Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM
Phase: NA
Conditions: HIV/AIDS, HIV Infections
Sponsor: Florida State University

ADOLESCENT MEDICINE TRIALS NETWORK FOR HIV/AIDS INTERVENTIONS 
PROTOCOL 
Enhancing Sexual Safety: Couples’ Communication and 
HIV Testing Among YMSM: ATN 156 
NCT04289116
Sponsor: 
National Institute of Child and Human 
Development (NICHD) 
National Institute on Drug Abuse (NIDA) 
Protocol Lead: 
Tyrel J. Starks, PhD 
Hunter College,  
New York, NY 
Protocol Lead: 
Sarah W. Feldstein Ewing, PhD 
Oregon Health & Science University 
Portland, Oregon 
Recruitment and Enrollment Center: 
PRIDE Health Research Consortium (PRIDE), 
Hunter College 
Analytic Core Analyst: 
Tyrel J. Starks, PhD 
Hunter College,  
New York, NY 
Study Procedure Guide Version Date: 
May 12, 2021

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Submitted: October 11, 2019
PROTOCOL TITLE:
Enhancing Sexual Safety: Couples’ Communication and HIV Testing Among YMSM 
(WE TEST)
PRINCIPAL INVESTIGATOR:
Name Naar, Sylvie
Department COLLEGE OF MEDICINE
Telephone Number (248) 207-2903
Email Address sylvie.naar@med.fsu.edu
Co-Investigators/Research Staff
Name Starks, Tyrel;  Protocol Lead
Department NON-FSU DEPARTMENT
Telephone Number 212-772-5550/5551
Email Address tstarks@prideresearch.org
Name Feldstein Ewing, Sarah; Protocol Lead
Department NON-FSU Department
Telephone Number 503-418-9604
Email address feldsteinewing@uri.edu
VERSION NUMBER/DATE:

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Submitted: October 11, 2019
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
0
7.8.19
Resubmission into new RAMP template
No
1
7.18.19
Change of randomization procedures, Updated 
Recruitment, increased age range to 15-24 
years
Yes
2
10.10.2019
Updated procedures for Phase 3. Added the 
STI online portal for Test results, new 
recruitment images, reporting names to Health 
Department
Added 
Phase 3 
consent
3
12.2.2019
Deleted 9 month follow-up, Clarified 
Conditions for Phase 3, Added Long chain 
referrals, 
Yes
4
1.2.2020
Phase 3 Condition revised, Deleted Long Chain 
Referrals, Changes to CASI questions
Yes
5
3.19.2020
Changed language to allow for remote follow-
ups, including HIV and STI at-home testing 
kits,
Yes
6
9.3.2020
Update Study procedures for COVID, Remote 
study procedures, remote HIV/ STI Testing 
options, Information sheet for in office 
appointments for COVID.
7
5.10.2021
Updated for national recruitment due to 
COVID

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Table of Contents
1.0
Study Summary ........................................................................................................3
2.0
Objectives* ...............................................................................................................4
3.0
Background*.............................................................................................................5
4.0
Study Endpoints*......................................................................................................6
5.0
Study Intervention ....................................................................................................6
6.0
Procedures Involved* ...............................................................................................8
7.0
Data and Specimen Banking*.................................................................................11
8.0
Sharing of Results with Subjects* ..........................................................................12
9.0
Study Timelines*....................................................................................................12
10.0
Subject Population*................................................................................................12
11.0
Vulnerable Populations*.........................................................................................13
12.0
Local Number of Subjects ......................................................................................13
13.0
Recruitment Methods..............................................................................................14
14.0
Withdrawal of Subjects*.........................................................................................15
15.0
Risks to Subjects*...................................................................................................16
16.0
Potential Benefits to Subjects* ...............................................................................17
17.0
Data Management* and Confidentiality.................................................................17
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*.........................19
19.0
Compensation for Research-Related Injury............................................................20
20.0
Economic Burden to Subjects.................................................................................20
21.0
Consent Process......................................................................................................20
22.0
Process to Document Consent in Writing...............................................................22
23.0
Setting.....................................................................................................................22
24.0
Resources Available ...............................................................................................23
25.0
Multi-Site Research* ..............................................................................................23

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1.0
Study Summary
Study Title
Enhancing Sexual Safety: Couples’ Communication and 
HIV Testing Among YMSM (WE TEST)
Study Design
Comparative Effectiveness Trial (CET), Randomized 
Control trial (RCT)
Primary Objective
We will conduct a comparative effectiveness trial (CET) of 
CHTC for adolescent-age (15-24 years) same-sex male 
couples. This design tests the added benefits of adjunct 
intervention components delivered prior to receipt of 
CHTC-Assertive Communication Training (ACT) videos 
viewed by the couple together and individually delivered 
Motivational Interviewing-based Communication Skills 
Training (MI-CST). These target the development of 
communication skills necessary to participate fully in HIV 
prevention and sexual safety discussions inherent to 
CHTC. This project will assess a continuum of intervention 
packages to address the developmental needs of YMSM 
(CHTC; ACT videos + CHTC; MI-CST + ACT videos + 
CHTC) to identify which package optimizes outcomes 
while minimizing delivery cost.
Secondary 
Objective(s)
Test a sustainable model of CHTC implementation in real 
world adolescent HIV clinics. In line with the 
implementation science focus of SIU U19, we utilize the 
EPIS to guide our implementation strategy. We will work 
with SIU Analytic Core’s (AC) health-economist, Dr. Kitt 
Simpson, to conduct cost-effectiveness analyses to inform 
implementation decision-making. In collaboration with 
SIU ISC, we will document provider feedback to training 
and intervention materials to modify materials and create 
training packages for broad dissemination. 
Research 
Intervention(s) 
We are comparing three conditions for HIV testing with 
adolescents and young adults: Couples HIV Testing and 
Counseling (CHTC), CHTC-Assertive Communication 
Training (ACT), and Motivational Interviewing-based 
Communication Skills Training (MI-CST). These will test 
the ways in which including communication training 
improves upon existing HIV testing services. 
Study Population
Adolescent-age (15-24 years) same-sex male couples
Sample Size
Phase 2 (n=36 couples  72 individuals)
Phase 3 (n=200 individuals)
Study Duration for 
individual 
participants
Phase 2: 3 months;
Phase 3: 6 months
Study Specific 
Abbreviations/ 
Definitions 
Adolescent Medicine Trials Network (ATN)
Comparative Effectiveness Trial (CET) 
Couples HIV Testing and Counseling (CHTC)
Individual HIV testing and Counseling (IHTC)
CHTC-Assertive Communication Training (ACT)
Motivational Interviewing-based Communication Skills 
Training (MI-CST)
Young men who have sex with men (YMSM)

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2.0
Objectives*
Aims: We will conduct a comparative effectiveness trial (CET) of Couples HIV Testing 
and Counseling (CHTC) for adolescent-age (15-24 years) same-sex male couples. This 
design tests the added benefits of adjunct intervention components delivered prior to 
receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple 
separately and individually delivered Motivational Interviewing-based Communication 
Skills Training (MI-CST). These target the development of communication skills 
necessary to participate fully in HIV prevention and sexual safety discussions inherent to 
CHTC. This project will assess a continuum of intervention packages to address the 
developmental needs of YMSM (CHTC; ACT videos + CHTC; MI-CST + ACT videos + 
CHTC) to identify which package optimizes outcomes while minimizing delivery cost. 
Aim 1: Conduct a sequence of randomized control trials (RCTs) to evaluate the 
acceptability, feasibility, and comparative effectiveness of novel treatment packages. 
Aim 1a: In study Phase 2, we will conduct a pilot RCT to evaluate the acceptability and 
feasibility of adjunct intervention components. This initial trial will recruit n=36 couples 
who will be randomized to one of 3 conditions: Condition 1: CHTC (only); Condition 2: 
couples’ joint observation of ACT videos + CHTC; Condition 3: each individual within 
couple receiving MI-CST + joint observation of ACT videos + CHTC. Youth will then 
complete follow-up assessments at 1 and 3 months post-intervention. YOUTH DO 
HAVE THE OPTION OF COMPLETING THE INTERVENTION ON THEIR OWN IF 
THEY CAN NOT GET THEIR PARTNER TO AGREE TO PARTICIPATE. During 
Phase 3, we will recruit 200 individuals into a CET with two conditions: Condition 1: the 
optimum adjunct intervention package identified in Phase 2 and Condition 2: Individual 
HIV Testing (IHTC) as usual. Youth in this CET will complete follow-up assessments at 
1, 3, and 6 months. Youth have the choice of attending the baseline visit alone or with 
their partner and have the option to bring their partner in later after completing the 
baseline alone.
Aim 1b: Assess self-management model; we posit that assertive communication skills 
will mediate intervention effects at all follow-ups. In study Phases 2 and 3, we anticipate 
between-condition differences will be greatest among YMSM with poor baseline 
assertive communication. 
Aim 2: Test a sustainable model of CHTC implementation in real world adolescent HIV 
clinics. In line with the implementation science focus of SIU U19, we utilize the EPIS to 
guide our implementation strategy. We will work with SIU Analytic Core’s (AC) health-
economist, Dr. Kit Simpson, to conduct cost-effectiveness analyses to inform 
implementation decision-making. In collaboration with SIU ISC, we will document 
provider feedback to training and intervention materials to modify materials and create 
training packages for broad dissemination. 
We will achieve our aims over two phases of the study. 

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Phase 2 (n=36 couples): involves a pilot randomized control trial (RCT) to evaluate the 
acceptability, feasibility, and preliminary efficacy of these adjunct components. 
Phase 3 (n=200 individuals): involves a CET comparing the most promising intervention 
package from Phase 2, consisting of individual MI, ACT video+ a recognition survey, 
and CHTC, compared to individual HIV testing and counseling (IHTC) delivered as 
usual. Participants in either condition can come as an individual or with their partner or 
come first as an individual and then bring their partner. This phase is focused on 
Implementation and Sustainment phases of the EPIS model informed by outcome 
analyses, cost analyses, and feedback from youth and ATN staff. 
Phase 3 has now been added to this protocol document.
Hypothesis: The primary hypothesis is that because of developing skills in self-
management and assertive communication, inclusion of adjunct components will be 
associated with clinically significant decreases in HIV transmission risk behavior as 
compared with partnered YMSM who receive individual testing and counseling (only). 
Secondarily, we propose that these intervention effects will be mediated by assertive 
communication skills.
3.0
Background*
Partnered young men who have sex with men (YMSM) are a uniquely vulnerable 
population. Adolescents in relationships continue to be an under-examined subgroup, 
despite the fact that YMSM (age 15-24) are at among the highest risk of HIV infection. 
Among men who have sex with men (MSM) age 18 and older, 35–68% of new HIV 
infections are transmitted between partners in primary (vs. casual) relationships. Of 
concern, primary partners account for 79% of new infections within the youngest MSM 
cohort.
Primary partner HIV transmission can result from a higher number of sex acts, more 
receptive anal intercourse, and lower condom use with primary (vs. casual) partners. 
Despite this elevated health risk, partnered MSM paradoxically perceive themselves to be 
at much lower risk of HIV infection, and test for HIV less often. Concomitantly, condom 
use may be suppressed with primary partners because condomless anal sex (CAS) is 
often interpreted as an indicator of commitment and emotional closeness. In fact, data 
reflect a strong, positive association between CAS and relationship seriousness for 
YMSM. Critical within this cohort, relationship development is still new, and romantic 
partnerships tend to be of short duration. Thus, frequent brief primary partnerships, low 
perception of CAS risk, and new negotiation of communicating emotional closeness 
during this developmental period may all escalate HIV infection among partnered 
YMSM.
Multilevel Intervention Integrating Couples Interdependence Theory (CIT) and 
Self-Management Theory as a framework for effective service delivery to partnered 
YMSM. We conceptualize individual HIV prevention (including HIV testing) in the self-

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management framework. Here, problem solving, decision making, and access to care 
collectively predict health behavior engagement. This in turn develops positive provider 
relationships that facilitate behavioral skills development and access to care. While 
useful, the self-management framework does not fully address or incorporate the 
inherently multilevel and dyadic nature of sexual health decision-making for partnered 
YMSM. Fortunately, this omission is addressed in Couples Interdependence Theory 
(CIT). Within CIT, health positive outcomes are proposed to require the coordinated 
effort of both partners, and partners must accommodate potentially divergent health and 
safety preferences. Dyads with partners who balance self-interests with relationship-
interests are more successful at conflict resolution, including HIV risk management. 
Work by Protocol Lead (PL) Starks and others, reflects that one strategy by which gay 
couples accommodate sexual health goals is through negotiating sexual agreements (e.g., 
rules and boundaries for outside partners).
The process of accommodation generally, and negotiation of sexual agreements 
specifically, requires advanced and flexible conceptual and communication skills. To be 
effective, individuals must identify both their own and their partner’s preferences and 
feelings, and then communicate those concepts in constructive ways. Couples HIV 
Testing and Counseling (CHTC) successfully enhances sexual agreement communication 
with adult MSM by utilizing CIT. However, CHTC has not been examined with young 
samples. Yet, this intervention may play a critical role because of their level of cognitive 
and social development (e.g., still emergent communication skills). Youth may need 
added support to effectively identify sexual goals and to learn to communicate them 
carefully and productively, and this support may come in the form of CHTC and 
additional communication skills training. 
Excitingly, our team has expertise across both the use of CHTC among partnered MSM 
(R34 DA036419 PL Starks) and support of partnered adolescents in communicating 
sexual and HIV risk reduction goals to their sexual and relationship partners. This is 
relevant, because data reflect that less than half of partnered adolescents feel comfortable 
advocating for and discussing condom use before sexual intercourse, contributing to 50% 
of youth consenting to CAS, despite wanting to use a condom. YMSM show even lower 
rates of assertive communication relative to heterosexual age-mates. Enhancing 
communication skills is thus a route to improve sexual safety in this age group.
4.0
Study Endpoints*
The primary goals of this study is to help participants reduce their HIV transmission risk 
behaviors by increasing their communication skills with their partners, which could lead 
to fewer number of sex acts, less receptive anal intercourse, and higher condom use with 
primary (vs. casual) partners.
5.0
Study Intervention
Intervention Design and Procedures: The primary innovation of this multilevel CET 
lies in the novel packaging of existing interventions in a manner that addresses the 

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specific developmental needs of YMSM. While MI-CST, video based ACT, and CHTC 
have individually established efficacy, this study will be the first to evaluate a continuum 
of prevention packages, which combine these components. In addition, this multilevel 
intervention seeks to leverage the power of the dyadic processes to enhance motivation 
for HIV testing and prevention (including biomedical prevention). Our adjunctive 
components (ACT and MI-CST) are specifically intended to enhance self-management 
skills (e.g., assertive communication) which are essential to effectively engage 
relationship partners in collaborative sexual goal development and problem solving. The 
underlying assumption of this strategy is that improvements in dyadic functioning will 
lead to reductions in sexual risk for both individuals within the relationship. Finally, we 
make innovative use of biomarkers to operationalize HIV-transmission risk. Our ability 
to draw conclusion about intervention effects is enhanced by examining biomedical and 
behavioral outcomes for both sexual partners regardless of relationship dissolution; this is 
critical to enhance sexual safety for both individuals of a couple, particularly in light of 
the short duration and rapid re-partnering of YMSM during this developmental period.
Intervention Training and Supervision: Following Phase 1, to prepare for the roll out 
of the CET, we will hold a week-long in-depth training on all study procedures. This 
training will include members of the two ATN sites where CHTC will be implemented in 
Phase 2. Any staff who cannot attend due to non-resolvable travel restrictions will 
participate via Skype. This training will include a 2-day training in CHTC (overseen by 
PL Starks), 2-day training on MI (overseen by PL Feldstein Ewing), and 1 day dedicated 
to reviewing/practicing protocol delivery, including administration of the ACT videos. 
Throughout training and fidelity monitoring activities, the implementation team, 
including the study PLs, will work closely with the SIU ISC to document CHW and 
supervisor performance and feedback on intervention materials and delivery (reflecting 
the Exploration and Preparation phases of EPIS). At the conclusion of the CET, the 
project implementation team will work closely with the ISC to package training and 
intervention materials in a manner that supports the dissemination of CHTC and adjunct 
components shown to be effective. 
We will build upon the existing ATN infrastructure to complete this in a parallel model to 
SIU U19. Here, we will use a train-the-trainer model, where CHW supervisors will be 
brought to OHSU to be trained in implementation and delivery, with the goal that they 
will serve as local implementation “champions” by instructing and overseeing 
implementation within their ATN clinics. To maximize accuracy, consistency, and 
fidelity of intervention delivery, each intervention (CHTC; ACT; MI-CST) will be 
codified into manuals. 
This training sequence will be offered again prior to Phase 3 in order to bring new ATN 
sites online and update staff at existing sites. 
Ongoing supervisor’s conference call. PL Feldstein Ewing has a demonstrated track-
record of training and supervising clinical interventions in real-world practice sites, 
including MI, from a distance. Using the same model proposed here with rural school-
based health providers (NHLBI R01; PL Kong, Co-Lead Feldstein Ewing), PL Feldstein 

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Ewing has shown a high degree of clinical impact, fidelity, and integrity for execution of 
MI for the 5 year roll-out of the project. And active interventionist will work directly with 
the CHW supervisors during weekly clinical supervision calls. PLs Feldstein Ewing and 
Starks will be on the phone during these calls, but not actively participate. PLs Feldstein 
Ewing and Starks will then work directly with clinical supervisor to debrief any issues 
that arose during the calls. Clinical Supervisor will follow up with the CHW supervisors 
to address outstanding clinical issues. Similarly, as with Dr. Feldstein Ewing’s prior work 
in implementation science, in addition to weekly supervision meetings, clinical 
supervisor will visit each site annually, and greater frequency in situations where there is 
therapist drift, to practice the intervention approaches with study providers to get them 
back to parity with other CHWs. As with Dr. Feldstein Ewing’s successful work with 
rural adolescent medicine, this procedure has been supported with a high degree of 
clinical success and integrity in prior multi-site implementation science work with 
underserved adolescents. 
Assurance of Intervention Fidelity: All sessions will be audio recorded for the purposes 
of systematic supervision so PLs can assess fidelity and prevent therapist drift. The 
PRIDE Research Consortium (formerly Center for HIV Educational Studies and Training 
(CHEST)) at Hunter College maintains a team of Motivational Interviewing Treatment 
Integrity (MITI) coders trained in the assessment of MI and Dr. Starks maintains a group 
of research assistants trained in the assessment of CHTC fidelity. These coders will 
review the first 10 sessions completed by each CHW and a random 20% of sessions for 
the remainder of the trial (approximately 25% of sessions completed by each CHW over 
the entire trial). Coding of all initial sessions will ensure fidelity across therapists at the 
start of the trial and subsequent coding will identify any therapist drift that occurs for the 
remainder of the trial. Tapes will be coded to ensure the presence of essential elements of 
the intervention. Consistent with procedures in our previous effectiveness trials, when 
therapists exhibit low levels of intervention integrity or significant drift, this feedback 
will be relayed to the on-site supervisor. The training team (PLs Starks and Feldstein 
Ewing) will then work with the local supervisor to develop a remediation plan to bring 
the CHW back up to parity with other interventionists. This process will be facilitated by 
regular contact with on-sight supervisors as detailed in our training and implementation 
plan below.
6.0
Procedures Involved*
Enrollment and Consent: Utilizing enrollment procedures established within ATN, clinic 
staff will invite YMSM who present for HIV testing services the opportunity to screen. 
These interested index partners will complete a brief iPad eligibility screener.  
For Phase 2, IF ELIGIBLE, THE SCREENER WILL RANDOMIZE THEM TO 
COMPLETE THE BASELINE AS A COUPLE OR AN INDIVIDUAL.
If randomized to individual, staff will schedule a baseline assessment for the invited 
youth. If randomized to couple, staff will schedule a baseline assessment for the invited 
youth at a time both they and their relationship/romantic partner are available. Partners 

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will independently complete informed consent at the beginning of the baseline visit, prior 
to assessment following ATN-wide established protocols.
FOR PHASE 2, IF THE YOUTH IS RANDOMIZED TO COMPLETE THE BASELINE 
AS A COUPLE, AND THEY INDICATE THAT THEY WILL BE UNABLE TO HAVE 
THEIR PARTNER COME FOR THE APPOINTMENT, THEY WILL BE ALLOWED 
TO COME TO THE BASELINE AS AN INDIVIDUAL.  
For Phase 3, study sites are given the options to deliver the intervention in-person as 
usual, or entirely remote delivery. This is to allow sites more flexibility surrounding 
COVID-19 closures and restrictions, which vary by site. 
For Phase 3, index partners will be able to choose to attend their baseline appointment on 
their own or with their partner. While scheduling the baseline, staff will ascertain whether 
the participant is planning to come in alone or with their partner so they can reserve 
adequate time, space and resources for the appointment. Regardless of whether the index 
partner attends alone or with their partner, after the participant(s) complete the survey at 
the beginning of the baseline appointment, the index partner will be randomized to the 
We Test intervention or individual HIV testing (IHTC) as usual. If alone and randomized 
to the We Test intervention, the index partner will participate in the intervention as an 
individual. If both members of the couple attend and are randomized to We Test, they 
will participate in the intervention as a couple. If both members of the couple attend and 
are randomized to IHTC, they will each receive IHTC as usual. The index partner who 
participates as an individual (in either condition) will be offered the opportunity to bring 
their partner to participate in the WeTest. The partner will be enrolled into the same 
condition as the index partner.
Baseline Visit – PHASE 2 (up to $50) 
1. Informed Consent process 
2. STI testing ($20) 
3. CASI survey ($10) 
4. Randomization to one of three conditions (phase 2)
5. Session 1 (phase 2): will occur at this time in accordance with the randomized 
condition. 
a. Condition 1: CHTC 
b. Condition 2: ACT videos + CHTC 
c. Condition 3: MI-CST + ACT videos + CHTC 
FOR COUPLES WHO ARE ASSIGNED TO A CONDITION THAT INCLUDES 
VIDEOS, PARTICIPATING COUPLES WILL WATCH THE VIDEOS 
SEPARATELY. AFTER VIEWING THE VIDEOS SEPARATELY, A VIDEO 
RECOGNITION SURVEY (ATTACHED) IS COMPLETED BY THE COUPLE 
TOGETHER.
Baseline Visit – PHASE 3 (up to $50) 
1. Informed Consent process 
2. CASI survey ($30) 

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3. Randomization
4. HIV testing ($10) 
5. STI testing ($10) 
6. Session 1: will occur at this time in accordance with the randomized condition. 
a. Condition 1:  individual HIV testing (IHTC) as usual condition  
b. Condition 2:  We Test intervention
Randomization Stratification: Randomization will be stratified by stratified by Site, Age 
(either partner under 18 vs both 18 & older), Race/Ethnicity (Both White vs not both 
White) and whether the index partner attended individual vs couple.
After completing the baseline assessment for both Phases 2 and 3, YMSM will complete 
follow-up assessments a month after baseline, and 3 months after baseline. In Phase 3, 
participants will also complete assessments at 6-months post-baseline. Online CASIs will 
be completed at each follow-up either at home or in-office. In addition, STI and HIV 
testing will occur at the 3-month and 6-month follow-ups. All follow-ups will be 
conducted individually to facilitate retention, even if the couples dissolve. 
Immediate Post-Test Assessment (1 month after BL) 
1. CASI ($30) 
Three Month Follow-Up (up to $50) 
1. CASI ($30) 
2. HIV testing ($10) 
3. STI testing ($10) 
Six Month Follow-Up ($50)
1. CASI ($30)
2. HIV testing ($10)
3. STI testing ($10)
All ATN clinics in this project are currently performing HIV testing as part of the 
services they offer to the local community. Therefore each clinic has a protocol in place 
to deliver HIV positive results and link patient who test HIV positive to timely access to 
health care, including antiretroviral therapy. Participating clinics will be performing HIV 
testing as part of their routine services and will follow their local protocol for delivering 
HIV positive results for those testing positive for HIV. Meaning of the test results will be 
discussed with all youth who test for HIV prior to screenings. 
Participants who test positive for HIV while enrolled will be referred for a confirmatory 
HIV test when needed. Research staff trained in HIV testing and counseling will discuss 
the meaning of the HIV test results and explain the importance of timely access to health 
care, including antiretroviral therapy. 
Participants WHO RELOCATE OR ARE UNABLE TO ATTEND AN ATN SITE 
AFTER BASELINE WILL HAVE THE OPTION for at home HIV and STI testing or 
TESTING THROUGH a central lab such as Quest. SUCH PARTICIPANTS WHO TEST 

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HIV positive at a follow up assessment will receive the result from a member of PRIDE 
team who are key personnel on the project and are trained in HIV testing and counseling. 
See the attached PRIDE Response Management Plan which includes the protocol for 
delivering HIV positive results. Due to COVID, there are now at home and central lab 
testing options for Baseline and intervention testing. 
Participants who test positive for an STI at baseline or follow up assessments will be 
referred using the ATN clinics’ local protocol for positive STI results if STI testing 
occurs at one of ATN clinics. Participants who test positive for an STI through at home 
or central lab testing such as Quest will follow the attached protocol for delivery of 
positive STI results. STI RESULTS WILL BE SENT TO THE PARTICIPANT VIA A 
SECURED WEBPAGE AND PARTICIPANTS WILL RECEIVE A UNIQUE 
PASSWORD TO VIEW THEIR RESULTS.
For at home HIV/STI testing, kits may be mailed to a home address. Research staff will 
allow kits to be shipped to an alternate location deemed as a safe space, such as a youth 
center, and will require youth to speak with a trained staff member to ensure these 
arrangements are both safe and allowable. The at-home testing kit will come either from 
Molecular Labs or as a OraQuick HIV test. 
If a couple comes in together they will view an assertive communication training video 
separately and complete a video recognition survey together after. If a participant comes 
in without their partner, they will view the ACT video and complete the video 
recognition survey after.
All compensation is payable as cash or gift card based upon site restrictions.
Specimen Collection: HIV data will be collected via a blood draw or oral swab using a 
HIV rapid test and biomarkers STI will be collected via urine and rectal screen. The only 
purpose of the collected data is research. Participants who test positive for STI’s will be 
reported to the local health department in accordance with state laws for surveillance 
purposes. Participants who test positive while enrolled in We Test will be referred for a 
confirmatory HIV test and care following standard procedures at the clinic. Following 
standard ATN procedures, data will be coded with a unique study ID number at the time 
of enrollment, unrelated to their name or other personal identifying information; all 
specimens and survey data will be labeled with this unique identifier to provide 
anonymization of the data. The people who will have access to the data include members 
of the research team. Test results will not be shared with individuals outside of the 
research team. For at home testing procedures, we will share name and address with 
Molecular Labs for shipping the test kit only. Anonymized data will be coordinated with 
the broader ATN using established multi-site data sharing avenues.
7.0
Data and Specimen Banking*
Data for Future Use
Participants consent to these procedures as part of the consent/assent process.

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The research team, authorized staff, and government agencies that run this type of 
research may have access to research data and records in order to check on the research. 
Research records given to approved researchers will be de-identified. If a researcher 
requests the data, they will be special permission from the Research Compliance 
Administrator. Data collected during this research study may be used for future research 
purposes. The data stored will be de-identified.
Data that cannot be linked to participants (i.e., de-identified data) will be kept 
indefinitely; this data will be saved for future use and may be shared with other 
researchers. 
Biological samples collected for the purposes of this study will not be used to conduct 
any future research. They will be destroyed after analysis is completed
At the end of the study data collected will be made available, in accordance with the NIH 
Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing). These data will be 
saved for future use and may be shared with other researchers. By participating in this 
study, you are agreeing to allow us to save and share your data anonymously.
8.0
Sharing of Results with Subjects*
Phase 2 and Phase 3: HIV and STI Testing Results
Rapid HIV tests are performed, and results shared with the participants at both the 
baseline and 3-month, and 6-month (Phase 3 only) assessments. HIV test results are 
delivered in-person with referrals for PrEP/PEP and linkage to care (in the event of a 
positive test result). STI test results are sent individually to the participant via email. 
Results are entered into an online Qualtrics portal and sent to participant’s email address 
where they can view and save their results. The participant can confidentially view their 
STI results through the Qualtrics portal.  
For at-home Testing- Rapid HIV testing is performed with the person over ZOOM during 
the intervention. STI testing samples are collected and returned to the central lab for 
processing. Results are provided to the study team via a secure website. Those results are 
entered into an online Qualtrics portal and sent to participant’s email address where they 
can view and save their results. The participant can confidentially view their STI results 
through the Qualtrics portal.  
In Phase 3, we will be reporting positive STI results to departments of health in New 
York, Michigan, and California for surveillance purposes. Reporting of names for this 
purpose is state law and not exempted by research studies. We will inform the 
participants in the consent form that this will occur. Name, Date of Birth, and phone 
number will be reported.  
All results are not shared with any other individuals.

PROTOCOL TITLE:
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Submitted: October 11, 2019
 
9.0
Study Timelines*
Phase 2: Individual participants are in the study for three months (Baseline, 1-month at-
home survey, 3-month follow-up).
Phase 3: Individual participants are in the study for nine months (Baseline, 1-month, 3- 
month, 6-month follow-ups).
All study subjects will be enrolled over the course of 60 months. 
10.0
Subject Population*
Inclusion Criteria:
YMSM couples who express interest in We Test must demonstrate the following inclusion criteria to be 
enrolled in the study: 
•At least one partner must be HIV-negative or status unknown 
•THE INDEX PARTNER must be 15-24 years old 
•YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS 
STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE 
MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN 
YEARS OLD. 
•INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO 
ORGASM) 
•CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A 
RELATIONSHIP 
•HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON 
•Both relationship partners must agree to attend an assessment together at an ATN affiliated clinic 
•Both partners must be able to communicate in English. 
• GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER 
NONCOMFORMING •MALE SEX AT BIRTH REMOVED ON 8.21.18 
•"HAVE THAT PERSON'S AGE BE OVER 14 BUT WITHIN 2 YEARS OF INDEX PARTNER"; ALL 
PREVIOUS APPROVED CRITERIA STILL APPLY EXCEPT FOR THE AFORMENTIONED 
DELETED CRITERIA
•To participate in the intervention remotely, youth must be at least 17 and over the age of sexual consent in 
their state of residence. If participating as a couple, both must be over the age of sexual consent in their 
state. If a participant lives in the following states and want to participate remotely, they will need to be 18 
years old: Arizona, California, Delaware, Florida, Idaho, North Dakota, Oregon, Tennessee, Utah, Virginia, 
and Wisconsin. 
Exclusion Criteria:
YMSM couples will be excluded from the study if they indicate any of the following: 
•Unstable, serious psychiatric symptoms 
•Current suicidal/homicidal ideation 
•Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner
•IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN 
THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY 
STUDY WHEN THEY DID NOT WANT TO.
We will include individuals who are not yet adults: 
Study procedures involve no more than minimal risk. The nature and scope of the proposed 
research study, communication skills training and the CHTC intervention do not pose more than 
"minimal risk" to participants as defined in 45 CFR Part 46.102, "the probability and magnitude of 
harm or discomfort anticipated in the research are not greater in and of themselves that those 

PROTOCOL TITLE:
Page 15 of 26
Submitted: October 11, 2019
ordinarily encountered in daily life or during the performance of routine physical or psychological 
examinations or tests".
We will not include individuals who are adults unable to consent, pregnant women, and prisoners. 
11.0
Vulnerable Populations*
We will enroll research participants 15-24 years of age. The nature and scope of the proposed 
research study and We Test intervention do not pose more than “minimal risk” to participants, as 
defined in 45CFR Part 46, 102. “the probability and magnitude of harm or discomfort anticipated 
in the research are not greater in and of themselves than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations or tests.”  Given that 
some participants will be under the age of 18, adequate provisions will be made for soliciting 
informed consent.
We will not require parental consent for study enrollment. Parental consent may decrease 
participation rates because some youth will fear that they may be "outed" as a result of 
participation. Disclosure of sexual orientation may place participating youth at risk for parental 
harassment, abuse or expulsion from the home.
The intervention and measures utilized in this study are standard in this population, as are 
waivers of parental permission for survey and interview studies. Additionally, consistent with 
national policy recommendations from the Society for Adolescent Medicine, requiring parental 
permission for the proposed study would have a number of possible negative effects, including: 
(1) reducing the validity of the findings by effectively eliminating potential participants unwilling to 
share permission forms with their parents/guardians; (2) increasing risk to some youth whose 
parents have a negative response to the material in the permission forms that would suggest their 
child has a minority or alternative sexual orientation; and (3) adding little in the way of actual 
subject protection, given the minimal risk of study participation. Our procedures for the waiver of 
parental consent are consistent with the guidelines provided by the Department of Health and 
Human Services: http://www.hhs.gov/ohrp/humansubjects/ guidance/45cfr46.html#subpartd.
We will obtain assent from participants who are under 18 years of age. 
We are protecting this vulnerable by limiting at home testing option to those who meet 
criteria for FDA approval for Oraquick home testing (17 years of age) and age of sexual 
consent in their respective state (17 in New York and Michigan, 18 in California). 
12.0
Local Number of Subjects
Phase 2: 36 Couples or 72 individuals
Phase 3: 200 individuals
13.0
Recruitment Methods
Recruitment and Screening: Leveraging existing ATN infrastructure, participants will be recruited 
and screened for eligibility via 2 different ATN sites in Phase 2 and 3 ATN sites in Phase 3 that 
provide HIV testing and prevention services to YMSM. All ATN clinics, as well as PRIDE, have 
extensive relations with the gay, lesbian, bisexual, and transgender communities, community 
service organizations, health service organizations, and providers for MSM. This may be 
supplemented by online advertising conducted through SIU’s Recruitment and Enrollment Core 
(REC). Potential Participants may be identified at these local sites through testing services, 
outreach activities, and online social media and dating apps (e.g., Facebook, Instagram, Reddit, 
Tumbler, Grindr, Scruff, Adam4Adam, Jack’d).  While advertising will be distributed through SIU’s 
REC, they will be targeted to the geographic areas surrounding the ATN sites for this project and 

PROTOCOL TITLE:
Page 16 of 26
Submitted: October 11, 2019
will contain information about participation at the ATN clinic. Given the shift to remote testing, 
intervention delivery, and study visits in Phase 3 due to COVID-19, recruitment via online 
advertisements will be expanded nationwide. Couples will be screened through an indexcase 
approach. One partner in the couple will be asked to provide screening information about 
themselves and their partner. If the couple is preliminarily eligible based upon the report of the 
index partner being screened, that index partner will be asked to schedule a baseline 
appointment SCHEDULING WILL TAKE PLACE VIA EMAIL, TEXT MESSAGE, AND PHONE at 
a time both they and their partner can attend. Contact information for the index partner will be 
collected at this point and added in REDCap for tracking purposes.
Additionally, PRIDE (formerly CHEST) at Hunter College will assist in referring potentially eligible 
participants to the We Test study through existing online recruitment efforts. PRIDE utilizes the 
Hunter College IRB-approved Online Master Screener (OMS) to preliminarily screen individuals 
who are interested in participating in studies being conducted through PRIDE. If an individual is 
preliminarily eligible for a study, the individual is asked to provide contact information to PRIDE 
for follow up. For the purposes of this study, the OMS will only be used to refer potentially eligible 
YMSM to HIV testing sites by sending them an email referral informing them about the We Test 
study and where to go to determine eligibility after completing the OMS. The contact information 
collected through the OMS will not be provided to the HIV testing clinic sites. However, We Test 
clinic sites will be made aware that a potentially eligible YMSM has been referred to their testing 
services for the study. The OMS, in this instance, will primarily be used as a referral mechanism 
for the study, directing participants to which study they may be eligible for, including We Test. 
YMSM who complete the OMS and screen preliminarily eligible, WILL BE CALLED FOR PHONE 
SCREENING TO DETERMINE STUDY ELIGIBILITY OR SENT A LINK VIA TEXT AND EMAIL. 
IF THEY ARE ELIGIBILE, THEY WILL BE REFERRED TO THE ATN CLINIC STAFF FOR THE 
BASELINE APPT. 
CHWs who conduct standard of care HIV testing services for the We Test clinic sites will be 
trained to provide information about the We Test study after HIV-negative results are delivered at 
their clinic or in the field at mobile testing events. The CHW will be trained in appropriate and 
ethical methods of recruiting participants in clinical settings and in the field. To minimize the risk 
for coercion, the staff member and the study information will emphasize the optional nature of 
participation and that it will not affect, in any way, their access to healthcare services. If the 
potential participant is interested in finding out if they are eligible for We Test after learning about 
the study, the CHW will provide an iPad with a secure online REDCap We Test Study Screener 
(IRB approved). The confidential We Test Study Screener will be completed on the iPad by the 
potential participant and no one will be able to see the responses; the iPad will only indicate 
whether the potential participant is eligible. THE WE TEST SCREENER WILL ALSO BE 
AVAILABLE FOR DELIVERY OVER THE PHONE WITH POTENTIAL PARTICIPANTS BY 
PRIDE STAFF OR CAN BE COMPLETED AT HOME VIA AN ONLINE LINK.
YMSM who screen ineligible for the study do not need to provide contact information and may 
screen again after 30 or more days provided they get tested HIV-negative at the clinic site in the 
past 90 days or they again test HIV-negative at the clinic site. Participants are also able to re-
screen should they test HIV-negative at the clinic site or through mobile testing efforts associated 
with the clinic site.
14.0
Withdrawal of Subjects*
Criteria for Premature Discontinuation

PROTOCOL TITLE:
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Submitted: October 11, 2019
On the next page, there are the categories of “dropping” participants along with their 
definitions. These categories should be accurately used in the site’s tracking materials if 
one of the conditions below occurs.
Category: Definition
Procedure
Notes
Refused baseline (BL) (Prior 
to Consent): Screened 
eligible, but never shows up 
for assessment and/or no 
longer wishes to be 
contacted.
Remove from rescheduling 
call lists and mark as “Do Not 
Contact” in REDCap. 
Counted towards screened 
number only.
Withdrew during BL (After 
Consent): Provided consent 
but refused to finish BL 
assessment.
Mark as “Baseline concluded” 
but not “Baseline completed”
Counted up to and including 
magic number; these 
participants get marked as 
“Withdrew from Study” for 
IRB purposes.
Withdrew during BL (After 
Consent): Provided consent 
but their partner refused to 
participate.
Mark as “Baseline concluded” 
but not “Baseline completed”
Counted up to and including 
magic number; these 
participants get marked as 
“Withdrew from Study” for 
IRB purposes.
Withdrew after BL (After 
Consent): Participant 
completed the BL but 
asked to be removed from 
the study thereafter.
Remove from Follow-Up Call 
Lists; should be Tracked as 
enrolled and have a condition 
assigned.
Counted up to and including 
randomized/enrolled and stays 
in all denominators for Follow-
Up retention; these participants 
get marked as “Withdrew from 
Study” for IRB purposes.
Ineligible during BL (After 
Consent): Provided consent 
but was found to be 
Ineligible during the BL 
assessment.
Mark as “Baseline concluded” 
but not “Baseline completed”
Counted up to and including 
magic number; these 
participants get marked as 
“Withdrew from Study” for 
IRB purposes.
Ineligible after BL (After 
Consent): Participant either 
completed the BL, both BL 
and sessions, OR all BL, 
sessions and follow-ups but 
was found ineligible for 
enrollment at a later date 
(e.g., found to have 
psychiatric conditions while 
collecting BL data◊)
Remove from Follow-Up Call 
Lists; should be Tracked as 
enrolled and have a condition 
assigned
Counted up to and including 
randomized/enrolled and stays 
in all denominators for Follow-
Up retention; these participants 
get marked as “Withdrew from 
Study” for IRB purposes.
Refused intervention (if 
applicable), Still Enrolled: 
Participants who are no 
longer interested in the 
Remain in Database to be 
called for Follow-Up visits
Treated as other enrolled 
participants except they 
wouldn’t show up on session-
specific call lists.

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Submitted: October 11, 2019
intervention sessions, but 
have indicated a willingness 
to continue to be followed 
for Follow-Up Visits
Passed away: Participant 
was enrolled but later 
passed away
Notify Clinical Site 
Management Center (CSMC) 
immediately with details 
regarding the situation (i.e. 
Date of Death, Date Notified, 
Cause of Death, Participant 
Age and Sex); Remove from 
Follow-Up Call Lists
Counted up to and including 
randomized/enrolled and stays 
in all denominators for Follow-
Up retention; these participants 
get marked as “Withdrew from 
Study” for IRB purposes.
Other
If a participant withdraws for 
any other reason not listed 
here, please contact the 
CSMC immediately to discuss 
how to proceed. 
15.0
Risks to Subjects*
- 
The study has the following risks:  The risks and discomfort associated with participation 
in this study are no greater than those ordinarily encountered in daily life, standard 
medical care or physical/psychological tests. However, there is some risk of emotional 
discomfort or distress due to the personal nature of the topics discussed in the training 
and counseling sessions. 
Other risks: There is a risk of pain at the site of the finger prick for the HIV test. 
16.0
Potential Benefits to Subjects*
The benefits to study participation are:  
This study can benefit you and other adolescents and young adults like you by helping 
develop a counseling intervention that is better suited for younger same-sex male 
couples. Of course, because everyone responds differently, no one can know ahead of 
time if it will help you.
17.0
Data Management* and Confidentiality
We have strict guidelines to protect privacy of participants during recruitment, consent 
process, and research procedures. 
For recruitment, the HIV tester or phone screener discusses the study with the participant 
in a private setting. The screening survey is done through an online survey to make the 
screening process private. If the participant is eligible, contact information is collected 

PROTOCOL TITLE:
Page 19 of 26
Submitted: October 11, 2019
electronically and not with paper and pencil. That contact information is password 
protected and kept separate from the screening questions. 
For the Consent process, being consented into the study will take place in a private 
setting. The signed consent will be kept separate from all other participant information, 
survey data, and other materials in a locked cabinet.
For the research process, authorized research staff who are trained on the ethical conduct 
of research will contact participants by telephone, email, or mail, depending on the 
participants' preferred method of contact, to schedule appointments for study visits. Staff 
are trained to be discrete when contacting participants. Furthermore, to offset the risk of 
violation of data confidentiality, strict confidentiality will be maintained; records that 
have personal identifiers (i.e., contact information) will be stored in files that have 
password protection and are kept separate from research records. All research forms are 
stripped of personal identifiers, with the participant number being used to identify 
specific research forms. No presentation or publication of the study results will refer to 
participants individually. Manuscripts published regarding this work will be based on the 
accumulated database. A federal Certificate of Confidentiality, which protects subjects' 
records against subpoena, will be obtained prior to study start. Exceptions to 
confidentiality for participants are those required by law (information that would lead to 
suspicion of child abuse, elder abuse, or threat of imminent action on suicidal or 
homicidal ideation). Participants will be informed of these exceptions in the informed 
consent process. 
No identifying information about participants will be recorded on audio files. Participants 
will be instructed not to identify themselves or third parties during their study visit. 
Audio record of the interviews conducted will be stored electronically; to which only 
research staff and those authorized will have access to transcribe the material. Audio 
recordings will only be identified with alphanumeric IDs. No identifying information 
about participants will be recorded in the Internet based survey. The structured 
questionnaires will be computerized and self-administered. We are using a software 
program called Qualtrics to program the online survey for this study. Developed by a 
social psychologist, the Qualtrics software program is a sophisticated electronic survey 
creation and management tool. It is recognized as a valuable assessment program and is 
currently used in a vast array of research and academic settings across the US. The survey 
will be SSL encrypted and accessible using an HTTPS URL. Data are encrypted, 
downloaded, and stored on a secure server, which is password protected and routinely 
backed up. Participants will be identified in the questionnaire only by an assigned 
numeric study ID. No identifiers (e.g., name, address, date of birth, social security 
number) will be collected using the questionnaire itself. The programmed questionnaire 
and any data resulting from it will reside on a server that is protected by an internal 
firewall. 
The information obtained during this research will be kept confidential to the extent 
permitted by law and will be stored at our research offices for 3 years after the study is 
completed. Data that cannot be matched to you may be saved for future use and may be 

PROTOCOL TITLE:
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Submitted: October 11, 2019
shared with other researchers. As part of the consent process, participants will be 
agreeing to allow us to save and share their data anonymously. 
In Phase 3, we will be reporting positive STI results to departments of health in New 
York, Michigan, and California for surveillance purposes. Reporting of names for this 
purpose is state law and not exempted by research studies. We will inform the 
participants in the consent form that this will occur. Name, Date of Birth, and phone 
number will be reported.  
How will you store participant data?: 
With codes Participants are assigned a unique ID number that is 10 digits. Links to codes 
are stored in our REDCap databases in our password-protected computers.
PRIDE staff and other site staff will have access to links, including the Protocol Leads, 
research assistants and project managers; will have access to the links to be able to 
contact participants for follow-up assessments during the period of time prior to 
anonymizing the data. Links will not be released to external researchers.
List the identifiers that will be stored:
For Interviews with site staff members only, audio files are stored on our secured server 
and may contain names of site staff members implementing the projects. After three 
years, we delete all audio files for this study, including any link between information on a 
site staff person and the information in the Qualitative interview. ATN We Test 
intervention sessions with the study participant will also be audio recorded, these audio 
files are stored on our secured server will not contain names and only be labeled with the 
participant ID number.
Will codes be deleted (and data anonymized) at a later date? Yes
When will codes be deleted? 
NIH, our funding agency, mandates that we keep records for a period of at least 3 years 
for auditing purposes and therefore, data will be retained for a minimum of 3 years after 
study completion. At the end of this time, all identified information (e.g., contact 
information) will be deleted, effectively destroying the link between the data, unique 
codes, and participants' identities and de-identifying/anonymizing the data. The codes 
themselves will be retained indefinitely to allow for identifying each participant across 
datasets, but the codes will no longer be linked to any identified information and thus the 
data will be anonymous.
What will you do with the data once the research has been completed?: Save data for 
future use / create data bank
Purpose of the data bank:
To allow external researchers to access the data bank for future analyses and meet 
requirements for submitting data to repositories as required for publication in some 
journals. This data is also collected as part of a larger NIH priority to study the 

PROTOCOL TITLE:
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Submitted: October 11, 2019
epidemiology of HIV; thus, researchers will likely conduct future analyses with pooled 
data across studies.
Data points that will be included in the data bank: All de-identified data (i.e., survey data 
and test results, but not the specimens themselves) will be included in the data bank.
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
This research involves no more than Minimal Risk to subjects.
The protocol has a Data Safety Monitoring Plan and is reviewed semiannually by 
a Study Monitoring Committee. 
The Scale-It-Up (SIU) U19 Data Safety and Monitoring Plan will utilize a single 
monitoring system for all SIU protocols (including We Test) in order to 
harmonize review standards across protocols. The review process of the most 
vulnerable protocol will be applied to all SIU protocols thereby ensuring adequate 
oversight. We propose utilizing an independent study monitoring committee 
(SMC). A SMC was selected as the Clinical Research Management (CRM) as it is 
the highest level CRM needed for the most vulnerable SIU protocol. The 
proposed SMC will be composed of three independent experts who possess the 
relevant expertise (e.g., HIV-related research and prevention, adolescent 
medicine, and sexual health) to evaluate each SIU protocol and whom do not have 
a conflict of interest. Mary Velasquez, Jim (Xinguang) Chen, and Dushyantha 
Jayaweera have formally agreed to serve on the SIU SMC. Together, they 
represent an academically diverse and highly experienced team capable of 
providing the necessary foresight and oversight to ensure data safety monitoring 
plans are diligently designed and implemented. SIU has the appropriate funding 
available to financially support the activities of the SMC. The SMC will review 
each research protocol and plan for data and safety monitoring every 6 months, 
with additional ad-hoc reviews as necessary. All SMC meetings and reviews will 
be held via telephone conference.
Adverse Events Reporting
The Site Protocol Lead (PL) is responsible for the detection and documentation of events 
meeting the criteria and definition of an adverse event (AE) or serious adverse event 
(SAE). Data for monitoring participants’ safety will be captured within the REDCap 
database as part of the required study data. Site study staff may ask questions concerning 
adverse events via the SIU query system, but must formally report them via email and 
REDCap. Information on unexpected events including SAE will be reported as per the 
policy of SIU’s single IRB (sIRB).
Information to be collected includes the nature, date of onset, stop date, intensity, 
duration, treatment, causality, and outcome of the event. Site PLs should follow usual 
clinical practices at their institutions for reporting serious, unexpected events related to 
standard of care. SAEs that occur after 30 days after completion of the study will be 

PROTOCOL TITLE:
Page 22 of 26
Submitted: October 11, 2019
collected only if they are considered by the PL to be related to study participation. In 
addition, any AE resulting in potential participant withdrawal must been reported to the 
SIU REC prior to participant withdrawal when possible.
Site PL s must report any AE to the REC within one business day of learning of it. The 
REC will then report all SAEs to the IRB within 3 business days and all AEs within 5 
business days, upon learning of them from site study staff.
19.0
Compensation for Research-Related Injury
NA: The research does not involve more than Minimal Risk to subjects.
20.0
Economic Burden to Subjects
Research subjects are responsible for their transportation to and from the 
research facility/office.  
21.0
Consent Process
Site PLs must ensure that participants are fully informed about the purpose, 
responsibilities of participating and potential risks or other critical issues related to 
participation in SIU studies. Written informed consent or assent must be obtained from 
every participant or, in those situations where consent cannot be given by participants, 
their legally acceptable representative, prior to clinical study participation. 
A waiver of parental permission has been obtained for minors choosing to participate 
with parental permission.  
The rights, safety, and well-being of SIU study participants are the most important 
considerations and should prevail over interests of science and society. If there is any 
question that the prospective participant will not reliably comply with study procedures 
and/or follow-up, they should not be enrolled in a SIU study.
Consent will be discussed and documentation obtained in person at subjects' baseline 
visits prior to any data collection or other study procedures. Informed consent procedures 
will be conducted privately with each participant in order to minimize the potential that 
youth feel pressured by a partner to participate in the study. For Phase 3, we are changing 
these procedures so informed consent occurs over the phone before sending any At-home 
testing kits. 
The Research Assistants (RAs) from Detroit, Hunter College, and San Diego (Phase 3 
only) will be the individuals who will obtain consent from participants. The RAs will be 
trained on the protocol and the consent process, RAs will obtain CITI training which will 
be submitted to the IRB. The RAs will not engage in any research activity until they are 
registered as Research Staff with the FSU IRB and IRB approval is granted for their role 
on the research project.

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Submitted: October 11, 2019
Subjects 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.
Non-English Speaking Subjects
Eligibility includes criteria that participants must speak English. No separate plan for 
obtaining consent is needed for non-English speakers. 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception).
We are obtaining a waiver of parental consent. Our research protocol is designed for 
conditions or for a subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects. 
Parental or guardian permission is not a reasonable requirement for our research with the 
15-17 year old participants. Youth will be completing surveys and discussing sensitive 
topics such as their sexual behavior and substance use. Parental permission would put 
those youth whose parents do not already know about their sexual orientation at risk of 
their parents learning about this by the nature of requesting their permission to participate 
in a study of this kind. This may then place these youth at risk for parental harassment, 
abuse or expulsion from the parental home. Parental permission could not only place 
these youth at increased risk, but it would also substantially limit the generalizability of 
our research. 
Our justification for this waiver is informed by prior research with the target population, 
which has demonstrated risks of parental victimization during coming out or discussions 
of sexual orientation. Most YMSM are unwilling to ask their parents' permission to be in 
an HIV-focused study and those who are willing are significantly different on key 
variables. In addition, research suggests that young YMSM have the capacity to make an 
informed decision regarding participation (e.g., appreciation of risks/benefits to 
themselves, understanding research components such as randomization) despite this not 
meeting the legal definition of consent. As shown in prior research—including that of our 
consultant, Dr. Brian Mustanski, parents with LGBT-identified children appreciate the 
rationale for waivers of their permission when the study and its purpose are explained. 
This evidence supports the fact that YMSM are a population for whom parental or 
guardian permission is not a reasonable requirement to protect the participants and a 
waiver of parental permission is appropriate under 45 CFR 46.408(c). This determination 
was further supported by the fact that this study poses minimal risk (i.e., does not expose 
participants to greater risk than encountered in everyday life) and therefore the waiver 
could also be approved under 45 CFR 46.116(d) based on the evidence described above 
that the research is not possible if parental permission is required. Additionally, 
consistent with national policy recommendations from the Society for Adolescent 
Medicine, requiring parental permission for the proposed study would have a number of 

PROTOCOL TITLE:
Page 24 of 26
Submitted: October 11, 2019
possible negative effects, including: (1) reducing the validity of the findings by 
effectively eliminating potential participants unwilling to share permission forms with 
their parents/guardians; (2) increasing risk to some youth whose parents have a negative 
response to the material in the permission forms that would suggest their child has a 
minority or alternative sexual orientation; and (3) adding little in the way of actual 
subject protection, given the minimal risk of study participation.
Cognitively Impaired Adults

NA
Adults Unable to Consent

NA
22.0
Process to Document Consent in Writing
Consent can  be obtained in writing using a consent or assent form which details all study 
procedures and expectations for participation or via an online consent/Assent in 
QualtricsFor in person consent, the RAs and the participant will both sign two copies of 
the consent/assent forms. The RA will retain one for filing and the participant will be able 
to take a copy with them.  For remote Baselines, the RA will call the participant to 
conduct the informed consent process. The link will be emailed to the participant that 
they will complete during the consent process. 
The consent and assent forms was written using the Template consent document (HRP-
502)
23.0
Setting
This research is being conducted at the PRIDE Health Research consortium at Hunter 
College, New York, NY and Wayne State University Prevention (W’SUP) at Wayne 
State University, Detroit, MI. In Phase 3, appointments will also occur at the LGBT 
Community Center of San Diego.  
Please see submitted Local context forms for additional information about each site.
Potential Participants are identified at these local sites through testing services, outreach 
activities, and online social media and dating apps. Please see recruitment sections for 
more information. 
At both locations, the research will be conducted in private assessment rooms equipped 
with either a computer or iPad for the participant to complete the online CASI. All 
research procedures will be performed in the offices of the research facility or remotely 
via a HIPAA compliant Zoom. Rapid HIV tests will be performed in the facilities’ 
phlebotomy room and STI sample collection will take place in a private restroom.  For At-
home testing, the Rapid HIV test will occur via zoom with the participant and the Community 
Health Worker as part of the intervention. The STI samples will be collected privately at the 
participant’s home and returned to the central lab for processing.

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Submitted: October 11, 2019
The Community Advisory Board for this protocol is a part of the national Youth 
Community Advisory Board for the Scale IT Up program of research. They meet on a 
quarterly basis via skype to discuss study progress, recruitment strategies, and 
recommendations for youth engagement. 
24.0
Resources Available
Since this study is currently in phase 2 of 3 phases, the goal is obtain enough information 
on feasibility and acceptability of the intervention. The information obtained will inform 
the RCT of the selected intervention versus the standard Couples HIV testing and 
Counseling. We plan to enroll for Phase 2 through until we have an N= 40 participants. 
We hope to obtain the desired number of anticipated participants. As of Decemeber 2019, 
we have  all participants enrolled for Phase 2. We have made substantial changes to the 
overall design (see previous amendments) and hope these changes will increase our 
recruitment. 
As we commence Phase 3, we will utilize the resources at Hunter College at CUNY to 
assist with this project. Hunter College's Promoting Resilience, Intersectionality, 
Diversity, and Equity in Health Research Consortium was created to serve as a hub for 
Hunter's expanding work in sexual and gender minority health and broader focus on 
sexuality, gender, and health. The PRIDE Consortium supports research at the nexus of 
psychology, public health, and the health and helping professions that is relevant to 
understanding and addressing the health needs of diverse SGM individuals. 
PRIDE Serves as the Management core (MC) to track project procedures and assist with 
study recruitment across the different sites. The MC, maintain responsibility for the 
overall conduct and implementation of the study; the MC is also responsible for 
management of recruitment and retention including enrollment and retention. The REC 
will also be responsible for Data Management while the AC will be responsible for 
analysis and reporting. The Protocol Leads are responsible for scientific leadership and 
dissemination. Protocol meetings are held bi-weekly to keep all assisting personnel 
informed about the protocol and its procedures. Moreover, Dropbox is utilized to 
facilitate the storage and sharing of study-related documents, which further informs 
protocol personnel about any updates to research procedures.
25.0
Multi-Site Research* 
This research is being conducted at the PRIDE Health Research consortium at Hunter 
College, New York, NY and Wayne State University Prevention (W’SUP) at Wayne 
State University, Detroit, MI. In Phase 3, this research will also be conducted at the 
LGBT Community Center of San Diego.

PROTOCOL TITLE:
Page 26 of 26
Submitted: October 11, 2019
Recruitment: Both sites will recruit individually for participants as outlined in the 
recruitment section above. This also applies to San Diego in Phase 3. Each site will have 
site specific recruitment materials for potential participants. See attached materials.
Enrollment: All Sites have site specific consent and assent forms for participants to sign.  
All data is collected with Qualtrics, which means that the sites will not have local copies 
of the data at their offices. All data will be stored on the cloud through program servers. 
Site oversight: The Scale It UP management core have daily contact with the sites 
regarding participant procedures. The Protocol Leads meet monthly with the site PIs. The 
Site PI for the PRIDE site is also the Protocol Lead for this protocol. So there is constant 
communication between sites. In addition there is an online support request form through 
the Scale It UP Site Communication System for sites to submit queries and questions 
regarding this protocol.  Additionally, the Management Core sends quarterly reports to 
each site outlining whether the site meets the established expectations for site enrollment 
and progress. 
Reporting of serious adverse events and unintended events: Both sites have procedures 
set in place to report any unintended events to the Scale It UP management core. The 
sites can submit an online support request of any events through the Scale It UP Site 
Communication System.