Developing Efficient Intervention Technologies to Reduce Stigma-Related Stress, Mental Health Problems, and HIV Risk Among Young Chinese MSM
Phase: NA
Conditions: LGBTQ, Sexual Behavior, HIV Risk
Sponsor: Yale University

APPROVED BY THE YALE UNIVERSITY IRB 5/5/2022
STUDY PROTOCOL
Social Behavioral Template
   
Developing Efficient Intervention 
Technologies to Reduce Stigma-Related 
Stress, Mental Health Problems, and HIV 
Risk among Young Chinese MSM
 Protocol Number
2000029433
 
Protocol Version
04/29/2022
 Version #2
Clinical Trials Registration Number (if applicable): NCT04718194
Confidentiality Statement:
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Protocol Number: 2000029433
04/29/2022, Version #2
2
Synopsis
Purpose
The purpose of the proposed study is to assess the efficacy of a culturally adapted, 10-
session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) among 
young men who have sex with men (YMSM) in Hunan province China. The therapy 
treatment called ESTEEM (Effective Skills to Empower Effective Men) is based on a 
minority stress-focused, CBT framework created in the US. In collaboration with 
colleagues at Central South University (CSU), we will assess in a 2-arm randomized 
controlled trial (RCT) whether a culturally adapted version of iCBT ESTEEM demonstrates 
significant reductions in human immunodeficiency virus (HIV) risk behavior and mental 
health symptoms (e.g., depression, anxiety) compared to self-monitoring of stress and 
mood (Aims 1 and 2). We will then conduct interviews with participants, counselors, and 
stakeholders to evaluate implementation barriers and facilitators (Aim 3). 
Objectives
The primary objective is to evaluate the preliminary efficacy of a Chinese-adapted version 
of iCBT ESTEEM on YMSM’s sexual health and HIV risk behavior. The secondary 
objectives of this study are to determine whether iCBT ESTEEM impacts HIV/sexually 
transmitted infections (STI) results and symptoms of depression and anxiety, as well as 
whether baseline minority stress exposure moderates treatment efficacy, such that 
participants with the most minority stress exposure benefit more from iCBT ESTEEM than 
those in the self-monitoring of stress and mood condition. An additional objective is to 
identify individual and institutional implementation barriers and facilitators of iCBT 
ESTEEM among Chinese YMSM.
Study Population
The study population for Aim 2 will consist of Chinese men (cisgender or transgender) 
between the ages of 16-30, fluent in Mandarin, living in Hunan province China, and 
identifying as gay, bisexual, and/or who report having sex with other men in the past 12 
months, and specifically condomless anal sex (CAS)/pre-exposure prophylaxis-(PrEP) 
less anal sex with other men in the past 3 months. Participants will also be confirmed HIV-
negative upon at home testing, report current symptoms of depression and/or anxiety, and 
report no use of mental health services in the past 3 months. 
Participants will consist of YMSM in Hunan province China, as the study will be 
exclusively conducted in Hunan province with the study team’s colleagues at CSU. We 
are restricting eligibility for this study to individuals with a current male gender identity 
because this group is a rapidly increasing risk group for HIV in China, with prevalence 
increasing from less than 1.0% in 2003 to 9.2% in 2016. The study will enroll participants 
ages 16-30 given that this age group contains the majority of newly diagnosed MSM in 
China and has experienced a severe lack of developmentally and culturally appropriate 
preventive intervention attention to date. The study will also include only MSM who are 
sexually active, ensuring that the intervention content is relevant to all participants. The 
upper age range was chosen given both the age group most affected by HIV in China is 
16-30 and also based on our previous research showing that the identity-focused aspects 
of our intervention are most suited to those MSM who are closest in age to developmental 
identity-based stress (e.g., minority stressors such as concealment).
Aim 3 will include a proportion of Aim 2 participants whose window of study completion 
has ended. This aim will also incorporate community stakeholders, including government 
officials, medical providers, HIV-related NGO staff members, LGBTQ community center 
staff members, and community advocates.
Number of Participants
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Protocol Number: 2000029433
04/29/2022, Version #2
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A total of 120 YMSM participants will be enrolled in this study (n = 60 per condition). 
Assigning 60 participants to each condition (iCBT vs. self-monitoring) and accounting for 
20% attrition, a liberal estimate based on our previous online RCTs (i.e., 93-100%), will 
provide ≥ 80% chance of detecting a difference (p < .05) between the conditions of d = 
.40, which is significantly lower than what we found when comparing in-person ESTEEM 
to waitlist (d = .59 for CAS, d = .55 for depression) and lower than even the smallest 
average meta-analytic effect (d = .66) of iCBT compared to weak control conditions for 
depression. While we likely do not have power to detect changes in our biologic HIV/STI 
outcomes, including them 1) verifies study eligibility, 2) establishes self-testing protocols 
for our future adequately powered research, and 3) promotes public health. For Aim 3, a 
total of 55 participants, including (n = 20) Aim 2 participants, (n = 6) study therapists and 
supervisors, (n = 8) government administrators and leadership, (n=7) LGBTQ community 
organization staff, and (n = 7) and medical providers will be interviewed in order to identify 
themes in regard to barriers and facilitators of implementing iCBT ESTEEM among 
Chinese YMSM.
 
Study Design
Aim 2 of the proposed prospective study will follow a 2-arm RCT design where 120 
Chinese YMSM participants will be randomly assigned to one of two conditions:
1) ESTEEM iCBT: This online CBT treatment consists of 10 weekly modules that 
participants will complete over the course of 10 weeks. Modules contain weekly 
psychoeducational text and vignettes about minority stress and mental health; 
brief videos illustrating the CBT skills; and homework exercises that therapists 
review and provide feedback on. Homework exercises include weekly tracking of 
stress and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), 
and exercises related to considering the origins of stress and negative emotions 
that participants may be experiencing. Therapists provide feedback after each 
homework assignment, including reviewing each participant’s treatment goals as 
part of the first session’s homework. Therapists who support this condition will be 
instructed to incorporate SGM-specific content and feedback into homework 
reviews. In the US, modules were adapted directly from the in-person materials 
(e.g., therapist manual, participant handouts) used in our previously successful 
trials of this treatment. The treatment has also been recently culturally adapted for 
in-person treatment among Chinese YMSM and found to be acceptable and 
feasible.
2) Self-monitoring control: In this control condition, participants will be asked to 
indicate their past 7-day mood, stress experiences, and mental and behavioral 
health on an online survey. This type of self-monitoring has been shown to yield 
improvement in behavioral health outcomes. Self-reporting SGM stress 
experiences has also been shown to produce reductions in depression symptoms 
over time. Participants will record these experiences once per week for 10 weeks.
Prior to randomization, participants will complete an online screener, video screener on 
WeChat, at-home HIV/STI testing kit for HIV and syphilis, and consent call on WeChat 
(see Section 6.1 Study Procedures for more information about these steps of the study). 
For the at-home HIV/STI testing kit for HIV and syphilis, rapid test results will be ready to 
be read by participants in 20 minutes. HIV/STI test results will be discussed with 
participants by study counselors during the same day as testing via WeChat. A CSU 
research team member will contact participants on WeChat after 5 business days of 
sending the HIV/STI testing kit if the participant has not sent the CSU team a photo of 
their results. Specific procedures regarding risks for the at-home HIV/STI testing is 
outlined in Section 2.2.
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To assess intervention efficacy, participants will be assessed at three time-points: 
baseline, immediately post-treatment (4-month follow-up), and 8-month follow-up. 
Participants will complete validated measures online of past-30-day HIV-risk behavior 
(e.g., condomless anal sex), mental health (e.g., depression, anxiety), and minority 
stressors (e.g., discrimination) at all three time points. At 8-month follow-up, participants 
will be mailed and asked to complete the same at-home HIV/STI testing kit for HIV and 
syphilis described above.
After completing the baseline assessment, participants randomized to ESTEEM iCBT will 
be assigned a study therapist and will be contacted by their therapist to schedule a 30-
minute introductory call via WeChat (i.e., a Chinese multi-purpose messaging, social 
media, and payment app; comparable to US apps, such as Google Voice, which the Yale 
research team has utilized in other studies). During this conversation, therapists will 
explain the structure of the study and briefly discuss the participant’s motivations and 
goals for participating in the study. Participants will then complete one session per week. 
If participants miss a session, as determined by daily therapist and RA review of session 
access and self-monitoring or homework completion, they will receive a reminder to 
complete the session. Participants will also be asked to schedule a check-in phone call 
with their study therapist two-weeks post-randomization to discuss their progress through 
the study sessions. Participants will have a window period of four months (approximately 
17 weeks) to complete all 10 sessions. 
Before we launch the full trial, we will ensure comprehension of the ESTEEM iCBT online 
module material with 10 separate YMSM, as well as gather their feedback on the usability 
of the iCBT online platform. Our two pilots for this proposal (i.e., cultural adaptation in 
China + iCBT usability testing in the US) have already led to the creation of the in-person 
delivery materials for Chinese ESTEEM (e.g., manual, participant handouts) and 
established the technical feasibility of our iCBT platform. As such, the Chinese-adapted 
materials (e.g., manual, handouts) are ready to be transformed into iCBT content (e.g., 
self-guided exercises, videos, counselor instructions). Given the previous efficacy testing 
of in-person Chinese ESTEEM and iCBT in our US study, this comprehension testing will 
occur over the course of 2 weeks with a focus on 10 YMSM reviewing the online 
treatment material, receiving counselor feedback, and providing feedback via answering 
brief questions after each module on its usability. For this comprehension testing, the only 
inclusion criteria for this comprehension test will be: 16-30 years old, live in Hunan 
province China, current gender identity as male, report past 12-month sex with men, 
weekly access to internet on a laptop, desktop, or tablet device, ability to read, write, and 
speak in Mandarin, and provision of informed consent (see Section 5.3 for inclusion 
criteria for the full study). These 10 YMSM for the comprehension testing will not complete 
the study measures, with the exception of the 30-day Timeline Follow-Back assessment 
at the end of the pilot in order to test the usability of this assessment on the Sojump 
platform. After review of the ESTEEM iCBT materials, participants will provide feedback to 
the CSU research team on their comprehension of the materials, as well as respond to 
questions from a qualitative interview conducted by the CSU research team about their 
experience.
Aim 3 of the study will identify barriers and facilitators for uptake and scale of Chinese 
ESTEEM iCBT within existing public and non-governmental organizations (NGO) settings. 
We will first review Aim 2 data for YMSM completion metrics (# sessions completed, 
points of drop-off) and moderators of intervention efficacy (as described below). Next, we 
will interview a subset of Aim 2 participants (n=20) as well as counselors and therapy 
supervisors (n=6) for their impressions of the acceptability of Chinese ESTEEM iCBT and 
needed improvements before implementation. We will also interview (n = 8) government 
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Protocol Number: 2000029433
04/29/2022, Version #2
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administrators and leadership, (n=7) LGBTQ community organization staff, and (n = 7) 
and medical providers who have expressed interest in online interventions for YMSM and 
who can ultimately implement this intervention, if efficacious. 
Study Duration
The entire study, including data analysis, is expected to last until May 2023. Participation 
for the 10 YMSM in comprehension testing will begin by January 2021. Participation for 
the full study RCT will begin by October 2021. The final 8-month follow-up assessments 
are anticipated to end by November 2022. Participation for the qualitative interviews will 
begin by June 2022 (upon final survey completion of the first RCT participants). Data 
analysis is expected to occur beginning in December 2022 until May 2023. 
Outcome Variables
Our primary outcome is YMSM’s sexual health and HIV risk behavior, which will be 
assessed at three study time points (baseline, 4-month follow-up, 8-month follow-up) via 
the following measures:

30-Day Timeline Follow-Back

Decisional Balance for Condom Use Scale

Safer Sex Questionnaire

Past 4-month HIV/STI Testing Questionnaire 
Our secondary outcomes, which will also be measured at baseline, 4-month follow-up, 
and 8-month follow-up, (unless otherwise noted) include the following with their 
associated measures:
Mental health outcomes:

Depressive symptoms – Patient Health Questionnaire-9, Overall Depression 
Severity & Impairment Scale

Anxiety symptoms – Generalized Anxiety Disorder-7, Overall Anxiety Severity & 
Impairment Scale, Social Interaction Anxiety Scale

Suicidal ideation – Suicidal Ideation Attributes Scale

Alcohol and substance use – Alcohol Use Disorders Identification Test, Drug Use 
Disorders Identification Test
Minority stress mechanism outcomes:

Concealment motivation – Lesbian, Gay, and Bisexual Identity Scale (LGBIS) 
Concealment Motivation subscale

Acceptance concerns – LGBIS Acceptance Concerns subscale

Internalized homonegativity - LGBIS Internalized Homonegativity subscale

Self-esteem – Rosenberg Self-Esteem Scale
Universal mechanism outcomes:

Emotion regulation – Difficulties in Emotion Regulation Scale-Short Form

Perceived social support – Multidimensional Scale of Perceived Social Support, 
Chinese version of the LGBIS - LGB-Specific Family Support subscale

Rumination – Ruminative Response Scale
Psychosocial variables:

Body image – Multidimensional Body-Self Relations Questionnaire, Appearance 
Evaluation subscale, Body Appreciation Scale-2

Adverse childhood experiences (ACEs; administered at baseline and 8-month 
follow-up) – Life History Interview of ACEs

COVID-19 experiences – COVID-19 questionnaire
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HIV/STI outcomes (only following video screener and at 8-month follow-up):

At-home HIV/STI testing kit for HIV and syphilis 
In addition to the assessments that will be administered at baseline, 4-month follow-up, 
and 8-month follow-up, three questionnaires will be administered weekly on the iCBT 
online platform for 10 weeks for the ESTEEM iCBT and self-monitoring conditions:

Overall Depression Severity & Impairment Scale

Overall Anxiety Severity & Impairment Scale

Tracking Minority Stress Experiences Questionnaire
For the pilot study, the 10 YMSM will complete the following:

Brief questionnaire (5 items) after completing each module

Follow-up interview after completing all 10 modules 

30-Day Timeline Follow-Back
For Aim 3, we will additionally review data for the following:

Number of sessions completed by participants

Points of study drop-off

Acceptability and feasibility – participants’ written responses to prompts within 
online modules will be coded for engagement and relevance to module content
Locations/Facilities
This study will be carried out in Hunan province China by our colleagues at CSU, who will 
serve as the site of study recruitment and all direct participant interaction. Yale University 
will serve as the primary scientific site of the study. Researchers at Yale will be 
responsible for ensuring the scientific, clinical, and technical robustness of the 
intervention, including its translation into the iCBT format and ongoing delivery. All 
participation will occur online and participants will be recruited in Hunan province, as 
specified below in Section 5.4 Recruitment Procedures.
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Abbreviations
Abbreviation 
Explanation
ACEs
Adverse Childhood Experiences
CAS
Condomless anal sex
CBT
Cognitive Behavioral Therapy
CSU
Central South University
EIA
Enzyme immunoassays
ESTEEM
Effective Skills to Empower Effective Men
GLMM
Generalized linear mixed model
HIV
Human immunodeficiency virus
iCBT
Internet-based, Cognitive Behavioral Therapy
LGBIS
Lesbian, Gay, and Bisexual Identity Scale
MSM
Men who have sex with men
NGO
Non-governmental
PI
Principal investigator 
PrEP
Pre-exposure prophylaxis
RA
Research assistant
RCT
Randomized controlled trial
RMB 
Renminbi (Chinese currency)
SGM
Sexual and gender minority
STI
Sexually transmitted infections
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YMSM
Young men who have sex with men
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Glossary of Terms
Glossary
Explanation
Cognitive-Behavioral Therapy (CBT)
A short term, structured, problem-
solving form of evidence-based 
psychotherapy based on a framework 
focused on the relationship between 
thoughts, feelings, and behaviors.
Minority stress
The unique and chronic stress (or 
stigma) that sexual minority individuals 
experience because of the inferior social 
status that social structures, institutions, 
policies, and social interactions 
communicate about individuals who do 
not identify as heterosexual.
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Table of Contents
Synopsis....................................................................................................................................2
Purpose .................................................................................................................................2
Objectives .............................................................................................................................2
Study Population..................................................................................................................2
Number of Participants .......................................................................................................2
Study Design ........................................................................................................................3
Study Duration......................................................................................................................5
Outcome Variables..............................................................................................................5
Locations/Facilities ..............................................................................................................6
Abbreviations............................................................................................................................7
Glossary of Terms...................................................................................................................9
Protocol Revision History.....................................................................................................13
1
Background.....................................................................................................................14
1.1
Background ............................................................................................................14
1.2
Prior Experience (if applicable) ...........................................................................14
2
Rationale/Significance...................................................................................................15
2.1
Rationale and Study Significance.......................................................................15
2.2
Risks........................................................................................................................17
2.3
Anticipated Benefits ..............................................................................................20
3
Study Purpose and Objectives.....................................................................................20
3.1
Purpose...................................................................................................................20
3.2
Hypothesis..............................................................................................................20
3.3
Objectives...............................................................................................................20
4
Study Design...................................................................................................................21
4.1
Study Duration .......................................................................................................23
4.2
Outcome Variables/Endpoints.............................................................................23
4.2.1
Primary Outcome Variables/Endpoints......................................................25
4.2.2
Secondary and Exploratory Outcome Variables/Endpoints (if 
applicable).......................................................................................................................25
5
Study Participants ..........................................................................................................27
5.1
Study Population....................................................................................................27
5.2
Number of Participants.........................................................................................28
5.3
Eligibility Criteria ....................................................................................................28
5.4
Recruitment Procedures.......................................................................................29
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5.5
Consent/Assent Procedures/HIPAA Authorization ..........................................31
6
Study Methods/Procedures ..........................................................................................34
6.1
Study Procedures..................................................................................................34
6.1.1
Data Collection...............................................................................................36
6.2
Method of Assignment/Randomization (if applicable) .....................................37
6.3
Adverse Events Definition and Reporting..........................................................37
6.4
Reaction Management..........................................................................................37
6.5
Withdrawal Procedures ........................................................................................38
6.6
Locations/Facilities................................................................................................38
7
Statistical Design............................................................................................................38
7.1
Sample Size Considerations................................................................................38
7.2
Planned Analyses..................................................................................................38
7.2.1
Secondary Objective Analyses (if applicable)...........................................38
7.2.2
Analysis of Subject Characteristics (if applicable) ...................................39
7.2.3
Interim Analysis (if applicable).....................................................................39
7.3
Data Relevance .....................................................................................................39
7.4
Data Coding............................................................................................................39
7.5
Data Analysis Tools ..............................................................................................39
7.6
Data Monitoring......................................................................................................39
7.7
Handling of Missing Data .....................................................................................40
8
Data/Specimen Handling and Record Keeping.........................................................40
8.1
Subject Data Confidentiality.................................................................................40
8.2
Data Quality Assurance........................................................................................41
8.3
Data or Specimen Storage/Security...................................................................41
8.4
Study Records........................................................................................................41
8.5
Access to Source...................................................................................................41
8.6
Retention of Records ............................................................................................41
8.7
Data and Safety Monitoring Plan ........................................................................42
9
Study Considerations ....................................................................................................43
9.1
Institutional Review Board (IRB) Review...........................................................43
9.2
Research Personnel Training..............................................................................43
9.3
Study Monitoring....................................................................................................44
9.4
Unanticipated Problems and Protocol Deviations............................................44
9.5
Study Discontinuation...........................................................................................45
9.6
Study Completion ..................................................................................................45
9.7
Conflict of Interest Management Plan................................................................45
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9.8
Funding Source......................................................................................................45
9.9
Publication Plan.....................................................................................................45
10
Appendices.................................................................................................................46
10.1
References .............................................................................................................46
11
List of Tables..............................................................................................................52
11.1
Table 1 – Visit Schedule Table of Full Study Conditions and Measures......52
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Protocol Revision History
Version 
Date
Summary of Substantial Changes
4/29/22
Inclusion of Aim 3 qualitative interview procedures as well as 
participant in-session response coding, inclusion of COVID-19 
questionnaire, revision of ACES survey instrument, addition of Ci 
Zhang to research team.
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1 Background
1.1
Background
HIV prevalence among gay, bisexual, and other men who have sex with men (MSM) in 
China has increased from less than 1.0% in 2003 to 9.2% in 2016.1The majority of newly 
diagnosed MSM are ages 16-30.2 China’s epidemic is at a crossroads: widespread 
implementation of effective interventions now can stem this trend. Lack of action will see at 
least 1 in 6 Chinese MSM infected with HIV by 2025.1 
Structural and psychological forms of stigma toward young MSM (YMSM) fuel China’s HIV 
epidemic.3-5 Structurally, Chinese YMSM face a lack of equal rights and legal protections, 
including no same-sex marriage, same-sex education, or recourse to discrimination.6-9 Not 
only are YMSM-focused evidence-based treatments lacking in China, but sexual orientation 
conversion therapy is widely promoted as a means to help YMSM who are often desperate 
to maintain heterosexual desires and create traditional families expected by Chinese 
culture.10-12 As is true in other countries, this structural stigma gives rise to maladaptive 
coping processes among YMSM.13-16  Known as minority stress, these processes include 
identity concealment, internalized homonegativity, and sensitivity to identity-based 
rejection,17-22 and they drive the substantial mental health disparity borne by YMSM in 
China.23-31 Both minority stress and poor mental health compromise HIV prevention and care 
behaviors through avoidance coping, low self-worth, impulsivity, and unasseriveness.32-34
Chinese public and non-governmental (NGO) leaders are open to deploying evidence-based 
interventions to reduce the HIV epidemic,35 yet no interventions address Chinese YMSM’s 
minority stress and mental health to prevent HIV. Our team in the US has created such an 
intervention – ESTEEM (Effective Skills to Empower Effective Men), a minority-stress-
focused cognitive-behavioral therapy (CBT) with strong preliminary efficacy across minority 
stress, mental health, and HIV risk behavior (R34MH096607).36-38 Yet three features of 
ESTEEM currently hamper widespread implementation in China or elsewhere. Specifically, 
ESTEEM: 1) has only been tested in the US without cultural adaptation to high-stigma, non-
US contexts, 2) currently requires in-person delivery of 10, 1-hour modules, and 3) has not 
been reviewed by multi-sector stakeholders to inform barriers and facilitators to its uptake 
within existing mental and sexual health services, both public and NGO.
1.2
Prior Experience (if applicable) 
Our ESTEEM treatment for the proposed training has been previously developed and tested 
by the current research team. In the pilot testing of the treatment among a sample of gay 
and bisexual men37, the treatment significantly reduced depressive, alcohol use problems, 
sexual compulsivity, and past-90-day condomless sex with casual partners, as well as 
improved condom use self-efficacy. The treatment yielded moderate and marginally 
significant improvements compared to a waitlist group in anxiety symptoms and past-90-day 
heavy drinking. Effects were generally maintained at follow-up. 
Since the pilot, the research team has been in the process of testing the efficacy of the 
treatment among gay and bisexual men in an RCT against Community Mental Health 
Treatment and Voluntary Testing and Counselling for HIV (see IRB protocol: 
1509016430).The research team has also adapted the SGM-affirmative CBT treatment for 
gender diverse, sexual minority women (see IRB protocol: 2000020997),36 as well as for an 
online platform (see IRB protocol: 2000025803). 
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In terms of the cultural adaptation of the treatment, we have culturally adapted the in-person 
ESTEEM intervention (and measures) for Chinese YMSM over the past year across an 8-
stage adaptation process with YMSM and stakeholders (n = 56), including a small open pilot 
with Chinese YMSM (n = 8). We also worked with our colleagues in Sweden at the 
Karolinska Institutet – world leaders in internet-based CBT (iCBT) – to create an iCBT 
version of ESTEEM. iCBT combines a self-guided interactive mobile web-platform with brief 
counselor feedback and online exercises and homework, requiring 80% less counselor time 
than in-person ESTEEM; caseloads can reach 200-300 per counselor. In a small US pilot (n 
= 10), iCBT ESTEEM was highly functional (see IRB protocol: 2000025803). Thus, we have 
incorporated these advances in the proposed study to develop Chinese ESTEEM iCBT – a 
highly efficient, private intervention that addresses minority stress and mental health as HIV 
prevention. Its mobile platform overcomes stigma-related barriers to broadly reach YMSM 
while still retaining in-person ESTEEM’s robust ability to reduce YMSM’s HIV risk. 
2 Rationale/Significance
2.1
Rationale and Study Significance 
The proposed study addresses several gaps in the literature on Chinese YMSM:
Chinese YMSM are at high and increasing risk of HIV infection in the world’s largest 
country. Although for many years the HIV epidemic appeared to have stabilized in China, 
recent trends raise alarm. In 2018, China saw a 14% increase in new infections; the number 
of new cases per year is now estimated at 100,000.1 While the early epidemic in China 
centered around injection drug use, sex work, and blood transfusions, MSM are now the 
highest-risk group in China, accounting for at least 28% of new infections,1,40 likely an 
underestimate given normative lack of MSM disclosure.41 HIV prevalence among Chinese 
MSM has increased from less than 1.0% in 2003 to 9.2% in 2016. At current trends, 1 in 6 
MSM will be infected with HIV by 2025.42 The majority of newly diagnosed MSM are young, 
under age 30 (YMSM).2 A recent meta-analysis found that only 1/3 of Chinese YMSM 
consistently used condoms during anal intercourse, and their average number of past-6-mo 
sexual partners was approximately six. PrEP is not readily available in China.43
Stigma drives the HIV epidemic among Chinese YMSM.3-5,23,24,44,45 Chinese YMSM are 
surrounded by stigma, which perpetuates maladaptive stress reactions and poor mental 
health.3-5 Structural stigma toward YMSM in China includes a lack of legal protection against 
discrimination, lack of same-sex relationship recognition, and legal barriers to open self-
expression.3,9,46 Same-sex behavior was considered a psychiatric disorder in China until 
2001.3,46 This history yielded sexual orientation conversion therapy, now proliferating in 
China against a relatively unregulated mental health system, despite known harm.10,11,47,48 
Stigma toward YMSM is exacerbated by Chinese values of filial piety and China’s 
collectivistic culture that emphasizes norm conformity; this drives family rejection and 
pressure to conceal.12,24,49 Chinese YMSM’s sex lives are thus often underground and out-of-
reach of HIV-prevention services.1,7,50 About half of Chinese MSM have never been tested 
for HIV and 62% have not been tested in the past 12 months, with fear of stigma as a 
primary barrier.51
Minority stress underlies substantial mental health disparities affecting Chinese 
YMSM. Our research shows that stigma gives rise to minority stress reactions including 
chronic, anxious expectations of rejection; internalized homonegativity; and identity 
concealment.13,14,24,52,53 We estimate that 81% of YMSM in China conceal their sexual 
orientation from all or most others.41 Structural stigma in Chinese cultural norms lead a 
significant proportion of Chinese MSM to have sex with women.49,54,55 A meta-analysis 
showed that 26% of MSM had female sexual partners during the past 6 months and only 
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26% used condoms then.56 An estimated 70% of MSM plan to eventually marry a woman.3,56 
These identity-related stressors help explain Chinese YMSM’s 2-6-times greater odds of 
depression, anxiety, and alcohol abuse compared to heterosexual men.12,24,27,43,57-61 
Minority stress and mental health problems drive Chinese YMSM’s HIV risk. Minority 
stress and poor mental health are clear risks for Chinese YMSM’s HIV transmission 
behaviors.12,26-31,50,52,62 Specifically, enacted and internalize stigma predict concealment, 24 
which in turn predicts lack of HIV-preventative knowledge and behaviors.50,63 Minority stress 
is also associated with emotion dysregulation,64-66 hopelessness,67-69 impulsivity,70 poor 
social support,26,71-73 and low self esteem,73 which are also associated with HIV-risk 
behaviors.18,74,75 The mental health consequences of minority stress further predict HIV-risk 
behaviors: moderate depression is associated with MSM’s condomless anal sex (CAS);32,76-
78 anxiety increases avoiding coping and poor condom use communication;79-81 and 
substance use encourages impulsive sexual behaviors.82-84 
Evidence-based interventions to reduce minority stress reactions and poor mental 
health are increasingly recognized as highly promising solutions to YMSM’s HIV risk. 
Our ESTEEM intervention, developed for high-risk YMSM in the U.S. (R01MH109413), 
represents the only intervention tested for efficacy for reducing YMSM’s HIV risk by 
addressing their minority stress and mental health.36-38 ESTEEM utilizes a 10-session CBT 
framework to address the cognitive, affective, and behavioral minority stress mechanisms 
through which stigma depletes mental and sexual health.18,36 Specifically, across an in-depth 
intervention development process involving consultation with 20 MSM and 21 expert YMSM 
providers (R34MH096607), we adapted the Unified Protocol (a transdiagnostic CBT 
manual)85,86 to specifically target minority stress processes (rather than more general stress 
processes).87 The resulting ESTEEM treatment teaches skills that specifically address 
minority stress mechanisms by: (1) normalizing the mental health consequences of minority 
stress, (2) reworking minority stress cognitions (e.g., low self-worth, internalized 
homonegativity), (3) decreasing avoidance-driven behaviors rooted in minority stress (e.g., 
compulsive sexuality, substance use), and (4) assertive responding to minority stress (e.g., 
authentic self-expression).36 By addressing these mechanisms linking stigma to poor mental 
and sexual health, the treatment shows robust effect sizes across transdiagnostic outcomes: 
depression (d = 0.55), alcohol abuse (d = 1.03), and CAS (d = 0.59). ESTEEM’s 
transdiagnostic approach bypasses the need to train multi-sector providers to deliver 
multiple treatments (e.g., motivational interviewing, relapse prevention, behavioral 
activation), as ESTEEM encompasses the core elements of all these treatments. 
Increasingly, YMSM cite mental health concerns as their primary burden,88,89 making mental 
health promotion an ideal opportunity for also intervening on HIV risk, given the synergistic 
relationship between mental health and HIV. Our work finds that Chinese YMSM, even those 
deeply closeted, are highly motivated to seek identity-affirming mental health services to 
cope with cultural pressures and developmental decisions, such as whether to marry a 
woman.12
Internet-based CBT (iCBT) can overcome barriers to broad implementation of 
evidence-based HIV-prevention interventions. iCBT, pioneered in Northern Europe to 
disseminate CBT broadly, involves participants engaging in several CBT tasks hosted on an 
online platform: reading self-guided psychoeducation, reviewing video demonstrations of 
more complex skills, completing CBT worksheets, and uploading between-session 
homework.90-92 Counselors respond to participants’ progress (e.g., motivational feedback on 
worksheets, suggesting homework tasks) within 1-2 days. Participants can also email 
counselors to clarify points of confusion. Because counselor and participant do not meet 
“live” at the same time, iCBT is asynchronous in that it allows participants to complete each 
module anytime anywhere and counselors to then spend an average of only 10 minutes 
reviewing each module within 1-2 days. Given its efficiency, iCBT counselor caseloads can 
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reach 200-300. Meta-analyses of iCBT find effects similar to those obtained in face-to-face 
CBT.93,94 In a cultural context of normative concealment and conversion therapy, our highly 
secure identity-affirmative iCBT offers an urgently needed alternative for tailored, sensitive 
mental and sexual health support. Indeed, Chinese YMSM expressed strong preferences to 
receive online versus in-person supports.95,96 
2.2
Risks
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:
Recruitment and Informed Consent: The investigative team at CSU and research team at 
Yale have conducted a number of studies involving SGM young adults and adolescents, 
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 training in issues pertinent to research among SGM young adults and adolescents 
and will sign a confidentiality pledge prior to any contact with participants or data. No 
identifying information is collected prior to the moment at which a participant provides 
informed consent. 
The primary mode of communication between the CSU team and participants will be via 
WeChat, (i.e., a Chinese multi-purpose messaging, social media, and payment app; 
comparable to US apps, such as Google voice, which the Yale research team has utilized in 
other studies). Dr. Li and her research team at CSU have successfully used WeChat to 
correspond with their participants in several other studies. 
At the end of the WeChat video screen (described in further detail in Sections 4 and 6), a 
research assistant (RA) at CSU will send eligible participants a copy of the consent form via 
WeChat and review the consent document with them. 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 during a 
separately scheduled consent call over WeChat; points of confusion will also be clarified. 
Once participants have fully understood the consent, they will be asked to provide verbal 
consent. The RA will be instructed to contact the CSU PI (Dr. Xianhong Li) or CSU project 
coordinator (Si Pan) if they are unsure about any participant's capacity to consent.
For participant who are minors (i.e., 16-17-years-old), a waiver of parental consent has been 
requested, as described in Section 5.5. 
Protections Against Emotional Discomfort: It is possible that participants may experience 
emotional discomfort in responding to assessments or session material. 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, participants will be reminded 
during the course of their assessments that they can refuse to answer any questions and 
may discontinue participation at any time. Research staff and counselors at CSU will be 
thoroughly trained in appropriate responses to participant distress through trainings by a 
licensed clinical psychologist. This training will address the appropriate handling of imminent 
threats and provision of referrals to counseling services in less imminent clinical situations. 
Protocols have been developed by the research teams at CSU and Yale for mitigating such 
risks as employed in our other online and in-person treatment studies with YMSM.  
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HIV/STI testing might invoke some emotional discomfort. The CSU project coordinator, 
trained by PI, Dr. Li, and staff from Zuo An Cai Hong, all of whom have previous experience 
conducting at-home HIV/STI testing with YMSM, will seek HIV/STI testing consent from all 
participants during the video screen consent process, prior to study commencement. 
HIV/STI counseling and testing will be led by study counselors, in consultation with Zuo An 
Cai Hong, which contributes an 11-year experience in HIV/STI testing and care and 
demonstrates high YMSM-sensitive testing expertise. Prior to study commencement, we will 
convene the counselors and review all protocols and reporting procedures (both to the 
Chinese epidemiological tracking system overseen and our study data system). 
Confidentiality of results will be stressed during consent and contact with counselors, and on 
the at home HIV/STI kit instructions. A positive test is insufficient for diagnosis and 
participants will be directed to the nearby Zuo An Cai Hong clinic for treatment and follow up, 
unless the participant prefers to access care at health clinic of his choice. Counselors will 
urge participants to access testing at these sites beyond study-related testing. We will make 
every effort to ensure that participants with positive results are referred and have access to 
care with a Zuo An Cai Hong clinic for confirmatory testing and follow-up care. Zuo An Cai 
Hong will also report positive HIV/STI test results to the national reporting system for HIV 
and STIs. 
Appropriate risk-reduction counseling will be provided to all participants at time of testing, as 
well as through the ESTEEM iCBT content they will receive. Enclosed within testing kits, all 
participants will receive lubricant and condoms. The rapid test results for both HIV and 
syphilis will be ready to be read by participants in 20 minutes. HIV/STI test results will be 
discussed with participants by study counselors during the same day as testing via WeChat. 
Like conventional HIV enzyme immunoassays (EIAs), rapid HIV/STI tests are screening (i.e., 
not diagnostic) tests that require diagnostic confirmation by Western Blots if reactive 
(positive). Participants who test preliminarily positive (or have inconclusive tests) will be 
immediately linked to Zuo An Cai Hong who would refer them to CDC for confirmatory 
testing, care, and treatment. Study counselors will offer to make an appointment for 
participants at a local Zuo An Cai Hong, which has 7 offices across Hunan province. 
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 our 
counselors, followed by medical attention referred by Zuo An Cai Hong to which they will be 
promptly linked. Further, we will employ the same procedures as above to address potential 
distress upon realization of an HIV-positive status after the rapid test. See Section 6 of the 
protocol for further information in regard to procedures around the at home HIV/STI testing 
for the study.
Protections against breach of confidentiality: The likelihood that any additional breaches of 
confidentiality would occur is minimal, as steps will be taken to guard against this risk. All 
counselors and research staff will undergo rigorous training in maintaining participants’ 
privacy and confidentiality and will be in possession of valid Collaborative Institutional 
Training Initiative (CITI) certificates or comparable trainings. Further, immediately upon 
providing consent, all participants will be assigned a unique study code number, which will 
only be kept on an electronic database that will be password-protected and located on a 
designated study computer at CSU that will not be connected to the Internet (i.e., offline). 
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 corresponding with 
participants. All materials with identifying information will be kept in one password-protected 
electronic file. Participants will provide alternative contact information (e.g., WeChat account 
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information) for compensation and study retention purposes. This information will be treated 
in the same confidential manner as all participant information, as described here.
Our iCBT platform employs numerous physical access controls (e.g., steel walls, keycard 
access system), systems access controls (e.g., login via two-factor authentication, encrypted 
passwords, required regular password changes), personal data access controls (e.g., 
privilege systems ensuring that study staff only can view information and edit settings that 
pertain to their role), data separation controls (e.g., study-specific database), data transfer 
access controls, intrusion and malware protection, audit logs, safety backups, and data 
erasure protocols. These protections ensure that participants’ data will remain secure 
throughout the duration of the study and beyond. Additionally, no identifiable information will 
be stored on the iCBT platform at any point during the study.
Study data will be stored on either the secure Sojump survey platform, Karolinksa Institutet’s 
secure server, Yale’s HIPAA-compliant Secure Box, and/or an offline computer in Dr. Li’s lab 
at CSU. Session homework assignment data will be received at the Karolinska Institutet’s 
server, which hosts the iCBT online platform for both study conditions (i.e., Chinese 
ESTEEM iCBT and self-monitoring). These session homework assignment data will also be 
downloaded to Yale’s Secure Box drive upon retrieval from the Karolinska Institutet server, 
which will not include identifiable participant information; it will also remain on the Karolinska 
Institutet server after transfer to Yale. Participant session notes will be stored on Yale’s 
Secure Box. One password-protected linking database containing participant names and ID 
codes will be kept on an offline computer in Dr. Li’s lab at CSU and will only be accessible by 
CSU study staff via a separate password. 
Participant tracking and scheduling data will be recorded on a study database stored on an 
offline computer in Dr. Li’s lab at CSU. All study measures will be administered online via the 
secure Sojump survey platform. Dr. Li and her team at CSU have used Sojump for several 
past studies. For data safety, Dr. Li has a signed confidentiality contract with Sojump. Per 
the Sojump confidentiality contract, requisite technical measures will be implemented to 
ensure the security of our data stored on the Sojump server. Sojump is hosted in Allyun BGP 
room, data is stored in RAID (disk array), protected by enterprise-level firewall, and 
combined with daily backup to ensure the data security. Sojump supports multiple public 
level settings and password protection for questionnaires and results. Their staff is tightly 
regulated and restricted in their access to our data to ensure that our critical data will not be 
leaked.” As part of this contract for this study, only one account login and password are 
provided to ensure confidentiality. Furthermore, each login requires a phone-based dual text 
authentication. All data from Sojump will be downloaded onto an offline computer. For 
weekly self-monitoring assessments and iCBT ESTEEM homework assignments conducted 
on the iCBT online platform, only participant IDs will be used; no participants’ names or other 
identifying information will be used or stored on the iCBT online platform. For qualitative 
interviews, participant names will not be recorded and any identifying information will be 
removed from recordings prior to transcription. Interviews will be recorded on a secure offline 
device and transferred to an offline computer kept in Dr. Li’s lab at CSU along with 
transcriptions. 
Reporting requirements might be invoked in the case of participants reporting suicidality, 
homicidality, severe distress, or violence. Our lab’s clinical protocol at Yale has successfully 
guided reporting of instances of suicidality, homicidality, severe emotional distress, violence, 
and child abuse/maltreatment in our other online-based RCTs (see IRB #2000025803). At 
CSU, a similar protocol has been adapted, and will be followed for participants reporting 
suicidality, homicidality, severe distress, violence, or child abuse/maltreatment. 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 
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staff will contact local police (110) or paramedics (120). 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 
available in their area. All therapy homework will be reviewed every 24-48 hours by a clinical 
staff member trained in suicide assessment. Research and clinical staff members will 
receive an alert if the participant answers the online questionnaires in a manner that signals 
distress; such participants will be called by a clinical staff member to assess risk. 
Participants will be notified of the reporting requirements under these circumstances during 
the consent process. See the attached Clinical Protocol on IRES for detailed information 
regarding this clinical protocol.
2.3
Anticipated Benefits
Mental health problems and associated behavioral health risks (e.g., substance abuse, 
suicidality, sexual risk) among YMSM is a clear public health concern in need of easy-to-
disseminate solutions. All participants in the present study will be exposed to information 
about mental and sexual health in relation to social stress. We anticipate that participants will 
acquire knowledge and skills and will receive support needed to improve their capacity for 
managing mental and sexual health 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 international public health agencies about potentially effective outreach and 
prevention strategies that can be delivered to YMSM who experience stress-sensitive mental 
health disorders, such as depression and anxiety, and related behavioral risks, such as HIV-
risk behavior. In sum, the potential benefits outweigh the potential risks to subjects.
3 Study Purpose and Objectives
3.1
Purpose
The purpose of the proposed study is to assess the efficacy of a culturally adapted, 10-
session SGM-affirmative, internet-based cognitive behavioral therapy (iCBT) YMSM in 
Hunan province China. The affirmative treatment called ESTEEM (Effective Skills to 
Empower Effective Men) is based on a minority stress-focused, CBT framework. In 
collaboration with colleagues at CSU, we will assess in a 2-arm RCT whether a culturally 
adapted version of iCBT ESTEEM demonstrates significant reductions in HIV risk behavior 
and mental health symptoms (e.g., depression, anxiety) compared to self-monitoring of 
stress and mood. (Aims 1 and 2). We will then conduct interviews with participants, 
counselors, and stakeholders to evaluate implementation barriers and facilitators (Aim 3).
3.2
Hypothesis
It is hypothesized that Chinese ESTEEM iCBT will yield significantly greater reductions in 
HIV-risk behavior, specifically CAS, and mental health problems (e.g., depression and 
anxiety) compared to weekly self-monitoring of stigma-related minority stress experiences, 
mental health, and HIV-risk behavior among Chinese YMSM.
3.3
Objectives
The primary objective is to evaluate the preliminary efficacy of a Chinese-adapted version of 
iCBT ESTEEM on YMSM’s sexual health and HIV risk behavior. 
The secondary objectives of this study are to determine whether iCBT ESTEEM impacts 
HIV/STI results and symptoms of depression and anxiety, as well as whether baseline 
minority stress exposure moderates treatment efficacy, such that participants with the most 
minority stress exposure benefit more from iCBT ESTEEM than those in the self-monitoring 
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of stress and mood condition. An additional objective is to identify individual and institutional 
implementation barriers and facilitators of iCBT ESTEEM among Chinese YMSM.
4 Study Design
Aim 2 of the proposed prospective study will follow a 2-arm RCT design where 120 Chinese 
YMSM participants will be randomly assigned to one of two conditions:
1) ESTEEM iCBT: This online CBT treatment consists of 10 weekly modules that 
participants will complete over the course of 10 weeks. Modules contain weekly 
psychoeducational text and vignettes about minority stress and mental health; brief 
videos illustrating the CBT skills; and homework exercises that therapists review and 
provide feedback on. Homework exercises include weekly tracking of stressful 
situations and mood, practicing new skills (e.g., mindfulness, cognitive restructuring), 
and exercises related to considering the origins of stress and negative emotions that 
participants may be experiencing. Therapists provide feedback after each homework 
assignment, including reviewing each participant’s treatment goals as part of the first 
session’s homework. Therapists who support this condition will be instructed to 
incorporate SGM-specific content and feedback into homework reviews. Therapists 
will be mental health counselors in Dr. Li’s lab at CSU who possess an advanced 
degree in a mental health field with significant prior experience treating Chinese 
YMSM with sexual and mental health concerns. In the US, modules were adapted 
directly from the in-person materials (e.g., therapist manual, participant handouts) 
used in our previously successful trials of this treatment. The treatment has also 
been recently, culturally adapted for in-person treatment among Chinese YMSM and 
found to be acceptable and feasible.
2) Self-monitoring control: In this control condition, participants will be asked to indicate 
their past 7-day mood, stress experiences, and mental and behavioral health on an 
online survey. This type of self-monitoring has been shown to yield improvement in 
behavioral health outcomes. Self-reporting SGM stress experiences has also been 
shown to produce reductions in depression symptoms over time. Participants will 
record these experiences once per week for 10 weeks.
Prior to randomization, participants will complete an online screener, video screener on 
WeChat, at-home HIV/STI testing kit for HIV and syphilis, and consent call on WeChat (see 
Section 6.1 Study Procedures for more information about these steps of the study). For the 
at-home HIV/STI testing kit for HIV and syphilis, rapid test results will be ready to be read by 
participants in 20 minutes. HIV/STI test results will be discussed with participants by study 
counselors during the same day as testing via WeChat. A CSU research team member will 
contact participants on WeChat after 5 business days of sending the HIV/STI testing kit if the 
participant has not sent the CSU team a photo of their results. Specific procedures regarding 
risks for the at-home HIV/STI testing is outlined in Section 2.2.
To assess intervention efficacy, participants will be assessed at three time-points: baseline, 
immediately post-treatment (4-month follow-up), and 8-month follow-up. Participants will 
complete validated measures online of past-30-day HIV-risk behavior (e.g., condomless anal 
sex), mental health (e.g., depression, anxiety), and minority stressors (e.g., discrimination) at 
all three times points. At 8-month follow-up, participants will be mailed and asked to 
complete the same at-home HIV/STI testing kit for HIB and syphilis described above.
After completing the baseline assessment, participants randomized to ESTEEM iCBT will be 
assigned a study therapist and will be contacted by their therapist to schedule a 30-minute 
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introductory call via WeChat. During this conversation, therapists will explain the structure of 
the study and briefly discuss the participant’s motivations and goals for participating in the 
study. Participants will then complete one session per week. If participants miss a session, 
as determined by daily therapist and RA review of session access and self-monitoring or 
homework completion, they will receive a reminder to complete the session. Participants will 
also be asked to schedule a check-in phone call with their study therapist two-weeks post-
randomization to discuss their progress through the study sessions. Participants will have a 
window period of four months (approximately 17 weeks) to complete all 10 sessions. 
Before we randomize participants into the full trial, we will test the ESTEEM iCBT treatment 
with 10 YMSM to ensure their comprehension of the online module material, as well gather 
their feedback on the usability of the iCBT online platform. Our two pilots for this proposal 
(i.e., cultural adaptation in China + iCBT usability testing in the US) have already led to the 
creation of the in-person delivery materials for Chinese ESTEEM (e.g., manual, participant 
handouts) and established the technical feasibility of our iCBT platform. As such, the 
Chinese-adapted materials (e.g., manual, handouts) are ready to be transformed into iCBT 
content (e.g., self-guided exercises, videos, counselor instructions). Given the previous 
efficacy testing of in-person Chinese ESTEEM and iCBT in our US study, pilot testing will 
occur over the course of 2 weeks with a focus on 10 YMSM reviewing the online treatment 
material, receiving feedback from the counselor, and providing feedback via answering brief 
questions after each module on its usability. For this pilot, the only inclusion criteria will be 
16-30 years old, live in Hunan province China, current gender identity as male, report past 
12-month sex with men, weekly access to internet on a laptop, desktop, or tablet device, 
ability to read, write, and speak in Mandarin, and provision of informed consent (see Section 
5.3 for inclusion criteria for the full study). These 10 YMSM for the pilot will not complete the 
study measures, with the exception of the 30-day Timeline Follow-Back assessment at the 
end of the pilot in order to test the usability of this assessment on Sojump. After review of the 
ESTEEM iCBT materials, participants will provide feedback to the CSU research team on 
their comprehension of the materials, as well as respond to questions from a qualitative 
interview conducted by the CSU research team about their experience.
Flow Diagram for the 2-Arm RCT China ESTEEM iCBT Design
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Aim 3 of the study will identify barriers and facilitators for uptake and scale of Chinese 
ESTEEM iCBT within existing public and non-governmental organizations (NGO) settings. 
We will first review Aim 2 data for YMSM completion metrics (# sessions completed, points 
of drop-off) and moderators of intervention efficacy (as described below). Next, we will 
interview a subset of Aim 2 participants (n=20) as well as counselors and therapy 
supervisors (n=6) for their impressions of the acceptability of Chinese ESTEEM iCBT and 
needed improvements before implementation. We will also interview (n = 8) government 
administrators and leadership, (n=7) LGBTQ community organization staff, and (n = 7) and 
medical providers who have expressed interest in online interventions for YMSM and who 
can ultimately implement this intervention, if efficacious.
4.1
Study Duration
The entire study, including data analysis, is expected to last until May 2023. Participation for 
the 10 YMSM in pilot testing will begin by January 2021. Participation for the full study RCT 
will begin by October 2021. The final 8-month follow-up assessments are anticipated to end 
by November 2022. Participation for the qualitative interviews will begin by June 2022 (upon 
final survey completion of the first RCT participants). Data analysis is expected to occur 
beginning in December 2022 until May 2023. 
4.2
Outcome Variables/Endpoints
Our primary outcome is YMSM’s sexual health and HIV risk behavior, which will be 
assessed at three study time points (baseline, 4-month follow-up, 8-month follow-up) via the 
following measures:

30-Day Timeline Follow-Back
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
Decisional Balance for Condom Use Scale

Safer Sex Questionnaire

Past 4-month HIV/STI Testing Questionnaire 
Our secondary outcomes, which will also be measured at baseline, 4-month follow-up, 8-
month follow-up, (unless otherwise noted) include the following with their associated 
measures:
Mental health outcomes:

Depressive symptoms – Patient Health Questionnaire-9, Overall Depression 
Severity & Impairment Scale

Anxiety symptoms – Generalized Anxiety Disorder-7, Overall Anxiety Severity & 
Impairment Scale; Social Interaction Anxiety Scale

Suicidal ideation – Suicidal Ideation Attributes Scale

Alcohol and substance use – Alcohol Use Disorders Identification Test, Drug 
Use Disorders Identification Test
Minority stress mechanism outcomes:

Concealment motivation – Lesbian, Gay, and Bisexual Identity Scale (LGBIS) 
Concealment Motivation subscale

Acceptance concerns – LGBIS Acceptance Concerns subscale

Internalized homonegativity - LGBIS Internalized Homonegativity subscale

Self-esteem – Rosenberg Self-Esteem Scale
Universal mechanism outcomes:

Emotion regulation – Difficulties in Emotion Regulation Scale-Short Form

Perceived social support – Multidimensional Scale of Perceived Social Support, 
Chinese version of the LGBIS - LGB-Specific Family Support subscale

Rumination – Ruminative Response Scale
Psychosocial variables:

Body image – Multidimensional Body-Self Relations Questionnaire, 
Appearance Evaluation subscale, Body Appreciation Scale-2

Adverse childhood experiences (ACEs; administered at baseline and 8-month 
follow-up) – Life History Interview of ACEs

COVID-19 experiences (administered at 8-month follow-up) – COVID-19 
questionnaire 
HIV/STI outcomes (only following video screener and at 8-month follow-up):

At-home HIV/STI testing kit for HIV and syphilis 
In addition to the assessments that will be administered at baseline, 4-month follow-up, and 
8-month follow-up, three questionnaires will be administered weekly on the iCBT online 
platform for 10 weeks for the ESTEEM iCBT and self-monitoring conditions:

Overall Depression Severity & Impairment Scale

Overall Anxiety Severity & Impairment Scale

Tracking Minority Stress Experiences Questionnaire
For the pilot study, the 10 YMSM will complete the following:

Brief questionnaire (5 items) after completing each module

Follow-up interview after completing all 10 modules 

30-Day Timeline Follow-Back
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For Aim 3, we will additionally review data for the following:

Number of sessions completed by participants

Points of study drop-off

Acceptability and feasibility – participants’ written responses to prompts within online 
modules will be coded for engagement and relevance to module content
See Sections 4.2.1 and 4.2.2. for further explanations of each measure.
4.2.1 Primary Outcome Variables/Endpoints
The following is the primary outcome variable and associated measures that will be 
administered at baseline, 4-month follow-up, and 8-month follow-up:

YMSM’s sexual health and HIV risk behavior
o
30-Day Timeline Follow-Back – assesses retrospective estimates of sexual 
behavior. Participants are first asked to enter questions related to any current 
main partners or casual partners in the past 30 days. Participants are then 
asked to indicate days in the past 30 days that they engaged in sexual 
behavior. For the present study, the CSU will use a Chinese-translated version 
of the measure.
o
Decisional Balance for Condom Use Scale – 18-items based on a 5-point 
Likert scale assessing to what extent participants consider the importance of 
each statement related to having anal sex with or without condoms. The 
Chinese version of the measure will be used for the present study.
o
Safer Sex Questionnaire – 13-items based on a 5-point Likert scale assessing 
one’s confidence in avoiding having anal sex without a condom in various 
contexts. A translated version of the measure in Chinese will be developed for 
the present study.
o
Past 4-month HIV/STI Testing Questionnaire – 7 multiple choice questions 
previously developed by Yale PI, Dr. Pachankis, of the present study for 
another RCT asking participants about their HIV/STI testing history. A 
translated version of the measure in Chinese will be developed for the present 
study.
4.2.2 Secondary and Exploratory Outcome Variables/Endpoints (if applicable)
The following are the secondary outcome variables and associated measures that will be 
administered at baseline, 4-month follow-up, and 8-month follow-up (unless otherwise 
noted):

Mental health outcomes
o
Patient-Health Questionnaire-9 – 10-items from a psychometrically validated 
measure of depression based on a 4-point Likert scale. The Chinese version 
of the measure will be used for the present study.
o
Overall Depression Severity & Impairment Scale – 5-items from a measure 
that has previously been used by the Yale research team to assess changes in 
depressive symptoms among gay and bisexual men in the US. A translated 
version of the measure in Chinese will be developed for the present study.
o
Generalized Anxiety Disorder-7 – 8-items from a psychometrically validated 
measure of depression based on a 4-point Likert scale. The Chinese version 
of the measure will be used for the present study.
o
Overall Anxiety Severity & Impairment Scale - 5-items from a measure that 
has previously been used by the Yale research team to assess changes in 
anxiety symptoms among gay and bisexual men in the US. A translated 
version of the measure in Chinese will be developed for the present study.
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o
Social Interaction Anxiety Scale - 20-items that specifically assess symptoms 
of anxiety in social situation based on a 5-point Likert scale. The Chinese 
version of the measure will be used for the present study.
o
Suicidal Ideation Attributes Scale – 5-items that assess thoughts related to 
suicide in the past month based on Likert scales from 0 to 10. The Chinese 
version of the measure will be used for the present study.
o
Alcohol Use Disorders Identification Test – 10-items based on eight 4-point 
Likert scales and two 3-point Likert scales assessing alcohol use behavior. 
The Chinese version of the measure will be used for the present study.
o
Drug Use Disorders Identification Test – 11-items based on nine 4-point Likert 
scales and two 3-point Likert scales assessing substance use behavior other 
than alcohol. The Chinese version of the measure will be used for the present 
study.

Minority stress mechanism outcomes
o
LGBIS Concealment Motivation subscale – a 3-item subscale from the LGBIS 
assessing sexual orientation concealment based on a 6-point Likert scale. The 
Chinese version of the measure’s subscale will be used for the present study.
o
LGBIS Acceptance Concerns subscale – a 3-item subscale from the LGBIS 
assessing rejection sensitivity based on a 6-point Likert scale. The Chinese 
version of the measure’s subscale will be used for the present study.
o
LGBIS Internalized Homonegativity subscale – a 3-item subscale from the 
LGBIS assessing internalized homonegativity based on a 6-point Likert scale. 
The Chinese version of the measure’s subscale will be used for the present 
study.
o
Rosenberg Self-Esteem Scale – 10-items based on a 4-point Likert scale 
assessing general aspects of self-esteem. The Chinese version of the 
measure will be used for the present study.

Universal mechanism outcomes
o
Difficulties in Emotion Regulation Scale-Short Form – 18-items that comprise a 
total score and six subscales related to emotion (dys)regulation with each item 
based on a 5-point Likert scale. The Chinese version of the measure will be 
used for the present study.
o
Multidimensional Scale of Perceived Social Support – 12-items assessing 
perceived social support from a significant other, family, and friends based on 
a 7-point Likert scale. A translated version of the measure in Chinese will be 
developed for the present study.
o
Chinese version of the LGBIS - LGB-Specific Family Support subscale – a 3-
item subscale from the LGBIS assessing social support specifically related to 
family support based on a 6-point Likert scale. The Chinese version of the 
measure’s subscale will be used for the present study.
o
Ruminative Response Scale – 5-items asking individuals to rate on a 4-point 
Likert-scale how they generally think when feeling down, sad, or depressed. 
The Chinese version of the measure will be used for the present study. 

Psychosocial variables
o
Multidimensional Body-Self Relations Questionnaire, Appearance Evaluation 
subscale – 7-items focused on feelings of body (dis)satisfaction with one’s 
physical appearance. All items are based on a 5-point Likert scale. The 
Chinese version of the measure’s subscale will be used for the present study.
o
Body Appreciation Scale-2 – 10-items assessing the level of acceptance 
people have for their bodies regardless of size or shape, respect and 
attendance to bodily needs, and protecting the body from internalization of 
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society’s pressure and standards of beauty. All items are based on a 5-point 
Likert scale. The Chinese version of the measure’s subscale will be used for 
the present study.
o
Life History Interview of ACEs – 10-items assessing whether participants have 
experienced different types ACES throughout their lives. The Chinese version 
of the measure will be used for the present study.
o
COVID-19 Questionnaire – 21 questions adapted from prior research by PI 
Pachankis for the current study. The questionnaire consists of 9 multiple-
choice questions assessing participants’ experiences related to the COVID-19 
pandemic, including diagnosis with COVID-19 and district lockdowns, and 6 
items based on a 10-point Likert scale assessing perceived impact of the 
pandemic on health and behaviors, with 6 follow-up questions to discern the 
direction of impact. A translated version of all measures will be used for the 
present study.

HIV/STI outcomes (only at pre-baseline [between video screener and consent video 
call] and 8-month follow-up):
o
At-home HIV/STI testing kit for HIV and syphilis – see Section 6.1 Study 
Procedures for more information about the at-home HIV/STI testing kit
The following are the weekly assessments that will be administered for 10 weeks on the 
iCBT online platform to both the ESTEEM iCBT and self-monitoring conditions:

Weekly surveys
o
Overall Depression Severity & Impairment Scale – see description above.
o
Overall Anxiety Severity & Impairment Scale - see description above.
o
Tracking Minority Stress Experiences Questionnaire – 14-items (13 on a Likert 
scale and 1 open-ended response item) assessing different type of sexual 
minority related stressors in the past week. A translated version of the 
measure in Chinese will be developed for the present study.
For the pilot study, the 10 YMSM will complete the following:

Brief questionnaire – 5-items assessing participants’ feedback on the usability 
of each session module 

Follow-up interview after completing all 10 modules – an approximately 1-hour 
interview via WeChat with an RA at CSU asking questions about participants’ 
feedback on the ESTEEM iCBT treatment in terms of comprehension and 
usability, as well as about the 30-day Timeline Follow-Back assessment

30-Day Timeline Follow-Back – see above for a description of this measure
For Aim 3, we will additionally review data for the following:

Number of sessions completed by participants

Points of study drop-off

Acceptability and feasibility – participants’ written responses to prompts within 
online modules will be coded for engagement and relevance to module content
5 Study Participants
5.1
Study Population
The study population for Aim 2 will consist of participants who are between the ages of 16-
30 living in Hunan province China and identify their gender identity as male as well as 
endorse having sex with men in the past 12 months. 
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We are restricting eligibility for this study to individuals with a current male gender identity 
because this group is a rapidly increasing risk group for HIV in China, with prevalence 
increasing from less than 1.0% in 2003 to 9.2% in 2016. As in our previous intervention 
studies with this population, transgender men who have sex with men will be included.
The study will enroll participants ages 16-30 given that this age group contains the majority 
of newly diagnosed MSM in China and has experienced a severe lack of developmentally 
and culturally appropriate preventive intervention attention to date. The upper age range was 
chosen given both the age group most affected by HIV in China is 16-30 and also our 
previous research showing that the identity-focused aspects of our intervention are most 
suited to those MSM who are closest in age to developmental identity-based stress (e.g., 
minority stressors such as concealment).
Hunan province, the site of this study, contains 41 ethnic groups, all of which would be 
considered “Asian” according to the NIH-recognized racial/ethnic minority categories.  
Approximately 90% of residents of Hunan are Han, whereas the other 10% are Tujia, Miao, 
Dong, Yao, Bai, Hui, Zhuang, Uyghurs, and so forth.  We therefore anticipate that our 
sample will be 100% “Asian” with the majority of participants being Han and the remainder 
following the general breakdown of ethnic minority groups in Hunan.
The study will also include only MSM who are sexually active, ensuring that the intervention 
content is relevant to all participants.
Aim 3 will include a proportion of Aim 2 participants whose window of study completion has 
ended. This aim will also incorporate community stakeholders, including government 
officials, medical providers, HIV-related NGO staff members, LGBTQ community center staff 
members, and community advocates.
5.2
Number of Participants
A total of 120 YMSM participants will be enrolled in Aim 2 of study (n = 60 per condition). 
Assigning 60 participants to each condition (iCBT vs. self-monitoring) and accounting for 
20% attrition, a liberal estimate based on our previous online RCTs (i.e., 93-100%), will 
provide ≥ 80% chance of detecting a difference (p < .05) between the conditions of d = .40, 
which is significantly lower than what we found when comparing in-person ESTEEM to 
waitlist (d = .59 for CAS, d = .55 for depression) and lower than even the smallest average 
meta-analytic effect (d = .66) of iCBT compared to weak control conditions for depression. 
For Aim 3, a total of 55 participants, including (n = 20) Aim 2 participants, (n = 6) study 
therapists and supervisors, (n = 8) government administrators and leadership, (n=7) LGBTQ 
community organization staff, and (n = 7) and medical providers will be interviewed in order 
to identify themes in regard to barriers and facilitators of implementing iCBT ESTEEM 
among Chinese YMSM.
5.3
Eligibility Criteria
In order to be eligible for inclusion in Aim 2 of the study, an individual must meet all of the 
following criteria:  

16-30 years old

Live in Hunan province China

Current gender identity as male

Report past 12-month sex with men

Be confirmed HIV-negative upon at-home testing

Report past 3-month condomless/PrEP-less anal sex
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
Past-week symptoms of depression or anxiety using the Brief Symptom Inventory-4 
cutoff of 2.5 on either the depression subscale, anxiety subscale, or both 

No past 3-month mental health services of more than 2 visits per month

Weekly access to internet on a laptop, desktop, or tablet device

Ability to read, write, and speak in Mandarin 

Provision of informed consent
Any individual who meets any of the following criteria will be excluded from participation in 
this study: 

Current active suicidality or homicidality (defined as active intent or concrete plan, as 
opposed to passive ideation)

Evidence of active and untreated mania or psychosis that could interfere with the 
participant’s ability to volitionally consent to research or interfere with their ability to 
safely and reliably complete research
5.4
Recruitment Procedures 
Recruitment strategy: For both the full RCT and pilot study, we will recruit YMSM via 
advertisements on YMSM’s social networking platforms (e.g., QQ, WeChat, Blued) and the 
lobbies of Zuo An Cai Hong (Cai Hong = “rainbow”), an SGM-friendly community-based 
organization with 7 offices in 7 cities of Hunan province that provides ~11,000 HIV tests/year 
and free counseling to YMSM and has a strong collaboration with the Chinese CDC Hunan 
office.
We will create online and paper (e.g., posters, flyers; see attached recruitment flyers on 
IRES) advertisements for this study to post widely on the above virtual and physical sites. 
Based on prior experience, we have allocated substantial recruitment funds to cover the cost 
of recruitment materials and outreach (e.g., in the unforeseen circumstance that QQ begins 
charging researchers to post recruitment ads). 
The CSU team has a graduate student under Dr. Li’s supervision who will serve in the role 
as a full-time recruiter. This individual, along with Dr. Li, has deep social connections with 
the YMSM community and is familiar with existing and emerging virtual and physical sites 
where YMSM socialize. They also possess knowledge of means to reach YMSM who might 
not be out (e.g., via virtual and physical cruising grounds), who therefore might be 
particularly suitable for our minority-stress-focused intervention.
Comprehension test: Before we randomize participants into the full trial, we will conduct a 
comprehension test the ESTEEM iCBT treatment with 10 YMSM to ensure their 
comprehension of the module material, as well as glean their feedback on the usability of the 
iCBT online platform. Our two pilots for this proposal (i.e., cultural adaptation in China + 
iCBT usability testing in the US) have already led to the creation of the in-person delivery 
materials for Chinese ESTEEM (e.g., manual, participant handouts) and established the 
technical feasibility of our iCBT platform. As such, the Chinese-adapted materials (e.g., 
manual, handouts) are ready to be transformed into iCBT content (e.g., self-guided 
exercises, videos, counselor instructions). Given the previous efficacy testing of in-person 
Chinese ESTEEM and iCBT in our US study, comprehension testing will occur over the 
course of 2 weeks with a focus on 10 YMSM reviewing the online treatment material, 
receiving counselor feedback, and providing feedback on the materials via answering brief 
questions after each module on its usability. For this comprehension test, the only inclusion 
criteria will be: 

16-30 years old

Live in Hunan province China

Current gender identity as male
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
Report past 12-month sex with men

Weekly access to internet on a laptop, desktop, or tablet device

Ability to read, write, and speak in Mandarin 

Provision of informed consent
These 10 YMSM for the comprehension test will not complete the study measures, with the 
exception of the 30-day Timeline Follow-Back assessment at the end of the pilot in order to 
test the usability of this assessment on the Sojump platform. After review of the ESTEEM 
iCBT materials, participants will provide feedback to the CSU research team on their 
comprehension of the materials, as well as respond to questions from a qualitative interview 
conducted by the CSU research team about their experience.
Evidence for successful attainment of recruitment goals: While recruiting 120 participants 
within a 10-month timespan is ambitious, we have easily exceeded this recruitment goal in 
equally high-stigma regions of much smaller population size. For instance, in our trial of a 
brief online intervention for sexual minorities in rural Appalachia, an area also with high 
stigma, we recruited 108 participants in 8 months, despite the six Appalachian counties of 
our geographic recruitment zone having 0.5M inhabitants (IRB #1512016952). By contrast, 
Hunan province, characterized by equally high stigma toward YMSM, has a population of 
nearly 70M (140 times more inhabitants than live in our Appalachia recruitment zone). Dr. Li 
has used the strategies proposed in this study (e.g., passive and active recruitment, 
leveraging her deep connections with YMSM-friendly community organizations) to previously 
enroll 80 MSM across 9 months into a multi-session motivational interviewing intervention. 
Finally, Dr. Pachankis has shown through his research with YMSM in Romania that he can 
meet this recruitment goal. In his current NIMH RCT in Romania, the research team has 
enrolled 60 YMSM over the first 6 months. This matches the rate at which he has recruited 
YMSM into his US-based RCTs, which have achieved sample sizes of 250 YMSM in 
approximately 25 months.
Retention: We have refined our retention strategies across several previous studies with 
YMSM in China, low-and-middle income countries, and in high-stigma regions of the US. 
First, to retain participants across the study, we will use all communication permitted by 
participants, including a study WeChat account, and frequent reminders. Second, to ensure 
high engagement with the iCBT sessions, we have built-in lessons-learned from our US-
based usability test. For instance, we now include an introductory phone call between the 
counselor and participant. Also, one of our videos – shown at the start of the intervention – 
includes a brief “how-to” demonstration that shows participants how to navigate the iCBT 
platform itself. Third, we include reasonable financial incentives in Chinese currency (i.e., 
Renminbi; RMB) to compensate participants for their time spent on study-related tasks, 
amounting to 50RMB per iCBT session (for those in the iCBT ESTEEM condition), 30RMB 
for each weekly self-monitoring survey (for those in the self-monitoring condition), and 
150RMB per assessment (baseline, 4-month follow-up, 8-month follow-up).  
We have used these retention strategies previously to attain very high retention in our online 
RCTs. Dr. Pachankis attained 100% retention with 77 YMSM in his first online RCT. Dr. 
Pachankis also retained 88% of participants at follow-up in an online HIV-prevention RCT in 
Romania. Using near-identical strategies as will be used here, Dr. Li retained 83% of YMSM 
in her in-person motivational interviewing-based HIV-prevention RCT in Hunan. We estimate 
that we will retain at least 80% of participants, a quite liberal goal given that we have 
exceeded this goal in our previous studies with YMSM in high-stigma contexts.  
Nonetheless, our study is powered with even 20% attrition, to detect effects smaller than 
those found for identical outcomes (e.g., condomless anal sex, depression) in our previous 
RCTs with YMSM. 
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Qualitative Interviews: For the interviews conducted with LGBTQ organization staff, 
government administrators and leadership, and medical providers, the PI at CSU and her 
research team will contact the governmental and NGO professionals in their network about 
participating in these interviews. All participants will be compensated 200 RMB ($31.48) for 
their participation in interviews.
5.5
Consent/Assent Procedures/HIPAA Authorization
Comprehension test. A waiver of documentation of consent is planned for the all portions of 
this comprehension test study (see attachments on IRES for the online screener). For the 
comprehension test, potential participants will take the online screener for the study via the 
secure CSU Sojump survey software. As previously noted, the only inclusion criteria for the 
comprehension test will be: 16-30 years old, live in Hunan province China, current gender 
identity as male, report past 12-month sex with men, weekly access to internet on a laptop, 
desktop, or tablet device, ability to read, write, and speak in Mandarin, and provision of 
informed consent (see Section 5.3 for inclusion criteria for the full study). An RA at CSU will 
schedule a WeChat call with 10 YMSM participants who express interest in participating in 
the comprehension test. Prior to the WeChat call, the CSU RA will send a copy of the 
consent form via WeChat to the participant and ask them to review the form before the 
WeChat call. During the WeChat call, the CSU RA will read through the consent form and 
answer any questions from the participants. Participants will be informed on the consent 
form that they will receive 200RMB for reviewing the 10 iCBT session modules and 50RMB 
for participating in a follow-up interview. Any ineligible participants will be informed at the end 
of the online screener of their ineligibility for the study.
RCT. For the full RCT study (Aim 2), consent will be obtained at three time points.  A waiver 
of documentation of consent is planned for all portions of this study:
First, participants will complete an initial online screener via the secure CSU Sojump survey 
software (see attachments on IRES for the online screener). 
Second, if participants are eligible for the study based on the online screen, a CSU RA will 
schedule a video screen via WeChat for further assessment. At the beginning of this video 
call, participants will provide verbal consent before continuing with the video screen (see the 
Measure Packet uploaded on IRES for the script that will be followed for the video screener). 
Ineligible participants will be informed at the end of the video screener of their ineligibility for 
the study. If participants are eligible following the video screener, an at home HIV/STl testing 
kit will be sent to the participant via mail within 2 days of the video screener. 
Third, a CSU RA will send participants who screen negative based on the at-home HIV 
testing a copy of the consent form via WeChat. A WeChat call will then be scheduled with 
each participant to review the consent form and assess whether participants understand the 
information in the consent form. As such, a waiver of signed documentation of consent is 
planned for the full RCT study (see attachments on IRES for the full RCT consent form). 
Participants will be informed on the consent form that they will receive 50RMB per iCBT 
session (for those in the iCBT ESTEEM condition), 30RMB for each weekly self-monitoring 
survey (for those in the self-monitoring condition), and 150RMB per assessment (baseline, 
4-month follow-up, 8-month follow-up). 
Participants will be provided with the PI’s contact information at CSU and directed to call or 
email the PI if they have any questions or concerns. The PI at CSU, Dr. Li, will be 
responsible for ensuring that online consent has been obtained.
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Waiver of Parental Consent for Participants Ages 16-17. Involving Chinese adolescent 
YMSM in research to develop interventions for reducing depression, anxiety, and suicidality 
is essential for addressing the substantial mental health disparities affecting this population. 
Sexual orientation disparities in depression, anxiety, and suicidality are well-documented 
among Chinese adolescent YMSM (Huang et al., 2018; Zhang, Wong, Ip, Fan, & Yip, 2017); 
however, no evidence-based intervention has been developed to address the unique 
stressors faced by Chinese adolescent YMSM to reduce their disproportionate burden of 
mental health problems. To develop an intervention tailored to the needs of this population, 
our research involvement.
As such, the present study proposes to waive parental consent for adolescents ages 16-17 
in the Hunan province of China for this study. Several reasons are presented in support of 
waiving parental consent. First, waiving parental consent would not adversely affect the 
rights and welfare of the participants and, in fact, obtaining parental consent would be 
impractical for many participants and potentially increase risk given the stigma toward sexual 
minorities in China. Parental rejection of one’s sexual orientation is a robust risk factors for 
resultant depression, anxiety, and suicidality (Puckett et al., 2015; Ryan et al., 2010). 
Requiring parental consent and, thus, concurrent disclosure of sexual minority identity, 
increases the risk of such rejection. In some cases, parental consent can also hinder sexual 
minority participants’ willingness to participate in research (e.g., Fisher, Fried, Puri, 
Macapagal, & Mustanski, 2018; Flores, McKinney, Arscott, & Barroso, 2018; Macapagal, 
Coventry, Arbeit, Fisher, & Mustanski, 2017; Taylor, 2018). For these reasons, parental 
consent for this study is not a reasonable ethical requirement to protect sexual minority 
adolescents in those states that do not require parental consent for adolescents ages 16-17 
to receive mental health treatment. 
Second, based on previous research (Melton, 1983; Susman, Dorn, & Fletcher, 1992; 
Weithorm, 1994), adolescents are fully capable of not only providing informed consent in 
situations in which parental consent poses significant risks, but are also as capable as adults 
of the decision-making capacity to provide informed consent. 
Third, throughout the multiple points of consent, research staff at CSU will provide 
substitutes for parental consent to protect all study participants, including those ages 16-17. 
These protections include those listed in our current IRB-approved protocol for this study, 
including: (1) reviewing all participant survey responses and therapy-related exercises for 
indications of suicidality and severe distress by a member of the CSU’s clinical team; (2) 
responding quickly to such distress by encouraging access to a 24/7 crisis hotline (see 
clinical protocol for more details); and, (3) contacting participants who indicate distress by 
our own clinical staff within one business day. The Clinical Protocol, successfully employed 
in our other studies of this treatment and its components when delivered both in-person and 
online, continues to guide the protection of study participants. 
 
Lastly, as described in Section 7.3 and throughout this protocol, the present study poses 
minimal risk. As previously described, Chinese adolescent YMSM present at greater risk for 
depression, anxiety, and suicidality compared to their heterosexual peers (Huang et al., 
2018; Zhang et al., 2017). The research procedures of the present study are not expected to 
increase this risk, but instead are intended to decrease it, as demonstrated in our pilot 
studies of this treatment and its components delivered both in person and online to young 
adults ages 18 to 35 (e.g., Pachankis, Hatzenbuehler et al., 2015; Pachankis, Williams et al., 
2019). Indeed, participation in our previous similar intervention studies, including an in-
person pilot study of the same intervention in China, reduced participants’ average risk of 
depression and suicidality from baseline levels. The research procedures of the present 
study involve completing sexual and mental health questionnaires, reading written materials 
about mental health and stress, and engaging in asynchronous (i.e., not live) communication 
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with a study counselor about mental health and stress. These procedures do not pose 
greater risk than those encountered in daily life (e.g., taking a health education class) or 
other activities not requiring parental consent for sexual minority adolescents (e.g., attending 
a community LGBTQ meeting).
Qualitative Interviews: For the qualitative interviews (Aim 3), all RCT participants will already 
have completed eligibility screening and associated consent procedures. Thus, participants 
will provide additional consent for the interview at the time of the interview. The interviewer 
and participant will together review a consent form together that details interview 
risks/benefits and precautions against risk. Once participants have demonstrated that they 
fully understood the consent, they will be asked to provide verbal consent as well as sign an 
interview consent form using the Sojump survey platform (see attached in IRES). We 
foresee minimal risk for the potential of emotional distress as a result of the interview. If 
participants do not feel comfortable/experience distress answering specific questions, they 
will be informed that they may refrain from answering any question. Nonetheless, in the 
event of disclosure of emotional distress, the same procedures will be followed as in Aim 2. 
Interviews with community stakeholders are unlikely to pose risks given these individuals’ 
professional involvement with LGBTQ-related stressors and therapies on a regular basis.
References (for Section 5.5)
Fisher, C. B., Fried, A. L., Puri, L. I., Macapagal, K., & Mustanski, B. (2018). “Free Testing 
and PrEP without Outing Myself to Parents:” Motivation to participate in oral and injectable 
PrEP clinical trials among adolescent men who have sex with men. PloS one, 13(7), 
e0200560.
Flores, D., McKinney Jr, R., Arscott, J., & Barroso, J. (2018). Obtaining waivers of parental 
consent: A strategy endorsed by gay, bisexual, and queer adolescent males for health 
prevention research. Nursing outlook, 66(2), 138-148.
Huang, Y., Li, P., Guo, L., Gao, X., Xu, Y., Huang, G., & Deng, X. (2018). Sexual minority 
status and suicidal behaviour among Chinese adolescents: A nationally representative 
cross-sectional study. BMJ Open, 8(8), e020969.
Macapagal, K., Moskowitz, D. A., Li, D. H., Carrión, A., Bettin, E., Fisher, C. B., & Mustanski, 
B. (2018). Hookup app use, sexual behavior, and sexual health among adolescent men who 
have sex with men in the United States. Journal of Adolescent Health, 62(6), 708-715.
Melton, G. B. (1983). Toward “personhood” for adolescents. Autonomy and privacy as 
values in public policy. American Psychologist, 38, 99 –103.
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. doi:10.1037/ccp0000037 
Pachankis, J. E., Williams, S. L., Mann, A., Job, S., Behari, K., McConocha, E., & Chaudoir, 
S. R. (2019).  Brief online interventions for LGBTQ mental health: A randomized controlled 
trial in the rural US. Presentation at the American Psychological Association annual 
conference, Chicago, IL.
 
Puckett, J. A., Woodward, E. N., Mereish, E. H., & Pantalone, D. W. (2015). Parental 
rejection following sexual orientation disclosure: Impact on internalized homophobia, social 
support, and mental health. LGBT health, 2(3), 265-269.
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Ryan, C., Russell, S. T., Huebner, D., Diaz, R., & Sanchez, J. (2010). Family acceptance in 
adolescence and the health of LGBT young adults. Journal of Child and Adolescent 
Psychiatric Nursing, 23(4), 205-213.
Susman, E. J., Dorn, L. D., & Fletcher, J. C. (1992). Participation in biomedical research: the 
consent process as viewed by children, adolescents, young adults, and physicians. Journal 
of Pediatrics, 121(4), 547-552. doi:10.1016/s0022-3476(05)81142-4
Taylor, C. G. (2008). Counterproductive effects of parental consent in research involving 
LGBTTIQ youth: international research ethics and a study of a transgender and Two-Spirit 
community in Canada. Journal of LGBT Youth, 5(3), 34-56.
Weithorn LA, Scherer DG. Children’s involvement in research participation decisions: 
Psychological considerations. In: Grodin MA, Glanz LH (eds). Children as Research 
Subjects: Science, Ethics, and Law. New York: Oxford University Press, 1994:133–79. 
Zhang, H., Wong, W. C. W., Ip, P., Fan, S., & Yip, P. S. F. (2017). Health status and risk 
behaviors of sexual minorities among Chinese adolescents: A school-based survey. Jourrnal 
of Homosexuality, 64(3), 382-396.
6 Study Methods/Procedures
6.1
Study Procedures
We propose to test the efficacy of an online CBT intervention (ESTEEM iCBT) among 120 
Chinese YMSM. The proposed prospective study will follow a 2-arm RCT design where 
participants will be randomized into either the ESTEEM iCBT treatment group or self-
monitoring control group (both conditions described in further detail in Section 4, Study 
Design). 
For the comprehension test, 10 YMSM will be recruited to review the ESTEEM iCBT 
treatment materials in order to assess their comprehension of the online treatment materials, 
as well as glean feedback in regard to usability of the iCBT online platform. In contrast to the 
full RCT, the only inclusion criteria for this comprehension test will be:

16-30 years old

Live in Hunan province China

Current gender identity as male

Report past 12-month sex with men

Weekly access to internet on a laptop, desktop, or tablet device

Ability to read, write, and speak in Mandarin 

Provision of informed consent
Additionally, these participants will not complete baseline surveys as will be conducted for 
the full RCT. Also, since the purpose of the pilot is to ensure comprehension of the treatment 
material, participants will be asked to complete the 10 modules of the treatment over the 
course of 2 weeks. These 10 YMSM participants will be asked to share their feedback about 
their experience with the online CBT intervention via a WeChat call with a CSU research 
team member at the end of their participation. 
For the full RCT study, 120 YMSM will be recruited via strategies and based on eligibility 
criteria described in Sections 5.4 and 5.3, respectively. Participants will first complete an 
online screener on the secure Sojump survey platform. If eligible, participants will be directed 
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to a separate Sojump survey where they will be asked to provide their contact information in 
order to be contacted for participation in the study. For participants who provide contact 
information, RAs at CSU will contact participants via their preferred contact method and ask 
to schedule a video screener on WeChat. Upon completion and deemed eligible from the 
video screener, participants will be mailed an at home HIV/STI testing kit. The estimated 
time of arrival based on the mailing system in Hunan province is 1-2 days. The RA at CSU 
will be able to check the mailing status of the testing kit. A CSU research team member will 
contact participants on WeChat after 5 business days of sending the HIV/STI testing kit if the 
participant has not sent the CSU team their results.
The kit will consist of a self-HIV testing kit using Alere Determine HIV 1/2 rapid assay (Alere 
Medical Co., Japan), a type of finger-prick-based HIV testing kit, approved by China’s State 
Food and Drug Administration and the US Food and Drug Administration (sensitivity: 
100.00%; specificity: 99.68%) on all participants. The same counseling and testing clinical 
protocol will be followed for syphilis testing, which will utilize the Treponema pallidum 
antibodies rapid test (emulsion process) (Abon biomedicine co., Hangzhou), a type of blood-
based testing kit to detect syphilis (sensitivity: 99.01%, specificity: 99.35%). Participants will 
self-administer these sample collections following instructions that will be provided via QR 
code that will be enclosed in their kits. 
Appropriate risk-reduction counseling will be provided to all participants on the same day of 
testing. Enclosed within testing kits, all participants will receive lubricant and condoms. The 
rapid test results for both HIV and syphilis will be ready to be read by participants in 20 
minutes. HIV/STI test results will be discussed with participants by study counselors. Like 
conventional HIV enzyme immunoassays (EIAs), rapid HIV/STI tests are screening (i.e., not 
diagnostic) tests that require diagnostic confirmation by Western Blots if reactive (positive). 
Participants who test preliminarily positive (or have inconclusive tests) will be immediately 
linked to Zuo An Cai Hong for confirmatory testing, care, and treatment. Counselors will offer 
to make an appointment for participants at a local Zuo An Cai Hong, which has 7 offices 
across Hunan province. 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 
HIV/STI counseling by one of our counselors, followed by medical attention by Zuo An Cai 
Hong to which they will be promptly linked. Participants who test negative will be given the 
option of continuing to move forward with the research study.
Participants who continue to express interest in the study will be sent a copy of the consent 
form via WeChat. Participants will be asked to read the consent form on their own. CSU RAs 
will schedule a consent call with participants via WeChat to read over the consent form with 
them, as well as check their understanding of the consent form via asking questions about 
the content of the study and ability for participants to withdraw from the study at any time. 
After participants provide verbal consent, we will assign them a username and password for 
the Karolinksa Institutet’s secure iCBT online platform that houses the ESTEEM iCBT 
treatment and self-monitoring weekly assessment for both conditions. Participants will be 
required to login to the Karolinksa Institutet’s secure iCBT platform before they are sent the 
baseline assessments. Upon signing into the iCBT online platform, a CSU RA will send a 
hyperlink to the participant via WeChat to complete the baseline surveys on Sojump. After 
completion of the baseline completion, a CSU RA will schedule a final WeChat call with each 
participant for their randomization into either the ESTEEM iCBT or self-monitoring condition. 
For participants assigned to ESTEEM iCBT, they will be assigned a study therapist and will 
be contacted by their therapist to schedule a 30-minute introductory call via WeChat. During 
this conversation, therapists will explain the structure of the study and briefly discuss the 
participant’s motivations and goals for participating in the study. All participants will then 
complete one session (i.e., ESTEEM iCBT or self-monitoring) per week. If participants miss 
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a session, as determined by daily therapist and RA review of session access and self-
monitoring or homework completion, they will receive a reminder via a WeChat message to 
complete the session. Participants will also be asked to schedule a check-in WeChat call 
with their study therapist two-weeks post-randomization to discuss their progress through the 
study sessions. Participants will have a window period of four months (i.e., 17 weeks) to 
complete all 10 sessions.
Lastly, all participants will be sent messages on WeChat to complete 4-month and 8-month 
follow-up assessments. For all assessment time points, automatically generated alerts from 
Sojump will be sent to CSU study staff in response to any participants who indicate 
suicidality in response to suicidality assessments, at which point a clinical staff member part 
of the CSU team will implement the clinical protocol. For the 8-month follow-up, a second at-
home HIV/STI testing kit will be mailed to participants. The same procedure as described 
above will be followed in regard to participants administering this test and reporting results to 
CSU study counselors for follow-up.
See Table 1 in Section 11.1 for a Visit Schedule Table with study procedures listing all 
points of data collection.
For Aim 3 qualitative interviews, a proportion of participants will be contacted following 
completion of their 8-month follow-up window to schedule the interview using their preferred 
method of contact. During the interview, the interviewer will ask about participants’ 
experience with the study, its online format, and its perceived efficacy (see IRES for 
attached interview guide). Community stakeholders will be contacted over email by the PI at 
CSU, Dr. Li, to participate in focus group discussions with other participants of similar 
professions/roles. Community stakeholder participants will be shown a brief presentation on 
the format and content of the treatment intervention, as well as preliminary findings. These 
participants will then be asked about barriers and facilitators to implementation (see IRES for 
attached interview guide).
6.1.1 Data Collection
Data collection will begin with the online screener. Additional data will be collected during 
the video screener, baseline assessments, ESTEEM iCBT treatment and weekly self-
monitoring surveys, 4-month follow-up assessments, and 8-month follow-up assessments. 
All data collection will occur online both via the secure Sojump survey platform and 
Karolinksa Institutet’s secure server that houses the iCBT platform. In-session text 
responses and session homework assignment data will be received at Karolinska 
Institutet’s server, which hosts the online platform for both study conditions (i.e., Chinese 
ESTEEM iCBT and self-monitoring). No identifiable data will be collected on the iCBT 
online platform. 
For data safety in regard to Sojump, Dr. Li has a signed confidentiality contract with 
Sojump. As part of this contract, only one account login and password is provided to ensure 
confidentiality. Furthermore, each login requires a phone-based dual text authentication. All 
the data from Sojump will be downloaded onto an offline computer. Both online 
assessments and the iCBT platform use will not ask for participants’ name or other 
identifying information, only participant ID number. The one exception will be a separate 
Sojump survey to which eligible participants will be directed after completing the online 
survey. This information will be collected in order to contact participants. This contact 
information will be stored in a contact database (previously discussed in Section 2.2) that 
will only be accessible by Dr. Li and the CSU team on their offline computer in Dr. Li’s lab. 
This contact database will be password-protected to further ensure participant 
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confidentiality. Aside from the password-protected contact database that will link 
participants’ names with their study IDs that will be kept on the offline CSU computer in Dr. 
Li’s lab, only participant IDs will be used in all other parts of the study.
For Aim 3, interviews will be conducted using Voov, a secure video conferencing software, 
and digital recording will be disabled for all participants. Interviews will be recorded 
following participant consent with an offline, independent voice recording device in a private 
environment by research staff. Recordings will then be uploaded to an offline computer; 
recordings will be destroyed from offline recording devices immediately after uploading. 
Qualitative interview recordings and Aim 3 participant tracking data will be kept in encrypted 
folders on two separate offline computers in Dr. Li’s lab, to which only Dr. Li and the CSU 
team will have access. Interview recordings will be transcribed by a member of the research 
team blind to participant identifying information, and transcriptions will be kept alongside 
recordings on an offline computer.
6.2
Method of Assignment/Randomization (if applicable) 
Participants who are confirmed eligible via the study screeners and who test negative for 
HIV based on the at home HIV/STI testing kit will then be randomized to ESTEEM iCBT or 
the weekly self-monitoring condition. Participant randomization will be stratified based on 
mental health (i.e., eligible based on depressive symptoms, anxiety symptoms, or both on 
the Brief Symptoms Inventory-4). Randomization will occur via use of a random number 
table generated by SPSS, which has been used reliably by Dr. Li and her team successfully 
when implementing stratified randomization for previous studies. 
6.3
Adverse Events Definition and Reporting
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans. An adverse event (AE) or suspected adverse reaction is considered 
"serious" if, in the view of either the investigator or sponsor, it results in any of the following 
outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions.
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 Data and Safety Monitoring Board will be informed of serious or unanticipated 
adverse events within 5 days of the event becoming known to the principal investigator.
6.4
Reaction Management
Participants will be reminded that they can stop participation at any time, skip any question, 
or take a break if experiencing mild distress during the assessments. In the unlikely event 
that a participant experiences considerable distress, the CSU research team will make a 
referral (if needed) for clinical assessment and/or counseling. Participants will be given the 
names and office phone numbers of the PI at CSU. In the event that a participant discloses 
intent to harm oneself or others, the PI at CSU will report disclosures of intent to harm to the 
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appropriate authorities immediately. Identified clinically trained staff members at CSU will be 
on call for emergency consultation. In the unlikely event that such an incident should occur, 
we will notify the Yale IRB within 5 days and appropriate measures will be taken, including 
necessary reporting to the IRB.
6.5
Withdrawal Procedures
Of the participants who are eligible and consent to the research study, participants will be 
able to withdraw from the study at any point. The online consent forms will clearly state the 
voluntary nature of the study and possibility of withdrawal at any point. Additionally, 
participants will have the option of having their data destroyed. 
6.6
Locations/Facilities
This study will be carried out in Hunan province China by our colleagues at CSU, who will 
serve as the site of study recruitment and all direct participant interaction. Yale University will 
serve as the primary scientific site of the study. Researchers at Yale will be responsible for 
ensuring the scientific, clinical, and technical robustness of the intervention, including its 
translation into the iCBT format and ongoing delivery. All participation will occur online and 
participants will be recruited in Hunan province, as specified below in Section 5.4 
Recruitment Procedures.
7 Statistical Design
7.1
Sample Size Considerations
A total of 120 YMSM participants will be enrolled in this study (n = 60 per condition). 
Assigning 60 participants to each condition (iCBT vs. self-monitoring) and accounting for 
20% attrition, a liberal estimate based on our previous online RCTs (i.e., 93-100%), will 
provide ≥ 80% chance of detecting a difference (p < .05) between the conditions of d = .40, 
which is significantly lower than what we found when comparing in-person ESTEEM to 
waitlist (d = .59 for CAS, d = .55 for depression) and lower than even the smallest average 
meta-analytic effect (d = .66) of iCBT compared to weak control conditions for depression. 
While we likely do not have power to detect changes in our biologic HIV/STI outcomes, 
including them 1) verifies study eligibility, 2) establishes self-testing protocols for our future 
adequately powered research, and 3) promotes public health. 
7.2
Planned Analyses
Our primary hypothesis is that Chinese ESTEEM iCBT will yield significantly greater 
reductions in CAS and HIV risk behavior than weekly self-monitoring. Repeated measures 
intent-to-treat generalized linear mixed models (GLMM) with negative binomial distributions 
and maximum likelihood estimation will be fit to CAS at 4- and 8-month follow-up adjusted 
for baseline CAS with intervention arm as a covariate. We will test the best-fitting correlation 
structure, but based on our previous studies, expect it to be compound symmetrical. We will 
conduct exploratory analyses to determine within- and across-condition effects of each arm 
over time, including appropriate parameters for any trends evident over time. These models 
may be adjusted for any potential covariates (e.g., urban vs. rural residence; level of outness 
or education) that are associated with our outcomes if the intervention arms are not 
balanced on these variables.
7.2.1 Secondary Objective Analyses (if applicable)
A similar approach will be taken for our secondary outcomes (i.e., depression, anxiety, and 
minority stress variables) as described in Section 7.2. We will also examine baseline 
depression, anxiety, and minority stress as potential moderators of ESTEEM iCBT efficacy, 
hypothesizing that YMSM with higher baseline minority stress benefit most. To do so, we will 
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run the GLMMs described previously including two-way moderator x arm interactions with 
post hoc probing of significant interactions via simple slopes. Based on similar moderator 
analyses with in-person ESTEEM, our expected sample size will provide ≥ .80 power to 
detect medium effects (f2=0.15, p < 0.05).
In addition, we will assess preliminary acceptability and feasibility of the ESTEEM iCBT 
intervention through textual analysis of participants’ written responses on the iCBT online 
platform. Select responses from each module of the treatment will be coded to assess 
participant engagement and relevance of writing content to the treatment; consensus 
meetings will be held with Co-PI Li and Co-I Sun to resolve disagreement in response codes. 
Linking IDs will be used to mask coders to participant IDs, and scores for response codes 
will be linked to participant IDs for analysis by research staff not involved in coding. 
Engagement in treatment and relevant of writing content will be examined as moderators of 
treatment efficacy by the approaches outlined above.
7.2.2 Analysis of Subject Characteristics (if applicable)
We will collect demographic data including age, ethnicity, sex assigned at birth, gender 
identity, sexual orientation, education level, marital/relationship status, family income, and 
migrant status. A complete list of all demographic variables is presented in the attached 
measures packet on IRES. All subject characteristics will be reported descriptively utilizing 
means and standard deviations for continuous variables and proportions for categorical 
variables.  
7.2.3 Interim Analysis (if applicable)
The DSMB will review all risk-related data (e.g., HIV risk behavior, suicidality, and 
depression) by condition during each annual meeting.  The DSMB will decide whether to 
review this information while masked to condition assignment. 
7.3
Data Relevance
In this study, our primary objective is to evaluate the preliminary efficacy of a Chinese-
adapted version of iCBT ESTEEM on YMSM’s sexual health and HIV risk behavior. The data 
that we will collect in this study is highly relevant to our primary objective. Our primary 
outcome measures will be an online version of a Timeline Follow-Back, which has been by 
both the research team at Yale and CSU conducted among MSM participants, as well as 
self-report questionnaires assessing sexual risk behavior. In alignment with our secondary 
objective to assess symptoms of depression and anxiety, as well as assessing whether 
baseline minority stress exposure moderates treatment efficacy, we will assess mental 
health symptoms and minority stress-related variables via several quantitative survey items. 
Of note, the majority of these survey items have previously been validated among Chinese 
samples. Finally, we will assess acceptability and feasibility of the intervention using 
qualitative coding of participants’ written responses to inform the adaptability of the iCBT 
ESTEEM intervention beyond the study and analyze these variables as moderators of 
treatment efficacy. All data collected as part of this study is highly relevant to our research 
questions.
7.4
Data Coding
Data will be scored based on each measure’s pre-specified ratings scale (see Measures 
packet on IRES). Outcomes utilized in statistical analyses will be continuous sum or mean 
scores, as applicable. Participant responses will be coded based on ratings of engagement 
and relevance of written responses to treatment content.
7.5
Data Analysis Tools
Data will be managed and analyzed utilizing SPSS Statistics and SAS.
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7.6
Data Monitoring
The PIs at Yale and CSU are responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews quarterly. During the review process, the PIs 
will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment. 
Additionally, a four-member monitoring committee will be convened to determine safe and 
effective study conduct and recommend conclusion of the study if significant risks develop or 
if the trial is unlikely to be concluded successfully. See Section 8.7 for more details regarding 
the Data and Safety Monitoring Board.
7.7
Handling of Missing Data
We will use an intent-to-treat analysis including all eligible cases. Maximum likelihood 
estimation will be employed, which is robust to missing data at followup. 
8 Data/Specimen Handling and Record 
Keeping
8.1
Subject Data Confidentiality
Participant confidentiality and privacy is strictly held in confidence by the participating 
investigators and their staff. Therefore, the study protocol, documentation, data, and all other 
information generated will be held in strict confidence. All research activities will be 
conducted in as private a setting as possible. Representatives of the IRB may inspect all 
documents and records required to be maintained by the investigator for the participants in 
this study. 
To maximize privacy and ensure confidentiality, participant names, which will only be 
recorded during the initial online screener, will be kept separate from all other data. All data 
will be collected via the secure Sojump survey server and on Karolinksa Institutet’s secure 
server, which hosts the online platform for both study conditions. Data will also remain on the 
Karolinska Institutet server after transfer to Yale for storage on Yale’s Secure Box. 
Participants will be assigned a unique code number prior to completion of a video screener, 
as well as a separate unique code after randomization to one of the two study conditions. 
The use of the unique code will permit linkage of the data being collected across all time 
points in the study. A master link file will connect participants’ names and WeChat accounts 
to their study code number. The link file will be password-protected and only accessible to 
the CSU PI and study team members on an offline computer. Upon collection of the study 
data, de-identified data will be stored on password-protected folders on Yale Secure Box 
that requires dual-factor authentication to access. De-identified survey data will be 
downloaded and organized in SPSS files or SAS files and stored on password-protected 
computers by the Yale and CSU study team. Taken together, these measures are 
anticipated to be highly effective in protecting the privacy and confidentiality of participants 
and have proven successful in other studies that the PIs and their research teams have 
implemented.
The study participants’ contact information will be held securely during the study. At the end 
of the study, all records will continue to be kept in a secure location for three years. After 
three years, all records for the study will be destroyed.
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Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored on a secure Yale Secure Box folder only 
accessible by the Yale and CSU research study team members. As previously noted, this 
will not include the participants’ identifying information. Rather, individual participants and 
their research data will be identified by a unique study code number. The study data entry 
and study management systems used will be secured and password-protected. At the end of 
the study, all study databases will be de-identified and archived on a secure Yale Box folder.
8.2
Data Quality Assurance
All assessment measures for the online screener, baseline surveys, 4-month follow-up, and 
8-month follow-up will be administered via the secure Sojump survey platform using contact 
list functions to accurately and consistently administer surveys to participants. Additionally, 
attention check questions will be placed throughout the survey at each time point in order to 
better ensure participant attention when answer the survey questions. CSU RAs and study 
therapists will be trained in using the iCBT platform by a consultant from Karolinksa 
Institutet, as well as Yale’s postdoctoral associate and senior RA on the research team who 
have previous experience working with the iCBT platform.
8.3
Data or Specimen Storage/Security
Participant names, which will only be recorded on a separate survey for those who are 
eligible based on the online screener, will be kept separate from all other data collection 
surveys. All data will be collected via the secure Sojump survey platform. Participants will be 
assigned a unique study code number upon providing consent to participant in the study. 
The use of the unique code will permit linkage of the data being collected across study time 
points. As previously noted, a master link file will connect participants’ names and WeChat 
accounts to their study code number. The link file will be password protected and only 
accessible to the CSU PI and study team members on an offline computer. Upon collection 
of the study data, de-identified data will be stored on password protected folders on Yale 
Secure Box that requires dual-factor authentication to access. De-identified survey data will 
be downloaded and organized in SPSS files or SAS files and stored on password-protected 
computers by the Yale and CSU study team.
Study participant research data from CSU will be transmitted to and stored on a Yale Secure 
Box folder only accessible by the research study team members. This will not include the 
participant's identifying information. Rather, individual participants and their research data 
will be identified by a unique study code number. The study data entry and study 
management systems used will be secured and password protected. At the end of the study, 
all study databases will be de-identified and archived on a secure Yale Box folder.
8.4
Study Records
Study records will consist of responses from self-report surveys. The PIs at CSU and Yale 
will be responsible for maintaining the study documentation, which will be maintained on an 
offline computer at CSU PI’s lab, as well as a Yale Secure Box folder. 
8.5
Access to Source
Source data will consist of surveys and other study measures that will all be administered 
online via the secure Sojump survey platform, as well as the iCBT platform through 
Karolinksa Institutet’s secure server. All source data will be electronic (i.e., no surveys with 
handwritten responses). Research data will only be accessible on an offline computer at 
CSU PI’s lab and a Yale Secure Box folder. Unidentifiable data, including homework 
assignments from ESTEEM iCBT participants and weekly self-monitoring surveys from all 
participants, will also be stored on the Karolinksa Institutet’s secure server.
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8.6
Retention of Records
At the end of the study, all records will continue to be kept in a Yale Secure Box folder and 
an offline computer at CSU PI’s lab. After three years, all identifiable records for the study 
will be destroyed.
 
8.7
Data and Safety Monitoring Plan 
The PIs at Yale and CSU are responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews quarterly. During the review process, the PIs 
will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment. 
Additionally, a four-member monitoring committee will be convened to determine safe and 
effective study conduct and recommend conclusion of the study if significant risks develop or 
if the trial is unlikely to be concluded successfully. 
DSMB members will have expertise in YMSM mental and sexual health, RCTs of HIV-
prevention interventions, and biostatistics. Notably, Yale and CSU have had a training grant 
for the past 9 years from Fogarty (R25 TW007700) specifically to enhance the ability of 
Chinese researchers to uphold ethical research standards.  Thus, we are highly optimistic 
that we will find highly qualified DSMB members in both the US and China. The DSMB will 
hold biannual meetings (or more as needed), which will be facilitated by the two PIs via 
Zoom. 
The DSMB shall be responsible for the following:
•
Reviewing the research protocol and planning for data and safety monitoring.
•
Monitoring that will take place on a regular basis (at least biannually or more as 
needed).
•
Evaluating the progress of the trial, including periodic assessments of data quality 
and timeliness, participant session attendance and assessment completion, 
participant risk versus benefit, and other factors that may affect study outcome. 
Monitoring may also consider factors external to the study when interpreting the 
data, such as scientific developments that may have an impact on the safety of 
the participants or ethical issues related to the study.
•
Inquiring for further information as necessary to accomplish their goals.
•
Maintaining confidentiality during all phases of the trial including the monitoring, 
preparation of interim results, review, and response to monitoring 
recommendations.
•
Generating a report that will be provided to the PI, the IRBs, and the NIH project 
officer.
The DSMB will conduct an open session prior to the initiation of the study. The DSMB will 
have been provided with all material associated with the trial and have had sufficient 
opportunity to review the documents. At the open session, all members will discuss any 
potential concerns for the safe and effective conduct of the impending study.
PIs Pachankis and Li shall be responsible for the following:
•
Preparation and establishment of a plan for the data and safety monitoring.
•
Evaluation of any members of the DSMB for a conflict of interest or financial 
stake in the outcome of the trial.
•
Delegation of the ongoing monitoring of the trial to the DSMB.
•
Ensuring that monitoring is timely and effective and that the DSMB is composed 
of individuals with appropriate expertise to accomplish their assigned tasks.
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•
Overseeing the monitoring activities.
•
Responding to and addressing recommendations that result from monitoring 
activities.
•
Provision of adverse event reports and other safety data to the DSMB, as well as 
any changes in the trial or annual reports to the IRBs and NIH.
•
Contributing to the report that the DSMB generates, which will be distributed to 
the IRBs and NIH.
•
Submitting the DSMB report to the IRBs.
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 PI 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 
DSMB will be informed of serious or unanticipated adverse events within 5 days of the event 
becoming known to the principal investigator.
9 Study Considerations
9.1
Institutional Review Board (IRB) Review
The protocol will be submitted to the IRB for review and approval. An IRB protocol will also 
be submitted at CSU. Approval of the protocol must be obtained before initiating any 
research activity. Any change to the protocol will require an approved IRB amendment 
before implementation. The IRB will have final determination whether informed consent and 
HIPAA authorization are required. Study closure will be submitted to the IRB after all 
research activities have been completed. Other study events (e.g. data breaches, protocol 
deviations) will be submitted per Yale policies.
9.2
Research Personnel Training
This study involves collaboration across four sites – Yale University (US; PI: Pachankis), 
Central South University (China; PI: Li), Karolinska Institutet (Sweden; Consultant: Ljóttson), 
and Brown University (USA; Co-Investigator: Sun). 
(1) Yale University will serve as the primary scientific site of the study. Researchers at Yale 
will be responsible for ensuring the scientific, clinical, and technical robustness of the 
intervention, including its translation into the iCBT format and ongoing delivery. Yale 
researchers will ensure supervision of all study counselors and will also oversee all data 
analysis, both quantitative and qualitative. In addition to the Dr. Pachankis as PI, Yale study 
team members will consist of Zachary Soulliard (postdoctoral associate), who will oversee 
preparation of the IRB protocol, ongoing reports to Yale’s IRB, scheduling DSMB meetings, 
and scheduling full research team meetings. Kriti Behari (senior RA) and Ben Eisenstadt 
(senior RA) will support Dr. Soulliard in the abovementioned tasks. Dr. Ashley Hagaman 
(Assistant Professor of Public Health) will assist with qualitative data analysis. 
(2) Central South University will serve as the site of study recruitment and all direct-to-
participant interaction. Researchers and staff at CSU will ensure that all recruitment goals 
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are met, that data are collected with rigor, and that participant interactions occur ethically. As 
one of the study PIs, Dr. Xianhong Li will supervise the entire flow of the study, as well as 
provide oversight of the data storage and eventual manuscript writing. She will also work 
closely with study therapists to ensure delivery of the counseling intervention on the iCBT 
platform. Along with Dr. Li, Si Pan will serve as the project coordinator of the study, and thus, 
will coordinate preparation of the CSU IRB concurrently with Dr. Soulliard’s oversight of the 
Yale IRB. Si Pan will also provide oversight to the CSU RA. Mengyao Yi will serve as the 
lead RA at CSU. Study therapists at CSU will include Xiangyu Li and Yang Xiong, who are 
both SGM-affirmative counselors with advanced training in working with Chinese YMSM. 
Mrs. Yang Xiong, MSN, RN, will also be the primary contact (in addition to Drs. Ying He and 
Xianhong Li) in regard to the clinical protocol. Ci Zhang, MSN, RN, is a graduate student 
working with Dr. Li who will interview counselors and supervisors as part of the qualitative 
interview process. Lastly, Dr. Ying He is a psychiatrist who will assist and provide support 
with the at home HIV/STI testing completed by participants. She will also be responsible for 
monitoring any clinical issues and make timely referrals as needed. 
(3) Dr. Ljóttson at the Karolinska Institutet will provide technical support for this study, 
including hosting the iCBT platform and providing training and trouble-shooting assistance 
regarding the iCBT platform across the study period. Karolinska Institutet also provides 
highly secure data collection servers where iCBT data will be stored, since the iCBT platform 
itself is also located there. 
(4) Brown University will provide supervision of study counselors. Dr. Sun will provide 
Chinese-language supervision and cross-cultural translation of intervention concepts and 
materials between the China and US teams. 
9.3
Study Monitoring 
The study will be monitored internally by the CSU study team members on a weekly basis 
and in joint meetings with the Yale-CSU team on a biweekly basis. 
 
9.4
Unanticipated Problems and Protocol Deviations
A protocol deviation is any noncompliance with the protocol. The noncompliance may be 
either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly.
It is the responsibility of the principal investigator to identify and report deviations within 5 
working days of identification of the protocol deviation. All deviations must be addressed in 
study source documents and the reviewing IRB per their policies.
Unanticipated problems (UP) involving risks to participants or others include, in general, any 
incident, experience, or outcome that meets all of the following criteria:

Unexpected in terms of nature, severity, or frequency given (a) the research 
procedures that are described in the protocol-related documents, such as the 
Institutional Review Board (IRB)-approved research protocol and informed consent 
document; and (b) the characteristics of the participant population being studied;

Related or possibly related to participation in the research ("possibly related" means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and

Suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.
If the study team becomes aware of an unanticipated problem (e.g. data breach, protocol 
deviation), the event will be reported to the IRB by via email.
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The UP report will include the following information:

Protocol identifying information: protocol title and number, PI's name, and the IRB 
project number;

A detailed description of the event, incident, experience, or outcome;

An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;

A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP.
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:

UPs will be reported to the IRB within 5 days of the investigator becoming aware of 
the event.
9.5
Study Discontinuation
The research team will discuss discontinuation of the study in the event that participants in 
either condition experience unanticipated adverse events (e.g., increased active suicidality) 
over the course of study completion. The DSMB and IRB will be involved in such a 
discussion.
9.6
Study Completion
Data collection for the study will end by November 30, 2022. Data analysis is expected to 
occur from December 2022 to May 2023. The study is anticipated to be completed by June 
1, 2023.
9.7
Conflict of Interest Management Plan 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.
All investigators will follow the applicable conflict of interest policies.
9.8
Funding Source
The study is funded by the 1R21TW011762-01 grant awarded to the MPIs (Drs. Li and 
Pachankis) of this study.
9.9
Publication Plan
Upon the completion of data analysis by May 2023, the research team anticipates submitting 
an initial manuscript for publication by August 31, 2023 that describes the primary efficacy of 
the study. It will be the MPIs’ responsibility for publishing the study results. 
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10 Appendices
Appendix #
Title
Sections
Topic
1
References
1 & 2
Background & 
Rationale/Significance
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11 List of Tables
11.1 Table 1 – Visit Schedule Table of Full Study Conditions and Measures
Online consent for 
initial online 
screener 
Video Screener on 
WeChat + At home 
HIV/STI Testing
Consent Call on 
WeChat
Randomization Call 
on WeChat
Visit 1: Baseline 
surveys (Day 1 ± 7)
Visit 2: Study 
Intervention 
(ESTEEM iCBT or 
Self-Monitoring) 
(Day 7 to 70-119) 
Visit 3: 4-month 
follow-up surveys 
(Day 119 ± 126)
Visit 4: 8-month 
follow-up surveys 
(Day 126 ± 133)
Informed Consent
X
X
X
Randomization
X
Demographics Assessment
X
Primary Measures
30-Day TimeLine Follow Back
X
X
X
Decisional Balance for Condom Use Scale
X
X
X
Safer Sex Questionnaire
X
X
X
Past 4-month HIV/STI Testing Questionnaire
X
X
X
Secondary Measures*
Mental Health Measures
X
X
X
Minority Stress Variables & Collective Self-
Esteem Measures
X
X
X
Potential Mechanism Variables
X
X
X
Psychosocial Variable Measures
X
X
X
HIV/STI outcomes
X
X
ESTEEM iCBT Treatment
X 
(ESTEEM iCBT group ONLY)
Weekly self-monitoring of mood and 
minority stress
X
Adverse Event Reporting
X
X
X
X
X
* = See Section 4.2.2. for a full list of secondary measures