Project EQuIP: Empowering Queer Identities in Psychotherapy
Phase: NA
Conditions: Sexual Minority Stress
Sponsor: Yale University

 
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NCT03721276 
 
Title of Research Project: Project EQuIP: Empowering Queer Identities in Psychotherapy 
 
Date 6.25.19 
 
 

 
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HRP-503E– Protocol for Social or Behavioral Science or Educational Research 
(2017-1) 
 
 
Protocol Title: ESTEEM-W 
 
 
Principal Investigator: Dr. John Pachankis 
 
 
Version Date: 6.25.19 
 
 
(If applicable) Clinicaltrials.gov Registration #: Click or tap here to enter text. 
 
 
INSTRUCTIONS 
 
This template is intended to help investigators prepare a protocol that includes all of the necessary 
information needed by the IRB to determine whether a study meets approval criteria. Read the 
following instructions before proceeding: 
 
1. 
Use this protocol template for a PI initiated study that includes direct interactions with research 
subjects. Additional templates for other types of research protocols are available in the system 
Library:  
• 
If the study involves genetic testing, blood draws, or MRIs, do not use this form. Use the 
biomedical protocol template. 
• 
If the study involves secondary analysis of data, use the Secondary Analysis of Data 
protocol. 
• 
For activities that may qualify as exempt research, use the Request for Exemption form 
(which includes a decision tree to determine whether or not your study qualifies as 
exempt). 
 
2. 
If a section or question does not apply to your research study, type “Not Applicable” 
underneath. 
 
3. 
Once completed, upload your protocol in the “Basic Information” screen in IRES IRB system.  
 
 
 
 
 

 
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SECTION I: GENERAL INFORMATION 
 
 
1. Probable Duration of Project: State the expected duration of the project, including all follow-up and 
data analysis activities.  May 2017-May 2018 
 
2. Study location: State where the study will take place and in what setting. ESTEEM Laboratory 220 East 
23rd Street New York, NY 10010  
3. If international, complete and submit International checklist (http://your.yale.edu/policies-
procedures/forms/450-ch-1-international-research-checklist) Note: If your research involves interactions 
with any embargoed countries you should contact the Director of Corporate Contracts and Export Control 
Licensing (Donald.Deyo@yale.edu or call 203.785.3817) for guidance on how to proceed.   N/A 
 
 
4. 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 IV: RESEARCH PLAN 
 
1. 
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.     
The aim of this study is to develop an evidence-based psychosocial intervention for sexual minority 
women.  This intervention will specifically target the adverse mental and behavioral health outcomes 
disproportionately experienced by sexual minority women, including depression, suicidality, and alcohol 
abuse, which are known to be driven by stigma-related stressors associated with their sexual orientation 
(i.e., minority stress processes). 
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.  

 
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Sexual minority women face significant psychosocial health disparities relative to both the general 
population and heterosexual, cisgender women (Cochran et al., 2001; Cochran et al., 2003; Sandfort et al., 
2001). Specifically, sexual minority women experience an increased risk for depression, suicidality, and 
alcohol abuse (Gilman et al., 2001; King et al., 2008; Matthews et al., 2002; Sandfort et al., 2001; Wilsnack 
et al., 2008). Minority stress theory posits that stigma, prejudice, and discrimination create a stressful 
environment that leads to adverse mental health outcomes and substance abuse problems in LGB 
populations (Meyer, 2003). Despite these well-documented disparities, there have been few resources 
and limited research dedicated to developing evidence-based psychosocial interventions targeted 
specifically to sexual minority women (Rutherford et al, 2008). 
 
ESTEEM (Effective Skills to Empower Effective Men), developed by Dr. John Pachankis, is a 
transdiagnostic, cognitive behavioral intervention that focused on improving health outcomes linked to 
minority stress processes in sexual minority men (Pachankis, 2015). Preliminary data suggest that ESTEEM 
has been effective in improving mental health outcomes and reducing risky sexual behavior in gay and 
bisexual men (Pachankis et al., 2015). One of the benefits of ESTEEM is its ability to target the co-occurring 
health risks that are driven by common minority stress pathways (Pachankis, 2015). Thus, a model based 
on ESTEEM could help to simultaneously target the multiple adverse health outcomes sexual minority 
women disproportionately face, including depression, suicidality, and alcohol abuse, that are linked to 
minority stress processes (Meyer, 2003).  
 
References 
 
Cochran, S. D., Keenan, C., Schober, C., & Mays, V. M. (2000). Estimates of Alcohol Use and Clinical 
Treatment Needs Among Homosexually Active Men and Women in the U.S. Population. Journal of 
Consulting and Clinical Psychology, 68(6), 1062–1071. 
 
Cochran, S. D., Mays, V. M., & Sullivan, J. G. (2003). Prevalence of mental disorders, psychological 
distress, and mental health services use among lesbian, gay, and bisexual adults in the United 
States. J Consult Clin Psychol, 71(1), 53-61. 
 
Gilman, S. E., Cochran, S. D., Mays, V. M., Hughes, M., Ostrow, D., & Kessler, R. C. (2001). Risk of 
psychiatric disorders among individuals reporting same-sex sexual partners in the National 
Comorbidity Survey. American Journal of Public Health, 91(6), 933–939. 
 
Meyer, I. H. (2003). Prejudice, Social Stress, and Mental Health in Lesbian, Gay, and Bisexual 
Populations: Conceptual Issues and Research Evidence. Psychological Bulletin, 129(5), 674–697. 
http://doi.org/10.1037/0033-2909.129.5.674 
 
King, M., Semlyen, J., Tai, S. S., Killaspy, H., Osborn, D., Popelyuk, D., & Nazareth, I. (2008). A 
systematic review of mental disorder, suicide, and deliberate self harm in lesbian, gay and bisexual 
people. BMC Psychiatry, 8, 70. http://doi.org/10.1186/1471-244X-8-70 
 
Matthews, A. K., Hughes, T. L., Johnson, T., Razzano, L. A., & Cassidy, R. (2002). Prediction of 
Depressive Distress in a Community Sample of Women: The Role of Sexual Orientation. American 
Journal of Public Health, 92(7), 1131–1139. 
 
Pachankis, J. E. (2015). A Transdiagnostic Minority Stress Treatment Approach for Gay and 
Bisexual Men’s Syndemic Health Conditions. Archives of Sexual Behavior, 44(7), 1843–1860. 
http://doi.org/10.1007/s10508-015-0480-x 

 
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Pachankis, J. E., Hatzenbuehler, M. L., Rendina, H. J., Safren, S. A., & Parsons, J. T. (2015). LGB-
Affirmative Cognitive-Behavioral Therapy for Young Adult Gay and Bisexual Men: A Randomized 
Controlled Trial of a Transdiagnostic Minority Stress Approach. Journal of Consulting and Clinical 
Psychology, 83(5), 875–889. http://doi.org/10.1037/ccp0000037 
 
Rutherford, K., McIntyre, J., Daley, A., & Ross, L. E. (2012). Development of expertise in mental 
health service provision for lesbian, gay, bisexual and transgender communities. Med Educ, 46(9), 
903-913. doi:10.1111/j.1365-2923.2012.04272.x 
 
Sandfort, T. M., de Graaf, R., Bijl, R. V., & Schnabel, P. (2001). Same-sex sexual behavior and 
psychiatric disorders: Findings from the netherlands mental health survey and incidence study 
(nemesis). Archives of General Psychiatry, 58(1), 85-91. doi:10.1001/archpsyc.58.1.85 
 
Wilsnack, S. C., Hughes, T. L., Johnson, T. P., Bostwick, W. B., Szalacha, L. A., Benson, P., . . . 
Kinnison, K. E. (2008). Drinking and drinking-related problems among heterosexual and sexual 
minority women. J Stud Alcohol Drugs, 69(1), 129-139.  
 
 
 
3. 
Research Plan: Summarize the study design and research procedures using non-technical 
language that can be readily understood by someone outside the discipline. If working with a Non-
Government Organization (NGO) or other organization, be sure to highlight which are research-only 
activities and which activities would occur regardless of the research. If working with survey firms, please 
specify what research activities the research firm will be responsible for.                                                                                           
This study will begin with two phases.                        
 
 
 
 
 
         
Phase 1 will involve conducting interviews with 20 sexual minority women (SMW) who report 
experiencing depression, suicidality, and alcohol abuse. We hope to use information from these interviews 
to gather insight from participants that can help inform the adaptation of a cognitive-behavioral treatment 
approach to specifically target sexual minority women’s unique experiences with minority stress. This 
study will entail recruitment of 20 participants (through online recruitment methods and passive poster 
recruitment), as well as participant incentives, recording of interviews, and transcription and analysis of 
these interviews. Recruitment will take place in New York City, and interviews will take place in New York 
at the ESTEEM lab office under the supervision of Dr. John Pachankis and ESTEEM staff. Interviews will be 
conducted by student research assistants and staff. An additional 10 interviews will be conducted with 
sexual minority women  in order to further explore some of the key themes identified during the initial 10 
interviews that were conducted. These participants will be recruited and compensated using the same 
methods and guidelines as the first 20 Phase 1 participants. 
 
 
         
Phase 2 will involve consultation interviews with 10 community-based mental health experts who treat 
psychosocial health problems among at-risk SMW. Involvement of key community members in 
intervention design optimizes intervention dissemination and allows frontline professionals to shape the 
intervention that they would be most willing to implement. We are seeking the input of mental health 
experts working with the SMW community in order to translate existing, but largely untapped, clinical 
wisdom regarding SMW's minority stress experiences, mental health, and alcohol use into the 
development of the intervention. This type of consultation bridges the research-practice divide that has 
hampered evidence-based intervention dissemination and increases the likelihood that primary 
stakeholders will implement evidence-based practice. Mental health experts will be invited to participate 
based on their specialization in clinical practice and their publication history. This phase will involve 

 
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recruitment of mental health experts, participant incentives, recording of interviews, and transcription 
and analysis of these interviews. Members of the ESTEEM lab’s clinical team will conduct the interviews.  
Phase 3 will involve pilot testing the adapted cognitive-behavioral treatment through a randomized 
controlled trial with 60 SMW who report experiencing depression, anxiety, and alcohol abuse. The SMW 
will be randomized to either therapy or waitlist. Individuals assigned to therapy will receive 10 weekly 
individually-delivered sessions, directly after baseline assessment, that address minority stress 
mechanisms underlying SMW’s depression, anxiety, and alcohol abuse. Individuals assigned to waitlist will 
be put on a waitlist for 3 months after baseline assessment, after which they will also receive the same 
treatment as the therapy group. While they are on waitlist, they are allowed to receive other 
treatment/therapy. There are no restrictions for participants on the waitlist. At their baseline appointment 
(and subsequently at their first therapy session) they will receive a list of community referrals containing 
sexual health and mental health resources. Participants on waitlist will not be re-assessed for eligibility 
once the 3 months have passed. At therapy, participants will be given questions to answer to track their 
progress (OASIS, ODSIS, and Heavy Drinking- these measures can be found in the therapy manual and 
measurements packet). At baseline, 3 months, and 6 months, participants will complete self-report 
surveys at home prior to coming in to their appointment. When participants are in the office, they will be 
given self-report assessments of mental and behavioral health outcomes and minority stress mechanisms, 
computerized behavioral tasks (Implicit Associations Task, Emotional Go No-Go Task, and Self-Referent 
Encoding Task), and a Time-Line Follow Back (TLFB) interview of past-90-day heavy alcohol use (all of 
which will be administered by trained research assistants). The TLFB will be recorded for quality assurance 
purposes and will only show the interviewers face and capture the participants voice. Incentives will be 
offered for each study visit: $25 at baseline, $25 at 3-month follow-up, $75 at 6-month follow-up, and $10 
for each therapy session (therapy manual has been uploaded with this application). This study will entail 
the recruitment of 60 SMW participants through online recruitment methods, passive poster recruitment, 
and an existing list of SWMs who have expressed interest and consented to be contacted for any future 
research studies we conduct. All aspects of Phase 3 will take place at the Yale-sponsored ESTEEM lab in 
New York City under the supervision of Dr. John Pachankis. Therapy sessions will be recorded and 
conducted by members of the ESTEEM lab’s clinical team. Therapy sessions that are videotaped will only 
contain the therapists face, not the participants, but will catch the participants voice. These video 
recordings are for supervision and quality assurance purposes. Recordings of both therapy and the TLFB 
are not optional. Additionally, 15-20 participants enrolled in the study will be invited at random via e-mail 
to complete a follow-up qualitative phone interview about their experience in the study. These interviews 
will be audio recorded. Participants will be receive a $40 Amazon gift card for completing a follow-up 
interview. 
4. 
Participant Population: Provide a detailed description of the types of participants who will be 
recruited into this study.  
 
 
 
 
 
 
 
                       
Phase 1: Participants who will be recruited for Phase 1 are sexual minority women ages 18-35 who reside 
in NYC and have experienced a history of depression, suicidality, and alcohol abuse.                         
        
Phase 2: Participants who will be recruited for Phase 2 are clinical experts across mental health 
professions (e.g., clinical psychology, psychiatry, substance use treatment) who report specializing in both 
evidence-based psychosocial treatment and clinical practice with SMW. 
Phase 3: Participants who will be recruited for Phase 3 are sexual minority women ages 18-35 who reside 
in NYC and have experienced depression or anxiety (≥ 2.5 on the BSI-4), as well as alcohol abuse (i.e., ≥ 4 
drinks in one sitting), in the past 90 days. 
5. 
Describe how access to the population will be gained in the study.      
 
 
         
Phase 1: SMW recruitment will occur through active and passive targeted, community-based sampling 
approaches. We will recruit through advertisements placed on social networking apps (i.e. Facebook, 
Scissr) and flyers and screening at SMW venues. We will use a multi-stage screening approach (i.e., online 

 
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screening, phone screening prior to first baseline) to maximize our pool of potentially eligible SMW 
participants. For our largest recruitment event, Manhattan Pride, we will hold a sweepstakes for people 
who complete our online screening survey in person. 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 Amazon giftcard that will 
be emailed to them immediately after the selection of the winners. 
 
 
 
         
Phase 2: Community health experts will be identified by searching public academic databases (e.g., 
PubMed, PsycINFO) to identify individuals who have published clinical research, case studies, or other 
clinical accounts of treating SMW. Phase 2 experts will also be identified by searching membership rosters 
of professional organizations serving SMW populations. 
Phase 3: SMW recruitment will occur through targeted, community-based sampling approaches. We will 
recruit through advertisements placed on social networking apps (i.e. Facebook, Scissr) and flyers and 
screening at SMW venues. We will also recruit from an existing list of SMWs who have previously 
expressed interest in participating in future studies we are conducting and have given us their contact 
information. Some SMW on this list were also in Phase 1 of the study and have consented to be re-
contacted. We will assess eligibility through an online screening assessment prior to scheduling 
participants’ first appointments.  
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 
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  
 
 
☐Fetal material, placenta, or dead fetus 
☐Non-English Speaking 
☐ Prisoners 
 
 
☐Economically disadvantaged persons 
☐Decisionally Impaired  
☐ Employees  
 
☐Pregnant women and/or fetuses 
☐Yale Students  
 
 
☐ Females of childbearing potential 
 
 Click or tap here to enter text. 
 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential 
participants? ☐Yes  ☒ No  
 
 
7. Inclusion/Exclusion Criteria: What are the criteria used to determine participant inclusion or 
exclusion?  
Phase 1 Inclusion Criteria: Eligible participants will meet the following criteria: 1) age 18-35; 2) self-
identification as lesbian or bisexual; 3) symptoms of depression within the past three months (≥ 2.5 on 
the BSI-2); 4) past-3-month passive suicidal ideation (≥ 3 on the SBQ-4); 5) at least one instance of 
past-3-month heavy drinking (i.e., ≥ 4 drinks in one sitting); 7) English fluency.  
Phase 1 Exclusion Criteria: Participants will be excluded for: 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; 
                                                    
Phase 2 Inclusion/Exclusion Criteria: 10 clinical experts across mental health professions (e.g., clinical 
psychology, psychiatry, substance use treatment) will be identified through a review of membership 
rosters of national professional organizations that promote either 1) evidence-based psychosocial 
treatment approaches (e.g., Association for Behavioral and Cognitive Therapies) or 2) affirmative 

 
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psychosocial treatment approaches for SMW (e.g., Association of Gay and Lesbian Psychiatrists). 
These rosters will be searched for those members who report specializing in both evidence-based 
psychosocial treatment and clinical practice with SMW. Scholarly search engines (e.g., PsycINFO, 
PubMed) will then be utilized to determine who among the identified individuals has also published 
theoretical, conceptual, or case study accounts of mental and behavioral health of SMW. Those 10 
professionals who have published most extensively in this area will be invited as experts to participate 
in a telephone interview. 
Phase 3 Inclusion Criteria: 1) age 18-35; 2) self-identification as queer, lesbian, or bisexual; 3) 
symptoms of anxiety or depression within the past 90 days (≥ 2.5 on the BSI-4 for either anxiety or 
depression); 4) at least one instance of past-90-day heavy drinking (i.e., ≥ 4 drinks in one sitting); 5) 6-
month NYC residential stability and availability; 6) English fluency. 
Phase 3 Exclusion Criteria: 1) active psychosis or active mania; 2) active suicidality or active 
homicidality; 3) currently in mental health treatment exceeding one day per month; 4) having received 
any cognitive-behavioral therapy treatment in the past 12 months; 5) evidence of gross cognitive 
impairment. 
 
 
SECTION V: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
 
1. 
Recruitment Procedures:  
a. Describe how potential participants will be identified and contacted, and by whom. 
Phase 1: Actively recruited participants will be asked to complete a brief screening instrument on a tablet 
at the venue in which they were recruited or will be given an information card highlighting the goals of the 
project with a link to the online screening instrument and phone number to contact should they want to 
participate. Passively recruited participants will be informed of the study through posted flyers containing 
identical information as the information card used for active recruitment. The phone number will be 
staffed five days per week during normal business hours. After hours, potential participants will be 
instructed to provide a contact phone number or to call during business hours. Upon contacting the 
research center, potential participants will be screened for potential eligibility using the same online 
screening instrument included on the tablet used for the venue-based active recruitment. Those who 
screen as preliminarily eligible for the study will be contacted to complete a phone screening with a staff 
member. Those who remain eligible following the phone survey will be scheduled for an assessment. 
Those who do not qualify for the study based on the initial screen will be referred to appropriate 
community resources.   
 
 
 
 
 
 
 
 
         
Phase 2: A member of the ESTEEM lab’s clinical team or the Project Coordinator will first call or email each 
identified expert to explain the process by which they were identified and the purpose of their invited 
participation in this phase of the study. Once an expert expresses interest in participation, a clinical team 
member of the Project Coordinator will direct them to an online consent form describing the details of 
participation, confidentiality of personal information, and associated risks and benefits.  
Phase 3: Actively recruited participants will be asked to complete a brief screening instrument on a tablet 
at the venue in which they were recruited or will be given an information card highlighting the goals of the 
project with a link to the online screening instrument and phone number to contact should they want to 
participate. Passively recruited participants will be informed of the study through posted flyers containing 
identical information as the information card used for active recruitment. The phone number will be 
staffed five days per week during normal business hours. After hours, potential participants will be 
instructed to provide a contact phone number or to call during business hours. Upon contacting the 
research center, potential participants will be screened for potential eligibility using the same online 

 
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screening instrument included on the tablet used for the venue-based active recruitment. Those who 
screen as eligible for the study will be contacted by a staff member to give more information about the 
study and schedule the first appointment. After the participant has completed the online screener, 
regardless of eligibility, will be given a list of mental health and sexual health community resources. 
Recruitment of individuals from our existing list of potentially interested participants will involve sending a 
recruitment email to these potential participants containing the same information provided on our flyers 
and information cards. Upon contacting the research center, potential participants will complete an 
identical process as described above. Participants will be recruited before we obtain the CoC. When the 
CoC is obtained, all participants that have consented will be notified. 
 
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.)  
We will use an online screening instrument to collect the following information: age, NYC residential 
stability and availability, gender identity, sexual identity, depressive symptoms, anxiety symptoms, and 
alcohol use.  Participants will provide consent before completing this eligibility screen.  
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
 
☒ Flyers 
☒ Internet/web postings 
☐ Radio 
☒ Posters 
☒ Mass email solicitation 
☐ Telephone 
☐ Letter 
☐ Departmental/Center website 
☐ Television 
☒ Through local NGO or other local contact 
☐ Departmental/Center research boards 
☐ Newspaper 
☒ Table set-up / in-person recruitment of 
public                   
☐ Snowball sampling 
 
☐ Classroom recruitment 
☒ Social Media (Twitter/Facebook):  
 
☐ Other:  
 
 
 
3. Targeted Enrollment: Give the number of participants: 
a. 
  Targeted for enrollment at Yale for this protocol  
 
 
 
 
         
Phase 1: 20 sexual minority women Phase 2: 10 SMW experts Phase 3: 60 sexual minority women 
b.    If this is a multi-site study, give the total number of participants targeted across all sites N/A  
 
4.   How was this estimate derived?  
For both Phase 1 and Phase 2, estimates were derived based on the number of interviews required to 
reach saturation in previous intervention development studies. For Phase 3, this part of the study is 
powered primarily to examine feasibility and acceptability. This phase will also allow us to determine the 
preliminary efficacy of the intervention. We will use Cohen’s d and Hedge’s g corrected for sample size, 
both of which express the average amount of individual change between intervention and control groups 
in terms of units of standard deviation. Group means on continuous variables typically begin to stabilize by 
20-30 participants, and our waitlist design enables us to estimate effect sizes both by comparing 
intervention and control conditions at 3-months (n = 30/condition) and by examining pre-post 
effect sizes for the entire sample (n = 60). Our sample size provides sufficient power (1 - β=.8) to detect 

 
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intervention effects consistent with effect size estimates identified in our intervention research with 
sexual minority men in which the relative reduction in depression was 0.55 between intervention and 
control groups. 
 
5. 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.  
Phase 1: A trained staff member will assess participants' consent in a private room. The staff member will 
ensure that the participant understands the risks associated with the disclosure of information that could 
indicate imminent threat to self or others. Staff members, if not PI Pachankis, will be instructed to contact 
PI Pachankis or the project coordinator if they are unsure about any participant's capacity to consent. 
Phase 2: Potential participants who have been identified as SMW mental health experts and therefore 
meet eligibility criteria for inclusion for this phase of the study will be contacted over the phone and 
provided detailed information about participation requirements. The trained staff member will read the 
consent form along with the prospective Phase 2 participant, who will concomitantly be able to access the 
form online. 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 electronically sign and submit the 
consent form online. A copy will then be mailed to them. 
Phase 3: Participants will electronically consent to the online screener. If eligible, the participant will be 
contacted to schedule their first appointment and to learn more about the study. At the beginning of the 
initial phone call, participants will be informed that they are preliminarily eligible for our study and be 
asked if they would like to continue the call to hear more about the study and potentially consent. If more 
than two weeks have lapsed since they screened eligible, participants will be rescreened for eligibility. 
There will be 2 consent portions to this study. At the end of the first phone call (which reviews key aspects 
of participation), participants will be informed that they will receive a consent form electronically via 
Qualtrics. They are instructed to read the consent form and to call us back if they have any questions. If 
the participant signs the consent form, they will be re-directed to the first set of at-home surveys to 
complete before their first scheduled appointment. Both the consent form and at-home surveys will be 
given via Qualtrics. The consent form and at-home surveys will be completely separate forms, where the 
participants name is not located with the same data as the responses to the at-home surveys. To know 
which participant filled out which survey, we will connect the consent form and the first set of at-home 
surveys using a unique participant ID number. The consent form itself will only contain the participant’s 
electronic signature. However, the participant ID will be attached securely to the consent form in the 
“backend” of Qualtrics in the data and kept completely confidential. When the participant comes in for 
their first appointment, the participant will meet with the staff member in a private room and do a review 
of the consent form that has been signed, including administering consent comprehension quiz questions 
to ensure complete understanding of study participation. The participant will then sign this 
comprehension quiz form if they would still like to participate in the rest of the study. This form will be 
locked in a filing cabinet that only PI Pachankis and research staff will have access. The staff member will 
ensure that the participant understands the risks associated with the disclosure of information that could 
indicate imminent threat to self or others. Staff members, if not PI Pachankis, will be instructed to contact 
PI Pachankis or the project coordinator if they are unsure about any participant's capacity to consent. For 
participants that are waitlisted, they will not be re-consented. Participants get a signed copy of the 
consent form to take home with them. Additionally,  they will have their therapy appointments scheduled 

 
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3 months in advance and get monthly reminder emails regarding their first therapy appointment, along 
with a reminder email of their 3-month follow-up appointment. 
 
 
6. 
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. 
Phases 1, 2, and 3: Participants will be asked if they understand the information presented to them and 
asked to verbally summarize the consent documentation (e.g., procedures, risk, benefits, voluntariness, 
compensation, eligibility, principal investigator).                                                                                                
 
 
7. 
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.  
Phases 1, 2: PI Pachankis will retain a copy of the signed consent forms in a locked filing cabinet across the 
duration of the study. 
Phase 3: Copies of electronically signed consent forms will be kept secure and confidential on Qualtrics 
and only accessible by research staff members. Copies of the signed consent comprehension questions 
will be kept in a locked file cabinet that only PI Pachankis and research staff will have access. For follow-up 
interviews, verbal consent will be obtained and recorded in Yale Qualtrics. 
 
8. 
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). 
N/A 
 
9. 
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.  
While the likelihood is minimal, if a participant reports a clear intention to harm himself or another 
person, health professionals are required to report this. Additionally, health care professionals are 
required by state law to report suspected cases of abuse or neglect. 
Our ESTEEM clinical protocol successfully guides reporting of instances of suicidality, homicidality, 
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. 
 

 
12 
 
 
10. 
Waiver of Consent/Documentation of Consent: In certain circumstances, the IRB may grant a 
waiver of documentation of consent, or a full waiver of consent, depending on the study. If you will 
request either a waiver of consent, or a waiver of signed consent for this study, complete the appropriate 
section below.   
 
☐Not Requesting any consent waivers  
 
☒Requesting a waiver of signed consent (e.g., verbal or online consent only): 
☒ Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only) 
☐ Entire Study (Note that an information sheet may be required.) 
 
 
 
Consent will be obtained for all study components either verbally or signed or online as described above.  
Phase 1: We will not require participants to provide their name when consenting to complete 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, substance use risk behavior, and depression 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.   
Phase 2: Experts who agree to participate in this study will be given an online consent form to complete. 
Phase 3: We will not require participants to provide their name when consenting to complete the brief 
screen to be administered via electronic tablets at local venues (e.g., gay bars, clubs, parks).  This screen 
will assess age, NYC residential stability and availability, gender identity, sexual identity, depressive 
symptoms, anxiety symptoms, and alcohol use to determine eligibility for this study.  This 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. Eligible 
participants will be asked if they would like to provide their name and contact information in order to 
 For a waiver of signed consent, address the following: 
 
• 
Would the signed consent form be the only record linking the subject and the research?  YES ☐  NO 
☒  
• 
Does a breach of confidentiality constitute the principal risk to subjects? YES ☐  NO ☒ 
  
 
OR 
• 
Does the research pose greater than minimal risk? YES ☐    NO☐  
• 
Does the research include any activities that would require signed consent in a non-research context? 
YES ☐   NO ☐ 
 

 
13 
 
receive a call to schedule the first assessment appointment.  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.    
 
  
☐ Requesting a waiver of consent (if you are not obtaining ANY consent): 
 
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will 
apply to recruitment activities only) 
☐ Entire Study  
 
 
 
 
 
 
 
  
SECTION VI: PROTECTION OF RESEARCH PARTICIPANTS 
 
1. 
Confidentiality & Security of Data: Describe the steps that will be taken to secure the data during 
storage, use and transmission as outlined in the below sections.  NOTE: Data can include paper files, data 
on the internet or websites, computer files, audio/video files, photographs, etc. and should be considered 
in the responses to the below sections.   Click or tap here to enter text. 
Phase 1: To protect participants’ confidentiality, all counselors and research assistants (RAs) have 
undergone rigorous training in maintaining participants’ privacy. 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 ESTEEM 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 
ESTEEM with contact information (email, phone numbers, and mailing address) for compensation purposes. 
This information will be treated in the same confidential manner as all participant information, as described 
here.   
 
 
 
 
 
         Phase 2: The 10 SMW experts consulted will 
be given the option of being acknowledged for their contributions, which could potentially involve sharing 
their names in any publications and presentations that may arise from this project. If they choose to keep 
their interview confidential, the procedures described for maintaining confidentiality and security of data 
for Phase 1 will be followed. 
Phase 3: To protect participants’ confidentiality, all counselors and research assistants (RAs) have 
undergone rigorous training in maintaining participants’ privacy. Further, immediately upon providing 
For a waiver of consent, please address all of the following: 
 
• 
Does the research pose greater than minimal risk to subjects?   
☐ Yes   If you answered yes, stop. A waiver cannot be granted.   
☐ No 
• 
Will the waiver adversely affect subjects’ rights and welfare? YES ☐    NO☐ 
• 
Why would the research be impracticable to conduct without the waiver?  
Click or tap here to enter text. 
• 
Where appropriate, how will pertinent information be returned to, or shared with subjects at a later 
date? Click or tap here to enter text. 
 

 
14 
 
consent, all participants will be assigned an identification number, which will be kept on an electronic 
database that will be password protected and located on a designated ESTEEM computer, as well as on a 
secure survey website (Qualtrics). 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 ESTEEM with contact information (email, phone numbers, 
and mailing address) for compensation purposes. This information will be treated in the same confidential 
manner as all participant information, as described here. 
 
2. 
What participant information will you be collecting? Describe the identifiers that will be included 
or associated with the data and/or specimens (e.g., names, addresses, telephone/fax numbers, email 
addresses, dates (date of birth, admission/discharge dates, etc.), medical record numbers, social security 
numbers, health plan beneficiary numbers, etc.) 
Basic demographic questions, such as age, race, gender identity, sexual orientation, and city of residence 
will be collected. Participants will also provide contact information (name, email, phone numbers) for 
scheduling and compensation purposes, but this information will be stored in a separate database from 
any demographics information we collect. In addition, videotapes of the interviews will be collected. This 
information will be treated in the same confidential manner as all participant information. 
 
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. 
How will the research data be collected and recorded?       
Phase 1: All interviews will be audio recorded and reviewed for protocol adherence and quality of protocol 
delivery. 
Phase 2: All interviews will be audio recorded with an audio recorder capable of capturing conversations 
by phone. 
Phase 3: Research data will be collected via telephone, on electronic tablets, electronic databases, 
survey websites, paper-and-pencil, electronic documents, and video recording. Screening 
data will be collected in the field using online tablets as well as collected on a secure 
survey website (Qualtrics.com). During the first appointment scheduling phone call, we 
will verify contact information in one of our password protected electronic databases at 
our research office. 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 (timeline follow-back of 
past 90 day alcohol abuse) into Qualtrics.com and one of our electronic databases during 
the interview. Timeline follow-back sessions will be videotaped for quality control 
(showing only the interviewer’s face) 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 and therapist post-session surveys will be entered directly into 
Qualtrics.com on electronic tablets. Participant tracking and scheduling data will be 

 
15 
 
recorded on a study database. One password-protected linking database containing 
participant names and ID codes will be kept on Secure Box and accessible only by study 
staff. 
 
All study computers will be encrypted and password protected.  All filing cabinets will be 
locked.  Online surveys (yale.qualtrics.com) will use an encrypted web service (https) and 
will not ask participants’ name or other identifying information, only participant ID 
number.  The linking database will be kept separate from study data and will be password 
protected. 
 
4. If identifiers will be associated with the data and/or specimens, describe whether a record or list 
containing a code (i.e., code number, pseudonyms) will be used, where the list will be stored, who will 
have access to the list and when it will be destroyed. 
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 ESTEEM 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 ESTEEM with contact information 
(email, phone numbers, and mailing address) for compensation purposes. This information will be 
treated in the same confidential manner as all participant information, as described here. 
 
5. Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) and/or 
specimens will be stored.  
All data (video recordings or electronic data) will be stored on a secured server and will be password 
protected. The database with contact information will be deleted 3 years after completion of the 
study, unless they have expressed interest in being informed of possible future studies. All other data 
provided for this study, including any video recordings that may be used for training or educational 
purposes, will be maintained securely for a minimum of three years.  
 
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical 
reason a device cannot be encrypted please submit an exception request to the Information Security, Policy 
and Compliance Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu  
  
6. Identify who will have access to the data and/or specimens. If the data and/or specimens will be 
transferred to and/or from outside collaborators, identify the collaborator to whom the data and/or 
specimens will be transferred and how the data and/or specimens will be transferred.    
      
Role: 
Principal 
Investigator 
Dr. John Pachankis 
Yale School of Public 
Health 
Jep69 
Role: 
Co-
Investigator 
Dr. Katie Wang 
Yale School of Public 
Health 
Pw255 
Role: 
Project 
Coordinator 
Erin McConocha 
Yale School of Public 
Health 
Em795 
Role: 
Senior 
Research Assistant 
Kriti Behari 
Yale School of Public 
Health 
kb936 

 
16 
 
Role: 
Protocol 
Deliverer 
Jillian Scheer 
Yale School of Public 
Health 
jrs265 
Role: 
Protocol 
deliverer 
Alex Belser 
Yale School of Public 
Health 
Ab2922 
Role: 
Research 
Assistant 
Dr. Charles Burton 
Yale School of Public 
Health 
Clb79 
Role: 
Protocol 
deliverer 
Tenille Taggart 
Yale School of Public 
Health 
TT443 
Role: 
Research 
Assistant 
Meghan Michalski 
Yale School of Public 
Health 
MM3536 
Role: 
Research 
Assistant 
Cal Brisbin 
Yale School of Public 
Health 
CB2254 
Role: 
Research 
Assistant 
Colin Kimberlin 
Yale School of Public 
Health 
CK624 
Role: 
Research 
Assistant 
Arjan Van Der Star 
Yale School of Public 
Health 
AV564 
Role: 
Protocol 
deliverer 
Nitzan Cohen 
Yale School of Public 
Health 
Nc545 
Role: 
Protocol 
deliverer 
Zach Rawlings 
Yale School of Public 
Health 
Zr63 
Role: 
Research 
Assistant 
Benjamin Fetzner 
Yale School of Public 
Health 
bf347 
There will be no outside collaborators for this study. 
 
7. 
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 
five years of study completion, the link to personal identifiers will be destroyed. 
 
8. 
Will a Certificate of Confidentiality be needed? (See also the NIH Certificate of Confidentiality Kiosk, 
http://grants.nih.gov/grants/policy/coc/index.htm)  Yes, we will notify the HSC once the CoC has been 
issued. 
 
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 survey or interview questions. These questions might 
cause the participant temporary embarrassment, worry, anxiety, or depressed mood. Breach of 
participants' confidentiality presents another possible risk. Such a breach could cause damage to one's 

 
17 
 
reputation and associated mental distress.  The investigative team's strategies to protect against both risks 
are described below. 
 
 
2. 
Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized. 
Protection Against Risk:  
Protection Against Emotional Discomfort: It is possible that participants may experience emotional 
discomfort in responding to the self-report measures. 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. Clinical staff members 
at the Esteem Research Program are thoroughly trained in appropriate responses to participant 
distress through regular trainings by this study's Yale University PI, John Pachankis, Ph.D., a licensed 
clinical psychologist. This training addresses the appropriate handling of imminent threats and 
provision of referrals to free counseling services in less imminent clinical situations. A designated 
staff member with an advanced degree in a mental health profession is always on site to enact the 
Clinical Protocol.  The Clinical Protocol clearly outlines procedures for assessing participant emotional 
distress and referring participants to appropriate care resources. 
 
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. All the Esteem Research 
Program counselors and research assistants (RAs) have undergone rigorous training in maintaining 
participants’ privacy and confidentiality. 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 the Esteem Research Program 
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 Esteem Research Program 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. 
 
 
3. 
Data and Safety Monitoring Plan:  Include an appropriate Data and Safety Monitoring Plan (DSMP) 
based on the investigator’s risk assessment stated below. (Note: the HSC will make the final 
determination of the risk to subjects.). 
a. 
What is your assessment of the overall risk level for subjects participating in this study? 
This study proposes to ask participants a series of questions assessing their life experiences as gay, 
bisexual, or other women who have sex with women.  Empirical data suggest that answering 
questions regarding sex and mental health is associated with minimal risk.1                                                                        
1Yeater, E., Miller, G., Rinehart, J., & Nason, E. (2012). Trauma and sex surveys meet minimal risk standards: 
implications for institutional review boards. Psychol Sci, 23(7), 780-787. doi:10.1177/0956797611435131 

 
18 
 
 
b. 
If children are involved, what is your assessment of the overall risk level for the children 
participating in this study? N/A 
 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are   
 available here http://your.yale.edu/policies-procedures/other/data-and-safety-monitoring-
plan-template  for 
i.Minimal risk 
ii.Greater than minimal/moderate risk 
We consider our study as minimal risk.  The principal investigator and the research assistants are 
responsible for monitoring the data, assuring protocol compliance, and conducting the safety 
reviews daily. During the review process, the principal investigator will evaluate whether the study 
should continue unchanged, require modification/amendment, or be closed to enrollment. 
The principal investigator, the Institutional Review Board (IRB), and Yale School of Public Health 
(YSPH) 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 through regular study meetings or via email as they are reviewed 
by the principal investigator. The protocol’s research monitor(s), the PI’s faculty supervisor, YSPH 
will be informed of any adverse events such as unanticipated reaction from the participants (e.g. 
suicidal ideation) within 5 days of the event becoming known to the principal investigator. 
 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: 
 
i. How will adverse events and unanticipated problems involving risks to subjects or others be 
reported, reviewed and managed? N/A 
ii. What provisions are in place for management of interim results? N/A 
iii. What will the multi-site process be for protocol modifications? N/A 
 
4. 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the participant(s) or to society at large. (Payment of participants is not considered a 
benefit in this context of the risk benefit assessment.)  
Benefits to participants: All participants in the present study will be exposed to information about how 
minority stress can contribute to depression, alcohol abuse, and other stressors. Also, this study will 
potentially contribute to the development of an evidence-based psychosocial intervention targeted 
specifically to sexual minority women. 
  
Benefits to society: The mental and behavioral health disparities experienced by sexual minority women 
constitute a clear public health concern.  Benefits to society in general are anticipated through the 

 
19 
 
dissemination of intervention findings. Results will better inform local and national public health agencies 
about potentially effective outreach and prevention strategies that can be delivered to gay, bisexual, and 
other women who have sex with women who also experience mental health problems, such as 
depression, suicidality, and alcohol abuse.  
 
 
         SECTION VIII: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1. 
Alternatives: What other alternatives, if any, are available to the study participants outside of the 
research? 
N/A 
 
2. 
Payments for Participation (Economic Considerations): Describe payments that will be made to 
participants, if any, the amount and timing of payments, and the conditions for receiving this 
compensation (if applicable). If you plan to hold a drawing, be sure to include the following on any consent 
or recruitment materials mentioning the lottery: 1) the value of the prize; 2) the sponsor of the prize (this 
cannot be a federal funding source); 3) the odds of winning; and 4) that there are no restrictions to 
winning. 
Phase 1: Participants will be paid $50 for completing a Phase 1 interview. Participants who come in to the 
Esteem Research Lab but who are deemed ineligible to begin an interview will be compensated $10 to 
cover their travel expenses. 
Phase 2: Participants will be paid $100 for providing their feedback and completing an interview with an 
ESTEEM lab clinical team member. 
Phase 3: Participants will be paid at each study visit: $25 at baseline, $25 at 3 month follow-up, $75 at 6 
month follow-up, and $10 for each therapy session. Additionally, as part of retention efforts, upon 
randomization, we will be providing all participants with an "EQuIP Swag Bag" that includes 
candy, safer sex supplies, and study-branded pens and stress balls in a tote bag. Participants who 
complete a follow-up qualitative interview about their experience in the study will receive a $40 
Amazon gift card. 
 
 
3. 
Costs for Participation (Economic Considerations): Clearly describe the participant’s costs 
associated with participation in the research, if any, and the interventions or procedures of the study that 
will be provided at no cost to participants.     
Study participation will generate no cost for participants.  The study treatment will be provided free of 
charge to all study participants.