent for screening for 
eligibility, and 2) consent to participate in the study. When participants click on the “interested in 
participation?” button, they are taken to the next page of the website. This page contains the 
first informed assent/consent survey (for screening). After reading the consent script participants 
can click on “agree” or “disagree”. If they click agree they will be taken to the eligibility screener 
(a Alchemer survey) and if they disagree they will be taken to a page that thanks them for their 
interest and links them to the CDC HIV toolkit page. Those who are ineligible will be asked if 
they want to provide their contact information to be contacted about future research 
opportunities. The consent/ decline decision will be recorded in the data base linked to a 
participant unique ID, that can then be linked to their data to allow an electronic record of 
consent/ assent for all participants.  For Phase I, after taking the eligibility screener (see below), 
those who are eligible will be taken to a page that shows the second consent/ assent form that 
explains the specific study activities for which they are being recruited. After reading the 
informed consent form the participant can consent/assent or decline in the same manner as the 
eligibility consent. For Phase III, participants will complete the eligibility screener in Alchemer, 
and if eligible and consent to participate in the study, will be automatically re-directed to a 

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SMART registration page where they will enter their contact information and be instructed to 
download the We Prevent-specific SMART app. For participants who are invited by the index 
partner and are eligible to participate, we will schedule an informed consent phone call 
immediately following their screening into the study. We will provide information about the study 
procedures to ensure they understand that they will be participating to a lesser extent than the 
index partner but still with their partner.    
 
Assessing for decisional capacity. The study staff reviews the informed consent/assent to 
make a formal assessment of the youth’s decisional capacity and ability to provide consent/assent 
prior to each video-conferencing session, using a 2-step process. First, the staff members 
determine if the person understands the study goals by asking “Can you tell me what this study 
is about?” In step 2, potential participants will be asked questions designed to assess their 
capacity to understand, appreciate, reason with, and express a choice about participation in our 
specific protocol. We will use a modified version of the widely used Evaluation to Sign Consent 
Form in which participants are asked to: 1) name things they will be expected to do during the 
study; 2) explain what they would do if they no longer wished to participate in the study; 3) explain 
what they would do if they experienced distress during the study; and 4) identify potential risks for 
participating in the study. Potential participants will be enrolled only if they are able to provide 
clear and correct answers to each of these items, without prompting or correction.  
 
 
Waiver of parental consent. We will request that the UNC-CH IRB as the central IRB (IRB of 
Record) grant a waiver of parental consent to participate in this research study for youth 
participants who are 15 to 17 years of age. The research team has been granted waivers of 
parental permission for all prior studies with sexual minority youth. Under 45 CFR 46.408 (c), an 
IRB has the authority to waive parental permission if it determines that “a research protocol is 
designed for conditions or a subject population for which parental or guardian permission is not 
a reasonable requirement to protect the subjects” and “an appropriate mechanism for protecting 
the children who will participate as research subjects is substituted” and “that the waiver is not 
inconsistent with Federal, State, or local law.” A waiver of parental permission for studies with 
lesbian, gay, bisexual, transgender, and questioning (LGBTQ) youth that do not involve greater 
than minimal risk is a common practice among researchers working in the area of gay and 
lesbian health/mental health. This is done to avoid the selection biases operating in only 
recruiting youth whose parents are both aware of and comfortable with their sexual orientation. 
Commonly youth have explored their sexual orientation without their parents’ knowledge as the 
youth struggle with issues of disclosure and its consequences within the social, religious, and 
economic context of their families. A requirement for parental permission in this type of study 
could not only affect a person’s willingness to participate but could also potentially impact the 
ability of researchers to engage in this type of research with sexual minority youth. 
If the purpose of requiring parental permission as stated in CFR is to protect the minor subject, 
then requiring parental permission for youth in these circumstances is not a reasonable 
requirement.  Additional privacy protections are provided in that all assessments, notes, reports, 
and other records will be identified by only a coded number to maintain participant 
confidentiality. These records and any forms that do contain identifying information (e.g., 
consent/assent forms, contact information) will be kept in a locked, limited access area (such as 
a locked file cabinet) at the participating site. 
 

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The study is requesting waiver of written informed consent from adult participants (18 years old 
and above) See sections 12.5 through 12.6 for additional information regarding waivers of 
written informed consent. 
 
4.8 Screening and Registration 
 
Participants will have completed the following process: clicking on a banner advertisement, 
learning about the study via the study landing page, consenting to be screened for eligibility, 
answering eligibility questions on a Alchemer survey, reading the informed consent/assent form 
and consenting/ assenting to participate. For participants in Phase III, after screening eligible, 
participants will be redirected to a SMART linked web page where they will enter their contact 
information, which will then be automatically populated into SMART and verified.  Study staff 
members will verify eligibility for all participants who screen eligible and provide consent. Once 
their eligibility is confirmed, participants will be sent instructions to download the SMART study 
application and all follow-up activities will be conducted through SMART. If the participant is 
randomized into the intervention arm and chooses to participate with their partner, the invited 
partner will be emailed a link to the eligibility screener. If they screen eligible, study staff will 
schedule an informed consent phone call with the invited partner (described above in the 
informed consent section). Contact information for the invited partner will be requested in the 
brief baseline survey and will be stored in a password-protected file within Box or Microsoft 
OneDrive. 
 
5.0 STUDY PROCEDURES 
5.1 Enrollment Procedures 
 
Phase I: The same processes will be used for Task 1 and Task 3. They will not operate in 
parallel. Task 1 will be completed first, with the data from the in-depth interviews being used to 
develop the intervention manual. After development of the manual, we will engage in Task 2. 
Feedback from Task 2 will then be incorporated into the manual. Once both Task 1 and 2 are 
complete, then we will begin Task 3, which involves cognitive interviews with an additional 10 
participants. Once the eligible participant has completed the screener and provided their contact 
information, a study staff member will email them with a link to the brief online survey in 
Alchemer. Once they have completed the brief survey, we will contact them to schedule the 
interview for Task 1 or Task 3 (dependent on what they are recruited for). Before the interview, 
the study staff member will review the consent process to ensure they understood their rights 
and the details of their participation. Alchemer has a business partner HIPAA agreement with 
Emory. Alchemer servers are HIPAA-compliant. The time between eligibility screening and 
completing the survey and interview will be tracked through SMART, and weekly reminders will 
be sent out (via the participant’s choice of SMS or email) to remind them to complete the survey 
and/or the in-depth interview. 
 
Phase II: If the prospective participant screens eligible, they will enter their and their partner’s 
contact information directly into the Alchemer screener. After email and phone validation, the 
invited partner will receive an emailed link to the screener. If eligible, the invited partner will also 
provide and verify their contact information. After both partners have screened eligible, verified 
their data and their contact information, both participants will be emailed a link to complete the 
baseline survey and all subsequent study activities. Once they have both completed the 
baseline survey, they can opt-in to the at-home STI testing process and schedule the 
relationship skills session that will be conducted via Zoom or VSee video-chat software. 

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Participants will then be mailed STI testing kits. Once they have completed the relationship skills 
session, they will be mailed HIV testing kits and scheduled for their CHTC session. Surveys will 
be completed at Baseline and 1-month follow-up. At-home STI testing will be offered at 
Baseline. With regard to the baseline survey, participants have four weeks to complete the 
survey from the time the screen eligible. Reminders will be sent to ensure that participants are 
aware of this study activity. If the baseline is not complete by either of the partners within the 
four weeks, the couple will be study-stopped. If only one of the participants completes the 
baseline survey, study staff will continue to follow that participant with the 1-month follow-up 
survey.  
 
Phase III: If the prospective participant screens eligible, they will enter their contact information 
into a registration page connected to SMART. After completing the registration page, 
participants will be instructed to download the SMART app where all subsequent study activities 
will take place. Participants will be randomized in DFexplore after completing the Baseline 
survey. Participants randomized to the control arm will complete the study entirely on their own. 
Those randomized into the intervention arm will have the option to participate alone or with their 
partner. If they choose to participate with their partner, their partner will be screened for 
eligibility, consented, and complete a brief survey (not the full baseline survey). The invited 
partner will not be put into SMART and the only information we will collect is the screener, 
consent and brief survey data, along with a satisfaction survey after the CHTC session. For 
invited partners who screen eligible and complete the brief survey, study staff will consent them 
over the phone prior to the CHTC session. . Index participants will complete surveys at 
Baseline, 3-month, 6-month, and 9-month follow-up. They will be mailed STI kits at Baseline 
and the 6-month follow-up.  
 
To ensure representation of racial/ethnic minorities, we have a target of 50% in all phases of the 
study be racial/ethnic minority participants. If enrollment of racial/ethnic minority participants 
drops below 50%, we will explore additional recruitment strategies 
 
5.2 Contact Information 
 
The collection of contact information procedures is the same for all study phases. After 
screening eligible, participants will be asked if they would like to be contacted by email, phone, 
or text message for any study communication and will have options to provide contact 
information for each mechanism. Study staff will not leave messages unless expressly permitted 
to do so by the participant which also will be documented on this form. If a participant selects 
the phone option, the study team will ask for explicit permission to leave voice messages that 
will not include any protected health information or information related to study participation. 
Participant contact information will be maintained using the same confidential data management 
practices used for all study data. 
 
5.3 Counselor Training and Intervention Fidelity  
 
We will train counselors in motivational interviewing, CHTC and the relationship building session 
in a 3-day training session. They will also receive a 3-day training in CTR from the Michigan 
Department of Health and Human Services. Counselors will demonstrate proficiency via 
audiotaped role plays prior to being “certified” to deliver sessions. All counseling sessions will be 
audiotaped (with participant informed consent), and every fourth session will be rated by Drs. 
Gamarel and Darbes. Counselors will be provided timely feedback at weekly supervision 
sessions. For emergent psychosocial problems such as relationship conflict, unemployment, or 

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loss of residence, a brief problem-solving discussion will be conducted in session and referrals 
to relevant local agencies and community therapists will be provided, which include a generated 
list of national services. Counselors will intervene immediately in the event that participants are 
an imminent threat to themselves or others and will discuss any cases of clinical deterioration 
with Dr. Darbes (a Clinical Psychologist) in order to determine whether more intensive treatment 
is required. In the event there is an immediate situation which requires attention during an 
assessment or session, Dr. Darbes will be available. We will use the manualized protocol for 
rating counselor competence to ensure intervention fidelity. In the RCT (Phase III), counselors 
will be rated bimonthly as part of supervision. The first 10 session tapes for each counselor will 
be rated and then subsequently every fourth session will be reviewed by Drs. Darbes and 
Gamarel. Counselors identified as having treatment drift will receive booster trainings as 
necessary.  
 
5.4 Intervention Condition (Phase II and III) 
 
In Phase II, all participant couples will be in the intervention condition in order to pilot the study 
before the RCT. This dyadic intervention is based on the standard one-session Couples HIV 
Counseling and Testing (CHTC) session that is now a CDC recommended prevention strategy 
for male couples and is being tested for adult male couples via video-based counseling. The 
intervention condition will be modified to include an additional couples sessions, which will be 
dedicated to relationship skills building. Thus, the intervention will consist of two couples 
sessions delivered over a two week time period. The first session is the relationship skills 
session and will focus on defining healthy and unhealthy characteristics of relationships, 
teaching and practicing effective communication skills, reviewing couples-based sexual health 
information (i.e., negotiated safety, PrEP, HIV and STI testing), and preparing for engaging in 
CHTC as a couple.  
 
In Phase III, participants will be randomized after they complete the baseline survey. 
Participants in the intervention arm will have the option to: (1) participate alone – this involves 
one CTR + Relationship Skills session within one to two weeks from completing the baseline;  
(2) participate with their partner – this involves one CHTC + Relationship Skills session; or (3) 
participate alone in the CTR + Relationship Skills session and also participate with their partner 
in the CHTC + Relationship Skills session. The choice on how participants want to participate 
will be recorded in Alchemer, where each option will be explained in detail so that participants 
can make the best choice for themselves. Regardless of their choice, the participant’s initial 
session should occur within four weeks of enrollment. If they choose to participate with their 
partner, the invited partner will be screened for eligibility and sent a brief baseline survey before 
scheduling the CHTC + Relationship Skills session. Participants and their partner (if they 
choose the couple option) will be mailed an HIV testing kit (OraQuick rapid fluid test) prior to the 
session. Foundational to this intervention is the individuals or couples talking about and forming 
a prevention plan using effective communication. Specifically, both sessions are designed to 
help YMSM learn and practice communication skills and set goals regarding HIV prevention and 
care which can be used throughout their lives.  
  
In the CHTC + Relationship Skills session, YMSM and their partner will receive all elements of 
counseling and testing together: pre-test counseling, HIV testing with an OraQuick rapid fluid 
(saliva) test that will be mailed to participants prior to the session, and discussion of HIV risks, 
delivery of test results and post-test counseling jointly as a couple. Importantly the dyadic 
intervention will focus on the future: participants will not be asked to reveal recent risk 
behaviors/ exposures. Instead the focus is on the couple learning their sero-status together and 

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building a prevention plan that reflects their relationship goals and sero-status. Foundational to 
this is the couple talking about and forming a prevention plan together using effective 
communication skills. Specifically, the session is designed to help YMSM and their partners 
learn and practice communication skills and set goals regarding HIV prevention and care which 
can be used throughout their lives.  
 
In the CTR + Relationship Skills session, YMSM will receive all elements of CTR counseling and 
HIV testing with an OraQuick rapid fluid (saliva) test that will be mailed to participants prior to 
the session, and discussion of HIV risks, delivery of test results and post-test counseling. 
Importantly the CTR+ Relationship Skills session will focus on the future: participants will not be 
asked to reveal recent risk behaviors/ exposures. Instead the focus is on the participant learning 
their sero-status and building a prevention plan that reflects their relationship goals and sero-
status. Foundational to this is the participant talking about and forming a prevention plan and 
learning effective communication skills to discuss HIV prevention strategies with their partner. 
Specifically, the session is designed to help YMSM learn and practice communication skills and 
set goals regarding HIV prevention and care which can be used throughout their lives.  
 
Participants (index partners) randomized to the intervention condition and who choose to do 
CTR + Relationships Skills will also be given the option to do invite their partner to complete the 
CHTC + Relationship Skills with them after they complete the individual session. The 
procedures for the second session will follow those of the CHTR + Relationship Skills session 
described above. 
 
5.5 Registration & Randomization (Phase III RCT) 
 
In Phase III, after completing the baseline survey participants will be randomized via DFexplore 
in a 1:1 ratio into the intervention or control condition. In order for interventions to be evaluated 
as potential “best evidence”-based interventions through CDC’s Prevention Synthesis Research 
activity, data must be available for at least a single follow-up time point for at least 70% of 
participants. We will use best practices to retain participants (e.g., comprehensive locator 
information that includes participants' cell phone number, and e-mail), while being sensitive to 
undue disclosure of YMSM participating in the study. Depending on the participants’ 
preferences provided upon registration, contacts will be made initially with the preferred mode of 
re-contact (for example, by SMS text message); if still unresponsive, other available modes 
(e.g., phone call) will be used. The study will use a HIPAA-compliant web-based platform 
entitled Study Management and Retention Toolkit (SMART), which is a SaaS (Software as a 
Service) based mobile application aiding studies with various aspects of participant recruitment, 
study implementation, and retention. SMART is a licensed service of the Center for AIDS 
Research (CFAR) at Emory University, Prevention Science Core.  We will follow YMSM for 9 
months and have contact with them every three months. The small time frames between 
assessments helps us to respond quickly to retention concerns. Incentives for completing the 
baseline and follow-up surveys will be $40 per individual, per assessment. If a participant 
completes all three follow-up surveys, they will receive an additional $40. 
 
For both conditions, participants will be taken to an online calendar asking them to schedule 
their first session. The calendar will be populated by study staff per their availability and will 
reflect local time zones. The page will explain the session format, will provide detailed 
instructions on using the Zoom video-chat software, and will contain a list of instructions for 
participating in the sessions (e.g., audio and visual privacy, etc.). For both conditions, the 

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sessions will be about 45 minutes... Each session will be delivered via Zoom, the HIPAA-
compliant video-chat software that can be used on a PC, tablet or smartphone. 
 
5.6 Control Condition 
 
Participants who are randomized to the control condition will engage in one CTR session 
delivered via Zoom video-counseling. Approximately one week prior to the scheduled session, a 
box containing a home oral fluid HIV-test (OraQuick) kit will be mailed by the study team to the 
address provided by each participant. The participants will be instructed to have the kits with 
them at the time of the scheduled session, but not to use them prior to the session. The CTR 
session will begin by discussing the participants’ perceptions of risk,, delivering the test result, 
and prevention planning, which will be followed by linkage and referrals to local services.  
During the session, the remotely located counselor will instruct the participant on how to self-
test using the home HIV-testing kits mailed to them. The counselor will observe the testing, 
ensure they can read and interpret the results correctly, and prevention planning will be 
centered on the results of the HIV testing. 
 
For both conditions, participants who receive an HIV-positive result will be counseled on the need 
for timely linkage to care. The counselor will arrange a time within 1 week of the initial session to 
conduct a second video session for participants who have preliminary positive results. During this 
session, new preliminary positives will be directly linked to medical care by connecting them with 
a medical care contact in their local area. Study staff will follow-up with them on the next business 
day to ensure that contact was made with a local facility closest to where the participant lives or 
with a medical care agency. The participant would be contacted at least three times: (1) to confirm 
an appointment was scheduled; (2) to confirm the appointment was attended; and (3) to report 
confirmatory results.  
 
6.0 SURVEYS AND COUNSELING SESSIONS 
6.1 Phase II and III Survey Measures 
 
All surveys taken by participants are taken via a secure Alchemer link. During Phase III, this link 
will be distributed to them via SMART. For Phase II and III, our primary outcomes relate to the 
uptake of HIV prevention, conceptualized as self-report condomless sex, HIV testing, STI 
testing and PrEP knowledge, and efficacy and uptake. In addition, we will provide participants 
with kits to self-collect samples that will be mailed back and laboratory tested for STIs (syphilis, 
gonorrhea and chlamydia). The surveys will ask about the following information: 
 
Demographics/Socioeconomic Characteristics:  
• 
Age, race/ethnicity, sexual identity, housing status, history of incarceration, employment 
status, educational attainment, and income level. 
• 
General sex and relationship history, including number of past partners stratified by 
female, male, transgender female, and transgender male partners, sexual intercourse 
with these partners, and length of relationships.  
 
Primary Outcome Measures:  
• 
Powered Outcome: The survey is powered on the 9-item HIV-related dyadic 
communication for men who have sex with men scale 

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• 
Sexual Behaviors: The survey will assess lifetime and past 1- or 3-month sexual 
intercourse, including the type and frequency of these sexual behaviors. 
• 
HIV, STI Testing and PrEP/PEP Use: The survey will contain a detailed description of 
different HIV prevention strategies, specifically HIV testing, STI testing, PrEP, CHTC, 
nPEP. Awareness will be single item measures of whether the participant had heard of 
each of these prevention strategies (binary: yes/no). Willingness will be assessed with 
single item measures that ask whether the participant would be willing to use the 
biomedical prevention strategy if it were available for free (binary: yes/no). History and 
current use will be asked by asking participants their HIV and STI testing history and 
whether they have ever used or are currently using other prevention strategies (i.e., 
CHTC, PrEP, nPEP). For participants that test positive in the CHTC or CTR session, 
they will be asked a series of questions about linkage to care in the 1-month (Phase II) 
and 3-month (Phase III) follow-up survey. These questions include most recent HIV 
care, viral load/CD4 testing, ARV treatment uptake, and future HIV care. 
 
Relationship Dynamic Measures:  
• 
Surveys in this section will assess relationship satisfaction, commitment, experiences of 
relational closeness, and interpersonal violence. 
 
Mechanism of Change Measures:  
• 
In these surveys participants will be asked about risk communication with their partner, 
preferences for sexual health outcomes, any sexual agreements the couple may have 
(including breaking agreements), and general communication.  
 
Psychosocial Measures:  
• 
The survey will assess each participants’ perception of their own HIV risk, perceived 
chances of success in life, anticipated HIV stigma, internalized heterosexism, everyday 
discrimination, family acceptance, sexual identity disclosure, depression and anxiety 
symptoms, and substance use. 
 
Study Satisfaction Measures: 
• 
Participants will be given a series of surveys that assess their satisfaction with the study, 
and give participants an opportunity to provide feedback on the relationship-skills 
session and the CHTC session.  
 
At-Home HIV Testing Survey: 
• 
In Phase III, participants are sent an HIV testing kit immediately after scheduling a 
session. It is possible that some participants who schedule a session will not actually 
complete the session. However, we would still like to know whether they completed the 
at-home HIV testing kit. If a participant is sent an HIV testing kit and does not complete a 
session within 45 days of enrollment, they will be sent a survey through SMART that will 
ask whether they took the test and the test result. 
 
6.2 Phase I In-Depth Interviews (IDI) 
 
Interviews for Phase I will be conducted via VSee, the HIPAA-compliant video-chat software 
that will also be used to deliver the intervention. The IDI will adopt a participatory methods 
approach, in which participants create timelines of their relationships. One way that participants 
can actively guide a qualitative interview process is through the use of activities in which 
participants are given guidelines or instructions by the researcher, but then take control of the 

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activity in a flexible and participant-centered approach. During the proposed IDI, participants will 
create a visual relationship timeline using virtual stickers to develop an overview of their dating 
and sexual history. The IDI follows a step-by-step process with discreet steps where participants 
place stickers on the timeline in response to questions about relationship dynamics, desires and 
communication. To construct the timeline, participants will add non-identifying nicknames for up 
to three “sexual and/or romantic partners” who were “significant or memorable” to the participant 
in some way; participants will define for themselves what “significant or memorable” means. The 
timeline begins with the age of when the participant first met the earliest partner and ended at 
the current age. Lines are added to show when and how long each relationship occurred. 
Participants are given flexibility on how to draw the lines in order to best represent the timeline 
of their relationship history (e.g. participants could choose to use different types of lines to 
represent different parts of the relationship, lines could stop and start again, lines for different 
people could overlap over the same time period). Participants then answer a series of questions 
on each relationship through an action-oriented process that involves participants applying 
stickers with predetermined labels to the timelines. Participants will first use “relationship tag” 
stickers with definition terms (e.g. partner, boyfriend, friends with benefits). Follow-up questions 
examine why terms were chosen, definitions of terms, relationship development and transitions, 
and relationship rules (e.g. monogamous vs. open relationship). Participants then answer the 
question, “How did you feel about this person when you were together?” by adding up to five 
positive and/or negative “emotion tags” for each partner (e.g. trusting, loved, disrespected, not 
myself). The timeline provides an anchor for discussion around relationship communication, 
negotiation and desires. Using the timeline, participants will be asked to define what a 
relationship is, their definition of a successful relationship, and their desires for future 
relationships. Participants will be asked to describe positive and negative experiences they have 
had in communicating within relationships. The IDI will ask participants to outline the 
communication skills they believe they have and the communication skills they desire to have. 
The IDI will end by asking the participants to describe their desired content and quality for a 
relationship-skills focused facilitated session. The goals and suggested outline of the session 
will be described, and participants will be asked to make suggestions for specific content areas. 
 
6.3 Phase I Cognitive Interviews 
 
After we complete the in-depth interviews, we will develop our intervention manual. The 
intervention manual is the counseling protocol which outlines the steps and scripts used for 
delivering the We Prevent condition. Following the intervention manual development, we  enrolled 
a total of 8 YMSM to complete cognitive interviews with a study staff member who is based at the 
University of Michigan via VSee. During these interviews, the study staff member will walk the 
participant through each portion of the intervention manual. Participants will be asked to think 
aloud as they navigate through the intervention. The study staff member will note the participant’s 
behavior and any questions that they have regarding the content and flow; data will be collected 
via a standard cognitive interview notes form. As they navigate through the intervention, 
recordings will be made of any nonverbal behavior that could be important to take into 
consideration (e.g., frowns, sighs, or fidgeting). Recordings will be made of valuable data related 
to how they respond to each module (i.e., How long does it take participants to understand and 
respond to different modules?). These data will be used as exploratory indicators of content 
difficulty, attentiveness, and task-difficulty. After participants have completed the interview, they 
will be asked to reflect on whether the intervention met or exceeded their expectations and their 
HIV prevention and relationship needs. These data will be used to revise content and study 
procedures in preparation for implementation in Phases II and III. Consistent with our recruitment 
goals, we will enroll at least 50% racial/ethnicity minority YMSM (n = 4). 

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6.4 Phase II and III Measures 
 
Demographics/Socioeconomic: Questions related to demographic characteristics were 
developed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 
research program. Characteristics assessed in these questions include age, race, ethnicity, sex 
at birth, gender identity, sexual identity, income, education, employment, living situation, 
incarceration history, and internet access, and technology use.  
General Sex and Relationship History: Questions related to history of relationships and sexual 
intercourse were developed by the Adolescent Medicine Trials Network for HIV/AIDS 
Interventions (ATN). Sex history questions assess age at first sexual intercourse, as well as 
lifetime and 3-month sexual intercourse with females, males, transgender females, and 
transgender males. Questions related to relationship history assess current relationship status, 
how participants identify their current relationship, length of current relationship, and the role of 
online technology in initiation of the current relationship.  
Sexual Behavior and Risk: Sexual behavior and risk will be measured by questionnaires 
developed for and adapted from Project Nexus: Providing Online Counseling for Home-Based 
HIV Testing (Stephenson et al., 2017) and Project Stronger Together: A Dyadic Intervention to 
Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US Cities 
(Stephenson et al., 2017). These questions focus on frequency of anal sex, condom use during 
anal sex, anal sex and condom use with outside partners.  
 
HIV, STI Testing, and PrEP/PEP Use: HIV, STI Testing, and PrEP/PEP Use will be measured by 
questions adapted from the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 
research program and Project Moxie: Providing Home-Based HIV Testing and Counseling for 
Transgender Youth (Stephenson et al., 2017). The baseline survey will include questions on 
lifetime HIV testing history. Follow-up surveys will repeat the questions from the baseline, and will 
also include questions on HIV testing in each 1- or 3-month period including test results. For 
Phase III, the HIV testing outcome will be: the proportion of YMSM tested for HIV 2 or more times 
at least 3 months apart in the 9-month follow-up period (“frequent tester”). As an additional 
analysis, we will also examine the proportions of participants who receive one HIV test.  
 
The STI testing outcome is defined as the proportion of YMSM tested for STIs at least once in the 
follow-up period. At baseline, we will assess lifetime STI testing history and knowledge about 
STIs. We will ask participants what STIs they have been tested for, the date of their most recent 
STI test (if known), and whether a medical provider had diagnosed them with an STI. In the follow-
up surveys, we will ask participants whether they had been tested for STIs in the past 1 or 3 
months, and if so we will ask them to indicate what tests they had received and whether they had 
been diagnosed with an STI by their medical provider. For Phase II, participants will receive at-
home STI test kits at baseline only. For Phase III, participants will receive at-home STI test kits at 
baseline and 6-month time points. The box contains instructions on how to collect the samples 
and how to mail them back to the study site. The samples will be laboratory tested for syphilis, 
gonorrhea, and chlamydia. We will measure the incidence of any STI in the follow-up period. 
 

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PrEP awareness will be a single item measure of whether the participant has heard of PrEP. At 
each follow-up assessment, PrEP-eligible HIV-negative YMSM will be asked whether they have 
begun using PrEP, and self-reported adherence to PrEP will be assessed at each follow-up.  
 
Relationship Dynamic Measures: The relationship satisfaction measure will assess satisfaction 
with current relationship. Questions about partner’s ability to provide support and companionship 
will be asked. Participants will also be asked questions about commitment, relational closeness, 
and interpersonal violence. These questionnaires will center on partner’s fulfillment of intimacy 
needs, desire to have alternative relationships, and experiences of sexual, physical, or emotional 
violence. These measures will total to 45 questions.  
 
Mechanisms of Change: These measures will include questions about communication between 
partners about sex and condom use, as well as questions about existing sexual agreements. 
Participant’s attitude toward existing sexual agreements, such as commitment to the agreement 
and breaking of the agreement will also be assessed. 
 
Psychosocial Measures: These measures will include questions HIV risk perception and 
anticipated stigma, and perceived changes of success in life. We will also assess experiences of 
stigma with questions about internalized heterosexism, everyday discrimination, family 
acceptance, and sexual identity disclosure. Depression, anxiety, and substance use will also be 
assessed in this section.  
 
 
Linkage to HIV Care: For any incident HIV-positive individuals, we will also collect the following 
outcomes as indicators of linkage to care, per the recent recommendations of the Institute of 
Medicine [48]. These are measured within three months of HIV diagnosis via self-report [49], [50]: 
(1) attending at least one clinical care appointment, (2) having at least one CD4 test performed, 
and (3) having at least one viral load test performed. Onset of ART initiation, self-reported 
adherence to ART, and viral suppression are exploratory indicators, as we recognize that our 
follow-up period may not be a sufficient amount of time to see these changes. We will obtain 
guidance from the ATN on the feasibility of collecting biomarkers of viral suppression and conduct 
medical chart reviews for youth who are newly diagnosed. 
 
Feasibility: In addition to the outcomes, the study will assess feasibility by examining (1) time to 
recruit YMSM to the intervention in both Phase II and III, and (2) rate of recruitment of YMSM 
expressing interest in participation. Acceptability of the intervention will be determined by analysis 
of data from a satisfaction survey on the intervention’s acceptability. In addition, the percentages 
of YMSM who do not complete the either of the intervention sessions will be assessed. Adequate 
feasibility will entail recruiting and enrolling at least 5-6 YMSM and their partners per month and 
ensuring at least 80-90% retention rate. 
 
6.5 Phase II Relationship-Skills Session 
 
After completing the baseline survey, participants will have four weeks to schedule their 
relationship-skills session. This session will be conducted via Zoom, the HIPAA-compliant 
video-chat software that will be used to deliver the two sessions for Phases II and III. The 
counselor will begin the session by introducing themselves, discussing confidentiality, and 
obtaining verbal consent from both participants. The relationship-skills session focuses on 
defining health and unhealthy characteristics of relationships, teaching and practicing effective 
communication skills, reviewing couples-based sexual health information (i.e., negotiated safety, 

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PrEP, HIV, and STI testing), and preparing for engaging in CHTC as a couple. The counselor 
will employ Motivational Interviewing (MI) strategies and style to elicit positive commination from 
each partner by: 1) asking questions about each partner’ strengths, 2) asking about each 
partners’ hopefulness for change, and 3) seeking to increase respectful, supportive interaction 
with the couple. 
 
Satisfaction survey: Within one week of the relationship-skills session, each member of the couple 
will receive an email asking them to complete a short satisfaction survey: the survey will include 
questions regarding satisfaction with logistics (i.e., length of session), content of session, and 
reactions to the session process (i.e. ease, comfort), in addition to willingness to utilize 
relationship skills sessions in the future.  
 
 
6.6 Phase II and III CHTC and CTR Session 
 
In Phase II, after participants complete the relationship-skills session, they will schedule their 
Couples HIV Testing and Counseling (CHTC) session. The session will be conducted via the 
HIPAA-compliant Zoom video-chat software. The test kit package containing oral fluid tests 
(OraQuick) will be mailed to the couple’s residence. Couples in long distance relationships or that 
have separate living arrangements will be sent their test kits separately. Couples will be informed 
to have their HIV testing kits present. The session will be conducted by a counselor who is trained 
in CHTC and will last approximately 45 minutes. Both members will conduct their own test and 
read their own results – together – as directed by the counselor. Participants will be asked to 
show the counselor their test result for confirmation of reading accuracy. Post-test counseling will 
focus on dyadic prevention messages, and will revisit the couple’s HIV risk concerns and sexual 
agreements in light of their test results. The counselor will record the couple’s HIV test results in 
the admin portal. The goal of the CHTC session is to facilitate the couple in thinking critically about 
the management of HIV in their relationship and to guide them in making a prevention plan – 
together – that best suits their relationship needs, context, and risks. It is easy to imagine that 
when a positive result is given that the CHTC session may devolve into a support session for the 
new positive. We have trained our counselors to keep focusing on the dyad in this situation, and 
while a focus on the immediate needs of the positive is required, the discussion remains focused 
on how the couple can work together to keep the positive partner healthy and to reduce 
transmission risks within the relationship while also meeting both partner of the couples’ needs.  
  
For preliminary positive results for either partner, at the end of the video CHTC session, the couple 
will be counseled on the need for timely linkage to care. Within 48 hours, the counselor will then 
send a confidential email to the participant(s) individually providing the contact information for 
providers in their area who can provide confirmatory testing and linkage to care. Then within 1 
week of the CHTC session, study staff will follow up with the participant(s) over the phone or 
Zoom to see if an appointment was made. If not, staff will urge participants to make an 
appointment as soon as they can and will emphasize the importance of confirmatory testing and 
linkage to care. Study staff will then follow up within 1 month of the CHTC session and 3 months 
to (1) confirm an appointment was scheduled, 2) to confirm the appointment was attended, 3) to 
report confirmatory results, and 4) assess linkage to care. 
 
Satisfaction survey: Within one week of the CHTC session, each member of the couple will 
receive an email asking them to complete a short satisfaction survey: the survey will include 
questions regarding satisfaction with the home testing process, logistics (i.e., length of session), 

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content of session, and reactions to testing process (i.e. ease, comfort), in addition to willingness 
to utilize CHTC in the future.  
 
In Phase III, the intervention-arm index partner will schedule their CHTC + Relationship Skills 
session (with their partner) or their CTR + Relationship Skills session (on their own). The session 
will be conducted via the HIPAA-compliant Zoom video-chat software. The test kit package 
containing oral fluid tests (OraQuick) will be mailed to the participant’s residence of choice. 
Participants who chose to do CHTC + Relationship Skills and are in long distance relationships 
or have separate living arrangements from their partner will be sent their test kits separately. All 
participants will be informed to have their HIV testing kits present. The session will be conducted 
by a counselor who is trained in CHTC and CTR. Sessions will last approximately 45 minutes. In 
the CHTC + Relationship Skills session, both members of the couple will conduct their own test 
and read their own results – together – as directed by the counselor. In the CTR + Relationship 
Skills session, the participant will conduct their own test and read their results as directed by the 
counselor. Participants will be asked to show the counselor their test result for confirmation of 
reading accuracy. Post-test counseling will focus on dyadic prevention messages and will revisit 
the couple HIV risk concerns and sexual agreements in light of their test results. The counselor 
will record each participant’s HIV test results in the SMART admin portal. The goal of both CHTC 
+ Relationship Skills session and CTR + Relationship Skills session is to facilitate the participant 
in thinking critically about the management of HIV in their relationship and to guide them in making 
a prevention plan that best suits their relationship needs, context, and risks. It is easy to imagine 
that when a positive result is given that the CHTC + Relationship Skills session may devolve into 
a support session for the new positive. We have trained our counselors to keep focusing on the 
dyad in this situation, and while a focus on the immediate needs of the positive is required, the 
discussion remains focused on how the couple can work together to keep the positive partner 
healthy and to reduce transmission risks within the relationship while also meeting both partner 
of the couples’ needs.  
  
For preliminary positive results for any participant, at the end of the video CHTC + Relationship 
Skills or CTR + Relationship Skills session, the participant will be counseled on the need for timely 
linkage to care. Within 48 hours, the counselor will then send a confidential email to the 
participant(s) individually providing the contact information for providers in their area who can 
provide confirmatory testing and linkage to care. Then within 1 week of the session, study staff 
will follow up with the participant(s) over the phone or Zoom to see if an appointment was made. 
If not, staff will urge participants to make an appointment as soon as they can and will emphasize 
the importance of confirmatory testing and linkage to care. Study staff will then follow up within 1 
month of the session and 3 months to (1) confirm an appointment was scheduled, 2) to confirm 
the appointment was attended, 3) to report confirmatory results, and 4) assess linkage to care. 
 
Satisfaction survey: Within one week of the CHTC + Relationship Skills or CTR + Relationship 
Skills session, each participant will receive an email asking them to complete a short satisfaction 
survey: the survey will include questions regarding satisfaction with the home testing process, 
logistics (i.e., length of session), content of session, and reactions to testing process (i.e. ease, 
comfort), in addition to willingness to utilize the intervention in the future. If the participant’s partner 
also took part in the session, they are also sent a satisfaction survey. 
 
6.7 Phase II Exit Interview 
 
A select number of participants (n=6) will be asked to participate in an exit interview following 
completion of the 1-month follow up survey. Exit interviews will be conducted with study staff 
members via Zoom, the HIPAA-compliant video chat software that is also being used to deliver 

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the intervention sessions. During these interviews, participants will be asked about their 
experience in Phase II of the research study. They will be asked what they liked and didn’t like 
about the study (e.g., intervention content, STI testing, advertising), and how, if at all, the study 
can be improved. These data will be used to revise the intervention content and study procedures 
in preparation for implementation of the RCT in Phase III. Consistent with our recruitment goals, 
we will ensure that exit interviews will include at least 50% racial/ethnic minority participants. 
 
6.8 Phase III Exit Interview 
 
A purposeful subset of participants (n=30) will be asked to participate in an exit interview following 
completion of the 9-month follow up survey. We would like to capture a range of experiences in 
the research study, so the purposeful sample will include up to 36 participants: those who 
participated alone (n=10-12), those who participated with their partner (n=10-12), and those who 
enrolled into the study and did not participate at all (n=10-12). Exit interviews will be conducted 
with study staff via Zoom, the HIPAA-compliant video chat software that is being used to deliver 
all video-chat sessions. During these interviews, participants will be asked about their experience 
in Phase III of the research study. They will be asked what they liked and didn’t like about the 
study (e.g. session content, surveys, STI testing, messaging), and how, if at all, the study can be 
improved. These interviews will be audio-recorded, transcribed, and analyzed to inform future 
individual or dyadic interventions for partnered YMSM. Consistent with our recruitment goals, we 
will ensure that exit interviews will include at least 50% racial/ethnic minority participants.  
 
7.0 TECHNICAL EXPERTS 
Seven Technical Experts were recruited for Task 2, consisting of members who engage with 
youth and diverse communities of YMSM, and have specific experience in the provision of HIV 
and LGBTQ clinical and social services. After modifying the intervention content, we l emailed 
TEG members to schedule a meeting to: (1) review the intervention content and training 
protocols for the two counseling sessions; and 2) explore existing screening and assessment 
tools that are culturally and linguistically appropriate for use with diverse groups of YMSM and 
their partners. VSee video-chat was used for TEG meeting, which focused on discussing the 
adaptation of intervention assessments and content, and developing or providing feedback 
associated with the counseling components of the intervention. Individuals identified as 
Technical Experts were offered a $200 gift card after participating in the virtual meeting.  All 
VSee interviews will be audio-recorded; however, TEG members will have the opportunity to opt 
out of audio-recording. 
 
8.0 DATA COLLECTION  
8.1 Development of Protocol and Case Report Forms 
 
The Protocol Team, in collaboration with the Management Core and Analytic Core, is 
responsible for the development of this protocol as well as the Case Report Forms (CRFs) 
needed to collect the information required to implement this protocol.  
 

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8.2 Data Records 
 
Participant-related study information will be identified through a study ID number (SID), a couple 
ID, and participant code (participant first initial and two-digit day of birth) on all participant CRFs, 
audio files, transcripts, and Alchemer surveys. Participant names or other personally-identifying 
information will not be used on any study documents and will be redacted from interview 
transcripts. All printed study-related information will be kept in double-locked, limited access at 
the University of Michigan study site. Original source documents for individual participants will 
be maintained at the University of Michigan study site and will be accessible only to the study 
staff.  
 
8.3 CRFs 
Study monitoring data, including information about enrollment, verification, survey/ session 
completion, and monitoring untoward effects, will be collected on electronic CRFs.   
 
8.4 Self-Administered Surveys 
 
All quantitative survey data will be collected using Alchemer. Data will remain confidential; no 
personal identifying information will be collected in the survey. The participant’s unique SID# will 
be used in order to link their responses to the participant’s qualitative data. The surveys will be 
completed by participants on personal devices via surveys hosted by Alchemer. To ensure data 
privacy, as soon as data is entered (in real-time), it will be encrypted during transmission to the 
AC using Secure Socket Layer (SSL) technology. The data will then be stored in a secure 
database on an AC server within the AC data center. 
 
The survey data collected through Alchemer utilizes Amazon Web Services servers for hosting, 
located in controlled data center facilities in Boulder, Colorado. We clean, manage, and 
download the survey data directly from the Alchemer application interface. The survey data 
collected through Alchemer is encrypted while in transfer using SSL certificates, encrypted at 
the disk level in the Amazon Web Services database servers, and encrypted at the row level. 
Access to the Alchemer account where the data can be downloaded is password-protected with 
a sufficiently complex password.  
8.5 At-home STI Testing 
 
At baseline (Phase II and III), study staff will mail participants an at-home STI test kit. For Phase 
III, STI kits will also be sent at 6-month follow up. STI kits for Phase II were opt-in, whereas STI 
kits for Phase III will be opt-out. STI test kits and condom packages are provided as a service 
through the iTech Technology Core and will be packaged and branded specifically for this 
project. STI home collection CareKits (for gonorrhea, chlamydia, and syphilis) will include a pre-
paid mailer to be returned to Emory University Clinical Virology Research Laboratory for testing. 
These kits have been used in an ongoing RCT of “Keep It Up”, for which U19 co-PI, Dr. Patrick 
Sullivan is the Atlanta site PI, and they have been acceptable to the young (18-29 year old) men 
in that study. The We Prevent study team will follow the STI CareKit, Condom and Lubricant 
Ordering Standard Operating Procedures developed by the CareKit team at Emory. The 
participant shipping addresses will be transferred to the Emory team through Box or Microsoft 
OneDrive via a password protected spreadsheet. Participants will be notified individually of their 
testing results via phone call from study staff. Participants that test positive for any STI will be 
referred to treatment services in their area from the resource sheet included in this application. 

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Due to COVID-19, the Emory University Clinical Virology Research Laboratory is no longer able 
to process at-home STI kits. Starting in June 2020, STI test kits will be assembled, shipped, and 
processed by a CLIA-certified laboratory, Molecular Testing Lab (MTL). MTL is a Centers for 
Medicare and Medicaid Services designated “covered entity” sworn to uphold all HIPAA 
considerations. Use of encryption is required on applicable communications, and Laboratory 
Information System (LIS) access if protected per HIPAA standards. Test kits will include written 
instructions for each sample to be collected, specimen collection materials, and a pre-paid 
mailer to return samples. Participants will be asked to register their test kit by creating an 
account on MTL’s secure online LIS portal, which can also be used to view their results report 
when available. Study staff will continue to call participants to make sure that they understand 
their results. MTL reports all positive test results to necessary health departments.   
 
 
8.6 VSee Platform Description  
 
When using VSee, participants will have the option to use VSee in several formats: face-to-face 
video chat, video chat in which they can see the interviewer (Phase I) or counselor (Phase II 
and III) but the interviewer cannot see them, audio chat only, or a text-based conversation. The 
consent form for this research project will include a full description of VSee, their options for 
using VSee, and will also make it clear what they can opt not to do. VSee is compatible on PCs, 
tablets, and smartphones. Unlike other video-chat platforms (e.g. Skype), VSee is HIPAA-
compliant. VSee includes the following functions to protect users: 
 
End-to-end encryption without a man-in-the-middle listener. In WebEx, Vidyo, Tandberg, and 
Polycom architectures, media is sent to a server (also called a video relay or MCU). Although 
encryption is applied from the user’s computer to these servers, the servers still have full access 
to the user’s media. In contrast, VSee uses end-to-end encryption where no server, including 
VSee servers, has the decryption key. VSee uses public/private RSA keys to exchange a 256-
bit AES session key with the property that only the endpoints have the AES session key. VSee 
uses FIPS 140-2 certified 256-bit AES encryption. 
 
One port. VSee uses a single port for call signaling and media. The VSee protocol is structured 
so that only the outgoing port needs to be open because return traffic is always structured as 
responses to outgoing traffic. This allows administrators to set a policy where if users inside 
their network are using VSee, then their firewall lets VSee traffic securely cross the firewall; 
however, if users inside their firewall stop using VSee, then the firewall will block external port 
scans. 
 
Automatic HTTP/SSL tunneling. VSee prefers to use UDP (User Datagram Protocol) since it 
allows higher performance video. However, if the firewall does not allow UDP, VSee will 
automatically switch to HTTP/SSL tunneling. 
 
Cloud Control. VSee's cloud solution allows enterprises to maintain central control of their 
security policies to a large number of end points even though the service is hosted by VSee. It 
does this by having VSee clients always connect first to VSee servers in the cloud, where the 
policies are controlled. The cloud servers determine whether any of these security policies 
should be applied and enforces them as the VSee client. This allows us to set our own security 
settings and to record the sessions. 
 

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No-install client. Video conferencing software clients tend to be large and to leave a big footprint 
on the user’s system. Almost all of them require administrator permissions to install. Once the 
client software gains administrator permissions, they can severely compromise computer 
security. VSee is a lightweight client that does not require administrator permissions or 
installation.  
 
8.7 Zoom Platform Description 
 
Zoom may also be used to conduct the study sessions. Participants will have the option to 
conduct face-to-face video chat, video chat in which they can see the interviewer, but the 
interviewer cannot see them, or audio chat only. Zoom is compatible on PCs, tablets, and 
smartphones; as well as maintains the option to conduct an audio conference without the video 
component. The consent form for this research project will include a full description of Zoom, 
their options for using Zoom, and will also make it clear what they can opt not to do. Unlike other 
video-chat platforms (e.g. Skype), Zoom is HIPAA-compliant. Zoom includes the following 
functions to protect users: 
  
End-to-end encryption. Zoom encrypts all presentation content at the application layer using the 
Advanced Encryption Standard (AES) 256-bit algorithm. Zoom end-to-end (E2E) chat 
encryption allows for a secured communication where only the intended recipient can read the 
secured message. Zoom uses public and private keys to encrypt the chat session with Advance 
Encryption Standard (AES256), and session keys are generated with device unique hardware 
ID to avoid data being read from other devices. This ensures that the session cannot be 
eavesdropped or tampered with. 
  
Cloud Control Infrastructure. A distributed network of low-latency multimedia routers (software) 
resides on Zoom’s communications infrastructure. With these low-latency multimedia routers, all 
session data originating from the host’s device and arriving at the participants’ devices is 
dynamically switched — never stored persistently through the Zoom communications 
infrastructure. Zoom’s communications infrastructure for real-time video, audio, and data 
communications resides on Zoom dedicated servers, which are housed in SSAE 16 SOC2 
compliant datacenters on opposite sides of the US. Zoom sessions are completely temporary 
and operate analogously to the popular mobile conversation over the public mobile network. In 
addition to unique security beneﬁts, Zoom’s communications infrastructure also enables an 
extremely scalable and highly available meeting infrastructure unrestricted by the limitations of 
physical data centers. 
  
The Zoom client communicates with the multimedia router to establish a reliable and secure 
connection. At the time of instantiation, the Zoom client will determine the best method for 
communication, attempting to connect automatically using udp and tcp port 8801, 8802 and 
8804 or HTTPS (port 443/TLS). 
  
Additionally, Emory University has entered into a BAA with Zoom, where Zoom agrees to be 
responsible for keeping all patient information secure and report any breaches of protected 
health information (PHI). 
 
8.8 Data Management 
 

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8.8.1 CRFs 
Although the iTech projects will involve substantial online follow-up, CRFs will be used to collect 
key study visit data (e.g., enrollment and randomization assignment), study milestones such as 
completion or discontinuation, study laboratory results, and adverse events (AE). AC staff will 
work with study investigators and the MC to develop and design the CRFs. During study 
conduct, the SRVs will maintain the CRFs in secured locations, and transmit CRF data to the 
AC either electronically using DFexplore or by submitting scanned paper forms using DFSend. 
DFexplore and its DFdiscover platform is a leading multi-site database environment for HIV 
RCT that can receive and transcribe CRF data via scanned PDFs, or allow for direct electronic 
data entry. It provides for monitoring form completion and data quality, and a system for data 
querying and resolution with SRVs, while maintaining an audit trail. The AC uses DFexplore for 
MSM studies and RCTs and data is maintained by the parent company DF/net on a cloud-
based server with Microsoft Azure.  
 
 
8.8.2 Audiotape Data 
In-depth Interviews (IDIs), cognitive interviews, relationship skills sessions, CHTC sessions, 
CTR sessions and exit interviews will all be audio-recorded to allow for verbatim transcription of 
the interview, and checked for accuracy and completion. All audio files will be kept confidential 
and stored in a locked/limited access folder on secured servers, which is only accessible to 
designated study staff. All members of the research team will be trained in confidentiality and 
have signed confidentiality agreements. We will format all transcripts and import them into 
qualitative data analysis software. Data analysis will be primarily conducted by Drs. Stephenson 
and Gamarel, and will also involve ATN members from the Analytic Core when appropriate. One 
year after the study is over, the audio recordings will be destroyed. 
 
8.8.3 Self-Administered Survey Data Transmission 
The data will routinely be downloaded and stored in a secure database on an AC server within 
the AC data center. 
 
8.9 Data Quality Assurance 
 
Investigators receiving federal funding must adhere to the Code of Federal Regulations (CFR) 
to protect research participants and produce reliable study information. The iTech AC will 
monitor data entry and will have an internal quality assurance plan that will identify problems 
and correct errors in research study records. 
 
8.10 Study Site Monitoring and Record Availability 
 
Site monitors from the MC may visit the University of Michigan to review a selected portion of 
the individual participant records, including assent/consent forms and supporting source 
documentation to ensure the protection of study participants, compliance with the protocol, and 
accuracy and completeness of records. Regulatory files, as required, will also be inspected to 
ensure that regulatory requirements are being followed. 
 
The principal investigators will make study documents (e.g., assent/consent forms) readily 
available for inspection by the local IRB, the central IRB, the site monitors, the NICHD, the 

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Office for Human Research Protections (OHRP), or the sponsor’s designee for confirmation of 
the study data. 
 
9.0 PARTICIPANT MANAGEMENT 
9.1 Tracking Participants 
All participants will be contacted before their scheduled in-depth qualitative interview and 
cognitive interviews (Phase I) and assessment and counseling sessions (Phase II and III). 
Participants will be asked whether or not messages can be left for each of the phone numbers 
that they provide. They will be informed that messages will not contain any information 
regarding the nature of the project. 
 
As described above, the study will use a HIPAA-compliant web-based platform entitled Study 
Management and Retention Toolkit (SMART), which is a SaaS (Software as a Service) based 
mobile application aiding studies with various aspects of participant recruitment, study 
implementation, and retention. The application has the ability to securely manage participant 
information across multiple studies and customers simultaneously, stratifying participant 
information by study and site. SMART includes an admin web portal and a participant facing 
mobile app (optional), which allows for secure messaging, study calendar management, self-
scheduling by participants, secure photo uploads, and longitudinal tracking of participants from 
screening to study completion. The ability to designate specific roles to all SMART users allows 
for greater control around permissions and accessibility to participant information. Users can 
even be limited to a reporting only role, which allows for study oversight through real time 
aggregate reporting, but no access to PHI. SMART is a licensed service of the Center for AIDS 
Research (CFAR) at Emory University, Prevention Science Core. Utilization of the mobile app is 
optional and the admin web portal will fully function without it. 
 
The following information outlines the security of the admin web portal. The admin web portal is 
a web-based application developed using Microsoft .NET technologies. It uses SQL server as 
backend database. The application requires two servers to host: (1) Web server [Windows 
server with IIS] and (2) SQL server [Standard or Enterprise version]. Both these servers are to 
be placed behind a firewall. Web server will have a public IP to access the server using VPN. 
SSL certificate is to be installed on the web server. The admin website will be rendered over 
SSL (https). The application uses form authentication (no integrated authentication such as AD). 
All passwords are stored encrypted within the database. System will also be using database 
level encryption, which will prevent any copying of information from one database to another. 
Web application also uses an automatic logout feature after a certain period of inactivity. By 
default, the inactivity duration is set to three minutes. 
 
Study staff can only first gain access to the admin web portal if granted by a study or site 
administrator. Their assigned user role will determine their permissions to perform different 
actions and even view PHI. Email notifications are sent from the system (without the need to 
login) when: (1) a staff member requests to reset their password, (2) role assignments to a 
study are made, (3) an event/visit staff are scheduled to work is nearing, (4) a new task is 
assigned to a staff member, or (5) they are designated as a staff member to receive alerts of 
positive test results. All participant communications are performed using secure messaging 
through the message center (inbox) implementation within the mobile app. If the mobile app is 
not utilized by a study, communications are sent as standard email or text messages to 
participants. 
 

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9.2 Compensation 
Phase I participants will receive $40 for completing the brief online survey and in-depth 
qualitative interview. Participants who complete the brief online survey and the cognitive 
interviews will also receive $40. Phase II participants will receive $40 for completing the 
baseline, $50 for the follow-up assessment, and $20 if they are selected to participate in an exit 
interview. Phase III participants will receive $40 for each survey they complete, including the 
Baseline and all Follow-up surveys (3, 6, and 9 months). If a participant completes all three 
follow up surveys, they will receive an additional $40. Invited partners will receive $20 for 
completion of the brief survey. Participants that are selected to complete an exit interview will 
receive $50.This is the standard compensation used by Dr. Stephenson in his ongoing YMSM 
studies. 
 
 
9.3 Intervening on “Social Harms" 
The University of Michigan has specific policies governing the treatment of human participants. 
These policies specify that medical and psychological assistance will be available in the 
immediate environment in the event a participant should experience any adverse reactions 
resulting from study procedures. 
 
While participants will be informed that they may refuse to answer any question at any time, 
responses or reactions to certain questions may indicate distress on the part of the participants. 
If at any time during the study, a participant divulges that he is at risk for harm, including but not 
limited to being abused or experiencing violence, if harm is suspected or likely, or if the 
participant states he is suicidal/homicidal, measures will be taken to ensure his or her safety. 
Reporting will be done as appropriate to the situation and the legal statutes, including reporting 
to child protection agencies or other appropriate agencies and referrals will be provided to 
appropriate support, counseling, or treatment resources. 
 
9.4 Criteria for Premature Study Discontinuation 
For the primary objective, participants will be prematurely discontinued from the study if any of 
the following occurs: 
9.4.1 The participant withdraws consent/assent (see below); 
9.4.2 The study is cancelled by the NIH (or iTech, or other administrative entity); 
9.4.3 The study is cancelled for other administrative reasons; 
9.4.4. The participant becomes incarcerated or placed in detention during the study; or 
9.4.5 Death of the participant. 
 
Participants may end their participation in the study at any time. Participants who experience 
distress during the survey can access our list of community referrals, which can be viewed on 
our study's website, or contact the research staff using the information provided to the 
participant within the consent/assent process. Any unexpected adverse events will be 
immediately reported to the UNC IRB as per the UNC IRB’s reporting requirements, and all 
study activities will halt pending UNC IRB review and recommendations if necessary. If a 
participant withdraws from the research, all data collected in the interview will be immediately 
destroyed and will not be used in subsequent analysis. 
 
If a participant withdraws or is removed from the study, the Study Stop CRF will be completed. 
 

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10. MONITORING UNTOWARD EFFECTS ASSOCIATED WITH OR RESULTING 
FROM THE STUDY 
 
For each phase of the project, untoward effects are those related to the participant. The study 
will catalogue any untoward effect related to the participant. Reporting is required for 
occurrences including social harms, psychological distress, and serious life-threatening events 
such as suicide attempts. These may be immediately apparent to the study staff, such as the 
participant’s emotional upset state requiring referral for counseling; or they may be delayed and 
reported later to study staff, such as physical harm to an individual for having participated in the 
study. Study staff will notify the team of these untoward effects using the iTech QNS accessible 
through the iTech website (https://itechnetwork.org). Study staff will be briefed during the 
training on the scope of possible untoward effects and instructed to report events. 
 
 
11. Phase I DATA ANALYSIS 
 
Qualitative data collection and analysis will be conducted in collaboration with the ATN analytic 
cores, using framework analysis,38 which is systematic and dynamic in its approach to qualitative 
data, resulting in the ability to produce accessible analyses focused on specific research 
questions. The thematic framework will be refined for coding by reading and re-reading the data, 
identifying themes that emerge, and writing analytical memos about those themes. Next, specific 
sections will be identified that corresponded to particular themes. Finally, we will refine the 
relationship between indexed data and the original thematic framework, interpreting the resulting 
themes. Reliability amongst the coders will be checked by having each coder code a subset of 
transcripts with acceptable agreement be ≥90% reliability. Disagreements will be resolved through 
discussion. This analysis will involve identifying and summarizing patterns of experiences related 
to manual content. Analysis will involve identifying how to improve the intervention. The study 
team will review analysis of qualitative data, and assess the strengths and weakness of the each 
of the components of the manual based on the findings. The research team will meet with TEG 
to share results and discuss how best to improve the intervention modules, exercises, and 
process. The survey data collected prior to the interviews will be used to describe the 
demographic, socio-economic and behavioral characteristics of the sample, to contextualize the 
qualitative data. 
 
11.1. Phase II DATA ANALYSIS 
 
The primary purpose of Phase II is to examine the feasibility of the We Prevent intervention to 
prepare for the RCT in Phase III. Phase II will include the following forms of data: self-reported 
data through Survey Gizmo questionnaires (baseline and 1 month), STI test results at baseline, 
and intervention acceptability (through satisfaction surveys and exit interviews). The analysis for 
Phase II will focus on the following domains: 
1. Feasibility, acceptability and safety is assessed through several data points. Data from 
the participant satisfaction surveys will provide measures of participant acceptability (of 
the intervention and each of its components), willingness to recommend the intervention 
to peers, and willingness to take part in the intervention in the future. CRFs detailing the 

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content of intervention sessions will provide information on issues of safety that may 
occur during the sessions. 
2. Logistics: process data will be monitored to examine recruitment and enrollment (data on 
number of clicks on advertisements, numbers creating accounts, rate of progression 
from account creation to eligibility, to consent, to enrollment). Process data will monitor 
the number of participants for whom successful partner matches are made, the numbers 
who order STI kits, provide a valid address for delivery and return samples for testing. 
Data will also capture the numbers completing surveys at baseline and three months 
and the numbers scheduling and attending each of the intervention sessions.  
Impact: unpowered analysis will examine trends from the survey data and STI testing on STI 
incidence, engagement in HIV prevention behaviors, and couples’ communication around HIV 
prevention. 
11.2 Phase III DATA ANALYSIS 
 
We will examine differences between the treatment groups for the index participants using t-
tests or Wilcoxon rank sum tests for continuous variables and chi-square tests for categorical 
variables. We will conduct analyses of our primary HIV and STI testing behavior outcome using 
regression analyses to compare each active treatment group to the control in pairwise 
comparison tests at an adjusted significance level of 0.017 to reduce Type-I errors in our 2-arm 
trial. The proportion of index participants who obtain at least 2 tests at least 3 months apart 
within the follow-up period will be calculated and presented with corresponding 95% exact 
binomial confidence intervals. The regression will be run with group assignment only in the 
model, as well as, controlling for participant characteristics, with a focus on understanding the 
role of reported relationship dynamics and mechanisms of change (i.e., information, motivation, 
and behavior) in mediating the outcome. The ability of the intervention to yield increase in PrEP 
knowledge and efficacy over time will be examined using two separate outcomes. Scores at 
baseline and all follow-ups will be analyzed using generalized linear models (GLM) with 
properly-chosen (based on the distribution of dependent variable) link functions to analyze 
longitudinal PrEP outcome data. The GLMs will be estimated using generalized estimating 
equations with robust standard error estimates (GEE), which provide an extension of regression 
analysis to the case of correlated or repeated observations with appropriate modeling of the 
covariance structure. Models will control for demographic characteristics and study arm and will 
explore interactions between treatment arm and individual characteristics. The incidence of at-
risk sex acts will be calculated as an incidence density, with the numerator being number of 
individual at risk sex acts, and the denominator being person-years of follow time. Comparisons 
of the incidence of at-risk sex acts and incidence of STIs will be made by comparing incidence 
densities across the arms. Period incidence rates (3-monthly incidence density rates) of at-risk 
sex will be estimated by performing a generalized estimating equations (GEE) Poisson 
regression analysis of the 3 monthly counts, implemented using SAS PROC GENMOD/ GEE 
models will control for demographic characteristics, baseline HIV testing history and relationship 
dynamics and hypothesized mediators, and examine interactions between relationship 
dynamics and sexual risk-taking.  Analysis will also consider differences in changes in 
information, motivation, and behavioral skills in accordance with the RELO-IMB model. 
 
Qualitative data from the exit interviews and will be conducted in collaboration with the ATN 
analytic cores, using framework analysis,38 which is systematic and dynamic in its approach to 
qualitative data, resulting in the ability to produce accessible analyses focused on specific 
research questions. The thematic framework will be refined for coding by reading and re-reading 

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the data, identifying themes that emerge, and writing analytical memos about those themes. 
Next, specific sections will be identified that corresponded to particular themes. Finally, we will 
refine the relationship between indexed data and the original thematic framework, interpreting 
the resulting themes. Reliability amongst the coders will be checked by having each coder code 
a subset of transcripts with acceptable agreement be ≥90% reliability. Disagreements will be 
resolved through discussion. This analysis will involve identifying and summarizing patterns of 
experiences related to participation in the RCT. Analysis will involve identifying how to improve 
the intervention and provide recommendations for future studies. The study team will review 
analysis of qualitative data, and assess the strengths and weakness of the each of the 
components of the intervention based on the findings. 
12. HUMAN SUBJECTS 
 
This study will be conducted in compliance with the protocol, ICH Good Clinical Practice 
guidelines, and 45 CFR Part 46. 
 
12.1 Participants’ Confidentiality 
All questionnaires, reports, transcripts, and other records will be identified by a study ID and 
participant code to maintain participant confidentiality. All records with personally-identifying 
information will be kept in a locked file cabinet in a limited secure access area at the University 
of Michigan site. 
 
All computer entry and networking programs will be done with coded numbers only. Clinical 
information will not be released without written permission of the participant, except as 
necessary for monitoring by the MC or NICHD. 
 
Every effort will be made to ensure that study participants are protected from risks. The main 
risk specific to the role of the Analytic Core is breach of confidentiality. 
 
Breach of Confidentiality: A potential risk to participants is violation of confidentiality. We will 
take the utmost caution to protect the confidentiality of all responses. We will minimize this risk 
by maintaining confidentiality and discretion throughout all iTech research procedures and data 
management and analysis. 
 
Participants may be concerned about the security of their data, particularly since it is collected 
and stored electronically. The Analytic Core has significant experience developing security 
protocols for Internet-based studies, and we will take a variety of steps to ensure participant 
security, including using a dedicated server behind a firewall, encryption of data, separation of 
identifiers from responses, and password-protected access to data. Therefore, we believe that 
this risk will be minimal. All of the apps and websites included in the iTech have features to 
ensure app security and privacy. 
 
12.2 Certificate of Confidentiality 
This research specifically targets a vulnerable population, children (YMSM ages 15-17). We will 
take every available step to minimize the risk of identifying/linking data being subpoenaed, 
stolen, or inadvertently released. First, the iTech has received a Certificate of Confidentiality 
from the NIH. Second, all research staff members are required to complete ethical clearance 
certification regarding protection of human’s subjects through their relevant IRBs. Third, all 
studies will have documented procedures to safeguard against the risk of the linking information 
being stolen by keeping such information in a locked spaces to which only essential study 

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personnel who have completed CITI certification for human subjects research ethics training 
(http://citiprogram.org) will have access.  
Per Section 2012 of the 21st Century Cures Act as implemented in the 2017 NIH Certificates of 
Confidentiality Policy, all ongoing or new research funded by NIH as of December 13, 2016 that 
is collecting or using identifiable, sensitive information is automatically issued a CoC. . As noted 
on the NIH website (http://grants.nih.gov/grants/policy/COC/faqs.htm#187), a Certificate of 
Confidentiality will help the research team “...avoid compelled ‘involuntary disclosure’ (e.g., 
subpoenas) of names and other identifying information about any individual who participates as 
a research subject (i.e., about whom the investigator maintains identifying information) during 
any time the Certificate is in effect.” 
 
12.3 Risks and Benefits 
 
The potential risk for participants in Phase II and III will be minimal. The study sessions will 
occur via a secure, encrypted teleconference interface (Zoom) to maximize security and privacy. 
To minimize risks to confidentiality, we will secure study data with all appropriate physical, 
electronic, and operational protections. Participants will provide their names and addresses or 
other personally identifying information as part of the study. There is a risk that these data could 
be unintentionally disclosed to someone not authorized to access the data, compromising the 
privacy of the participant. To reduce this risk, data will be stored in a physically secure 
environment. All data files will have encryption and strong password protection. Any identifiable 
data will either be stored on the University of Michigan's secure servers or will be on fully 
encrypted laptops as well as SMART. Surveys and online eligibility screening will take place on 
an encrypted commercial survey website, Alchemer. This site has been used by the 
investigators for thousands of online surveys with YMSM with no data security breaches. 
Access to data will be on a role-based standard; only those study staff who require access to 
each type of data to complete their study-related roles will be allowed access.  
 
All study staff will be trained in security and confidentiality procedures, and will sign a 
confidentiality agreement before receiving access to any participant data.  We will also develop 
procedures to minimize indirect disclosure that a participant is participating in an HIV-related 
research study, or a study that enrolls YMSM. For each mode of contact information, we will ask 
specifically whether anyone else potentially has access to that mode of communication, and if it 
is acceptable to leave a non-specific message about participation in a health study. Because 
this study also includes couples, we cannot guarantee confidentiality. We have additional 
precautions to avoid inadvertent transfer of confidential information from one partner to another 
in the assessments. We send each participant the quantitative assessment and STI kits 
separately so avoid participants revealing information about the other partner and ask them to 
complete the survey and STI kits in a private location. No study-related messages will ever 
mention HIV prevention or the nature of the research study. Additionally, all scripts for email, 
text message, and telephone contact with participants will be reviewed and approved by the 
UNC IRB before being used for contact with participants.  We use SSL encryption for transfers 
of information online. 
 
Some participants may be uncomfortable talking with their partner or a counselor about their 
past sexual behavior and HIV-related behaviors, or may feel uneasy about having HIV testing 
done. Each of the study counselors will be trained, and have experience, in the provision of 
CHTC and CTR, and thus will have experience in answering research participants concerns 
about HIV testing, comprehending the HIV testing process, and concerns around discussing 

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sexual behavior with a counselor. At each video-conference session we will follow existing 
protocols for HIV testing, which include establishing the client’s willingness, readiness and 
comprehension of the HIV testing process.  
 
Participants who learn that they are HIV-positive may be distressed to learn of their health 
condition. This poses the greatest emotional and physical risk to participants in the research 
study. The informed consent documents will outline the HIV testing process, stating that results 
will be delivered the same day, and study staff will explain in full what a positive, negative or 
indeterminate HIV test result mean before conducting the HIV tests. The counselor will assess 
the individual’s readiness to receive both the HIV test and the result, following standard HIV 
testing guidelines. All study counselors are experienced in the delivery of HIV test results, and 
will follow standard clinic guidelines for results delivery. Individuals (or couples) receiving 
positive HIV test results will be provided with counseling and referrals to care that are 
appropriate to their economic situation (e.g. those eligible for Ryan White Care will be linked to 
the appropriate services). All those receiving a positive result will be given a full list of local 
service providers. 
 
It is also possible that having a discussion about past sexual behaviors with a participant’s 
partner might lead to subsequent conflict, or even violence, within their relationship. To 
ameliorate this risk, we propose to screen out those with a history of intimate partner violence 
(IPV) in the relationship. It is possible that new, incident, IPV may occur. This will be recorded 
through questionnaires on the surveys at each study visit. Individuals reporting IPV will be 
offered the opportunity to also meet individually with the study counselor, and will be provided 
with referrals to local services. All study participants, regardless of whether or not they report 
IPV, will be given a local resource guide that outlines programs and sources of support for 
people dealing with a wide range of circumstances (e.g., mental health, suicide), such that no 
partner will be able to identify that the other has reported IPV to study staff. 
 
Although not a risk caused by the trial, a potential ethical issue that could arise is the counselor 
or study staff learning that one member of a couple is having risky sex outside the relationship, 
and not disclosing this risk to their main partner if the index partner is randomized to the 
intervention arm and selects the CHTC + Relationship Skills session with their partner. The 
issue of disclosure of sex risk outside the relationship is difficult. If we inform participants in the 
consent process that information about sex outside the relationship would be disclosed to an 
unknowing partner, then we will likely reduce truthful reporting and bias against consent by the 
participants who are in most need of intervention. However, we also appreciate the ethical 
imperative to protect our study participants. We suggest the following compromise. First, all 
participants randomized to the intervention condition who choose to have their partner complete 
the CHTC + Relationship Skills session, will have the session with a counselor that will provide 
a supportive and protective environment in which to disclose such risk from sex outside the 
relationship. Previous qualitative work with MSM has suggested that some MSM seek HIV 
testing as a means to find a supportive environment for disclosure of HIV status, so providing 
such an environment may be an important step to promoting disclosure. Second, all couples in 
the CHTC + Relationship Skills session will be counseled about the benefits of communication 
within their relationship. This seems to us to be a reasonable compromise that will both allow 
collection of research data that hold promise of reducing new HIV infections for YMSM couples, 
and extend multiple opportunities in a supportive environment for disclosure. 
 
The Analytic Core will use Dedoose software to perform all qualitative analyses. Dedoose is a 
web-based application for organizing and analyzing textual, audio, and video data (qualitative) 
along with outstanding functionality for their integration with survey, test score, ratings, and 

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demographic data (quantitative). Dedoose employs the highest levels of data encryption 
available for a web application in all data storage, back up, and transmission. Dedoose allows 
for project specific encryption feature. When using this feature, only Dr. Muessig or her 
designee will hold the additional encryption key needed to be entered in order to view the 
project. This gives Dr. Muessig exclusive control over who can view the project under any 
circumstances.  
In addition to a Certificate of Confidentiality, we will protect participants in the following ways: 
 
1. Breach of confidentiality. We will take every precaution to minimize risks to study 
participants. All research staff members are required to complete ethical clearance 
certification regarding protection of human subjects through UNC-CH or the University of 
Michigan. We also have a strong data and safety monitoring plan in place to protect 
participants. Adverse events will be reported to the UNC-CH and the University of Michigan 
IRBs using Adverse Event Reporting Forms created by the Analytic Core (AC). When 
possible, reports will be sent within 24 hours of notification by the PIs. Annual updates on 
enrollment and retention will also be sent to the IRBs.   
 
2. All data collection will take place in secure and supervised research settings. All study 
personnel have completed training and received certification in Human Subjects Research 
Protection (CITI Program) and HIPAA regulations. They will continue to renew this training in 
compliance with institutional policies.   
 
12.3.1 Benefits 
Participants will have the opportunity to learn their own HIV status and STI results, and to 
receive information and counseling about how to reduce their future risk of HIV infection 
Participants may benefit from becoming cognizant of their risk behaviors as they discuss HIV 
and STI topics, including circumstances and motivations behind their HIV and STI risk behaviors 
and the potential to reflect on changing behaviors or taking steps to reduce risk. Participants will 
receive a resource guide listing HIV/STI/PrEP services. In sum, potential benefits for the 
research far outweigh the risks for the participants.   
  
Others will benefit because the study will result in increased knowledge about prevention 
interventions to serve YMSM and their primary partners who are at high risk for HIV infection. 
 
12.4 Institutional Review Board (IRB) Review and Informed Consent 
This protocol, the informed assent/consent documents, and any subsequent modifications will 
be reviewed and approved by the UNC IRB who is responsible for the oversight of the study. 
Phase II findings will inform Phase III study procedures; therefore, we will submit a modification 
before beginning these phases. The informed assent/consent will describe the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. 
 
12.5 Waiver of the Requirement for Parental Permission for Special Circumstances 
Under 45 CFR 46.408 (c), an IRB has the authority to waive parental permission if it determines 
that “a research protocol is designed for conditions or a subject population for which parental or 
guardian permission is not a reasonable requirement to protect the subjects” and “an 
appropriate mechanism for protecting the children who will participate as research subjects is 
substituted” and “that the waiver is not inconsistent with Federal, State, or local law.” 
 

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Given our study population, we seek to avoid asking for parental consent as YMSM may not 
have disclosed their sexual orientation to their parents/legal guardians. Rather, we would like 
YMSM to give their assent to be in the study themselves. This procedure aligns with state laws 
that allow minors to receive HIV/STI testing without parental consent. 
 
We are requesting a waiver of documentation of parental consent given the eligibility criteria of 
the study. Participants must report being male and being in a relationship with a man. Given the 
stigma that continues to surround same-sex behavior in many families, it is inconceivable to ask 
parents for consent and thereby endanger the privacy and safety of those participants aged 15-
17 years. 
 
12.6 Waiver of the Requirement for Signed Consent Form 
12.6.1 For Study Participation 
In order to maintain the anonymity of the survey and fully protect the privacy of the volunteer 
study participants, the UNC IRB will be requested to waive the requirement for a record of a 
signed consent form. 
 
Under 45 CFR §46.117 (c) (1) and (2), an IRB may waive the requirement for the investigator to 
obtain a singed informed consent for some or all of the participants if it finds either: (1) That the 
only record linking the participant and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each participant 
will be asked whether he/she wants documentation linking him/her with the research, and the 
participant’s wishes will govern; or (2) that the research presents no more than minimal risk of 
harm to the participants and involve no procedures for which written consent is normally 
required outside the research context.” 
 
The protocol team believes that both #1 and #2 applies to this study and, both combined, justify 
a waiver of written consent. Once a participant is deemed eligible by completing the eligibility 
screener, he will be presented with the assent/consent form. The assent/consent form will 
outline the voluntary nature of the study, YMSM’s freedom to discontinue the survey at any time, 
approval to retain data for future research, approval to retain email addresses for future study 
opportunities, and the procedures to guarantee their confidentiality. Email addresses of the 
participants who agree to the content of the assent/consent will be stored in a password-
protected file housed within a secure, encrypted sever at the University of Michigan School Of 
Nursing and only available to designated study staff.  
 
12.6.2 For Eligibility Screening 
No identifying information on participants is recorded during the eligibility screening. Therefore, 
documented assent/consent for this screening would constitute the only identifying link to 
participants who are ineligible or choose not to participate, unless they consent to providing 
contact information for future studies. In addition, the screening presents minimal risk to 
participants and involves no procedures that would require written consent outside of a research 
context. Under these conditions the IRB is authorized to modify the requirements to obtain a 
signed consent form for some or all participants (45 CFR 46.117 [c]).  
 
 
12.7 Prisoner Participation 
NICHD has concluded that this protocol does NOT meet Federal requirements governing 
prisoner participation in human subject research and should NOT be considered by local IRBs 

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for the recruitment of prisoners. Participants enrolled who subsequently become incarcerated or 
are placed in detention may not continue study participation. Study interviews cannot be 
conducted during the period of incarceration or detention. 
 
12.8 45 CFR Parts 160 and 164 Standards for Privacy of Individually Identifiable Health 
Information ("Privacy Rule" Pursuant to the Health Insurance Portability and Accountability Act - 
HIPAA) 
 
The University of Michigan will be responsible for adherence to their individual institution’s 
HIPAA policies and procedures. 
 
12.9 Study Discontinuation 
This study may be discontinued at any time by the UNC IRB, NICHD, or other government 
agencies as part of their duties to ensure that research participants are protected. 
 
13.0 PUBLICATION OF RESEARCH FINDINGS 
 
Any presentation, abstract, or manuscript will be made available for review by the study 
sponsor(s) prior to submission. 
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30. 
Muessig KE NM, Bauermeister J, Bull S, Hightow-Weidman LB.  Curr HIV/AIDS Rep 
201. A Systematic Review of Recent Smartphone, Internet and Web 2.0 Interventions to 
Address the HIV Continuum of Care. Curr HIV/AIDS Rep. 2015;12(1):173-190. 
31. 
Chiasson MA, Shaw FS, Humberstone M, Hirshfield S, Hartel D. Increased HIV 
disclosure three months after an online video intervention for men who have sex with 
men (MSM). AIDS Care. 2009;21:1081-1089. 
32. 
Horvath T, Azman H, Kennedy GE, Rutherford GW. Mobile phone text messaging for 
promoting adherence to antiretroviral therapy in patients with HIV infection. Cochrane 
Database Syst Rev. 2012;3:CD009756. 
33. 
Lelutiu-Weinberger C, Pachankis JE, Gamarel KE, Surace A, Golub SA, Parsons JT. 
Feasiblity, acceptability, and preliminary efficacy of a life-chat social media intervention 
to reduce HIV risk among young men who have sex with men. AIDS Behav. 
2015;18(7):1214-1227. 
34. 
Mustanski B, Greene GJ, Ryan D, Whitton SW. Feasibility, Acceptability, and Initial 
Efficacy of an Online Sexual Health Promotion Program for LGBT Youth: The Queer Sex 
Ed Intervention. J Sex Res. 2015;52:220-230. 
35. 
Macapagal K, Greene GJ, Andrews R, Mustanski B. Evaluating the Relationship-
Oriented Information, Motviation, and Behavioral Skills Model of HIV preventive 
behaviors in young men who have sex with men. AIDS Educ Prev. 2016;28:165-179. 
36. 
Misovich SJ, Fisher JD, Fisher WA. Close relationships and elevated HIV risk behavior: 
Evidence and possible underlying psychological processes. Rev Gen Psychol. 
1997;1:72-107. 
37. 
Newcomb ME, Macapagal K, Feinstein BA, Bettin E, Swann G, Whitton SW. Integrating 
HIV prevention and relationship education for young same-sex male couples: A pilot trial 
of the 2Gether intervention. AIDS Behav. 2016. 
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Applied Policy Research. Journal of Administration & Governance. 2009;42(2):72-79. 
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Patton ME, Kidd S, Llata E, et al. Extragenital Gonorrhea and Chlamydia Testing and 
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ATN 157 We Prevent Informed Consent  
 
The University of Michigan School of Nursing  
Consent to participate in a Research Study – Phase III Participants (survey, CTR session, CHTC 
+ Relationship Skills session, CTR + Relationship Skills session, STI testing, and follow-up 
surveys) 
 
 
Title of Study: ATN 157 – We Prevent: A dyadic approach to HIV prevention and care among 
young male couples 
 
Site Principal Investigator: Rob Stephenson, PhD, MSc, MA 
Site Principal Investigator: Department of Systems, Populations, and Leadership  
Site Principal Investigator phone: 734-615-0149  
Site Principal Investigator email: rbsteph@umich.edu 
 
Sponsor: The University of North Carolina at Chapel Hill (UNC-CH) 
 
Funding Source: National Institute of Health (NIH) 
 
Study Contact: Matthew Rosso 
Study Contact phone: 734-647-7260 
Study Contact email: mtrosso@umich.edu 
 
 
What are some general things you should know about research studies? 
You are being asked to take part in a research study. Your participation in the study is voluntary. 
You may refuse to join, or you may withdraw your consent to be in the study at any time, for any 
reason, without penalty. If you decide not to take part or if you change your mind later, there will 
be no penalties or loss of any benefits to which you are otherwise entitled. 
 
Research studies are designed to obtain new knowledge. This new information may help people 
in the future. You may not receive any direct benefit from being in the research study. There also 
may be risks to being in research studies. 
 
Details about this study are discussed below. It is important that you understand this information 
so that you can make an informed choice about being in this research study. You will receive a 
copy of this document and may ask the researcher named above if you have any questions about 
this study at any time. 
 
Please consider the study time commitments and responsibilities as a research subject when 
making your decision about participating in this study. 
 
 
 
 
What is the purpose of this study? 

 
 
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Researchers are trying to find better ways to address the relationship and HIV prevention needs 
of young, gay, bisexual, and other men who have sex with men.  The purpose of this part of the 
study is to test out a new type of session as an addition to the current HIV prevention 
interventions. We are comparing two different types of sessions: A) Couples HIV Testing and 
Counseling and B) Individual HIV Counseling, Testing and Referral. The study involves the 
completion of a baseline survey, collection of samples at-home for sexually transmitted infection 
(STI) testing, an online HIV testing session, and follow up surveys  3, 6, and 9 months from 
now. There is a chance that you will be asked to invite your partner to the HIV testing session. 
The HIV testing sessions will be completed via Zoom, a secure video-conferencing software.  
 
What makes me eligible for this study? 
You can participate in this study if all of the following apply to you: 
• You are between the ages of 15 and no more than 24 years-old 
• You are a current US resident 
• You are of sufficient age for sexual consent in the state in which you live (we will confirm 
this for you) 
• You self-identify that you are in an emotional and/or sexual relationship with another male  
• You are a cisgender man (assigned male at birth and identify as male) or a transgender man 
(assigned female at birth and identify as male or a transgender man) who reports intentions 
to have sex with men  
• You have had oral, anal, or vaginal sex in your lifetime 
• You have access to a computer with internet access 
• You are HIV-negative or not sure of your HIV status 
• You can read and speak English 
• You have not experienced intimate partner violence in the past 6 months  
 
How many people will take part in this study? 
Approximately 320 individuals will participate in Phase III of We Prevent.  
 
How long will your participation in this study last? 
Your participation will involve one baseline survey that you will fill out on a computer, an HIV 
testing session (individually and possibly with your partner), and 3-, 6-, 9-month follow-up 
surveys. At the time of the baseline survey, you will also be asked to  collect samples at-home to 
be mailed in for STI testing. All components of the study will be completed online. HIV and STI 
testing kits will be sent to a physical mailing address of your choice.  Depending on when you 
complete the surveys and counseling sessions, your participation in this phase of the study will 
last approximately 9 to 10 months.   
 
What will happen if you take part in the study? 
The different study activities are described below. After reading through them, you will be asked 
to agree to participate at the end of this consent form before you can begin your participation. 
 
Baseline Online Survey. If you are eligible to participate, you will provide contact information 
for yourself. You will be asked to complete an online baseline survey. This survey will include 
questions about your relationships, sex life, HIV and STI testing, and PrEP use. Once the 
baseline is complete, you will be randomly assigned to one of two study groups. Participants in 
both groups will receive the HIV testing video-chat sessions. There is a possibility that your 

 
 
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partner will be asked to join the study, but only if you would like them to and if you are 
randomized to that part of the study. If your partner agrees to join, they will be asked to complete 
a brief baseline survey. When you are completing the survey, you may skip questions that you 
don’t want to answer. You can also stop the survey at any time. The survey will take about 30 
minutes to complete.  
 
STI Testing. After completing the baseline survey, you will be mailed an STI testing kit (you will 
have the option to opt-out or not to complete this activity). If you choose to receive the kit, you 
will be asked to complete the tests at home and to return the test samples by mail to a specified 
address. The at-home STI test kits will collect urine, throat and rectal tissue from a self-swab, 
and blood collected by a self-administered finger prick. The STI kit that we mail you will contain 
instructions on how to complete each test and should only take 5-10 minutes to complete.  
 
HIV Testing Session. After completion of the baseline survey, you (and possibly your partner) 
will participate in an online video-chat HIV testing and counseling session. During this session, 
you will test for HIV and review your test results with a trained counselor. The HIV testing kits 
will be shipped to you at an address that you specify. This session will be completed online 
through the Zoom video-conferencing system. If you and/or your partner test positive for HIV 
during this session, study staff will provide resources to link you to appropriate care.  This part 
of the study takes about 45 minutes. 
 
Follow-up Surveys: After the HIV testing session is complete, you will be asked to complete 
follow-up surveys at three, six and nine months from the time you took the baseline survey. The 
surveys will be similar to the baseline survey, and will ask questions about your relationships, 
sexual health, HIV testing, and PrEP use. Additionally, these follow-up surveys will ask you 
about your experience during the HIV testing session that you will complete in the study.   
 
Exit Interview. You may be selected to complete a study exit interview. If this happens, the 
interview will be conducted online by one of the trained counselors  using the  Zoom video-
conferencing software. During the interview, you will be asked about your thoughts about We 
Prevent and how the study could be improved. This is an independent interview, which means 
you do not need to complete it with your partner.  
 
What are the possible risks or discomforts involved from being in this study? 
Potential discomfort with survey questions and HIV testing sessions. It is possible that some of 
the survey questions may make you feel embarrassed or uncomfortable. You do not have to 
answer any questions you do not wish to answer. You can stop the survey at any time. HIV 
testing may also produce discomfort. If you feel discomfort during the HIV testing session, you 
can discontinue your participation at any time. During self-testing, you may also experience 
physical discomfort or bruising at the site of the finger prick.  
 
Potential risks of data collection and loss of confidentiality. We will use several strategies to 
protect your confidentiality. All information that you provide to us, including your test results, 
will be stored on secure servers with restricted access. We will assign you an identification 
number that will replace your name on the data files. Only members of the study team will have 
access to your files.  We will make every effort to protect your confidentiality, but there is a 
small possibility that information you provide could become known to others. 
 

 
 
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You will be informed if the study staff learns of any new risks. 
 
What if you want to stop before your part in the study is complete? 
You can withdraw from this study at any time for any reason, without penalty. You do not have 
to give a reason. The investigators also have the right to stop your participation at any time. This 
could be because you have failed to follow instructions, have undermined the right or privacy of 
another participant, or because the entire study has been stopped. 
 
How will your privacy and confidentiality be protected? 
We have your email address and phone number for administrative purposes. Email addresses are 
necessary for sending an appointment reminder and connecting you to the Zoom program to do 
the online sessions. Your phone number is used in the event that the Zoom program stops 
working in the middle of the interview. The study staff member will call you to work on fixing 
the problem. Your email and phone number will be kept for five years after the study ends, given 
your consent. Personal information will not be linked to any of the information that you provide 
in the survey or interview. Your personal information will not be used for any additional 
correspondences after the completion of the study. 
 
Your participation in this study will be kept confidential and private as permitted by law. This 
includes the information you provide to us in the baseline and the 3, 6, 9-month follow-up 
surveys, the HIV testing and counseling sessions, and the exit interviews. Every effort will be 
taken to protect your identity as a participant in this study.  You will not be identified by name in 
any report or publication of this study or its results. Instead, you will be known only through a 
study ID number. Any data linking your name to your study ID number will be kept in a locked 
cabinet in a locked room at the study site but separate from where your study records are stored. 
Staff members involved in this study are required to sign a form stating that they will protect and 
keep private all information on every person in the study. 
 
Self-collection biospecimen kits will be mailed from a CLIA-certified testing laboratory and 
fulfillment center, Molecular Testing Labs (MTL).  Participant information including name and 
mailing address will be entered by study staff into an online ordering portal where MTL will 
process the shipment. None of the information you share in the surveys you take as part of your 
study visits will be included with the participant addresses that study staff share with MTL. Test 
kits will be mailed in a generic USPS mailer so that the contents will not be visible to anyone 
unless the mailer is opened.  
 
MTL is a Centers for Medicare and Medicaid Services (CMS) Designated “Covered Entity” 
sworn to uphold all HIPAA Considerations. Use of encryption is required on applicable 
communications. Laboratory Information System access is protected per HIPAA Guidelines.  
 
 
Although every effort will be made to keep research records private, there may be times when 
federal or state law requires the disclosure of such records, including personal information. This 
is very unlikely, but if disclosure is ever required, the University of Michigan will take steps 
allowable by law to protect the privacy of personal information. In some cases, your information 
in this research study could be reviewed by representatives at the University of Michigan and the 
University of North Carolina at Chapel Hill, research sponsors, or government agencies for 
purposes such as quality control or safety. At the end of the study, all of your de-identified data 

 
 
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collected from the study will be coded and stored in our We Prevent servers in Ann Arbor, 
Michigan. 
 
Every effort will be made to keep your participation in the study and any personal information 
about you private and confidential. However, absolute confidentiality cannot be guaranteed. For 
example, if a study staff member learns something that would immediately put you or others in 
danger, the study staff member is required by law to take steps to keep you and others safe. This 
means that study staff members have to report to the authorities (hospital, police, or social 
services) any information you say that suggests that you might be in danger, such as telling staff 
that you plan to hurt or kill yourself, hurt or kill someone else, or if someone is abusing or 
neglecting you. 
 
In addition, your records may be reviewed by certain agencies or people who make sure that the 
study staff are doing what they are supposed to and everyone in the study is being protected. 
Under the guidelines of the Federal Privacy Act, the sponsoring agency at the National Institutes 
of Health (NIH) and the UNC IRB may look at your records. If your study records are reviewed, 
your identity could become known to them. However, these persons are expected to maintain 
your individual confidentiality. This means that they will not tell others information about you or 
that you are in the study. By signing this form, you are allowing such access. 
 
Most people outside the research team will not see your name on your research information. This 
includes people who try to get your information using a court order in the United States.  There 
are exceptions for information that is required to be reported under law, such as information 
about child or disabled abuse or neglect or certain harmful diseases that can be spread from one 
person to another.  Personnel of a government agency sponsoring the study may also be provided 
information about your involvement in the research study. 
 
Will you receive anything for being in this study? 
You will receive $40 in the form of an Amazon eGift Card after completing the baseline survey. 
If your partner participates in the study, they will receive a $20 Amazon eGift Card for 
completing a brief baseline survey. You will receive another $40 Amazon eGift Card for each 
follow-up survey completed at the 3-, 6-, and 9-month follow-up points, totaling in $120 for 
completing all of the follow-up surveys. If you are selected to complete the exit interview, you 
will also receive $20 for your participation. Therefore, you can receive up to $180 by 
participating in this study and your partner can receive up to $20. 
 
What are the benefits from participating in this study?  
Participating in our study may not benefit you directly. We hope that what we will learn from 
your participation will help us to implement an HIV prevention program to meet the needs of 
young gay, bisexual, and other men who have sex with men and their partners. 
  
Are there any costs to you for taking part in this study? 
No, there are no costs to you for taking part in this study. 
 
Who is sponsoring this study? 
This research is being sponsored by the University of North Carolina at Chapel Hill and funded 
by the National Institutes of Health (NIH). This means that the sponsor, the University of North 
Carolina at Chapel Hill (UNC-CH), is providing money from NIH to the University of Michigan 

 
 
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to help conduct this study. The researchers do not, however, have a direct financial interest with 
the sponsor or funding source or in the final results of the study. 
 
What if you are an employee of the University of Michigan? 
Taking part in this research is not a part of your job duties and refusing will not affect your job. 
You will not be offered or receive any special job-related consideration if you take part in this 
research. 
 
What if you have questions about this study? 
You have the right to ask, and have answered, any questions you may have about this research at 
any time before, during, or after your participation. If you have questions, or concerns, you 
should contact the researchers listed on the first page of this form. 
 
What if you have questions about your rights as a research participant? 
All research on human volunteers is reviewed by a committee that works to protect your rights 
and welfare. If you have questions or concerns about your rights as a research subject you may 
contact, anonymously if you wish, the University of North Carolina at Chapel Hill (UNC-CH) 
Institutional Review Board (IRB) at 919-966-3113 or by email to IRB_subjects@unc.edu. 
 
You can also call the University of Michigan Institutional Review Board (IRB) at 734-936-0933 
or by email to irbhsbs@umich.edu  
 
 
 

 
 
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UNC IRB Study #18-0200 
 
Title of Study: ATN 157 – We Prevent: A dyadic approach to HIV prevention and care among 
young male couples 
 
Site Principal Investigator: Rob Stephenson, PhD, MSc, MA 
 
Participant’s Agreement: 
If you agree to voluntary participate in this study, please select the appropriate response: 
o I agree to participate in this research study 
o I do NOT agree to participate in this research study