Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (ESTEEM-conneCT)
Phase: NA
Conditions: HIV in MSM
Sponsor: Yale University

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NCT03464422 
 
Title of Research Project: Adapting an Evidence-based Intervention for Stigma-related Stress, 
Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (ESTEEM-conneCT) 
 
Study Protocol Last Approved by IRB Date 4.24.2019 
 
 
 

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HRP-503E– Protocol for Social or Behavioral Science or Educational Research 
(2017-1) 
 
 
Protocol Title: Adapting an evidence-based intervention for stigma-related stress, mental health, and HIV 
risk for MSM of color in small urban areas (ESTEEM-conneCT) 
 
 
Principal Investigator: John Pachankis, PhD and Krystn Wagner, MD  
 
 
Version Date: 4/24/2019 
 
 
 
(If applicable) Clinicaltrials.gov Registration #: NCT03464422 
 
 
 
INSTRUCTIONS 
 
This template is intended to help investigators prepare a protocol that includes all of the necessary 
information needed by the IRB to determine whether a study meets approval criteria. Read the following 
instructions before proceeding: 
 
1. 
Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system 
Library:  
• 
If the study involves genetic testing, blood draws, or MRIs, do not use this form. Use the 
biomedical protocol template. 
• 
If the study involves secondary analysis of data, use the Secondary Analysis of Data protocol. 
• 
For activities that may qualify as exempt research, use the Request for Exemption form 
(which includes a decision tree to determine whether or not your study qualifies as exempt). 
 
2. 
If a section or question does not apply to your research study, type “Not Applicable” underneath. 
 
3. 
Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system.  
 
 
 
 
 
 
 
 
 

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SECTION I: GENERAL INFORMATION 
 
 
1. 
Probable Duration of Project: State the expected duration of the project, including all follow-
up and data analysis activities.  
 
The study timeline will take place over the course March 1, 2018 to November 30, 2019. The first three 
months will be dedicated to IRB processes and staff development, followed by participant recruitment and 
pre-test assessments. Starting in the 7th month and continuing through August of 2019, participants will be 
enrolled and participate in the ESTEEM-conneCT intervention. Two separate intervention cohorts will be 
recruited: one in the Fall of 2018 and one in the Spring of 2019. The final quarter of the project timeline will 
be committed to post-test assessments, the dissemination of findings, and preparation of an R34 NIH grant 
application.  
 
 
 
  
2. 
Study location: State where the study will take place and in what setting.  
 
The intervention study will take place in New Haven, CT with a partnership between the Fair Haven 
Community Health Center (FHCHC) and the Yale School of Public Health (YSPH).  Participants will only 
participate at FHCHC; data will be collected and stored at both sites. 
 
If international, complete and submit International checklist (http://your.yale.edu/policies-
procedures/forms/450-ch-1-international-research-checklist) Note: If your research involves interactions 
with any embargoed countries you should contact the Director of Corporate Contracts and Export Control 
Licensing (Donald.Deyo@yale.edu or call 203.785.3817) for guidance on how to proceed.    
 
 
3. 
Help us categorize your research. Are you using any of the following? 
☐ Class Project 
☐ Participant Observation 
☒ Interviews 
☒ Surveys 
☒ Focus groups (study is not anonymous) 
☐ Research in K-12 schools (submit a School Agreement form for the study) 
☐ Deception (submit a Debriefing sheet) 
☒ Audiotaping, videotaping or photography of individuals (study is not anonymous) 
☐ Public viewing of videotapes or photographs  
☐ Yale Psychology Pool (study does not qualify for exemption) 
☐ International research sites (attach the International Checklist) 
☒ Online (web-based) activities 
☐ Social networks 
 
 

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SECTION IV: RESEARCH PLAN 
 
1. 
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be 
tested.  
 
Gay, bisexual, and other men who have sex with men (MSM) represent the only major risk group 
for whom new incident cases of HIV are increasing in the US; indeed, MSM of color living in the 
US represent one of the most at-risk populations in the world.1-3 At current rates, 1 in 3 MSM of 
color in the US will be diagnosed with HIV in their lifetime.1 Vast racial disparities in HIV exist 
despite the fact that MSM of color do not engage in greater rates of risk behaviors (e.g., 
condomless anal sex with serodiscordant partners, substance abuse) compared to white MSM.3-5 
Explanations for these disparities, therefore, lie in the structural disadvantage surrounding MSM 
of color.4 Experiences of racial stigma and discrimination can erode coping resources and social 
support and ultimately drive poor mental health,6-9 HIV risk behavior,10,11 and their co-
occurrence.10,12 In fact, MSM of color report greater depressive distress than white MSM,13 which 
in turn predicts HIV risk behavior.14 MSM of color’s exposure to racism and homophobia together 
drive HIV-risk behavior, lack of testing, lack of status disclosure, and among HIV-positive MSM, 
lack of antiretroviral adherence.15 While the ultimate elimination of structural barriers should 
represent the primary goal of HIV prevention programs for MSM of color, as long as such barriers 
persist, another justifiable target of public health interventions is the empowerment of MSM of 
color to develop resilience against stigma through building mental health and stigma coping 
strategies.  
 
MSM of color who reside in small urban areas of the US are at particular risk of acquiring HIV,16 
yet the majority of preventive interventions have only been developed and tested in major cities. 
Our research shows that MSM of color living in small urban areas face distinct barriers to 
psychosocial health, including a loss of physical “safe” gay spaces and community visibility as a 
result of increasing technology use, and exclusion from the limited remaining gay spaces because 
of segregation and racism.17,18 Through psychological experiences of social exclusion, low self-
worth, and hopelessness, sexual and racial stigma drive mental health problems (e.g., 
depression, substance abuse), which in turn serve as a known risk factor for HIV infection among 
syndemically affected populations.11,12,14,15  
 
The proposed research will draw upon our previous qualitative work with MSM of color in small 
urban areas17,18 and other qualitative work documenting the resilience displayed by MSM 
communities of color19,20 to create and deliver a group-based intervention to improve stigma 
coping and mental health among MSM of color. Because the psychosocial effects of interpersonal 
and structural stigma represent the syndemic precursors to HIV risk,21-23 we expect that this 
intervention will help buttress MSM of color’s defenses against HIV transmission in small urban 
areas. This intervention addresses three gaps in current approaches. First, although our team has 
created the first evidence-based intervention to reduce MSM’s HIV risk behavior by improving 
stigma coping and mental health,24-26 this intervention has been developed and delivered in major 
cities.  Second, although about half of the participants in our original intervention trials were MSM 
of color, the treatment has not specifically addressed the intersecting sources of stigma that MSM 
of color face. Third, because this treatment has only been delivered in one-on-one settings, it has 
not taken advantage of the ability of group delivery to promote healthy peer norms, role modeling, 
and social connections that might be particularly important in the social and sexual networks of 
MSM living in small urban areas.27,28  
 

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In Aim 1, we will modify our existing intervention manual using feedback from our previous 
qualitative interviews with MSM in New Haven and Hartford, CT, and other recent qualitative 
research on MSM of color’s resilience, regarding the ways in which racial minority stigma impacts 
the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in 
the face of these health threats.  
 
In Aim 2, we will deliver the intervention to approximately 30 young MSM to gather the feasibility 
and acceptability pilot data necessary for an NIMH R34 intervention development grant. Pre-post 
comparisons of quantitative assessments will yield effect sizes estimates for powering future 
proposals. Qualitative interviews will provide information regarding intervention feasibility, 
acceptability, and refinement. 
 
This project integrates expertise in culturally-sensitive evidence-based interventions for MSM’s 
HIV risk into a community-based HIV prevention and care context at the Fair Haven Community 
Health Center, where the intervention will be delivered to the existing patient population. This 
community-research alliance maximizes this project’s ability to receive widespread community 
implementation to improve stigma coping and mental health en route to reducing HIV-
transmission risk among one of the highest-risk populations in our region and the world. 
 
2. 
Background: Describe the background information that led to the plan for this project. 
Provide references to support the expectation of obtaining useful scientific data.  
 
MSM of color living in the US represent one of the highest-risk groups for HIV infection in 
the world. While gay, bisexual, and other men who have sex with men (MSM) represent the only 
risk group for whom new incident cases of HIV are increasing in the US, MSM of color are at even 
greater risk.1,2 Like many preventable diseases in the US,29-32 as the HIV epidemic progresses, its 
burden has become most strongly carried by already disadvantaged populations. At current rates, 
1 in 2 African American MSM and 1 in 4 Latino MSM in the US will become infected with HIV in 
their lifetimes.1 This rate is nearly four times the rate of White MSM and over 40 times the rate of 
US men overall. Far from being an equal health threat to all, HIV is increasingly concentrated 
among MSM of color.1,3 
 
As a fundamental cause of health disparities,29-32 structural racism drives vast racial 
inequities in the HIV epidemic. Vast racial disparities in HIV exist despite the fact that MSM of 
color do not engage in greater rates of individual risk behaviors (e.g., condomless anal sex with 
serodiscordant partners, substance abuse) compared to white MSM. Explanations for these 
disparities, therefore, lie in the structural disadvantage surrounding MSM of color. In addition to 
experiencing the structural stigma affecting all MSM (e.g., sexual orientation discrimination, lack 
of legal protections, concealment demands), MSM of color also face structural inequities 
associated with race in the US. Specifically, MSM of color are more likely to be unemployed and 
incarcerated, and therefore to be economically disenfranchised, than white MSM.3 Because of 
structural racism and associated economic inequities, MSM of color are also less likely to have 
health insurance, more likely to have untreated sexually transmitted infections, and, among those 
with HIV, less likely to adhere to antiretroviral therapies and to be virally suppressed.33 Thus, any 
effective preventive intervention for MSM of color must address structural forms of stigma and 
racism, rather than solely individual risk behaviors.4 
 
Despite the fact that small urban areas now represent the highest-risk locations for MSM of 
color in the US, HIV-preventive interventions continue to be focused on MSM in major 
cities. 20 of the 25 US metropolitan areas with the highest HIV prevalence among MSM are 

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characterized as small urban areas.16 One in four MSM living in small US cities like Jackson, 
Mississippi; Columbia, South Carolina; and El Paso, Texas, are infected with HIV.16 The majority 
of new HIV cases among MSM in Connecticut occur among MSM of color living in one of 
Connecticut’s four small urban areas.34 The racial disparities in HIV infection in small urban areas 
of Connecticut parallel national trends: While Blacks and Hispanics make up only 23% of 
Connecticut’s population, they comprise 66% of all HIV cases. In 2014, Black males in 
Connecticut were diagnosed at a rate approximately 8 times that of white males and Hispanic 
males were diagnosed at a rate approximately 4 times that of white males.34 
 
MSM of color living in small urban areas face distinct risks for HIV infection, which are 
currently overlooked in HIV-prevention interventions. Our pilot research recently uncovered 
distinct sources of HIV risk among MSM of color living in Connecticut’s small urban areas. 
Specifically, in qualitative interviews with 29 HIV-negative and HIV-positive MSM (n = 16 MSM of 
color), participants noted that the advent of social and sexual networking technologies has 
ushered a decline of physical spaces that historically served as “safe” venues for gay and 
bisexual men regardless of race.35,36 Participants perceived the remaining spaces as catering to 
white MSM or university affiliates and excluding MSM of color. MSM of color also noted a loss of 
the intergenerational mentorship, free of sexual overtones, facilitated by these spaces. Many 
frequently travel to nearby gay enclaves, typically New York City, where personal health-
protective values are often discarded in the context of this relatively unfamiliar urban environment 
full of sexual opportunities.35-37  
 
Sexual and racial stigma drive HIV infection risk through diminished coping and social 
support. As noted above, structural racism represents the primary driver of US racial disparities 
in HIV infection. Structural racism is known to be particularly intractable in that it operates through 
interchangeable mechanisms to perpetuate its effects over time.31 For instance, while separate-
but-equal (i.e., Jim Crow) laws have been recognized as unconstitutional since 1964, Black men 
today have a 1 in 3 chance of being imprisoned in their lifetimes, 1 in 8 currently cannot vote, and 
the racial disparity in unemployment remains what it was in 1954.38,39 Racist financial lending 
policies have created under-resourced racially segregated neighborhoods, such as those in small 
urban areas like New Haven.40 Clearly, powerful forces ensure that barriers to racial equity 
persist, with undeniable consequences for the health of MSM of color.4,5,41 MSM of color’s 
experiences of racial stigma and discrimination can erode coping resources and social support 
and ultimately drive poor mental health,6-9 HIV risk behavior,10,11 and their co-occurrence.10,12 In 
fact, MSM of color report greater depressive distress than white MSM,13 which in turn predicts HIV 
risk behavior.14 MSM of color’s exposure to racism and homophobia together drive HIV-risk 
behavior, lack of testing, lack of status disclosure, and among HIV-positive MSM, lack of 
antiretroviral adherence.15 While the ultimate elimination of structural barriers should represent the 
primary goal of HIV prevention programs for MSM of color, as long as such barriers persist, 
another justifiable target of public health interventions is the empowerment of MSM of color to 
resist stigma through building mental health and stigma coping.  
 
3. 
Research Plan: Summarize the study design and research procedures using non-technical 
language that can be readily understood by someone outside the discipline. If working with a Non-
Government Organization (NGO) or other organization, be sure to highlight which are research-
only activities and which activities would occur regardless of the research. If working with survey 
firms, please specify what research activities the research firm will be responsible for.  
 
 

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Recruitment and consent. Participants will be recruited through referrals from Fair Haven 
Community Health Center, posters in New Haven community venues frequented by young MSM, 
and online via gay-related websites and mobile apps. Consent will take place at four points – 
before the eligibility screener, before the phone assessment, before the online assessment, and 
before the first group intervention session.  For these latter three assessments, the same consent 
form will be used, 
 
Screening and pre-intervention (baseline) assessment. Interested participants will complete a 
brief online screener, where they will be prompted to provide contact information that will not be 
linked to the remainder of their data, and instructed that, if they are eligible, a study team member 
will email them with a consent form and schedule an interview by phone. The project coordinator 
will email eligible participants with a copy of the consent form and will schedule a phone 
assessment of HIV risk behavior. During the call, study staff will briefly review the consent form 
and gain verbal consent before proceeding to the phone assessment. After the phone 
assessment, participants will complete a baseline survey assessment containing questions 
regarding demographics, HIV-risk behavior, social cognitive mediators of HIV risk, mental health, 
substance use, and experiences of homophobic and racist stress. Participants without internet 
access will be invited to complete the baseline survey using a laptop at Fair Haven Community 
Health Center before the first group session.  
 
Intervention. Up to 30 participants will be assigned to one of two groups, a first cohort in Fall 
2018 and a second cohort in Spring 2019. 10 group sessions will take place at regular times once 
per week over the course of four months. The group will be “closed,” in that no new members will 
be allowed to join after the first week in order to promote open self-disclosure and trust among 
group members. Prior to the start of the first session of the ESTEEM conneCT intervention, study 
staff will again review the same study consent form and participants will sign a copy to indicate 
consent for study participation. All group sessions will take place in a reserved room at the Fair 
Haven Community Health Center, where many participants will be currently receiving care. 
Although group members will be told that confidentiality from the group cannot be guaranteed, all 
members will be asked to not share information about other group members outside of the group 
sessions during and after the study (see Human Subjects). Participants will be told that 
attendance is required and that missing more than four sessions will result in dismissal from the 
group. The project coordinator will contact participants who miss more than one session in order 
to ascertain their reason for missing the session, problem-solve barriers to attendance, and 
assess motivation for future attendance.  
 
Post-intervention assessment. 3 months after the final session, participants will complete the 
same phone interview and survey assessments they completed at baseline. 3 months after the 
final session, both therapists and all study participants will be individually contacted by the project 
coordinator to complete a qualitative interview that assesses participants’ experience in the 
intervention and suggestions for future refinement. We have used this qualitative procedure 
successfully in previous pilot intervention trials with young MSM.26 
 
Participant payment. At the end of the baseline assessment, participants will receive $40. After 
each session, participants will receive $10 plus transportation costs (up to an additional $10). 
Upon completing the post-intervention assessment measures, participants will receive $40 for 
their time spent completing the measures. Upon completion of the qualitative interview, 
participants will also receive $60. 
 
 

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4. 
Participant Population: Provide a detailed description of the types of participants who will 
be recruited into this study.  
 
 
Recruitment Rationale 
We focus on young MSM (ages 18-35) because the ESTEEM intervention has been developed 
for young MSM given the developmental-specific impact of minority stress exposure, the 
importance of intervening at this critical age period during which behavioral risk peaks and 
unhealthy behavioral patterns potentially become crystallized, and because young MSM represent 
the highest risk group for new HIV infection. We focus on HIV-negative and HIV-positive MSM 
given that partner pool risk, rather than individual risk behaviors, is a key driver of HIV infection 
among MSM of color. Because the intervention targets the psychological mechanisms (e.g., 
internalized homophobia, rejection hypervigilance, identity concealment, emotion regulation) 
through which stigma exposure drives risk behavior, its principles and exercises are broadly 
applicable regardless of sero-status, as empirically established by PI Pachankis and colleagues. 
In fact, in addition to its initial test with 63 HIV-negative MSM, the ESTEEM intervention was also 
tested with 12 HIV-positive MSM and showed strong preliminary effect sizes in mental, 
behavioral, and sexual health. Including men regardless of serostatus in the proposed group-
based adaptation trial provides pilot data for future research focused on either HIV-prevention 
among HIV-negative MSM or the reduction of mental health problems and behavioral comorbidity 
(e.g., substance use, antiretroviral nonadherence) among HIV-positive MSM. We will form two 
groups, one for HIV-positive and one for HIV-negative MSM, given that young HIV-positive MSM 
may not be willing to disclose their status to HIV-negative or status-unknown men, especially 
within the tight social networks of young MSM of color in small urban areas. Including men 
regardless of HIV-risk behavior ensures feasible recruitment during this time-limited pilot study 
and is also commensurate with the study aims to determine feasibility and acceptability of this 
novel intervention in preparation for future testing during which stricter risk eligibility criteria might 
be employed. Heterogeneity of HIV-risk outcomes does not pose a problem to estimating 
feasibility and acceptability and, instead, ensures the broadest possible use of this pilot data in 
future intervention development. Participants must speak fluent English in order to communicate 
with the potentially linguistically diverse group members. 
 
Describe how access to the population will be gained in the study.  
 
Participants will be recruited through existing community services and online. PI Wagner currently 
oversees the care of 25 HIV-positive young MSM of color and 15 HIV-negative young MSM who 
are currently prescribed PrEP and will communicate the existence of this study to her patients 
directly. Because Dr. Wagner maintains close connections with AIDS Project New Haven, we also 
plan to work with this community setting to recruit MSM for this study. We will also 
recruit additional HIV-negative MSM of color from the general clinic patient population at Fair 
Haven Community Health Center. Finally, we will follow our previously successful online 
recruitment strategies in New Haven to recruit MSM who might be out-of-reach of existing 
services, including those who conceal their sexual identities. In fact, 20.7% of participants in our 
prior research in New Haven were not out. These online recruitment strategies include 
advertisements placed on social-sexual networking apps (i.e., Grindr, Scruff, GROWLr), online 
sex-seeking forums (e.g., the “M4M casual encounters” section of Craigslist.com), and Facebook 
posts targeting local LGBT-oriented groups.  
 
5. 
Participant classification: Check off all classifications of participants that will be specifically 
recruited for enrollment in the research project. Will participants who may require additional 

9 
 
safeguards or other considerations be enrolled in the study? If so, identify the population of 
participants requiring special safeguards and provide a justification for their involvement. 
 
☐   Children  
 
             ☐X   Healthy   
☐   Fetal material, placenta, or dead                  
fetus 
 
☐    Non-English Speaking 
 
☐   Prisoners  
☐ 
Economically 
disadvantaged      
persons 
 
☐    Decisionally Impaired 
 
☐    Employees 
 
☐      Pregnant women 
 
☐    Yale Students  
 
 
☐    Females of childbearing potential   ☐   Fetuses 
 
 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
participants? ☐Yes  ☒ No  
 
 
6. Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion or    
exclusion?  
 
Eligible participants will: 1) be between the ages of 18 and 35, 2) report anticipated 6-month 
residential stability in New Haven county, 3) self-identify as a gay or bisexual man or report being 
a man who has had past-12-month sex with a man; 4) self-identify as an ethnic or racial minority, 
including Black, African American, Caribbean American, Hispanic, and Latinx, 5) speak fluent 
English; and 6) provide consent.  
 
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
 
1. 
Recruitment Procedures:  
a. Describe how potential participants will be identified and contacted, and by whom. 
 
Participants will be recruited through existing community health services, gay community venues, 
and online.  
 
Existing community health services. PI Wagner currently oversees the care of 25 HIV-positive 
young MSM of color and 10 HIV-negative young MSM who are currently prescribed PrEP and will 
communicate the existence of this study to her patients directly. Because Dr. Wagner maintains 
close connections with AIDS Project New Haven, we also plan to work with this community setting 
to recruit MSM for this study. We will also recruit additional HIV-negative MSM of color from the 
general clinic patient population at Fair Haven Community Health Center. Dr. Wagner and other 
medical staff will provide potentially eligible patients at Fair Haven Community Health Center with 
study flyers and contact information for eligibility screening.   
 

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Gay community venues.  We will post study flyers in gay bars, clubs, and other community 
venues frequently by MSM in and around New Haven. Flyers will contain study contact 
information for eligibility screening.  
 
Online. Finally, we will follow our previously successful online recruitment strategies in New 
Haven to recruit MSM who might be out-of-reach of existing services, including those who conceal 
their sexual identities. Recruitment strategies in our previous work have involved ads placed on 
social-sexual networking apps (i.e., Grindr), online sex-seeking forums (e.g., the “M4M casual 
encounters” section of Craigslist.com), and Facebook posts targeting local LGBT-oriented groups. 
Upon recruitment, interested participants will be contacted by research staff who will conduct an 
eligibility screen by phone. Individuals interested in study participation will indicate this through a 
brief online screener described above.  
 
Are you collecting any information about the individuals prior to their signing a consent form?  
Yes ☒     No ☐ 
 
If yes, indicate what information you will be collecting and how it will be gathered (phone screen, paper 
questionnaire, etc.)  
 
Prior to signing a physical copy of the consent form, study participants will undergo a phone 
screen, over-the-phone Timeline Follow-Back (TLFB) interview, and complete an online survey 
composed of several baseline questionnaires.  The screener, interview, and online survey will ask 
participants questions regarding study eligibility, contact information, demographics, sexual risk 
behaviors, past substance use behaviors, and past and/or current mental health with particular 
focus on stigma and stress regarding sexual identity and/or behaviors and racial identity. 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
 
☒ Flyers 
☒   Internet/web postings 
☐   Radio 
☒   Posters 
☐   Mass email solicitation 
☒   Telephone 
☐   Letter 
☐   Departmental/Center website 
☐   Television 
☒   Through local NGO or other local contact 
☐   Departmental/Center research boards 
☐   Newspaper 
☒   Table set-up / in-person recruitment of 
public                   
☒   Snowball sampling 
 
☐   Classroom recruitment 
☒   Social Media (Twitter/Facebook):  
 
☐   Other:  
 
 
 
3. Targeted Enrollment: Give the number of participants: 
a. 
  Targeted for enrollment at Yale for this protocol  
 
Up to 30 participants will be enrolled into two separate cohorts, one beginning in the fall of 2018 
and one in the Spring of 2019. 
 
b. If this is a multi-site study, give the total number of participants targeted across all sites  
 
N/A 
 
4.   How was this estimate derived?  

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This pilot study is powered to identity feasibility and acceptability of the ESTEEM intervention 
adapted for delivery in groups to young MSM of color in small urban areas. We believe that one 
group per HIV status (i.e., positive and negative) is the minimum possible number of groups to 
gain this information.  Using PI Pachankis’ clinical experience delivering psychotherapy groups, 
we believe that approximately 10-15 participants per group is the ideal number of group members 
to facilitate optimal learning and information exchange.  
 
Our primary analysis plan involves 1) qualitative interviews with the intervention recipients and 
therapists to gather feedback necessary for future testing and implementation and 2) quantitative 
analyses appropriate for estimating effect sizes necessary to power future trials. We are recruiting 
30 men to participate in the pilot study to generate sufficient depth and breadth of qualitative data. 
Drawing from similar research in the field, we estimate that 30 participants will allow us to gather 
data until saturation is reached and no new data will be introduced through further interviews. The 
quantitative data gathered from the ~30 participants at baseline and post-intervention will provide 
preliminary data to guide a future trial with a larger sample population.  
 
5. Assessment of Current Health Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical 
relationship with any potential subject?  
☐Yes, all subjects 
☒Yes, some of the subjects 
☐No 
 
If yes, describe the nature of this relationship. Several study participants are likely to be patients of 
Fair Haven Community Health Center who are seen by Krystn Wagner, MD for primary care 
services. 
 
6. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization 
for either the entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part 
of a phone or email screen, you must request a HIPAA waiver for recruitment purposes.) 
Choose one:  
☐ For entire study  
☒ For recruitment/screening purposes only 
☐ For inclusion of non-English speaking subject if short form is being used and there is no 
translated HIPAA research authorization form available on the University’s HIPAA website at 
hipaa.yale.edu. 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data:  
 
It would be impracticable to obtain potential study participants’ authorization for use of 
this data given the large number of individuals to be screened for this study weighed 
against the protections in place to protect sensitive data (see above and below).   
 
ii. If requesting a waiver of signed authorization, describe why it would be impracticable to 
obtain the subject’s signed authorization for use/disclosure of this data: It would be 
impracticable to obtain study subjects’ signed authorization for use/disclosure of 

12 
 
screening data because all screening communications will be conducted over the phone 
and staff will therefore be unable to obtain signed authorizations from study participants. 
 
The investigator assures that the protected health information for which a Waiver of 
Authorization has been requested will not be reused or disclosed to any person or entity other 
than those listed in this application, except as required by law, for authorized oversight of this 
research study, or as specifically approved for use in another study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-
Covered entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, 
date, recipients, and a description of information provided.  Logs are to be forwarded to the Deputy 
HIPAA Privacy Officer. 
 
 
7. Process of Consent/Assent (NOTE: When a study includes minors, parent provide permission [not 
consent] for the child’s participation, and the child provides assent for participation) 
 
Describe the setting and conditions under which consent/assent will be obtained, including parental 
permission or surrogate permission and the steps taken to ensure participants’ independent decision-
making.  
 
Participants will consent to participation at four separate points prior to study enrollment—1) At 
the start of the online screener, 2) during the call for the phone assessment of HIV risk behavior, 
3) before the online assessment, and 4) before the first group therapy session.  
Screening consent.  Individuals interested in participation in the study will be directed to 
the online screener and complete a brief consent form at the start of the screener agreeing to 
participation in screener survey. At the close of the screener they will be directed to a 
separate survey to provide study staff with contact information. Data from the two surveys 
will not be linked to protect participant confidentiality. They will be told a study staff 
member will contact them via email if they are eligible with the details for consenting to 
participate and to schedule an interview by phone.  
Phone assessment consent.  Interested individuals who meet eligibility criteria for the 
study will be contacted by a research staff member via email and will receive a copy of the 
full informed consent form as well as details for scheduling their phone assessment. Study 
staff will instruct them to read the form before the call and that they will have an opportunity 
to discuss and ask questions about the form during the call. The project coordinator will call 
the participant at the scheduled time and spend the first few minutes of the call discussing 
study details, reviewing the consent form, and answering any questions the participant might 
have. Before initiating the phone risk interview, the project coordinator will gain verbal 
consent from the participant for study participation.  
Online assessment consent. Participants will be presented with the identical consent form 
before completing the online assessments that they will be asked to complete prior to the 
first group session.  

13 
 
Intervention consent. At the first group session, participants will physically sign the same 
consent form that they have already received via email and seen in the baseline survey.  
 
8. 
Evaluation of Participant(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential participant’s ability and capacity to consent to the 
research being proposed, if applicable. 
 
For the online screener, participants will be asked to read details of the screener and be provided 
information about potential risks and benefits of completing the online screener. They will be 
asked to provide consent for completing the screener prior to answering the screener questions.  
 
Participants will be emailed a version of the full study consent form to read and review prior to 
their phone assessment with research staff. At the start of the call, a trained Research Assistant 
(RA) will dedicate time to review key points of the consent form with participants and to answer 
any questions about the study or ICF. Verification of comprehension will be gained by asking 
participants to recall key points of the study participation process. Participants will be asked to 
provide verbal consent prior to proceeding in the study and beginning the phone risk assessment.  
 
Prior to the start of the first group session, a trained RA will gather participants' consent and 
assess comprehension in a reserved room at the Fair Haven Community Health Center. The RA 
will ensure that the participant understands the risks associated with the study. Verification of 
comprehension of study participation requirements will be accomplished by asking participants to 
recall central points in the consent process; points of confusion will be clarified. Once participants 
have fully understood the consent form and the steps required for participating in the study, they 
will be asked to sign a physical copy of the consent form. RAs will be instructed to contact the PI 
or project coordinator if they are unsure about any participant's capacity to consent.   
 
 
 
 
9. 
Documentation of Consent/Assent: Specify the documents or verbal scripts that will be used during 
the consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given or spoken to participants.  
 
Please find attached a copy of the: 1) online screener consent text, 2) full study informed consent 
form to be presented a) before the phone assessment, b) before the online assessment, c) before 
the first group intervention. 
 
10. 
Non-English-Speaking Participants: Explain provisions in place to ensure comprehension for 
research involving non-English speaking participants. Translated copies of all consent materials must be 
submitted for approval prior to use. Do you speak the local language? Will you require a translator? (If so, 
please elaborate on how the translators will be trained). 
 
This study will only be recruiting English-speaking participants.  Therefore, this section does not 
apply for this study. 
 

14 
 
11. 
Are any of the study procedures likely to yield information subject to mandatory reporting 
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -incidents of child 
abuse, elderly abuse, etc.). Please verify to whom such instances will need to be reported.  
 
Suicidality, Homicidality  
 
Our ESTEEM clinical protocol successfully guides reporting instances of suicidality and 
homicidality in our ESTEEM pilot trial. We will employ the same protocol in this study.  The clinical 
protocol is attached. The protocol specifies that, in the event that a participant is at imminent risk 
of harming themselves or another person, as determined by a study staff member with mental 
health training, study staff will contact 911 to dispatch police or paramedics. Only the minimal 
necessary identifying information will be provided to these personnel. In less imminent instances 
of distress, we will refer distressed participants to local mental or behavioral health services. 
Clinical staff members will receive an alert if the participant answers the online questionnaires in a 
manner that signals distress; such participants will be contacted by a clinical staff member to 
assess risk.  
 
Participants will be notified of the reporting requirements under these circumstances during the 
consent process. 
 
12. 
Waiver of Consent/Documentation of Consent: In certain circumstances, the IRB may grant a 
waiver of documentation of consent, or a full waiver of consent, depending on the study. If you will request 
either a waiver of consent, or a waiver of signed consent for this study, complete the appropriate section 
below.   
 
☐Not Requesting any consent waivers  
 
☒Requesting a waiver of signed consent (e.g., verbal or online consent only): 
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will apply 
to recruitment activities only) 
☐ Entire Study (Note that an information sheet may be required.) 
 
 
 
 
Consent will be obtained for all study components: 1) consent for answering screener questions will 
be gauged at the start of the screener survey, 2) verbally for the phone risk assessment and online 
baseline assessment, and 3) signed on paper prior at first group session for the group therapy 
 For a waiver of signed consent, address the following: 
 
• 
Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO 
☒  
• 
Does a breach of confidentiality constitute the principal risk to subjects? YES ☒  NO ☐ 
  
 
OR 
• 
Does the research pose greater than minimal risk? YES ☐    NO☒  
• 
Does the research include any activities that would require signed consent in a non-research context? 
YES ☐   NO ☒ 
 

15 
 
participation, post-intervention survey, and qualitative interviews, as described above. The brief 
online screener survey will assess age, HIV status, race/ethnicity, sexual orientation identity and 
recent same-sex sexual behavior, HIV status, and substance use risk behavior, and depression and 
anxiety symptoms to determine preliminary eligibility for this study.  This brief online screener does 
not pose greater than minimal risk. Participants’ identifying information, including their name, will be 
kept in a separate database from the remainder of their study responses. Participants will ultimately 
provide verbal, typed, and signed consent before engaging in the group intervention sessions.   
 
☐  Requesting a waiver of consent (if you are not obtaining ANY consent): 
 
☐  Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only) 
☐  Entire Study  
 
 
 
 
 
 
 
  
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS 
 
1. 
Confidentiality & Security of Data: Describe the steps that will be taken to secure the data during 
storage, use and transmission as outlined in the below sections.  NOTE: Data can include paper files, data 
on the internet or websites, computer files, audio/video files, photographs, etc. and should be considered 
in the responses to the below sections.         
 
The primary potential risk to participants is breach of confidentiality. Breaches of confidentiality 
will occur if a participant reports a clear intention to harm himself or another person. Health care 
professionals are required by state law to report suspected cases of abuse or neglect. Breach of 
confidentiality can also occur if participants in this group-based intervention disclose information 
about participants to outside parties. Participants will be informed during the consent process that 
any information shared during group sessions may be discussed outside of the intervention, 
although study staff will encourage participants to respect each other’s privacy. Moreover, 
participants will be reminded at the beginning of each session that all information shared in the 
intervention setting is private and confidential. Participants will also be notified on the consent 
form and at the start of each session that by participating in the study they acknowledge the risk 
that other participants will become aware of any information they disclose during the group 
intervention sessions and might disclose such information to others outside of the study.   
 
For a waiver of consent, please address all of the following: 
 
• 
Does the research pose greater than minimal risk to subjects?   
☐   Yes   If you answered yes, stop. A waiver cannot be granted.   
☐   No 
• 
Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐ 
• 
Why would the research be impracticable to conduct without the waiver?  
Click or tap here to enter text. 
• 
Where appropriate, how will pertinent information be returned to, or shared with subjects at a later 
date? Click or tap here to enter text. 
 

16 
 
The likelihood that any additional breaches of confidentiality would occur is minimal, as steps will 
be taken to guard against this risk. To protect participants’ confidentiality, NIH funded studies 
automatically receive a Certificate of Confidentiality (CoC) prior to enrolling participants. All 
counselors and research assistants (RAs) will undergo rigorous training in maintaining 
participants’ privacy and confidentiality and will be in possession of valid Collaborative Institutional 
Training Initiative (CITI) certificates. Further, immediately upon providing consent, all participants 
will be assigned an identification number. Study staff will maintain four password protected 
databases tracking participant data. The first database, and only database to link participant 
contact information (ie: name, age, email, address, phone number) with their ID, will be used for 
scheduling participant appointments and follow-ups. The second database will track participant 
attendance and study task completion. The third database will track participant payment, and the 
fourth and final database will contain data gathered about participants through assessments and 
therapy sessions. These databases will all be stored on a secure server to which only study staff 
will have access. Confidential participant information will not be stored with any other data and no 
other identifying information will appear on any form. All contact with participants will be made by 
counselors and research staff under explicit guidelines to preserve confidentiality when 
telephoning, emailing, or mailing information to participants. Upon enrollment participants will also 
be asked to provide study staff with an alternative contact information (email, phone numbers, and 
mailing address) for compensation and study retention purposes. This information will be treated 
in the same confidential manner as all participant information, as described here.   
 
Secure digital (SD) memory cards for the recording equipment will be stored at the research study 
site. The SD card in the video camera at Fair Haven Community Health Center will be retrieved 
weekly and brought back to PI Pachankis’ office at YSPH. Data will immediately be uploaded to 
the Secure Box server on a Yale computer and the memory cards will be cleared.  Additionally, 
participants will have the choice of using pseudonyms in the audio-recordings to protect their 
confidentiality on the audio-recordings. 
 
What participant information will you be collecting? Describe the identifiers that will be included or 
associated with the data and/or specimens (e.g., names, addresses, telephone/fax numbers, email 
addresses, dates (date of birth, admission/discharge dates, etc.), medical record numbers, social security 
numbers, health plan beneficiary numbers, etc.) Click or tap here to enter text. 
 
We will collect online numeric data, video-recorded data, and audio-recorded data.  Participant 
name and contact information will be collected at the end of the online screen and will not be linked 
to participant data except in the case of emergency (e.g., to provide paramedics with participant 
address). All data will be stored in a password protected contact database on secure Box only 
accessible to research staff. Participant names and contact information will only be used to 
schedule or reschedule participant appointments, or to reach contact nearby emergency services if 
necessary, and will not be connected to any data.   
 
The full packet of study measures and assessments is attached to this application.  We propose to 
collect information about participants’ general mental health status; HIV risk; demographics; HIV 
status; experiences with stigma-related stress; depression and anxiety; cognitive, affective, and 
interpersonal functioning (e.g., rumination, social support, assertiveness); mental health treatment 
history and perspectives; substance use; sexual compulsivity; and perceptions of intervention 
helpfulness.   
 

17 
 
We will also video video-record all intervention sessions and audio-record post-treatment 
qualitative interviews.  Participants will have the choice of using pseudonyms in the audio-
recordings to protect their confidentiality on the audio-recordings. 
 
 
 
 
Other potentially identifying information to be collected: 
☒Audiotapes 
☒Videotapes 
☐Faces (focus groups, photographs or other way that an individual would be physically recognized) 
☐Potential for identification from the bulk of the information, even if direct identifiers are not collected 
(deductive disclosure). 
 
2. 
How will the research data be collected and recorded? Click or tap here to enter text. 
 
Research data will be collected via telephone, electronic databases, survey websites, paper-and-
pencil, electronic documents, and video recording. 
 
Screening data will also be collected on a secure survey website (Qualtrics.com) to determine 
eligibility. Participants will complete online surveys at home via yalesurvey.qualtrics.com. If a 
participant does not have personal computer or internet access we will invite them to complete the 
baseline survey at the Fair Haven Community Health Center. Participants themselves will enter 
most data into Qualtrics directly. Online surveys (yalesurvey.qualtrics.com) will use an encrypted 
web service (https) and will not ask participants’ name or other identifying information, only 
participant ID number. Intervention sessions will be audio-recorded for quality control and will be 
downloaded to Yale’s HIPAA-compliant Secure Box drive upon retrieval from study cameras.  
 
4. If identifiers will be associated with the data and/or specimens, describe whether a record or list 
containing a code (i.e., code number, pseudonyms) will be used, where the list will be stored, who 
will have access to the list and when it will be destroyed.       
 
Participant tracking and scheduling data will be recorded on a study database.  One password-
protected linking database—the study contact database—containing participant names and ID 
codes will be kept on Yale’s HIPAA-compliant Secure Box drive and will only be accessible to 
study staff. 
 
All study computers will be encrypted and password protected.  All filing cabinets will be locked.  
Online surveys (yale.qualtrics.com) will use an encrypted web service (https) and will not ask 
participants’ name or other identifying information, only participant ID number. The linking 
database used for participant scheduling and retention will be kept separate from study data, on a 
secure server, and will be password protected.  All study materials, including recordings, will be 
destroyed three years after the conclusion of the study.   
 
5. 
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) and/or 
specimens will be stored.  
 

18 
 
During the study, data will be stored on an encrypted, password-protected server at the Yale 
School of Public Health. The identifiable data will remain separate from the remainder of 
participant data. After three years of study completion, the link to personal identifiers will be 
destroyed.  Additionally, all study recordings will be destroyed after three years of study 
completion. 
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical 
reason a device cannot be encrypted please submit an exception request to the Information Security, Policy 
and Compliance Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu  
  
6. Identify who will have access to the data and/or specimens. If the data and/or specimens will be 
transferred to and/or from outside collaborators, identify the collaborator to whom the data and/or 
specimens will be transferred and how the data and/or specimens will be transferred.    
 
Access to the data will be limited to members of the IRB-approved research study staff including, 
but not limited to, principal investigators, project coordinators, research assistants, and clinically 
trained psychological counselors.  Dr. Krystn Wagner will not have access to identifiable study data 
and she will not be analyzing study data.  However, Dr. Krystn Wagner may have access to patient 
health information for several study participants since we will be recruiting from her patient panel at 
Fair Haven Community Health Center. 
 
What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data or the link to personal identifiers? If yes, describe how, by whom and when identifiers will be destroyed. 
If no, describe how the data and/or identifiers will be secured. Click or tap here to enter text. 
 
After three years of study completion, the link to personal identifiers will be destroyed by IRB 
approved study staff. 
 
 
7. 
Will a Certificate of Confidentiality be needed? (See also the NIH Certificate of Confidentiality Kiosk, 
http://grants.nih.gov/grants/policy/coc/index.htm) Click or tap here to enter text. 
 
We have received an NIH Certificate of Confidentiality. 
 
SECTION VII: POTENTIAL RISKS AND BENEFITS 
 
1. 
Risks: Describe the reasonably foreseeable risks, including risks to participant privacy, discomforts, or 
inconveniences associated with participants participating in the research. Note: All studies have the 
potential for risk, if not physical, there may be psychological, reputational, or financial risks or risks to 
breach of confidentiality. 
 
The study participants are at minimal risk of harm as a result of participation in the proposed 
research study. Although unlikely, one risk of the proposed study is that participants will experience 
emotional discomfort as a result of completing the quantitative assessments or the intervention. 
Breach of participants' confidentiality presents another possible risk. Breach of confidentiality can 
also occur if participants in this group-based intervention disclose information about other 
participants to outside parties. The investigative team's strategies to protect against these risks are 
described below.  
 

19 
 
2. 
Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
 
Recruitment and Informed Consent: The investigative team has conducted a number of studies 
involving young gay and bisexual men, which have involved asking participants to complete 
potentially sensitive interviews and self-report measures. Thus, we have extensive protocols in 
place for all aspects of the study. All staff will complete IRB (re)certification as required. All new 
staff and research volunteers will receive local training in issues pertinent to research among young 
gay and bisexual men, and will sign a confidentiality pledge prior to any contact with participants or 
data. No identifying information is collected prior to the moment at which a participant provides 
informed consent.  
 
Participants will be actively recruited into the study through referral by a health professional at 
FHCC or through venue-based flyers or online advertisements. When completing the online 
screener, participants will be prompted to provide consent for answering screener questions. If 
determined eligible for the study, research staff will email them a copy of the full consent form and 
establish a call to discuss the study and set up a phone assessment of HIV-risk behavior. During 
the call, a study staff member will review key points of the study and participation requirements with 
the participant and clarify any participant questions. Participants will verbally consent to 
participation during the call prior to completing the phone assessment. Participants will again see 
the consent form at the beginning of the baseline survey that they will complete after the phone 
assessment and again, in print, before their first group therapy session.  
 
Prior to the in-office appointments, a trained Research Assistant (RA) will assess participants' 
consent in a private room. The RA will ensure that the participant understands the risks associated 
with the disclosure of information that could indicate imminent threat to self or others. Verification of 
comprehension of informed consent will be accomplished by asking participants to recall central 
points in the consent process; points of confusion will be clarified. Once participants have fully 
understood the consent, they will be asked to sign the consent form. RAs will be instructed to 
contact the PI or project coordinator if they are unsure about any participant's capacity to consent.  
 
Protection Against Emotional Discomfort.  It is possible that participants may experience emotional 
discomfort in responding to assessments. While every possible step will be taken to minimize such 
risk, consent documentation will make it clear that if participants have any concerns about any 
aspect of the study they may refuse to continue with the study at any time, without penalty. In 
addition, we will remind participants during the course of their assessments that they can refuse to 
answer any questions and may discontinue participation at any time. Research team members will 
receive training from a licensed clinical psychologist in appropriate response practices in instances 
of participant distress and will follow the clinical protocol in any situation where a participant 
indicates risk of self-harm or harm to others. This training will address the appropriate handling of 
imminent threats and provision of referrals to free counseling services in less imminent clinical 
situations. As noted above, our Clinical Protocol, attached to this application, will guide this training 
and its implementation during instances of participant distress. 
  
Protection Against Breach of Confidentiality. The primary potential risk to participants is breach of 
confidentiality. Breaches of confidentiality will occur if a participant reports a clear intention to harm 
himself or another person. Health care professionals are required by state law to report suspected 
cases of abuse or neglect.  Breach of confidentiality can also occur if participants in this group-
based intervention disclose information about participants to outside parties. Participants will agree 
in their signed consent forms that any information shared during group sessions may not be 
discussed outside of the intervention.  Moreover, participants will be reminded at the beginning of 
each session to keep all information shared during the group intervention sessions private; that is, 

20 
 
the session therapist will ask all group members to not disclose any other participant’s information 
outside of the group setting. Participants will also be told, however, that this protection cannot be 
guaranteed by the group leader. Participants will also be notified on the consent form and at the 
start of each session that by participating in the study they acknowledge the risk that other 
participants will become aware of any information they disclose during the group intervention 
sessions and might disclose such information to others outside of the study. The likelihood that any 
additional breaches of confidentiality would occur is minimal, as steps will be taken to guard against 
this risk. To protect participants’ confidentiality, NIH funded studies automatically receive a 
Certificate of Confidentiality (CoC) prior to enrolling participants. All counselors and research 
assistants (RAs) will undergo rigorous training in maintaining participants’ privacy and confidentiality 
and will be in possession of valid Collaborative Institutional Training Initiative (CITI) certificates.  
Further, immediately upon providing consent, all participants will be assigned an identification 
number. Only one database will contain participant information with a link to identification numbers 
and no data will be stored on this file. This database will be stored on Yale’s HIPAA-compliant 
Secure Box server and will be password protected. This information will not be stored with any 
participant data and no other identifying information will appear on any form. All contact with 
participants will be made by counselors and research staff under explicit guidelines to preserve 
confidentiality when telephoning, emailing, or mailing information to participants.  
 
3. 
Data and Safety Monitoring Plan:  Include an appropriate Data and Safety Monitoring Plan (DSMP) 
based on the investigator’s risk assessment stated below. (Note: the HSC will make the final 
determination of the risk to subjects.). 
a. 
What is your assessment of the overall risk level for subjects participating in this study? 
Minimal 
 
b. 
If children are involved, what is your assessment of the overall risk level for the children 
participating in this study?  
N/A 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
 available here http://your.yale.edu/policies-procedures/other/data-and-safety-monitoring-plan-
template  for 
i.Minimal risk 
ii.Greater than minimal/moderate risk 
 
 
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews quarterly. During the review process the principal investigator will 
evaluate whether the study should continue unchanged, require modification/amendment, or close 
to enrollment. 
 
The principal investigator and the Institutional Review Board (IRB) have the authority to stop or 
suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to 
Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event 
that such events occur, Reportable Events (which are events that are serious or life-threatening and 
unanticipated (or anticipated but occurring with a greater frequency than expected) and possibly, 
probably, or definitely related) or Unanticipated Problems Involving Risks to Subjects or Others that 
may require a temporary or permanent interruption of study activities will be reported immediately (if 
possible), followed by a written report within 5 calendar days of the Principal Investigator becoming 

21 
 
aware of the event to the IRB (using the appropriate forms from the website) and any appropriate 
funding and regulatory agencies. The investigator will apprise fellow investigators and study 
personnel of all UPIRSOs and adverse events that occur during the conduct of this research project 
(e.g., through regular study meetings, via email as they are reviewed by the principal investigator.)  
The protocol’s research monitor(s), e.g., the DSMBs, NIH, will be informed of serious or 
unanticipated adverse events within 5 days of the event becoming known to the principal 
investigator. 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: 
 
i. How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? N/A 
ii. What provisions are in place for management of interim results? N/A 
iii. What will the multi-site process be for protocol modifications? N/A 
 
4. 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the participant(s) or to society at large. (Payment of participants is not considered a 
benefit in this context of the risk benefit assessment.)  
 
Sexual risk behavior among young gay and bisexual men is a clear public health concern. All 
participants in the present study will be exposed to information about HIV transmission risks in 
relation to social stress and co-occurring mental health disorders. We anticipate that participants 
will acquire knowledge and skills and will receive support needed to improve their capacity for 
managing HIV risk. Benefits to society in general are anticipated through the dissemination of 
intervention findings. Results will better inform local and national public health agencies about 
potentially effective outreach and prevention strategies that can be delivered to YGBM who 
experience lifetime stress-sensitive mental health disorders, such as depression and anxiety, and 
HIV risk behavior. Given the unique experiences of YGBM men of color experiencing sexual 
orientation stigma and race-based discrimination, research to incorporate knowledge of stigma and 
discrimination mechanisms into a tool for HIV prevention can be a significant benefit for this 
community. In sum, the potential benefits outweigh the potential risks to subjects, which are 
minimal. 
 
We propose to further test a preliminarily efficacious intervention to better help YGBM manage their 
HIV risk. Findings from this study can be used to help guide prevention efforts for both YGBM and 
other socially disadvantaged groups who experience stress-sensitive mental health disorders and 
are at risk of HIV infection.  Given the public health importance addressed by this project and the 
potential benefit of the information to be gained, we believe that the risk to subjects is reasonable. 
Further, the information from this intervention can serve to benefit more widespread sexual risk-
reduction efforts. Specifically, information from this study will inform public health agencies 
regarding the effectiveness of an intervention that addresses co-occurring behavioral risk factors for 
HIV infection.  This test will lay the groundwork for future studies examining the strategic 
implementation of this intervention alongside effective structural and biomedical approaches.   
 
         SECTION VIII: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1. 
Alternatives: What other alternatives, if any, are available to the study participants outside of the 
research? 
 

22 
 
All participants and potential participants will be provided with a list of community referrals, including 
medical, HIV/STD testing, psychological, substance use, and housing supports. 
 
2. 
Payments for Participation (Economic Considerations): Describe payments that will be made to 
participants, if any, the amount and timing of payments, and the conditions for receiving this compensation 
(if applicable). If you plan to hold a drawing, be sure to include the following on any consent or recruitment 
materials mentioning the lottery: 1) the value of the prize; 2) the sponsor of the prize (this cannot be a 
federal funding source); 3) the odds of winning; and 4) that there are no restrictions to winning. 
 
You will receive the following compensation for completing each portion of the study:  
 
• 
Ten counseling sessions: $10 per session plus transportation costs (up to an additional $10), 
equaling a total of $100 plus transportation costs (up to an additional $100).  
• 
The online survey & phone interview (before the first counseling session): $40 
• 
The follow-up online survey & phone interview (3 months after the final counseling session): 
$40 
• 
The final interview (3 months after the final counseling session): $60  
 
Payment for the pre-counseling surveys & phone interview will be provided during the first 
counseling session along with the payment for the first counseling session.  All other counseling 
session payments will be provided during those respective counseling sessions.  Payment for the 
post-counseling surveys & phone interview and for the final interview will be provided at a date/time 
agreed upon by each study participant and the ESTEEM-conneCT research staff.  If you withdraw 
from the study, you can keep the compensation that you have earned up to that point, but you will 
not receive compensation for those parts of the study that you have not completed. 
 
3. 
Costs for Participation (Economic Considerations): Clearly describe the participant’s costs 
associated with participation in the research, if any, and the interventions or procedures of the study that 
will be provided at no cost to participants.     
 
Study participation will generate no cost for participants. All study treatment (ESTEEM-conneCT) 
will be provided free of charge to all study participants. 
 
 
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Reisner SL, Mimiaga MJ, Skeer M, et al. Clinically significant depressive symptoms as a 
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