A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Phase: NA
Conditions: HIV, Acquired Immunodeficiency Syndrome
Sponsor: Yale University

Page 1 of 34 
 
Study Protocol 
 
ClinicalTrials.gov ID: NCT02929069 
Study Title: A Unified Intervention for Young Gay and Bisexual Men's Minority 
Stress, Mental Health, and HIV Risk 
Final Date: 8/5/2020 
 

Page 2 of 34 
 
 
YALE UNIVERSITY IRBs 
 
                    Application for Full or Expedited IRB Review of a Study  
Involving Human Participants in 
Social or Behavioral Science or Educational Research 
 
100 FR 28 (2015-1)  
 
NOTE: IF YOUR STUDY INVOLVES: 
 
Genetic Testing 
 
Blood Draws  
Do not use this form. Use the biomedical HIC application 
MRI scans 
 
Secondary analysis of data 
  Use the Request for Approval of Secondary Analysis of 
Data 
 
 
 
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). 
 
 
SECTION I: ADMINISTRATIVE INFORMATION 
 
Title of Research Project: A unified intervention for young gay and bisexual men's 
minority stress, mental health, and HIV risk 
 
Principal Investigator: John Pachankis, Ph.D. 
 
Yale Academic Appointment: Associate Professor 
 
Department: Chronic Disease Epidemiology, YSPH 
Campus Address: 60 College St., Ste. 316 
 
Campus Phone: 203-785-3710  
 
E-mail: john.pachankis@yale.edu 
Protocol Correspondent Name & Address (if different than PI): Roxanne Winston 
  
Campus Phone:  
 
E-mail: roxanne.winston@yale.edu 
 
Faculty Advisor: (required if PI is a student, 
resident, fellow or other trainee)           
 NA 
 
Yale Academic Appointment: 
 
Campus Address:  
 
Campus Phone:  
 
 
E-mail:  

Page 3 of 34 
 
Investigator Interests: 
Does the principal investigator, or do any research personnel who are responsible for the design, 
conduct or reporting of this project or any of their family members (spouse or dependent child) 
have an incentive or interest, financial or otherwise, that may affect the protection of the human 
participants involved in this project, the scientific objectivity of the research or its integrity? Note: 
The Principal Investigator (Project Director), upon consideration of the individual’s role and 
degree of independence in carrying out the work, will determine who is responsible for the 
design, conduct, or reporting of the research.  
See Disclosures and Management of Personal Interests in Human Research 
http://www.yale.edu/hrpp/policies/index.html#COI  
  Yes  
X  No  
 
Do you or does anyone on the research team who is determined by you to be responsible for the 
design, conduct or reporting of this research have any patent (sole right to make, use or sell an 
invention) or copyright (exclusive rights to an original work) interests related to this research 
protocol? 
  Yes  
X  No  
 
 
 
If yes to either question above, list names of the investigator or responsible person: 
 
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale 
University individuals who are responsible for the design, conduct or reporting of research must 
have a current financial disclosure form on file with the University’s Conflict of Interest Office. Yale 
New Haven Hospital personnel who are listed as co-investigators on a protocol with a Yale 
University Principal Investigator must also have a current financial disclosure form on file with the 
University’s Conflict of Interest Office. If this has not been done, the individual(s) should follow 
this link to the COI Office Website to complete the form:  http://www.yale.edu/coi/   
 
NOTE: The requirement for maintaining a current disclosure form on file with the University’s 
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital 
personnel.  Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any 
interests that are specific to this protocol. 
 
SECTION II: GENERAL INFORMATION 
 
 
1. 
Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities.  
 
November 1, 2015 to December 31, 2020 
 
2. 
Study location: State where the study will take place and in what setting. 

Page 4 of 34 
 
This study will primarily take place in two sites – one affiliated with the Yale School of Public 
Health, the other affiliated with the University of Miami Department of Psychology.  The Yale-
affiliated site, overseen by Dr. Pachankis, will be an off-campus research office in New York City 
(220 East 23rd St., Suite 405, New York, NY 10010). The Miami-affiliated site will be the University 
of Miami Medical School (1120 NW 14th St, Suite 787, Miami FL 33136). 
 
Data collection will also take place in the offices of our community partners, the Institute for 
Human Identity (322 8th Ave, New York, NY, 10001) in New York City and Care Resources (3510 
Biscayne Blvd., Miami, FL) in Miami.  
 
Dr. Pachankis’ office at the Yale School of Public Health (60 College St., Ste. 316) and Dr. Safren’s 
office at the University of Miami Department of Psychology will serve as secondary locations 
limited to meetings with project staff and data analysis.  Study participants will not be seen at 
these secondary sites. 
 
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 
 
 
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING 
 
Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply. 
Provide information regarding the external funding source.  This information should include 
identification of the PI on the award, agency/sponsor, the funding mechanism (grant or 
contract), and whether the award is pending or has been awarded. Provide the Yale 
institutional proposal number and Agency name (if grant-funded).  If the funding source 
associated with a protocol is “pending” at the time of the protocol submission to the IRB (as is 
the case for most NIH submissions), the PI should note “Pending” in the appropriate section 
of the protocol application, provide the Yale institutional proposal number and Agency name 
(if grant-funded) and further note that University (departmental) funds support the research 
(until such time that an award is made).   
 

Page 5 of 34 
 
 
 
 
 
 
 
 
 
PI of grant (if 
applicable) 
Title of Grant (if 
applicable) 
Name of Funding Source 
(i.e. Dept name or 
Fellowship) 
Funding type Funding Mechanism 
John Pachankis, 
Ph.D. 
A unified intervention 
for young gay and 
bisexual men’s 
minority stress, mental 
health, and HIV risk 
 
National Institute of Mental 
Health 
Yale 
fellowship 
Yale 
department 
No funding 
(student 
projects, etc.) 
  Federal 
  State 
  Non Profit 
  Industry 
  Other For 
Profit  
 
  Other 
 
Grant: Yale Inst. #  
Contract# 1R01MH109413-
01 
Contract Pending 
  Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify: 
IRES #:  15-005155          
 
 
Note – IRB fees are charged for projects funded by Industry or Other For-Profit Sponsors. Provide the 
name and Address of the Sponsor Representatives to whom the invoice should be sent.   The PI’s home 
department will be billed if this information is not provided. 
  
1. 
Research Team:  List all members of the research team. Indicate under the affiliation 
column whether the investigators or study personnel are part of the Yale faculty or staff, 
or part of the faculty or staff from a collaborating institution, or are not formally affiliated 
with any institution. ALL members of the research team MUST complete Human Subject 
Protection Training (HSPT) and Health Insurance Portability and Accountability Act 
(HIPAA) training (if applicable) before they may be listed on the protocol.  See NOTE 
below. 
 
 

Page 6 of 34 
 
 
NOTE: The HSC will remove from the protocol any personnel who have not completed required training. A 
request to change study personnel will need to be submitted when training is completed. 
 
 
 
SECTION IV: RESEARCH PLAN 
 
1. 
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
 
 
Name 
Affiliation: Yale/Other 
Institution (Identify) 
 
Net ID 
Principal Investigator  
John Pachankis, Ph.D. 
    Yale 
jep69 
Role: Co-Investigator 
Steven Safren, Ph.D. 
University of Miami 
 
Role: Co-Investigator 
 
Mark Hatzenbuehler, Ph.D. 
Columbia University 
 
Role: Co-Investigator 
 
David Paltiel, Ph.D. 
Yale 
adp6 
Role: Co-Investigator 
(biostatistician) 
 
Denise Esserman, Ph.D. 
Yale 
dae6 
Role: Senior Research Assistant 
TJ Sullivan 
Yale 
tjs66 
Role: Study Therapist 
Ingrid Solano, MA 
SUNY Stony Brook 
ias26 
Role: Study Therapist 
Craig Rodriguez-Seijas, MA 
 SUNY Stony Brook 
cr672 
Role: Postdoctoral Fellow 
Chuck Burton, Ph.D. 
Yale 
clb79 
Role: Research Assistant 
Richard Branstrom, Ph.D. 
Yale 
pb659 
Role: Part-time Research Aide 
Colin Kimberlin 
Yale 
ck624 
Role: Research Assistant 
Maxwell Richardson 
Yale 
Mbr42 
Role: Study statistician 
Jesse Reynolds, M.S. 
Yale 
Jsr67 
Role: Project Coordinator 
Roxanne Winston, MPH 
Yale 
Rw527 
Role: Summer Research Assistant 
Dominic Schnabel 
Yale 
Dds36 
Role: Research Assistant 
Erin McConocha 
Yale 
Em795 
Role: Study Therapist 
Tenille Taggart 
SUNY Stony Brook 
TT443 
Role:  Study Therapist 
Alexander Belser, M.Phil.  
New York University 
 AB2922 
Role: Research Assistant 
Meghan Michalski 
Yale 
 MM3536 
Role: Research Assistant 
Arjan van der Star, M.Sc. 
Yale 
 AV564 
Role: Study Therapist 
Nitzan Cohen 
Fordham University 
 NC545 
Role: Study Therapist 
Zach Rawlings 
Long Island University  ZR63 

Page 7 of 34 
 
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention 
designed to reduce young gay and bisexual men’s (YGBM) co-occurring health risks by reducing 
the underlying cognitive, affective, and behavioral pathways through which minority stress 
impairs YGBM’s health.33,34 ESTEEM is based on the Unified Protocol, a cognitive-behavioral 
therapy (CBT) approach with efficacy across mental health and risk behaviors.35,36 The Unified 
Protocol changes underlying stress pathways using motivational interviewing, emotional and 
situational exposure, cognitive restructuring, mindfulness, and self-monitoring exercises.35-37 To 
create ESTEEM, through an NIMH R34 award, our team adapted the Unified Protocol by 
conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious 
YGBM at high risk for HIV infection. These stakeholders helped our team infuse the Unified 
Protocol with minority stress coping content.34 ESTEEM aims to normalize the adverse impact of 
minority stress, reduce internalized homophobia and rejection schemas, reduce YGBM’s 
unhealthy avoidance tendencies (e.g., substance use during sex, condom use non-assertion), and 
validate YGBM’s unique strengths. In a preliminary trial (n=63), ESTEEM significantly reduced 
YGBM’s spectrum of interrelated health threats, making it the first evidence-based intervention 
to simultaneously improve mental health, substance use, and sexual health outcomes among 
YGBM.33  
 
Important questions remain in order to validate the efficacy and potential cost-effectiveness of 
ESTEEM.  Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) 
demonstrates significant improvements compared to existing LGBT-affirmative community 
mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing 
(VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes 
through reducing hypothesized cognitive, affective, and behavioral minority stress processes.  A 
transdiagnostic treatment like ESTEEM capable of simultaneously improving mental, behavioral, 
and sexual outcomes in a relatively short amount of time maximizes treatment resources in 
constrained economic contexts because it reduces the need for training in multiple interventions 
for multiple problems. Yet, as the field has been re-examining the potential utility of individual 
interventions to affect the HIV epidemic, ESTEEM’s potential cost-effectiveness in terms of 
averted mental disorders and HIV infections represents an essential public health question. These 
unanswered questions will be addressed: 
 
Aim 1: Test the efficacy of ESTEEM against (1) community mental health treatment (CMHT) and 
(2) HIV/STD voluntary counseling and testing (VCT). Our primary outcome is condomless anal 
sex in the absence of PrEP, with any HIV+ partner (except primary partners with a known 
undetectable viral load), casual partner, or status-unknown partner. Knowing whether ESTEEM 
yields greater improvement than time-matched CMHT will establish the benefit of our 
transdiagnostic approach. Comparing ESTEEM to VCT offers a strong test of ESTEEM’s 
incremental cost-effectiveness. 
 
Aim 2: Determine whether ESTEEM works through its hypothesized cognitive, affective, and 
behavioral minority stress processes. 4-, 8-, and 12-month follow-ups will determine if 
improvements in minority stress processes precede and statistically mediate outcome 

Page 8 of 34 
 
improvements. Mediation will validate the minority stress theory of ESTEEM and provide 
transdiagnostic targets for future YGBM health interventions. 
 
Aim 3: Estimate ESTEEM’s incremental cost-effectiveness compared to VCT in terms of HIV 
infections averted and improved mental health. ESTEEM shows preliminary efficacy for 
improving the full spectrum of YGBM health. We will collect resource use and cost data to 
estimate return on investment of this transdiagnostic health approach compared to standard 
single outcome/stand-alone treatment approaches. 
 
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.  
 
Clear and consistent evidence now suggests that young gay and bisexual men (YGBM) 
disproportionately experience depression, anxiety, and substance use problems compared to 
heterosexual men.1-6 Diverse methods locate the source of these disparities in YGBM’s exposure 
to minority stress—the stress associated with stigma-related social disadvantage.7-10 Minority 
stress also drives YGBM’s HIV risk11-14 contributing to the reemerging epidemic in this group.15,16 
In fact, minority stress, mental health and substance use disparities, and HIV risk fuel each other, 
forming a synergistic threat to YGBM’s health.17-20 Yet, no existing evidenced-based intervention 
addresses minority stress and its impact on HIV risk in HIV-uninfected YGBM. 
 
Minority stress theory suggests that stigma compromises YGBM’s health through several 
cognitive, affective, and behavioral pathways.10,21 These pathways emerge early in development 
and include negative thinking styles, unhealthy emotion regulation habits, low behavioral self-
efficacy, and behavioral avoidance. Some of these processes are YGBM-specific, such as 
internalized homophobia and expectations of gay-related rejection;22,23 others are universal but 
elevated among YGBM, such as low self-worth and unassertiveness.24,25 All are related to poor 
mental health, substance use problems, and HIV risk.12,23,25-31 Our conceptual model suggests that 
an intervention that reduces these minority stress processes could simultaneously improve the 
full spectrum of YGBM’s mental, behavioral, and sexual health risks.32   
 
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.  
 
We propose to test the efficacy of a principle-based, transdiagnostic (cross-cutting) CBT 
intervention (ESTEEM) that addresses the pathways through which minority stress compromises 
YGBM’s co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., 
condomless anal sex) health problems. In this RCT, we expand upon the initial success of our R34 
pilot to examine stronger control conditions (Aim 1), test intervention mechanisms (Aim 2), and 
estimate cost-effectiveness (Aim 3).  
 

Page 9 of 34 
 
Aim 1: We will utilize two comparison conditions—LGB-affirmative community mental health 
treatment (CMHT) and brief voluntary HIV testing and counseling (VCT). VCT offers a strong 
control, as it has been shown to reduce condomless anal sex, but not mental disorders or 
substance abuse, in a brief risk-reduction session.104 Standard, non-protocoled LGB-affirmative 
community mental health treatment (CMHT) represents another important test. The efficacy of 
CMHT for YGBM has never been tested. This represents a startling gap given the significant male 
sexual orientation mental health disparities1-4 and YGBM’s disproportionate treatment use.59 In 
our R34 pilot, we only compared ESTEEM to waitlist. Thus, comparing ESTEEM against two 
interventions—one brief (VCT), both widespread—represents an essential next step in 
determining ESTEEM’s efficacy and cost-effectiveness.  
 
Aim 2: Follow-up assessments at 4, 8, and 12 months will allow us to test whether changes in 
minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. Our 
pilot’s small sample size and lack of follow-up precluded us from testing mediation, but provides 
path estimates necessary to determine sample size and power in full prospective mediation, as 
proposed here.  
 
Aim 3: CBT-based interventions, such as ESTEEM, are as effective as medication for depression 
and anxiety, effects last longer with fewer side effects, and recipients are typically satisfied.119 
However, CBT is costlier than one-session VCT interventions, which have been shown to avert HIV 
infection but not co-occurring mental health problems. Because of additional time requirements 
for CBT (e.g., training), CBT is also costlier than CMHT. While the current approach of delivering 
stand-alone interventions for isolated health risks is inefficient, the cost-effectiveness of 
multisession skills-based interventions for simultaneously addressing co-occurring health risks 
among the most vulnerable YGBM remains unknown. Two control groups will allow us to 
determine whether ESTEEM yields greater return on investment across the spectrum of YGBM’s 
mental, behavioral, and sexual health than current single-outcome interventions. Collecting cost 
and resource utilization data for all intervention conditions will allow us to determine if the 
relatively costlier ESTEEM yields greater cost effectiveness and quality-adjusted life years across 
the spectrum of YGBM’s mental, behavioral, and sexual health than common single-outcome 
interventions, namely CMHT and VCT.  
 
Participants will be randomly assigned to receive one of the following three conditions (ESTEEM, 
CMHT, VCT only).  We will use a 2:2:1 randomization scheme such that for every two participants 
randomized to ESTEEM, two participants will be randomized to CMHT and one participant will be 
randomized to VCT only.   
 
Components of all assessments (baseline 1, baseline 2, 4-month, 8-month, 12-month) will take 
place in our research offices. In the event that a participant moves out of the New York City area 
or is no longer able to come in to our offices for their follow-up assessessments, we will conduct 
remote assessments via phone or video conference. The entire baseline 1 assessment will be 
done in office. Self-report online surveys will be sent to participants via email to complete prior 
to the in-office components of the baseline 2 and all follow up assessments. Allowing participants 
to do the online surveys in a location of their choice reduces the concentrated time burden of 

Page 10 of 34 
 
each appointment and allows them to answer the questions where they feel most comfortable. 
Survey questions assessing suicidality will be completed in office under the supervision of a 
clinical staff member for the baseline 2 and follow up assessment visits. When scheduling any 4-
month, 8-month, and 12-month remote follow-up assessment, prior to the appointment a 
trained study staff member will request participant address via email and locate the nearest 
emergency services. While assessing suicidality, if there is a concern for safety, just as with any 
participant seen in the offices, the study staff will contact the nearest emergency services and 
adhere to the remainder of the established clinical protocol.  
 
ESTEEM treatment will take place over 10 sessions delivered in our offices. All participants, 
including those randomized to receive VCT only, will receive VCT during the baseline 1 and 12 
month follow up appointments, which will take place over one session in our offices.  Participants 
assigned to receive CMHT will receive 10 sessions of CMHT at the Institute for Human Identity 
(NYC) or Care Resources (Miami).  CMHT is not prescribed in our treatment manuals, but is 
instead delivered by community providers as they usually provide treatment. These two sites are 
known for providing LGBT-affirmative treatment in safe, supportive environments. ESTEEM and 
CMHT sessions will be videotaped in the settings where they are delivered [i.e., the Institute for 
Human Identity (NYC) or Care Resources (Miami)] and both therapists and participants will 
complete short surveys after each therapy session at the appointment site; all assessments will 
be completed in our research offices and at home for the baseline 1, baseline 2, 4-month, 8-
month, and 12-month assessment visits. Tapes of CMHT sessions will be immediately retrieved 
from the video recording devices at the CMHT offices by study stuff and provided to PI Pachankis 
via secure server. 
 
Condition 1: ESTEEM.  ESTEEM is a 10-session intervention based on the Unified 
Protocol,35,36,120,121 an individually-delivered CBT intervention with efficacy for reducing stress-
sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation 
skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior 
change.35,122 The Unified Protocol employs modules for motivation enhancement, interoceptive 
and situational exposure, cognitive restructuring, mindfulness, and self-monitoring techniques. 
Through an extensive R34 adaptation process described above,34 we adapted the Unified 
Protocol to enhance YGBM’s stigma coping by reducing minority stress processes. For example, 
modules were adapted to help YGBM identify minority stress experiences; track unhealthy 
reactions to minority stress, focusing on avoidance reactions, like substance use and condomless 
anal sex; attribute distress to minority stress rather than to personal failure; and assert 
themselves against unjust minority stress in safe situations.  Adaptations were infused 
throughout the Unified Protocol Therapist Workbook;123 this adaptation served as the therapist 
manual. The full manual is attached. ESTEEM participants will complete 10 sessions of therapy, 
with one session per week. If participants miss sessions or need to reschedule, we will make 
every effort to reschedule sessions such that participants stay as close to a one session per week 
schedule. If participants miss a week, they may be rescheduled to do two sessions in one week, 
but they will be told the goal is once per week. All sessions must be completed within four 
months. 
 

Page 11 of 34 
 
Condition 2: CMHT.  The current standard of care for LGB individuals who seek mental, 
behavioral, or sexual health care is LGB-affirmative therapy.124 The practice of LGB-affirmative 
therapy is outlined across 21 guidelines published by the American Psychological Association. 
However, the efficacy of LGB-affirmative psychotherapy has never been tested,125 despite several 
promising case studies.126-128 Following previous tests of innovative NIMH-funded 
interventions,129 we will refer YGBM to community clinicians who provide this standard of care.  
In NYC, this community clinic will be the Institute for Human Identity (322 Eighth Ave., New York, 
NY 10001).  In Miami, this community clinic will be Care Resources (3510 Biscayne Blvd., Miami, 
FL 33137). CMHT therapists and participants randomized to CMHT will complete short surveys 
after each CMHT therapy session. Similar to participants randomized to ESTEEM, CMHT 
participants will complete 10 sessions of therapy, with one session per week. If participants miss 
sessions or need to reschedule, we will make every effort to reschedule sessions such that 
participants stay as close to a one session per week schedule. If participants miss a week, they 
may be rescheduled to do two sessions in one week, but they will be told the goal is once per 
week. All sessions must be completed within four months. 
 
Condition 3: VCT only.  Participants in all arms will receive VCT at their first baseline visit, before 
being randomized to their respective arms—ESTEEM, CMHT, or VCT only and again at the 12 
month follow-up visit. Participants randomized to the VCT only arm will not receive any further 
intervention.  We base VCT on CDC guidelines and the control arms of large community-based 
RCTs (e.g., Projects RESPECT, EXPLORE, AWARE).101-104 VCT will consist of one unique 45-minute 
session given that 1-session VCT is as effective as 2-session VCT for GBM.103 At the beginning of 
the session, the counselor will explain the purpose of HIV and STD testing, and with the 
participant’s consent, administer an OraQuick® Rapid HIV-1/2 antibody test. While waiting for test 
results, the participant will provide a urine sample and oral and rectal swabs for chlamydia and 
gonorrhea testing, and, when done, the counselor will review a handout containing facts about 
HIV/STD transmission risk and PrEP. Misconceptions will be clarified. This handout will contain 
provider referrals for participants interested in PrEP or other HIV/STD prevention services. The 
counselor will then engage in a person-centered discussion to elicit the participant’s current risk 
behavior, the contextual drivers of the behavior, perceptions of the pros/cons of continuing the 
behavior, and self-efficacy for changing the behavior based on the participant’s past success. A 
personalized risk-reduction plan will be created that includes specific, achievable goals the 
participant can implement to reduce risk.103 These goals will be written on the pamphlet. 
Participants who receive a preliminary positive HIV test result will be referred to nearby 
community health centers (e.g., Care Resource, Gay Men’s Health Crisis, Callen-Lorde Community 
Health Center, Mount Sinai Beth Israel) for confirmatory testing and appropriate care.  Urine, 
oral, and rectal samples will be sent to a lab (Quest Diagnostics) for testing. We will notify 
participants who screen positive for chlamydia or gonorrhea immediately upon receiving the lab 
results and refer them to a nearby community health center or their own medical provider for 
treatment. 
 
4. 
Participant Population: Provide a detailed description of the types of participants who will be 
recruited into this study. 
 

Page 12 of 34 
 
Intervention Participants: 
 
Inclusion criteria.  Eligible participants will meet the following criteria: (1) aged 18-35, (2) identify 
as a gay or bisexual man, (3) HIV-negative status, (4) diagnosis of any DSM depressive, anxiety, or 
trauma- and stressor-related disorder; (5) HIV sexual risk (≥1 act of condomless anal with a male 
partner of unknown status or HIV+ status, unless with a HIV+ primary/main partner with known 
undetectable viral load); (6) not currently adherent to PrEP (defined as taking 4 or more days per 
week) (7) NYC or Miami residential stability and planned availability for 12 months; and (8) 
provision of informed consent. 
 
Exclusion criteria. Participants will be excluded for any of the following: 1) current active suicidality 
or homicidality (defined as active intent or concrete plan, as opposed to passive suicidal ideation); 
2) evidence of active untreated mania, psychosis, or gross cognitive impairment; 3) current 
enrollment in an intervention study; 4) current enrollment in intensive mental health treatment 
(receiving treatment more than once per month or 8 or more sessions of CBT within the past year); 
or 5) HIV-positive status.  
 
CMHT Therapist Participants: 
 
Therapists at our CMHT sites will be considered participants in the study, as they will be videotaped 
and will complete short assessments after each therapy session. We will also collect demographic 
information about each therapist, including race, sexual orientation, and years of work experience 
from the CMHT therapists prior to their meeting with therapy participants. To be included as 
participants in the study, CMHT therapists must be currently providing therapy on an ongoing basis 
at the CMHT sites (Institute for Human Identity in New York City and Care Resources in Miami). 
 
5. 
Describe how access to the population will be gained in the study. 
 
We will use active and passive recruitment strategies. Active approaches will involve conducting 
eligibility screening via electronic tablet at bars/clubs and support groups (e.g., coming out 
groups and 20-somethings group at the NYC LGBT Center). Passive approaches will involve 
advertising on YGBM-oriented mobile apps and websites (e.g., Grindr, Scruff, BGCLive, Growlr), 
clinic waiting rooms (e.g., Callen-Lorde Community Health Center, college counseling centers), 
YGBM-focused media (e.g., Craigslist, Facebook, Reddit, party listservs), and referrals from 
previous or current study participants. As part of passive recruitment we will also contact 
participants from previous research studies who consented to be contacted for future studies. 
Advertisements will engage help-seeking YGBM by emphasizing the study as a safe venue for 
discussing sex and HIV.  
 
CMHT therapists will be identified by directors at our CMHT partner sites. 
 
6. 
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 safeguards or 

Page 13 of 34 
 
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 
 
 
 Healthy  
 
 Non-English Speaking 
 Prisoners 
 
 Economically disadvantaged  
 Decisionally Impaired 
 Employees  
 Pregnant women  
 Yale Students 
 
 
 Other vulnerable population (who?): 
 Psychology Pool 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as 
potential participants? 
 Yes  
 No (If yes, see HRPP Policy 310.4  for further requirements) 
 
 
7. 
Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion 
or    exclusion? 
 
Inclusion criteria.  Eligible study participants will meet the following criteria: (1) aged 18-35, (2) 
identify as a gay or bisexual man, (3) HIV-negative status, (4) diagnosis of any DSM depressive, 
anxiety, or trauma- and stressor-related disorder; (5) HIV sexual risk (≥1 act of condomless anal sex 
with a male partner of unknown status or HIV+ status, unless with a HIV+ primary/main partner 
with known undetectable viral load); (6) not currently adherent to PrEP (defined as taking 4 or 
more days per week); (7) NYC or Miami residential stability and planned availability for 12 months; 
and (8) provision of informed consent. Eligible CHMT therapists must be approved therapists at the 
CMHT sites. 
 
Exclusion criteria. Intervention participants will be excluded for any of the following: 1)  current 
active suicidality or homicidality (defined as active intent or concrete plan, as opposed to passive 
suicidal ideation); 2) evidence of active, untreated mania, psychosis or gross cognitive impairment; 
3) current enrollment in an intervention study; 4) current enrollment in intensive mental health 
treatment (receiving treatment more than once per month or 8 or more sessions of CBT within the 
past year); or 5) HIV-positive status. There are no exclusion criteria for CMHT therapists other than 
refusal to provide consent to study procedures. 
 
 
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
 
1. 
Recruitment Procedures:  
1. 
Describe how potential participants will be identified and contacted, and by 
whom. 
 
We will employ a number of strategies to recruit intervention participants. These strategies are 
designed to recruit an ethnically diverse sample from multiple types of venues in which gay and 
bisexual men are likely to be accessed (e.g., online social networking apps and websites, social 

Page 14 of 34 
 
venues, community based organizations, health care organizations, gay bars/clubs). 
 
1) Online recruitment.  Online recruitment for our existing studies has been successfully utilized. 
The proposed study's ads will target HIV-negative gay and bisexual men who are over 18 years 
old and who experience symptoms of depression or anxiety.  We will advertise on Facebook, 
Craigslist, and other social networking sites for gay and bisexual men. Potential participants will 
link to our website, read about the study and undergo a screener. 
 
2) Passive recruitment.  Passive recruitment will be employed at different venues, including, for 
example, locations and events serving YGBM, such as bars and dance clubs, Pride events, street 
fairs, bookstores, community centers, and health care clinics. These venues will have given us 
permission to post recruitment materials. Our recruitment staff will provide venues with 
recruitment materials such as tear off flyers and recruitment cards containing information such as 
study name, goals, and contact information for those interested in screening for eligibility. 
 
3) Recruitment of participants from past studies. At the end of one of our current studies (Urban 
Migration, Self-Regulation, and Drug Abuse and HIV Risk Among Young Men, Protocol #: 
1405013946), we ask participants whether they would be willing to be contacted for future 
studies. Participants who consented to be contacted for future research will be contacted using 
contact information they provided. We will also recruit from a prior study called Gay Community 
Stressors Among Gay, Bisexual, and Queer Men (Protocol #:1512016893). Additionally, 
participants from a colleague’s study (Intervention to Promote PrEP Awareness and Equitable 
Prescription among Providers, Protocol #: 1308012487) who consented to being contacted for 
future studies for which they may qualify may be contacted using the contact information they 
provided. As well as participants who consented to being contacted for future studies from the 
Center for Human Identity and Behavior Prevention studies lab.  
 
4) Active recruitment. In active recruitment, our recruitment staff will approach potential 
participants in a wide range of venues frequented by gay and bisexual men and ask if they might 
be willing to speak with them for a couple of minutes about HIV prevention and psychosocial 
health research. If the individual is willing, the recruiter will briefly describe the study and ask if 
they would be willing to answer a few questions to see if they might be eligible. If the potential 
participant does not want to answer the questions right then, the recruiter will give the 
participant a recruitment card and ask them to call the study number should they decide they 
would like to participate at some point in the future. 
  
If the potential participant agrees to answer the eligibility questions, the recruiter will give the 
participant a tablet device so that they may answer the screening questions in private. The field 
screening questions are designed to give a general sense of eligibility for the project (such as age, 
recent sex, and HIV status), but not to determine strict eligibility for the study. At the end of the 
screening questions, the participant will be prompted to provide their name and contact 
information for later follow up. The participant will have the opportunity to have his contact 
information deleted in the event he is not eligible nor interested in future studies. The recruiter 
will inform interested participants that they will receive a call to participate in a full study 

Page 15 of 34 
 
screener if they are eligible for the study. If not, participants will not be follow up with.  
 
Recruiters will visit bars/clubs to post study materials and hand out study contact information. 
Recruiters will also visit bars/clubs and other venues with tablets set up with screening questions 
for the potential participant to complete; this field screening survey is preliminary and if the 
potential participant screens eligible, he will provide contact information within the survey, after 
which the recruiter will inform him that he can expect a call/email from a research assistant to 
complete the full study screener. The tablet will be password protected. No data will be stored on 
the tablet. The survey will be hosted on Qualtrics and only accessed if wifi is available to 
complete it. Use of a tablet to complete a preliminary screening helps to maintain privacy, even 
in a crowded bar setting, given that the potential participant can read the survey to himself, 
rather than answering questions aloud to the recruiter; a privacy screen protector will also be 
used on the tablet so as to prevent outsiders from overseeing questions/responses on the tablet. 
As an additional measure of privacy, recruiters will locate the most private part of the bar/club to 
do these screenings. 
 
Throughout the course of the study, we will periodically hold sweepstakes for people who 
complete our in-person screening survey. We will pool the contact information for all people who 
completed the survey during our event (noted by timestamp) and will use a random number 
generator to select people to win the prize. The sweepstakes prize will be a $25 gift card that will 
be emailed to them immediately after the selection of the winners. 
 
5) Letters and postcards sent to community organizations.  We will send a letter and postcards to 
community organizations, including community-based organizations supporting the LGBT 
community and local college counseling centers.  The letter will ask these organizations to 
distribute the postcards in their waiting areas and to potentially eligibile individuals.   
 
6) Peer-recruitment and referrals by previous and current study participants. Participants in the 
study will be asked to distribute study recruitment materials to peers who may be interested in 
participating in the study. Participants will be reminded that staff will never disclose any 
information about an individual’s participantion in the study, but that participants are free to 
disclose information about their own participation to whomever they desire. Participants are not 
required to distribute recruitment materials as a condition of study participation and the strictly 
voluntary nature of this request will be emphasized by study staff.  
 
Recruitment text and images are attached to this application. 
 
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.) 
 
 

Page 16 of 34 
 
2. 
Indicate recruitment methods below.  Attach copies of any recruitment materials that will be 
used. 
 
 Flyers 
 
 
 
 
 Internet/Web Postings 
 
 
 Radio 
 Posters  
 
 
 
 Mass E-mail Solicitation  
 
 Telephone 
 Letter 
 
 
 
  
 Departmental/Center Website 
 
 Television 
 Newspaper 
 Through local NGO or other local contact  
 Social Media (Facebook, Twitter) 
Classroom recruitment  
Table set-up / in-person recruitment of public                   
Snowball sampling  
 
 
 
Other (describe): 
 
 
3. 
Targeted Enrollment: Give the number of participants: 
1. 
Targeted for enrollment at Yale (site: New York) for this protocol:  150 
2. 
If this is a multi-site study, give the total number of participants targeted across all 
sites: 
 
New York:  150 (60 ESTEEM, 60 CMHT, 30 VCT) 
Miami:  100 (40 ESTEEM, 40 CMHT, 20 VCT) 
 
 
4. 
  How was this estimate derived? 
 
Our primary goal is to demonstrate a greater reduction at 4, 8, and 12 months in “unprotected 
sex” as defined as past-90-day condomless anal sex without PrEP or with HIV+ or status-unknown 
casual partners or with HIV+ primary partners without known undetectable viral load, in the 
ESTEEM arm versus the CMHT and VCT arms. In our pilot study, we saw a 60% reduction in 
condomless anal sex at 6 months in the ESTEEM arm. Based on previous studies of VCT104 and the 
fact that CMHT does not specifically focus on condomless anal sex, we expect that these arms will 
yield lower reductions compared to ESTEEM, but a slightly larger reduction in CMHT (20%) 
compared to VCT (15%). To achieve at least 90% power at a 5% type I error rate, accounting for 
an R-square of 0.1 between treatment arm and the covariates, we will need 80 individuals in the 
ESTEEM and CMHT arms, and 40 individuals in the VCT arm.  Although we plan to take steps to 
increase our retention rate from our pilot study, we conservatively estimate the retention at 6 
months to be 80%. Therefore, we plan to randomize 100 ESTEEM, 100 CMHT and 50 VCT YGBM. 
Sample size calculations were carried out using PASS 12 (Kaysville, Utah) for logistic regression. 
For secondary outcomes (e.g., mental health, substance use), we will have 80% power to detect 
an effect size of 0.55 and 0.70 for ESTEEM vs. CMHT and ESTEEM vs. VCT, respectively, at a type I 
error rate of 0.01 (conservative due to multiple testing). These effect sizes are smaller than those 
found in the pilot.   
 

Page 17 of 34 
 
5. 
Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent.  
 
John Pachankis, Ph.D. 
Steven Safren, Ph.D 
Richard Branstrom, Ph.D. 
TJ Sullivan, BA 
Craig Rodriguez-Seijas, MA 
Ingrid Solano, MA 
Chuck Burton, Ph.D. 
Roxanne Winston, MPH 
Dominic Schnabel 
Erin McConocha 
Tenille Taggart 
Colin Kimberlin 
Cal Brisbin 
Meghan Michalski 
Alexander Belser 
Arjan van der Star, M.Sc. 
Maxwell Richardson 
Nitzan Cohen 
Zach Rawlings 
 
6. 
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.  
 
Informed consent will be obtained for all participants at two points – before completion of the 
phone screener and/or in-person screener and before completion of the first in-office baseline 
assessment. A small selection of participants previously randomized to ESTEEM will also be 
contacted an additional time by research staff to gain consent for our team to display short clips 
of their therapy sessions during training of community therapists in ESTEEM therapy techniques.  
 
Before administering the phone screener, a project staff member will first assess participants’ 
willingness and capacity to consent to completing the brief (15 min) screener to determine 
eligibility.  Participants will provide their verbal consent for the phone screener. Participants’ 
identifying information, including their name, will be kept in a separate database from the 
remainder of their study responses. 
 
Before completing the in-person screener, participants will review an online consent form 
describing the screening purpose and risks/benefits and indicate their consent by selecting the 

Page 18 of 34 
 
commensurate button. Participants’ identifying information, including their name, will be kept in 
a separate database from the remainder of their study responses. Participants who are deemed 
preliminarily eligible based on the in-person screen will be contacted by our study staff to 
confirm eligibility by phone screen. 
 
Participants who are deemed eligible based on the phone screener will then be invited to the 
office for a baseline 1 appointment. During this appointment, participants will complete a written 
consent. After the baseline 2 appointment, participants will be randomized to either the ESTEEM 
intervention, CMHT, or VCT.  
 
During phone and in-office consent, a trained staff member will review the consent form in 
person, including details of the full study and study risks and precautions against risk.  
Participants who choose to participate in the remainder of the study will be asked to sign the 
consent form in the presence of the staff member (in-office) or provide verbal consent (phone 
screen). 
 
We will select video clips from approximately 12 total sessions delivered to approximately five 
currently and formerly enrolled study participants. These videos do not contain participants’ 
faces or identifiable information other than participants’ voice and therapists’ image and voice. 
Selected participants who have completed ESTEEM therapy will be contacted prior to completion 
of the study or after completion of the study in order for us to gain consent to present small 
portions of their therapy videos during future professional trainings at community-based clinics 
and agencies. Participant will be contacted by either an ESTEEM therapist or a research team 
member. The research team member or therapist will clearly explain that videos will only be used 
for instructional purpose to train community clinicians and future trainees on the ESTEEM 
therapy protocol. They will also be reminded in that videos do not include the participant’s face 
or any identifiable information, only their voice and the therapist’s face and voice. The therapist 
or research team member will explicitly state that the participant is free to decline or to ask any 
questions about the purpose of this request. Newly recruited participants will be able to note on 
the informed consent form whether or not they consent to have a small selection of their therapy 
recording used in the future for new therapist trainings.  
 
CMHT therapists will provide written consent prior to providing therapy to their first participant. 
 
7. 
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 
 
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.  

Page 19 of 34 
 
RAs will be instructed to contact the PI or project coordinator if he or she is unsure about any 
participant's capacity to consent.   
 
For the phone screener, participants will be asked to provide verbal consent prior to answering 
the screener questions.  
 
For the in-person screener, recruitment staff will assess willingness and capacity to consent to 
completing the brief (4 min) screener to determine eligibility (e.g., visible signs of substance 
intoxication).  Those who are deemed capable of providing consent will be asked to review the 
consent form and indicate their consent on the consent form delivered via iPad / tablet.  
Participants who are deemed to be incapable of providing consent will be provided with a 
recruitment card with our contact information in order to contact our office for a phone screen 
once they are not incapacitated.    
 
CMHT therapists will receive hard copies of consent forms and will sign the consent forms prior 
to providing therapy to their first participant.  
 
 
8. 
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) phone screener consent text, 2) in-person consent, 3) in 
office consent, 4) therapy video viewing consent text, 5) consent form for CMHT therapists. 
 
9. 
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). 
 
At this point, only English speakers will be enrolled in this study. 
 
10. 
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.  
 
HIV and STI Testing 
We will be conducting HIV testing using OraQuick® HIV-1/2 Antibody Test, an oral swab rapid test 
[sensitivity: 99.6% (98.5–99.9); specificity: 100% (99.7–100)] on all participants at two time points 
(in-office baseline and 12-month follow-up assessment appointments). All project staff will 
complete HIV/STI testing and counseling training.   
 
Like conventional HIV enzyme immunoassays (EIAs), rapid HIV tests are screening (i.e., not 
diagnostic) tests that require diagnostic confirmation by Western Blots if reactive (positive).  

Page 20 of 34 
 
Participants who test preliminarily positive will be immediately referred to local community HIV 
clinics (e.g., Callen-Lorde Community Health or Beth Israel in NYC, Care Resources in Miami) for 
confirmatory testing, care, and treatment.  If a participant is unaware of his HIV status and tests 
positive for the first time in our study, he will be referred for immediate counseling and 
treatment. Appropriate risk-reduction counseling will be provided to all participants as part of 
their study participation as part of the VCT condition, which all participants will receive. 
Participants testing HIV positive will not be randomized into the study, as HIV negative status is 
one of the inclusion criteria, so they will receive immediate counseling by study staff. Study staff 
will provide all participants with lubricant and condoms. Study staff will seek HIV testing consent 
from the participants during the informed consent process. HIV test results will be returned to 
participants by trained study staff during the same day as testing. If the participant is 
preliminarily determined to be HIV-infected, study staff will direct the participant to established 
services for HIV-infected individuals in NYC or Miami; study staff will make an appointment for 
participants at the participant’s desired confirmatory testing site (either our recommendation or 
their current provider). We will provide a staff escort to one of the recommended testing sites for 
participants who explicitly request such. 
 
Participants will receive results of the HIV rapid testing in person from the VCT counselor, 
following the guidelines in the VCT manual. The rapid test results will be ready in 20 minutes. In 
the rare event that a participant needs to leave prior to receiving the results, the counselor will 
schedule a time to return to the study site to be retested so that he can receive results in person. 
If for some reason, the participant cannot return to be retested, we will provide results by phone 
with clear instructions regarding how to seek confirmatory testing if necessary. The clinical 
protocol will be followed. 
 
STI testing (chlamydia and gonorrhea) will utilize the Quest Diagnostics collection kits for urine 
sample and rectal and oral swap collection. Participants will self-administer these sample 
collections following instructions of the trained research staff member. The counselor will follow 
Quest Diagnostics protocol for sending the samples to the assigned Quest laboratory location for 
assaying. Quest will send the test results to ESTEEM within one week, at which point ESTEEM 
staff will immediately notify participants of the results. A positive test is sufficient for diagnosis 
and participants will be directed to the respective partnering community clinic for treatment and 
follow up, unless participant prefers to access care at health clinic of his choice. 
 
Sites that conduct screening tests such as our HIV screening test are required to connect 
participants to a site capable of providing confirmatory testing in the event of a preliminary 
positive.  With regards to gonorrhea or chlamydia testing, participants who test positive for 
gonorrhea or chlamydia must be reported to the Department of Health. However, participants 
themselves will not be contacted if nucleic acid amplification testing is used to determine results, 
as planned for this study. Participants will be notified of this requirement in the written consent 
form given at the baseline assessment. In Florida law, there is a provision for identity protection 
of participants for “authorized medical or epidemiological researchers who may not further 
disclose any identifying characteristics or information;” participants are assured of their identity 
protection throughout the course of the study, and given the epidemiological nature of this 

Page 21 of 34 
 
research, in accordance with Florida law, we will not be required to report individuals who screen 
as STI-positive during ESTEEM. Click here to access Florida reporting laws. 
 
We will make every effort to ensure that participants with positive results are referred and have 
access to care at formal health clinics for confirmatory testing and follow-up care. These health 
facilities and healthcare providers will be subject to mandatory reporting laws governing their 
services, as any of the testing that takes place outside of ESTEEM will not be considered as testing 
for research purposes. 
 
Suicidality, Homicidality, Severe Distress, Violence 
Our ESTEEM clinical protocol successfully guided reporting of instances of suicidality, 
homicidality, severe emotional distress, and violence 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.  All self-report questionnaires assessing 
suicidality will be given in-office where participants can be monitored by a clinical staff member. 
Clinical staff members will receive an alert if the participant answers the online questionnaires in 
a manner that signals distress; such participants will be met by the clinical staff member on site 
to assess risk.  
 
Participants will be notified of the reporting requirements under these circumstances during the 
consent process. 
 
In the event that a participant is unable to complete the self-report questionnaires in the office, 
we will conduct remote assessments. Prior to these assesments, the Senior Research Assistant 
will contact the participant to locate their nearest emergency services. The session will be 
completed via video or phone call depending on participant preference. It will be conducted by a 
clinically trained research staff member who will administer the assessment and will follow the 
same in-office clinical protocol for expressed imminent participant distress, by contacting the 
participant’s nearest emergency services only in the instance of imminent risk.  
 
 
11. 
Consent/Consent Waiver: 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.   
  I plan to obtain signed consent 
  I plan to obtain verbal or online consent       
  I plan to obtain signed consent for part of the study, and verbal or online consent for 
another part of the study. 
 
  I do not plan on obtaining consent due to the nature of the study (explain): 
    

Page 22 of 34 
 
 Requesting a waiver of documentation of consent (Note that an information sheet may be 
required.) 
 
  
If requesting a waiver of documentation of consent, please address the following: 
a. Would the signed consent form be the only record linking the participant and the 
research? 
 Yes  
 No 
b. Does a breach of confidentiality constitute the principal risk to participants?  
 Yes  
 No 
 
 
 
 
 
OR 
 
a. Does the research pose greater than minimal risk? 
 Yes If you answered yes, stop. A 
waiver cannot be granted.    
 No  
AND 
b. Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No 
 
  
Consent will be obtained for all study components either verbally or signed or online as described 
above.  However, we will not require participants to provide their name when consenting to 
completing the brief screen to be administered via electronic tablets at local venues (e.g., gay bars, 
clubs, parks).  This brief (4 min) screen will assess age, HIV status, HIV and substance use risk 
behavior, and depression and anxiety symptoms to determine preliminary eligibility for this study.  
This brief screen does not pose greater than minimal risk.  Before completing this screen, 
participants will be told via online text that this screen will ask several personal questions to 
determine eligibility for a larger study and that participants can choose to provide their name and 
contact information after they have found out if they are eligible via the electronic screen. 
Preliminarily eligible participants will be asked to provide their name and contact information in 
order to receive a call or email containing more information on how to complete a more 
comprehensive phone screen to verify study eligibility.  Participants’ identifying information, 
including their name, will be kept in a separate database from the remainder of their study 
responses. Participants will provide consent before completing this more comprehensive phone 
screen, as described above.   
 
 
 Requesting a full waiver of consent  
 
  
 
If requesting a full waiver of consent, please address the following: 
 
 
  
a. Does the research pose greater than minimal risk to participants?   
 Yes  If you answered yes, stop. A waiver cannot be granted.   
 No 
 
  
b. Will the waiver adversely affect participants’ rights and welfare? 
 Yes  
 No 
 
  
c. Why would the research be impracticable to conduct without the waiver?  
 
d. Where appropriate, how will pertinent information be returned to, or shared with 
participants at a later date?  

Page 23 of 34 
 
 
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS 
 
    Confidentiality & Security of Data: 
 
1. 
What participant information will you be collecting? 
 
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; chlamydia and gonorrhea infection; experiences with stigma-related stress; depression and 
anxiety; cognitive, affective, and interpersonal functioning (e.g., rumination, social support, 
impulsivity, assertiveness); mental health treatment history and perspectives; substance use; 
sexual compulsivity; and perceptions of intervention helpfulness.  We will also video tape-record all 
intervention sessions. Counselors will also complete session notes. Each participant will have a 
binder that contains all session notes. No name will be attached to the binder, only participant ID. 
The binders will be locked in a filing cabinet. 
 
Participants will provide the following data at baseline and 4-, 8-, and 12-month follow-up 
appointments: (1) quantitative assessments, previously used with young gay and bisexual men, of 
mental health, substance use, and stigma-related stress, (2) interviewer-administered timeline 
follow-back of HIV risk behavior, including condomless anal, sex while under the influence of drugs 
or alcohol, PrEP use and adherence, and number of sexual partners, during the previous 3 months, 
(3) interviewer-administered mental health assessment with the Mini-International 
Neuropsychiatric Interview (MINI), (4) OraSure rapid HIV 1/2 antibody test (at baseline and 12-
month follow-up), (5) urine sample and rectal and oral swabs for chlamydia and gonorrhea testing 
(at baseline and 12-month follow-up), and (6) engagement in the intervention.   
 
Participants who complete remote assessments will be asked to provide their address to research 
staff to aide in establishing contact with the nearest emergencies services, if necessary. This 
information will be stored in a password protected contact database on secure Box only accessible 
to research staff. Once addresses are stored in the database, any emails containing identifiable 
participant information will immediately be hard deleted from study inboxes.  
 
2. Will any of the following identifiers be collected? 
 Names  
 All geographic subdivisions smaller than a State, including: street address, city, county, precinct, 
zip codes  
 Telephone numbers 
 Fax numbers  
 E-mail addresses 
 Social Security numbers  
 Medical record numbers 
 Health plan beneficiary numbers  
 Account numbers  

Page 24 of 34 
 
  All elements of dates (except year) for dates related to an individual, including: birth date, 
admission date, discharge date, date of death, all ages over 89 and all elements of dates (including 
year) indicative of such age, except that such ages and elements may be aggregated into a single 
category of age 90 or older  
 Certificate/license numbers  
 Vehicle identifiers and serial numbers, including license plate numbers  
 Device identifiers and serial numbers  
 Web Universal Resource Locators (URLs)  
 Internet Protocol (IP) address numbers  
 Biometric identifiers, including finger and voiceprints  
 Full face photographic images and any comparable images  
 Any other unique identifying numbers, characteristics, or codes  
 
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). 
 
3. If applicable, what methods and procedures will be used to safeguard the confidentiality and 
security of the identifiable study data and the storage media indicated above during and after the 
participant’s participation in the study? 
Do all portable devices contain encryption software? 
 Yes   
 No 
         If no, seehttp://its.yale.edu/secure-computing/protecting-yales-data/data-encryption and 
http://hipaa.yale.edu/guidance/policy.html 
 
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. Additionally, 
health care professionals are required by state law to report suspected cases of abuse or neglect.  
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, we will obtain a Federal 
Certificate of Confidentiality 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, 
which will only be kept on an electronic database that will be password protected and located on a 
designated study computer. This 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 
therapists and research staff under explicit guidelines to preserve confidentiality when 
telephoning, emailing, or mailing information to participants. All materials with identifying 
information will be kept in one password protected electronic file.  Participants will provide the 
respective site, Yale or Miami, with 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.  For participants 

Page 25 of 34 
 
who consent to the presentation of small portions of their therapy videos to future trainees at 
community clinics and agencies, they will be reminded by the therapist or research team member 
acquiring this specific consent that all therapy video sessions only contain their voice and no 
images of their face or other identifying information.  
 
Secure digital (SD) memory cards for the recording equipment will be stored at the research study 
site. When the video cameras are at community sites they will be retrieved weekly and brought 
back to the study site in a lock box. Data will immediately be uploaded to the Secure Box server on 
a Yale computer and the memory cards will be cleared. 
 
4. How will the research data be collected, recorded and stored?  
 
Research data will be collected via telephone, on electronic tablets, electronic databases, survey 
websites, paper-and-pencil, electronic documents, video recording, and specimen sample for HIV, 
chlamydia, and gonorrhea.  
 
Preliminary screening data will be collected in the field using online tablets.  Screening data will 
also be collected on a secure survey website (Qualtrics.com) and via telephone, whereby a study 
staff member asks the potential participant a series of eligibility questions and enters this 
information into an electronic database at our research offices.  Participants will complete 
surveys at our study sites/offices via yale.qualtrics.com. Participants themselves will enter most 
data into Qualtrics.com directly.  However, study staff will enter interviewer-based data (e.g., 
clinical diagnostic assessment, timeline follow-back interview of risk behavior) into Qualtrics.com 
during the interview. Study sessions will be videotaped for quality control and will be 
downloaded to Yale’s HIPAA-compliant Secure Box drive upon retrieval from study cameras. 
Participant session notes will be stored in a binder unique to each participant; these binders will 
be stored in a locked filing cabinet. Participant tracking and scheduling data will be recorded on a 
study database.  One password-protected linking database containing participant names and ID 
codes will be kept at each of our offices and accessible only be study staff. 
 
Participants will be identified with participant ID number, not with participant name.  The 
diagnostic laboratory that will assay for chlamydia and gonorrhea will not have access to 
participants’ names, only their ID number. 
 
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 will be kept separate from study data and will be password protected. 
 
5. How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard    
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
Audiotaping 
Videotaping 
Handwritten notes 
 Other 
 

Page 26 of 34 
 
1. 
If applicable, how will transfer of data to Yale be completed? See http://its.yale.edu/secure-
computing/protecting-yales-data/data-and-information-classification-yale-university 
 
Data will be transferred from the University of Miami to Yale using the HIPAA compliant Yale Box. 
Videotape data from our CMHT sites will be retrieved in person by a study staff member 
transported via lock box to the research study office and downloaded to Yale Box upon arriving to 
our offices.  
 
2. 
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. 
 
After study completion, 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. 
 
3. 
Will a Certificate of Confidentiality be needed? (See also the NIH Certificate of Confidentiality 
Kiosk, http://grants.nih.gov/grants/policy/coc/index.htm) 
 
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 for 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.  The 
investigative team's strategies to protect against both risks are described below. 
 
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 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 

Page 27 of 34 
 
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 by completing a brief screening instrument on 
a tablet device at the venue in which they were recruited or will be given an information card 
highlighting the goals of the project as well as a number to contact should they wish to participate. 
Passively recruited participants will be informed of the study through a posted flyer or website 
banner containing identical information as the information card used for active recruitment, 
including instructions to call the number should they wish to participate.  Before completing phone 
screening questions, participants will be briefed on consent and asked to provide verbal consent 
specific to the screening. 
 
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 he or she is 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 or receiving HIV/STD test results.  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.  Staff members at our Yale and Miami labs will be thoroughly trained in appropriate 
responses to participant distress through tri-annual trainings by a licensed clinical psychologist.  
This training will address the appropriate handling of imminent threats and provision of referrals to 
free counseling services in less imminent clinical situations. We have developed a protocol for 
immediately referring participants who learn that they are HIV-positive or infected with chlamydia 
or gonorrhea as a result of our study to a local LGBT-affirmative HIV care clinic (Callen-Lorde 
Community Health Center or Mount Sinai Beth Israel at the New York site; Care Resource at the 
Miami site).  
  
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. Additionally, health care professionals are required by state law to 
report suspected cases of abuse or neglect.  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, we will obtain a Federal Certificate of Confidentiality 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 

Page 28 of 34 
 
Institutional Training Initiative (CITI) certificates.  Further, immediately upon providing consent, all 
participants will be assigned an identification number, which will only be kept on an electronic 
database that will be password protected and located on a designated study computer. This 
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. All materials with identifying information will be kept in one password protected 
electronic file.  Participants will provide the respective site, Yale or Miami, with 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.   
 
2. 
Data and Safety Monitoring Plan: All studies require the inclusion of a Data and Safety Monitoring Plan 
(DSMP) with an explicit statement of overall risks (e.g., minimal, greater than minimal/moderate, or 
high), a means to address attribution and grading of adverse events and a description of procedures for 
monitoring the ongoing progress of the research and reporting adverse events. The Data and Safety 
Monitoring Plan should describe how the principal investigator intends to provide ongoing supervision 
and evaluation of the activities of the study including whether appropriate progress is being made. It 
should document the procedures and means to protect the welfare and safety of subjects and protect 
the integrity of the data.   
 
The plan must include provisions for data review and performance of safety reviews, at a specified 
frequency, as well as the plan for reporting to the HSC and/or other internal or external organizations.  
When participating in a multi-site study, the Yale principal investigator must indicate how safety 
reports and/or reporting of serious adverse events from other sites will be provided to the Yale HSC.   
 
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.). 
1. 
What is your assessment of the overall risk level for subjects participating in this study?  
 
minimal 
 
2. 
If children are involved, what is your assessment of the overall risk level for the children 
participating in this study?  
 
N/A 
 
c. 
Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan  
from http://www.yale.edu/hrpp/forms-templates/biomedical.html  for 
1. 
Minimal risk 
2. 
Greater than minimal/moderate risk 
3. 
High 

Page 29 of 34 
 
 
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, the Institutional Review Board (IRB) or the Data Safety Monitoring Board 
(DSMB) 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 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. 
 
3. 
For multi-site studies for which the Yale PI serves as the lead investigator: 
1. 
How will adverse events and unanticipated problems involving risks to 
subjects or others be reported, reviewed and managed? 
2. 
What provisions are in place for management of interim results? 
3. 
What will the multi-site process be for protocol modifications? 
 
The Miami site-PI, Dr. Steven Safren, will notify PI Pachankis within one day of any adverse events 
and unanticipated problems involving risks to subjects or others. PI Pachankis and PI Safren will 
discuss any adverse events and unanticipated problems and PI Pachankis will be ultimately 
responsible for implementing the protocol described above for reporting these events to the IRB, 
the DSMB, and the NIH. 
 
This behavioral/educational intervention trial is sufficiently powered to detect effects consistent 
with those found in our pilot trial of a highly similar intervention.  We therefore do not expect 
that this trial will produce results that warrant early termination of this study or any of its 
components.   
 
Protocol modification will be coordinated between the two sites in meetings between Dr. 
Pachankis (Yale) and Dr. Safren (Miami). 
 

Page 30 of 34 
 
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 and community trainings in the ESTEEM treatment approach. 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. 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? 
 
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 any 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 sweepstakes: 1) the value of the prize; 2) 
the sponsor of the prize (this cannot be a federal funding source); 3) the odds of winning; 4) that 
there are no restrictions to winning. 
 
Participants will receive $25 for completing each of the two baseline assessments (baseline 1 and 
baseline 2), $50 for completing the 4-month and 8-month follow-up assessments, and $75 for 

Page 31 of 34 
 
completing the final 12-month follow-up assessment (total = $225). Participants randomized to the 
ESTEEM condition and CMHT condition will receive $10 per session for $10 sessions (total = $100). 
Therefore, depending on condition assignment, participants will receive between $225 and $325 
for completing all aspects of the study.  Payment will be prorated for partial study completion (i.e., 
participants will only be paid for the parts of the study that they completed). 
 
Throughout the course of the study, we will hold a monthly sweepstakes at the New York site for 
participants who have completed their 4-month, 8-month, or 12-month follow-up appointments in 
the previous month. This sweepstakes winner will be selected using a random number generator. 
Winners will receive a $20 gift card which will be emailed to them directly after the selection of the 
sweepstakes winner. Participants will be notified about the sweepstakes prize, odds of winning, 
and prize sponsor in their monthly appointment reminder emails from the ESTEEM research team. 
 
Annually, we will also hold a sweepstakes at the New York site for all randomized New York 
participants who successfully completed all of their follow up assessments (4, 8, and 12 month). 
This sweepstakes will occur every October beginning in 2018 and ending in 2021. Winners will be 
selected using a computer random number generators and receive a $200 gift card via email.  The 
annual sweepstakes will be explained to participants during their first appointment and clearly 
explained during the consent process in the ICF.  
 
The sweepstakes will only take place in New York due to the differential cost of living in New York 
city compared to that of Miami. According to the US Census cost of housing in Miami is 7.7% 
greater than the national average, where comparatively the cost of living in New York city is 286.7% 
the national average.1 However, to maintain as much parity between sites we will account for the 
differential cost of living through the possibility to earn additional compensation through the 
sweepstakes.  
 
Participants will also receive welcome bags with upon randomization into the study. The value of 
the welcome bags will be approximately $5.00-$10.00 and will include condoms, lubricant packets, 
a lanyard, candy, a welcome card, stickers, a pen, and a stress ball.  
 
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. If participants screen inconclusive or receive 
an HIV+ result during the rapid HIV testing, the testing site provides the confirmatory testing at 
no cost to the study and bills the participant directly if either the testing site or participant 
insurance is unable to cover the costs. Either way, it will be at no cost to the participant. 
Participants are welcome to use their private insurance for any confirmatory testing.    
   
Study participation will generate no cost for participants.  All study treatment (ESTEEM, CMHT, 
VCT) will be provided free of charge to all study participants. 
 
 
1 C2ER, Arlington, VA, ACCRA Cost of Living Index, Annual Average 2010 (copyright). 

Page 32 of 34 
 
 
 
 
 
 
 
 
 
 
SECTION IX: 
 PRINCIPAL INVESTIGATOR AGREEMENT 
 
 
 
 
 
 
 
 
 
SECTION X 
 FACULTY ADVISOR AGREEMENT 
 
As the faculty advisor of this research project, I certify that: 
1. The information provided in this application is complete and accurate. 
As the principal investigator of this research project, I certify that: 
1. The information provided in this application is complete and accurate. 
2. I assume full responsibility for the protection of human participants and the proper conduct of the 
      research. 
3. Subject safety will be of paramount concern, and every effort will be made to protect participants’ 
      rights and welfare. 
4. The research will be performed according to ethical principles and in compliance with all federal, 
      State and local laws, as well as institutional regulations and policies regarding the protection of   
      human participants. 
5. All members of the research team will be kept apprised of research goals. 
6. I will obtain approval for this research study and any subsequent revisions prior to my initiating the 
      study or any change and I will obtain continuing approval of this study prior to the expiration date      
      of any approval period or submit a request to close the study prior to its expiration.. 
7. I will report to the HSC any unanticipated problems involving risk to 
      participants. 
8. I am in compliance with the requirements set by the University and qualify to serve as the 
      principal investigator of this project or I have a faculty advisor. 
9. I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities, if applicable 
 
____John Pachankis, Ph.D._ 
 
 
 
 
May 23rd, 2017 
 
 PI Name (PRINT)   
 
 
 
 
 
Date 
_   
 
 
 
 
Signature 

Page 33 of 34 
 
2. This project has scientific value and merit and that the student or trainee investigator has the  
      necessary resources to complete the project and achieve the aims. 
3. I will train the student investigator in matters of appropriate research compliance, protection 
of human subjects and proper conduct of research. 
4. The research will be performed according to ethical principles and in compliance with all 
federal, state and local laws, as well as institutional regulations and policies regarding the 
protection of human subjects. 
5. The student investigator will obtain approval for this research study and any subsequent 
revisions prior to initiating the study or revision and will obtain continuing approval prior to 
the expiration of any approval period. 
6. The student investigator will report to the HIC any serious injuries and/or other unanticipated  
      problems involving risk to participants.  
7. I am in compliance with the requirements set forth by the University and qualify to serve as 
      the faculty advisor of this project.  
8. I assume all of the roles and responsibilities of a Principal Investigator even though the 
student may be called a PI. 
 
 
 
 
___________  
______ 
 
 
_____ 
      Advisor Name (PRINT) 
 
 
 
 
 
 
Date 
 
_    
_____  
 
 
_______ 
 
Signature 
 
For School of Medicine Applications only: 
SECTION XI 
DEPARTMENT CHAIR’S ASSURANCE STATEMENT  
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project? 
 Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
 No 
 
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC) 
No 
 
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately. 
 
   ____________________________  
 
 
 
 
 
 

Page 34 of 34 
 
   Chair Name (PRINT) and Signature   
     
 
 
 Date 
 
   _________________________________ 
   Department 
 
 SECTION XII 
YNHH HUMAN SUBJECTS PROTECTION ADMINISTRATOR ASSURANCE STATEMENT  
Required when the study is conducted solely at YNHH by YNHH health care providers. 
 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that: 
1. 
I have read a copy of the protocol and approve it being conducted at YNHH. 
2. 
I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest. 
3. 
The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project. 
 
  ______________________________________ 
 
 
 
 
 
 
 
 
    YNHH HSPA Name (PRINT) and Signature        
 
 
 
Date 
 
 
 
 
For HIC Use Only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date Approved  
 
 
 
Human Investigation Committee Signature 
 
This protocol is valid through ______________________________________________