Standardized Patients to Measure and Address Intersectional Stigma: An HIV Prevention Engagement Strategy
Phase: NA
Conditions: Hiv, HIV Infections, AIDS
Sponsor: University of Minnesota

PROTOCOL TITLE: Standardized Patients to Address Intersectional Stigma 
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PROTOCOL COVER PAGE 
 
 
Protocol Title 
Standardized Patients to Measure and Address Intersectional 
Stigma: An HIV Prevention Engagement Strategy  
Principal 
Investigator/Faculty 
Advisor 
Name: Kumi Smith (PI) 
Department: Epidemiology, UMN 
Telephone Number: (612) 301-3051 
Email Address: smi00831@umn.edu 
Principal 
Investigator/Faculty 
Advisor 
Name: Sean Sylvia (Co-PI) 
Department: Health Policy and Management, UNC 
Telephone Number: (919) 888-0821 
Email Address: sean.sylvia@unc.edu 
Scientific 
Assessment 
Nationally based, federal funding organization. 
Version 
Number/Date: 
Version 0.2, 11/2/2021 
 

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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1.2 
9/19/2019 
Response to stipulations following IRB 
from 9/13/2019. Clarifications 
regarding provider consent for case 
script field testing, contact information 
for study team, details on terms of 
study termination, details of clinic 
visits, and procedures for informing 
SPs of what to expect as part of the 
job. 
Yes 
1.3 
11/04/2019 
Adopted alternative approach to 
recruitment and maintenance of CABs 
based on local input. 
Yes 
1.4 
12/1/2020 
Amended clinic recruitment 
procedures (12.1) to reflect the 
assistance we are now receiving from 
the Guangzhou CDC and to record 
the actual number of clinics in our 
sample pool (46 instead of 81) 
Yes 
1.5 
1/5/2021 
Amended the consent procedures 
(22.1 and 22.3 sections): Waiver of 
written consent 
Yes 
1.6 
1/12/2021 
Added a new qualitative research 
component: Aiming to study how the 
SPs’ background, sexual identity and 
LGBT community experience play a 
role in their study engagement and 
potentially change after the 
participation, by conducting interviews 
before and after their clinic visits: 
Study endpoints (3.2): Inserted the 
description of the endpoints/findings 
we expect from this qualitative 
interview 
Procedures involved (5.2): Illustrated 
the main change on the study 
procedures in the preparatory stage 
Consent process (22.1): Illustrated the 
add-on consenting process for this 
particular purpose 
Yes 

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1.7 
2/17/2021 
Added a clause in consent procedures 
pertaining to qualitative sub-study 
indicating that participation is 
voluntary and will not impact their 
work as an SP. 
Yes 
1.8 
5/27/2021 
The measurement tools (SP scripts 
and healthcare checklist) were revised 
to reflect the suggestions provided by 
the recruited SPs and volunteer 
clinicians during the training. The 
changes were notified to the SP 
members (p13).  
No 
2.0 
7/29/2021 
Updated the version 1 protocol to 
include new descriptions of the phase 
2 research which includes the RCT 
related activities such as the 
intervention design and 
implementation, as well as collection 
of follow-up data. 
No 
2.1 
11/02/2021 
Update the payment details for 
participants, clarified logistics for the 
qualitative interviews. 
Consent forms revised to remove any 
language pertaining to arm, as well as 
to include information about the hybrid 
training design and participant 
compensation. 
Yes 
2.2 
09/01/2022 
Update the data banking plan in 
section 6 
Yes 
 
 
 

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Table of Contents 
 
1.0 
Objectives 
6 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
11 
4.0 
Study Intervention(s)/Interaction(s) 
11 
6.0 
Data Banking 
14 
7.0 
Sharing of Results with Participants 
14 
8.0 
Study Duration 
14 
9.0 
Study Population 
15 
11.0 Number of Participants 
19 
12.0 Recruitment Methods 
19 
13.0 Withdrawal of Participants 
22 
14.0 Risks to Participants 
23 
15.0 Incomplete Disclosure or Deception 
24 
16.0 Potential Benefits to Participants 
25 
17.0 Data Management 
25 
18.0 Confidentiality 
28 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
29 
20.0 Provisions to Protect the Privacy Interests of Participants 
29 
21.0 Compensation for Research-Related Injury 
30 
22.0 Consent Process 
30 
23.0 Setting 
33 
24.0 Multi-Site Research 
34 
25.0 Resources Available 
35 
26.0 References 
35 
 

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ABBREVIATIONS/DEFINITIONS 
 
 
CAB 
Community advisory board 
EOC 
Erosion of care 
MSM 
Men who have sex with men 
GDCDC 
Guangdong Center for STD Control and Prevention 
PLWH 
People living with HIV/AIDS 
RCT 
Randomized control trial 
RERI 
Relative excess risk due to interaction 
ROR 
Return of results 
SMC 
Safety monitoring committee 
SP 
Standardized patient 
STD 
Sexually transmitted disease 
 
 
 

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1.0 
Objectives 
1.1 Purpose 
This is the second phase of a two-phase study that aims to develop and evaluate 
an intervention to reduce enacted stigma in healthcare settings aimed at PLWH 
and MSM in China. The 1) preparatory phase consists of collecting baseline data 
and conducting formative research in order to inform design of the 2) RCT phase 
of research. Although funding for both the preparatory and RCT phases have been 
secured, we developed study protocols for each phase in an iterative fashion to 
ensure the opportunity to properly incorporate results from the preparatory phase 
into the final design of the RCT. The overall scheme of the two study phases are 
illustrated in Figure 1 below. 
Figure 1. Schemata for overall study design. 
 
Having completed all preparatory phase activities, this protocol will describe 
activities related to the RCT phase which will be conducted in two stages:   
Stage 1 of the RCT Phase: Implementation of the stigma reduction intervention. A 
three-module provider training course designed during the preparatory phase will 
be administered to consenting providers employed at clinics randomized to the 
treatment arm of the study. The first module will be administered as a one-day 
training on site at the Guangdong Center for STD Control and Prevention. This will 
be followed by two online modules that provider participants will complete on their 
own. Design of this intervention has been informed by results of the baseline study 
and incorporates expert input from members of our community advisory boards 
(CAB), one made up of community members and the other of providers. Content of 
the intervention will include knowledge and skills training on topics including clinical 
management of common STIs, shared decision making, sexual history taking, and 
working with non-traditional/marginalized populations. Training methods for the 
onsite training will include didactic lectures, group-based discussion, and medical 
simulation and feedback with trained SPs. Methods for the online follow-up 
sessions will include webinars, short training videos, and multiple choice quizzes. 
Stage 2 of the RCT Phase: Follow-up data collection. Follow-up collection using 
the same unannounced SP visit approach as in the baseline data collection will 
take place within 1-3 months of the end of the stigma reduction intervention. 
Briefly, this will consist of working with trained actors who are recruited from the 
community, who receive training to conduct unannounced clinic visits with 
consenting providers for the purposes of observing their clinical performance. SPs 

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will present clinically standardized case scenarios, but the HIV status and sexual 
orientation of each case will be randomly varied in order to quantify the extent to 
which HIV stigma and/or homophobia potentially contribute to the deterioration of 
care quality. Enrolled providers already provided their consent for both rounds of 
unannounced clinic visit during the preparatory phase of research. 
Research activities in all phases of the project will take place in Guangzhou, China. 
 
2.0 
Background 
2.1 Significance of Research Question/Purpose 
Consistent data highlight the central role of stigma in limiting uptake of HIV related 
testing, treatment, and care.1–3 This is particularly true for gay, bisexual, and other 
MSM who have the lowest rates of engagement with the healthcare system4,5 
despite bearing the highest HIV incidence burden.6 Particularly for MSM seeking 
HIV testing services, enacted stigma—acts of discrimination or hostility directed at 
a person because of their perceived stigmatized status7—both on account of their 
same-sex behaviors8 (i.e. sexuality stigma9 or homophobia) and the perception of 
their elevated HIV risk10 (HIV stigma) is all too common.  
A major challenge to date in reducing healthcare stigma is our limited ability to 
measure it.11 Numerous interventions for providers, for example, have assessed 
program impact by comparing participants’ self-reported attitudes towards PLWH 
before versus after the intervention, a measure fraught with social desirability bias. 
Documentation of patient experiences in clinical settings, though less subject to 
social desirability, may suffer recall bias and also lack standardization across 
patients. Inability to observe the very behaviors they seek to change also limits the 
design of these interventions from using insights beyond theoretical reasoning to 
specify the underlying causes and solutions of stigma.2,12,13  
By contrast our experimental SP audit method provides a window of insight into 
provider behaviors as they unfold in real clinical settings, providing an objective 
and standardized measure of stigma amenable to comparison across studies and 
settings. Our SPs will be recruited from among MSM living locally, whose group 
makeup will be managed to reflect the overall characteristics of the local MSM 
community in terms of age, ethnicity, and socioeconomic status. SPs will be 
trained to consistently present a standardized case to providers. Using an 
experimental audit design, we will randomly vary the HIV infection status and 
sexual orientation of all of our SPs. Stigma will be evaluated by comparing the 
quality of care that SPs experience during provider visits. Quality of care will be 
measured by administration of a standard of healthcare checklist to SPs following 
each visit, and which will include items related to provider behaviors including the 
types of questions asked, accuracy of the preliminary diagnosis, body language 
and bedside manner (checklist included in Appendix 1). Differences in tallied 
aggregate scores across SP visit scenarios (e.g. HIV positive versus HIV negative 
presentations) will be quantified as the enacted healthcare stigma attributable to 
the condition in question (i.e. HIV infection). In addition, SPs will participate in post-
visit “debrief sessions” with another member of the study staff immediately 
following each visit to recount any other possible features of the visits—both 
positive and negative—not accounted for in the healthcare quality checklist. This 
method of quantifying stigma will not be used to identify individual providers or 

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instances of poor treatment but rather to characterize population level incidence 
and patterns of stigma enacted by providers towards vulnerable patients. Lastly, 
the impact of the intervention on overall HIV testing volumes in study facilities will 
also be evaluated by examining aggregate counts of facility-level HIV tests 
conducted during the baseline and follow-up observation periods. This information 
will be provided by the laboratory departments of all participating facilities. This 
technique of data collection has been successfully piloted with a clinic-based 
intervention administered by the GDCDC. 
In the final step of the initial preparatory phase of this project, we conducted a 
preliminary and descriptive analysis of the SP-collected baseline clinic visits in 
order to characterize the nature and patterns of enacted healthcare stigma towards 
PLWH and MSM. Results quantified the amount of HIV and sexual stigma 
observed in study clinics (further details of the outcome in Section 3.0), and also 
stratified results by broadly descriptive characteristics such as age, sex, and rank 
of provider. These results were shared in Return of Results (RoR) sessions with 
members of community advisory boards (CABs), one made up of MSM and the 
other of providers through separate share back sessions. We convened meetings 
with CAB members to solicit their insights about drivers of provider behaviors 
observed in their community. The team incorporated CAB feedback to develop the 
intervention, a stigma reduction training program for provider participants employed 
at clinics randomized to the treatment arm. Details of the final design were 
informed by feedback from study team members and each of the two CABs, the 
overall structure consists of  didactic content as well as experiential learning using 
simulation-and-feedback sessions with trained SPs. We may re-consult our CABs 
at later stages of the design for iterative feedback on any adjustments made to the 
intervention design.  
In the RCT phase of this project, covered by the current protocol, we will 
administer the intervention to all consented and enrolled providers employed at 
study clinics randomized to the treatment arm. We will also conduct a second 
round of unannounced SP clinic visits to collect follow-up data in order to estimate 
the impact of the intervention on provider behaviors. The intervention design is 
largely informed by the Information-Motivation-Behavioral Skills model of behavior 
change as well as by input from the two CABs during the return of result sessions. 
The finalized version of the intervention is expected to take a hybrid form 
consisting of both in-person, onsite sessions and self-directed online sessions for 
participants to complete in their own time within a specified window of time. Within 
1-3 months following the stigma reduction intervention, unannounced SP clinic 
visits will recommence using the same procedures and data collection techniques 
as for the baseline visits. Data from the healthcare quality checklists will be 
integrated into a score for each visit and used to estimate the impact of the stigma 
reduction intervention. Facility level information on HIV testing will also be collected 
in the form of aggregate counts as a secondary outcome in order to compare 
testing volume in the baseline versus follow-up observation periods. 
2.2 Preliminary Data:  
Members of our research team have made key contributions to the field’s 
understanding of the Chinese HIV epidemic, prevention seeking barriers among 
MSM, and the role of stigma plays in both phenomena. Co-PI Dr. Sean Sylvia and 
project consultant Dr. Li Li have both successful implemented use of unannounced 
SP approaches for evaluation of healthcare quality,14–17 including one application to 

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assess HIV stigma in China.18 These projects demonstrate the feasibility of our 
approach and provide our team with a wealth of knowledge on best practices. Dr. 
Li’s extensive research on HIV-related stigma in Chinese healthcare settings19–22 
underlies the central justifications of this proposal and driving the central 
hypothesis that its remedy will lower HIV testing barriers for marginalized 
communities. 
In preparation for the current study, the research team previously conducted 
preliminary pilot activities from September 2018 to January 2019 in Guangzhou, 
China. We enlisted local stakeholders (MSM, PLWHA, and STD providers) to 
provide input on preliminary study materials such as disease case scripts, recruited 
and trained 4 SPs, and conducted 17 total visits with 10 local consenting STD 
clinics. Though the sample size is too small to draw population level conclusions, 
instances of both positive and negative interactions with providers were 
documented by our SPs. The pilot study also allowed the team to resolve logistical 
challenges (e.g. consent procedures, number of clinic visits to be conducted in a 
day) and to monitor for potential adverse events, of which none were reported.   
2.3 Existing Literature:  
Limitations to measuring of Stigma Experienced in Healthcare Settings: Existing 
studies have documented how stigma towards PLWH and marginalized groups 
including sexual minorities impede access to the HIV prevention continuum at 
multiple points. An extensive body of literature documenting past stigma reduction 
interventions suggests that these efforts have had moderate to mixed 
success.12,23,24 Yet common across the literature is the collective uncertainty about 
the state of the science given issues with existing approaches to measurement of 
stigma.11 Nearly all studies rely on the self-reported attitudes and beliefs among 
providers regarding PLWH or other associated groups, an approach fraught with 
recall and social desirability bias.25,26 Alternative approaches include direct 
observation of provider behaviors or monitoring of the patient population for 
reporting of adverse provider interactions. But both approaches face their own 
limitations, as providers have known tendencies to alter behaviors under 
observation (the Hawthorne effect); whereas the lack of standardization across 
patient-reported events makes it difficult to draw firm conclusions about 
discriminatory treatment.  
Standardized Patients to Measure Care Quality: A key feature of medical training in 
many settings,27,28 SPs are an increasingly common tool for researching healthcare 
quality.14,15,29,30 Their ability to objectively document provider behaviors through 
unannounced visits to practices presents a simple solution to the longstanding 
challenges of stigma measurement such as low provider willingness to self-report 
discriminatory behaviors or the Hawthorne effect.13,31 Studies have used 
unannounced visits from SPs to evaluate the quality of care received by patients in 
the US32 and several low and middle-income countries30 including China.14–17 
Experimental Audits: Our use of the unannounced SPs in an experimental audit 
approach (common in social science studies of race and sex discrimination33–35) by 
randomly varying the sexual orientation and HIV status of each SP case scenario. 
Measuring stigma as both a healthcare quality index score and through 
documentation of adverse clinical encounters (e.g. care refusal, discriminatory 
language) provides quantitative and qualitative measures of sexual, HIV, and 
intersectional stigma. 

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2.4 Research Team 
This research will be carried out under the auspices of a multi-PI structure, co-led 
by co-PI’s Dr. Kumi Smith of the University of Minnesota Twin Cities and Dr. Sean 
Sylvia of the University of North Carolina Chapel Hill.  
Administration: Both PIs (Drs. Smith and Sylvia) will provide oversight of the entire 
program and development and implementation of all policies, procedures and 
processes. In these roles, they will be responsible for the implementation of the 
scientific agenda and ensure that systems are in place to guarantee institutional 
compliance with US and Chinese laws as well as DHHS and NIH policies, including 
protection of human subjects 
PI#1 Dr. Smith will serve as contact PI and will assume fiscal and administrative 
management for this project. She will be responsible for communication with NIH 
and submission of annual reports. She will also be responsible for implementation 
of all human subject research approvals at the University of Minnesota and 
Guangdong Center for STD Control and Prevention in China. 
PI#2 Dr. Sylvia will be responsible for development and adherence to the study 
protocol and will maintain routine communication with local study staff to monitor 
for any adverse events related to the study. He will also be responsible for 
implementation of all human subject research approvals at the University of North 
Carolina.  
Communication and coordination: The PIs will be responsible for overall conduct of 
the study. During the initial study period, the PIs will conduct weekly meetings with 
all the co-investigators to discuss study design and research implementation. 
Subsequently, weekly meetings will be held either by phone, email, Skype 
conference, or in person for the discussion of project operations and other 
activities. Throughout the study implementation period the PIs will conduct weekly 
calls will local study staff and co-I’s based at the study site in Guangzhou to ensure 
adherence to the study timeline, maintain protocol standards, and to address any 
issues that may arise. The two PIs will develop a comprehensive data analysis 
plan to be presented to all co-investigators prior to start of analyses. The PIs will 
work together to discuss any changes in the direction of the research projects. A 
publication policy will be established based on the relative scientific contributions of 
the PIs and key personnel. Dr. Smith will serve as the contact PI and be 
responsible for submission of progress reports to NIH and all communication.  
Conflict Resolution: If a potential conflict develops, the PIs shall meet and attempt 
to resolve the dispute. The PIs have worked successfully together for the past 
several years and there is very low probability that differences of opinion cannot be 
managed effectively between them. If they fail to resolve the dispute, the 
disagreement will be referred to an arbitration committee consisting of two impartial 
senior executives from the University of Minnesota and the University of North 
Carolina and a third impartial senior executive mutually agreed upon by both PIs. 
No members of the arbitration committee will be directly involved in the research 
grant or disagreement. 
Change in PI Location: If a PI moves to a new institution, attempts will be made to 
transfer the relevant portion of the grant to the new institution. In the event that a PI 
cannot carry out his/her duties, a new PI will be recruited as a replacement at one 
of the participating institutions. 

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3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome 
Our primary endpoint of the RCT phase of the study will be the quality of 
healthcare received by SPs in each clinical encounter with an enrolled provider. As 
a measure of the quality of healthcare provided in each interaction between 
physicians and standardized patients, we will create an index using 38 items from 
the structured post-interaction survey questionnaire administered to SPs following 
each unannounced visit. Individual items will be combined into a global index, 𝑠𝑠𝚤𝚤ഥ, 
which is calculated as a weighted average of all 38 items, for which weights are 
calculated as the sum of its row entries in the inverted covariance matrix as 
follows: 
𝑠𝑠𝚤𝚤ഥ= ൫1′Σ෠−11൯
−1൫1′Σ෠−1𝑦𝑦𝑖𝑖൯ 
where 1 is a column vector of 1s, Σ෠−1 is the inverted covariance matrix, and 𝑦𝑦𝑖𝑖 is a 
column vector of all items for individual 𝑖𝑖. 
Using the analysis approach presented in section 17.3, we will estimate the impact 
of the intervention on the extent to stigma faced by SPs when presenting as MSM 
or HIV infected patients relative to the “standard” care experienced by the referent 
case scenarios of a straight, HIV uninfected man. 
3.2 
Secondary Endpoint(s)/Event(s)/Outcome(s):  
Three secondary endpoints will be collected.  
The first will take the form of findings from debrief sessions (i.e. structured 
interviews) with SPs that will be administered by another study team member 
immediately following each unannounced visit. This qualitative data is intended to 
identify emergent episodes of adverse care not captured by the healthcare quality 
checklist used to quantify the primary endpoint. Findings will take the form of a 
written report to describe patterns and themes emergent in the interviews, with 
direct quotes to illustrate concepts where helpful.  
The second endpoint will be the aggregate clinic-level number of HIV tests 
conducted in each enrolled clinic during the study period. This data will be 
abstracted from the provincial case report system. 
The third endpoint will be the qualitative data collected through in-depth interviews 
with our SPs after their participation in each round of clinic visits (baseline and 
follow-up). The collected data will provide insight into how their sexual identity and 
experience in community activities may motivate their participation in a research 
project like ours, and how they may change their views regarding stigma after their 
study engagement. Findings will take the form of transcribed scripts of recorded 
interviews. 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 
Description: 
As described in Section 1.1, the main study activities associated with the RCT 
phase of this project and this protocol involve Stage 1) implementation of the 
stigma reduction intervention and Stage 2) follow-up data collection using the 
unannounced SP visit approach.  

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The main study activities associated with Stage 1 will involve administration of the 
intervention. The intervention design is largely informed by the Information-
Motivation-Behavioral Skills model of behavior change;36 final details of the 
intervention design will also be informed by feedback from study team members 
and each of the two CABs. Information related programming will involve didactic 
sessions to inform providers on clinical diagnosis and management of common 
STIs and HIV/STI epidemiology with a focus on its public health impact on 
marginalized populations including MSM and PLWH. Motivation related sessions 
will explore providers’ intrinsic motivations for practicing medicine and use group 
discussions to explore their self-perceived roles in addressing the HIV/STI crisis, 
particularly in socially marginalized groups including MSM. Lastly the behavioral 
skills sessions will involve both active (role play, group critiques of recorded 
patient-provider interactions) and passive skills training (watching videos that 
demonstrate target skills). To reduce travel and time burden on provider 
participants, the training will be delivered in a hybrid format consisting of both in 
person, on-site training delivered at the offices of the GDCDC as well as self-
directed online units for provider participants to complete on their own within a pre-
specified window of time. 
The main interactions associated with research activities in Stage 2 involve 
collection of follow-up data using the same face-to-face surveys and unannounced 
SP approach as in the baseline visits. The face-to-face survey will be administered 
by study staff with consented and enrolled providers to collect follow-up data on 
their attitudes towards working with marginalized populations. In addition 
consenting providers will have an unannounced SP dispatched to their clinic over 
the course of the observation period (between 1-3 months from the completion of 
the stigma reduction intervention) to collect data on observed clinical behaviors. As 
in the baseline round, SPs will present standardized cases with indications of early 
stage syphilis infection without informing provider participants that they are 
incognito patients. Immediately following the visits, SPs will report on the specifics 
of the encounter by responding to a standardized healthcare quality checklist 
administered to them by a study enumerator. Enumerators will not accompany SPs 
into the clinic but will instead wait nearby location such as inside the hired car used 
for transport to and from clinics. Provider will have been instructed not to confront 
any patient they suspect may be an SP, and to instead make note of the patient 
name and visit date. At the conclusion of the follow-up procedures, providers will 
be given an opportunity to ask whether a particular patient was in fact an SP, 
findings from which will be included in our study findings as an “SP detection rate.”  
5.0 
Procedures Involved 
5.1 Study Design 
The design of the overall study is a pilot RCT to evaluate the preliminary 
effectiveness of the stigma reduction intervention developed in the course of the 
project, with randomization taking place at the facility level (cluster randomization). 
As activities related to the preparatory phase of research have been completed, 
the activities described below pertain only to the RCT phase.  
5.2 
Study Procedures:  
As described in Section 1.1, study procedures relevant to the RCT Phase (Phase 
2) to which this protocol pertains will be divided into the following two stages:  

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Stage 1: Implementation of the stigma reduction intervention. The intervention will 
consist of three sections as informed by the Information-Motivation-Behavioral 
Skills model of behavior change as follows:  
1. Information: this unit will consist of substantive information on a) clinical 
diagnosis and management of common STIs and b) HIV/STI epidemiology with 
a focus on its public health impact on the MSM population. 
2. Motivation: this unit will include sessions exploring providers’ intrinsic 
motivations for practicing medicine and use group discussions to explore their 
self-perceived roles in addressing the HIV/STI crisis, particularly in socially 
marginalized groups including MSM.  
3. Behavioral skills: these sessions will involve both active (role play, group 
critiques of recorded patient-provider interactions) and passive skills training 
(watching videos that demonstrate target skills).  
 
To reduce travel and time burden on provider participants, the training will be 
delivered in a hybrid format consisting of both in person, on-site training delivered 
at the offices of the GDCDC as well as self-directed online units for provider 
participants to complete on their own within a pre-specified window of time. 
Stage 2: Follow-up data collection using unannounced SP visits: Immediately 
following the intervention, staff will conduct clinic visits to administer an in person 
survey of a shorter version of the baseline survey on their attitudes towards 
marginalized populations. Within 1-3 months the intervention, SPs will conduct a 
second round of unannounced clinic visits across the study facilities. As with the 
baseline visits, providers will not be informed that a particular visit is from an SP. 
Although all SPs will present to providers a standard case of presumptive syphilis, 
the case script used in each interaction will be randomly chosen from four slightly 
different versions that vary only in whether HIV or MSM status is revealed to 
providers. Draft versions of each of the SP case scripts are in Appendix 3. 
The general protocol for SP visits will be as follows: SPs will be paired with an 
enumerator (members of the study team) to conduct clinic visits. Upon arrival 
enumerators will wait outside the clinic in the hired car while SPs will present at 
facilities using the pseudonym in the case script and be processed by clinic in-take 
staff according to standard local procedures. Before entering the clinic, 
enumerators will remind SPs of the names of any providers who have not 
consented to the study. If SPs are offered appointments with a non-consenting 
provider, they will follow a fixed script indicating their preference for a different 
“highly recommended” doctor for whose name they will feign a memory lapse. If a 
visit with a non-consenting provider cannot be avoided, the SP will accept the 
appointment but abort the visit immediately following intake (a not uncommon 
occurrence in the local setting). Once presenting to a consented provider, SPs will 
begin with the opening statement in the script which describes the patient’s chief 
compliant/symptom. SPs will then use standardized language detailed in the case 
scripts to respond to provider questioning. In interactions where HIV or MSM status 
will be revealed, SPs will provide this information using standardized language, 
determined in the formative phase, immediately following the common opening 
statement. Study staff will accompany occasional SP visits to ensure adherence to 
protocol and will be available by phone throughout the audit to answer questions or 
troubleshoot unexpected problems. 

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As in the baseline study procedures, SPs will exit facilities immediately following 
the visits and debrief with an enumerator in an area at some distance from the 
clinic (and most importantly out of earshot of any clinic staff or attendees) where 
enumerators will administer a health care quality checklist and conduct a debrief 
session with the SP. The health care quality checklist (Appendix 1) will be 
administered to SPs in a survey format and collect information on multiple 
dimensions of care quality including: adherence to Chinese clinical guidelines for 
syphilis prevention and management, clinical conduct, and communication. Debrief 
sessions with SPs will be guided by a structured interview guide to ensure each 
session covers the same content regarding SP perceptions of the clinical 
interaction. 
5.3 Individually Identifiable Health Information:  
Data collected on provider participants will not include any individually identifiable 
health information.  
 
6.0 
Data Banking 
Data will not be banked for this study.  
 
7.0 
Sharing of Results with Participants  
Although results of the interim analysis (the ROR results) and the results of the full 
trial have been and will continue to be shared regularly with our CAB members, we 
will abstain from an explicit sharing of results session with providers. The reason 
for this is to preserve the integrity of the SP stigma measure and the validity of the 
intervention evaluation. If providers who participate in this study are made aware of 
our true research objectives this could give the impression that their superiors at 
the GDCDC are committed to addressing HIV and sexual stigma, which could in 
turn influence provider behaviors in future trials. Naturally, such widespread 
improvement of provider attitudes towards PLWH or MSM would be a welcome if 
inadvertent change. However given that the ultimate goal of this research is to 
successfully pilot the proposed intervention in anticipation of an eventual full-scale 
RCT, maintaining the impression that the research is on generic health services 
improvement is essential to a valid future trial and eventual real-world 
implementation of this evaluated intervention.  
 
8.0 
Study Duration 
8.1 The time span for the full research project (Preparatory and RCT phases) is 
designed to be achieved in 4 years. The activities associated with stage 1 
preparatory phase is finished near the end of the second study year. Stage 2 which 
involves intervention development, intervention run, follow-up survey and follow-up 
SP clinic visits is anticipated to take 15 months, followed by 9 months to conduct 
data analysis.  
8.2 The time span for the qualitative sub-component will be from the initial to the 
follow-up round of interviews, a time span of about 1 year.  
 
Deleted: Measures pertaining to data banking have 
not yet been implemented given pending guidance 
from IRB experts. A separate modification will be 
submitted at a separate time addressing this 
component.
Deleted: All the collected data will be de-identified 
and stored in the Box Secure Storage. Data 
involving personal identifiable information will be 
saved in password encrypted folders. Its access is 
only granted to project researchers.
Deleted: Considering the project needs and the 
challenge of re-approaching the participants, the 
de-identified datasets will not be shared through 
any data depositories. ¶
¶

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9.0 
Study Population 
9.1 
Inclusion Criteria:  
Randomization of provider participants took place at the facility level (clutser-RCT); 
as such inclusion criteria are provided for both facilities and providers. Eligible 
facilities were those with 1) formal government accreditation as a medical center (a 
basic tenet of all public hospitals in China); and 2) possession of an accredited on-
site laboratory with capacity to provide enzyme-linked immunosorbent assay 
testing for HIV, treponemal (e.g. Treponema pallidum particle agglutination) and 
non-treponemal tests (e.g. rapid plasma regain) for syphilis. Within eligible and 
consenting facilities, eligible providers are those who are licensed at the time of the 
study to practice dermatovenereology in China. 
Note that individuals recruited to participate in study activities are considered part 
time study staff and so are not subject to formal inclusion or exclusion criteria. 
Guidelines regarding recruitment and hiring strategies for SPs are detailed in 
internal protocols detailing the SP visits approach to stigma measurement. 
Participants of the qualitative sub-study will be any SP who took part in the 
baseline round of unannounced clinic visits. Their participation in the sub-study is 
fully voluntary and will not affect their eligibility to continue work as an SP in the 
main study. 
 
9.2 
Exclusion Criteria:  
None 
9.3 
Screening:  
Facility level screening took place at the time of facility enumeration and sampling 
to ensure that only facility directors of eligible practices were approached for study 
participation. Records on the institutional details for each facility are maintained by 
the GDCDC and were used to identify eligible clinics. All active providers at eligible 
facilities were assumed to have up to date medical licensure, which was confirmed 
by study staff at the time of baseline procedures (in-person recruitment, 
enrollment, and consent). 
. 
10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 

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Pregnant women/fetuses/neonates 
Included/Allowed to 
ParticipateIncluded/Allowed to 
ParticipateIncluded/Allowed to 
ParticipateIncluded/Allowed to 
Participate 
Prisoners 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Adults lacking capacity to consent and/or 
adults with diminished capacity to 
consent, including, but not limited to, 
those with acute medical conditions, 
psychiatric disorders, neurologic 
disorders, developmental disorders, and 
behavioral disorders 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Non-English speakers 
Targeted PopulationTargeted 
PopulationTargeted 
PopulationTargeted Population 
Those unable to read (illiterate) 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Employees of the researcher 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Students of the researcher 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Undervalued or disenfranchised social 
group 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Active members of the military (service 
members), DoD personnel (including 
civilian employees) 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 

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ParticipationExcluded from 
Participation 
Individual or group that is approached 
for participation in research during a 
stressful situation such as emergency 
room setting, childbirth (labor), etc. 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Individual or group that is disadvantaged 
in the distribution of social goods and 
services such as income, housing, or 
healthcare. 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Individual or group with a serious health 
condition for which there are no 
satisfactory standard treatments. 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Targeted PopulationTargeted 
PopulationTargeted 
PopulationTargeted Population 
Any other circumstance/dynamic that 
could increase vulnerability to coercion 
or exploitation that might influence 
consent to research or decision to 
continue in research. 
Excluded from ParticipationExcluded 
from ParticipationExcluded from 
ParticipationExcluded from 
Participation 
 
10.2 
Additional Safeguards:  
Provider participants in our study may be considered a group with a justified fear 
of negative consequences for not participating in the research. As in other 
professions, medicine in China is a relatively hierarchical field in which junior 
level physicians generally follow orders of their superiors. Therefore if a facility 
director has issued consent for his/her facility to take part in the study, some 
providers may feel an implicit pressure to take part in the study even if against 
their will. Some may fear retribution (e.g. pay cut, demotion) from their superiors 
for refusal to participate in research. To ensure that our providers are protected 
from either of these risks we will take the following precautions. 
To minimize the risk of providers feeling pressured to participate in the study 
against their will, we explained the importance of voluntary participation to all 
facility directors in the course of facility-level recruitment procedures. In addition, 
all in-person study activities (recruitment, consent, survey administration) were 

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conducted in private office spaces out of sight from colleagues and directors. 
Study staff assured providers that information about their participation would not 
be shared with anyone else at the facility. All approached providers—particularly 
those who refuse to participate—were provided with a copy of the unsigned 
consent form to ensure they had contact information for our local study manager, 
Dr. Cheng Wang of the GDCDC in case of any concerning events following study 
initiation. In the event study staff suspect coercive participation, Dr. Ligang Yang 
was designated as the first study team member who would reach out first to the 
provider and then to the facility director in order to investigate the issue and 
mediate a resolution. Two reasons that we feel risk of coercion is low is that 1) 
medical facilities in China are expected to generate a large share of their 
operating costs through hospital revenues and so are financially independent of 
oversight organizations. The GDCDC itself provides only oversight and technical 
capacity. Therefore facility directors do not necessarily feel institutional pressure 
from Dr. Ligang Yang to consent to study participation. By extension, facility 
directors are also unlikely to feel that they have anything personally to gain from 
ensuring that all of their providers take part in the study. Second, given the 
growing demands for modern medical care in China, qualified doctors are 
currently in short supply, making it unlikely that supervisors would seek 
retribution on their medical personnel for reasons as minor as study participation. 
An additional factor that could contribute to provider participants’ vulnerability is 
the fact that our study collected data on their behaviors including potentially 
discriminatory or stigmatizing behavior towards patients. If data on these adverse 
interactions are to get leaked, this could generate negative press for the provider 
or the facility and even form grounds for a medical malpractice suit. We therefore 
have and will continue to take the following precautions to protect the identity of 
provider participants and to ensure the security of data collected throughout the 
study. First, all study staff including SPs and enumerators have undergone 
human subjects/research ethics training, including the need for complete data 
protections and anonymity. All US-based Principal Investigators/Co-Investigators 
and China-based GDCDC staff have taken and passed the CITI training courses 
in Research Ethics/Human Subject Protection. Second, all data collection 
procedures that follow each unannounced SP visit were conducted wit the use of 
a unique study ID number to identify both the provider participant and the study 
facility, linkage files for which are only accessible to senior study staff and the co-
PIs. Debriefings between SPs and enumerators for the purposes of data 
collection have been and will continue to be conducted in a private location such 
as a park bench at a safe distance from the facility. All data has been and will 
continue to be collected on encrypted tablet or laptop computers and transferred 
only via Box Secure Storage unsecure transfer of information online (details on 
Box provided in Section 18.1). All study information has been and will continue to 
be de-identified as soon as possible after collection. Lastly, any breaches of 
confidentiality or unanticipated problems that occur during the study will be 
brought to attention of the two co-PIs who will notify the IRBs of the University of 
Minnesota and GDCDC for further review and action. No presentation or 
publication of the study results will refer to participants individually.  
Please note that members of other vulnerable populations—namely MSM and 
PLWH—take part in this study as CAB members and SPs. Protocols and 
procedures are in place to ensure protection of their identities and to minimize 
any undue risk as a result of taking part in this study. However as they are 

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considered advisers and members of the study staff, detailed discussion of their 
safeguards are not described in this protocol. 
 
11.0 Number of Participants 
11.1 
Number of Participants to be Consented:  
To demonstrate the preliminary effectiveness of the intervention we recruited 
approximately 20 facilities within which an estimated 8 eligible providers work. 
For the baseline visits a total of 160 unannounced SP visits were made, or about 
8 visits per clinic. Given the nature of patient intake procedures at outpatients 
facilities of the type that our SPs will visit, we were unable to control which of the 
consented providers in a given facility consented to SP visits. It is therefore 
possible that some consented providers in these clinics will never receive an 
unannounced SP visit, while others may receive multiple visits. 
 
12.0 Recruitment Methods 
12.1 
Recruitment Process:  
Sampling of study facilities will take place across the 46 candidate STD practices 
across the Guangzhou metro area (Fig 2) and which meet our eligibility criteria of 
1) having formal government accreditation as a medical center (a basic tenet of 
all public hospitals in China); and 2) possession of an accredited on-site 
laboratory with capacity to provide enzyme-linked immunosorbent assay testing 
for HIV, treponemal (e.g. Treponema pallidum particle agglutination) and non-
treponemal tests (e.g. rapid plasma regain) for syphilis. Sampling will be 
conducted using a stratified approach to sample evenly across the 11 districts of 
Guangzhou city which includes urban and rural areas in order to maximize 
comparability between arms. Sampling will also consider travel distance between 
study facilities in order to minimize risk of contamination across arms following 
the intervention. Lastly, twice the number of facilities as needed for the final 
sample size will be screened and randomized in anticipation of the fact that a 
subset of facilities may refuse to take part in the study. Following randomization 
of sampled clinics, we will implement an additional randomization scheme to 
balance the distribution of the four SP scenarios (MSM only, HIV+ only, MSM 
and HIV+, and non-MSM HIV- man) and the 8 different SPs across the 20 study 
clinics. The scheme will also ensure that case scenarios and SP choice will be 
distributed over the clinic visit duration to balance the potential effects of these 
design features on our outcome measurement.  
Recruitment took place in a staged manner, first at the facility level and then at 
the provider level. Following sampling and randomization of facilities to the 
treatment versus control condition (see Section 22.0 for justification of the 
randomization approach), facility directors of the chosen sites were contacted by 
Dr. Ligang Yang, a co-investigator on this study and Director of the STD Clinical 
Quality Control Program at the GDCDC, as well as officials at a subsidiary 
organization at the Guangzhou City STD Control Center (GZCDC). STD control 
officials at the GZCDC report to their counterparts at the GDCDC for all matters 
pertaining to surveillance, disease control, and intervention work. Both Dr. Yang 
and his subordinates at the GZCDC maintain regular contact with administrators 

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of eligible health facilities in the sample pool who they contacted by phone to 
explain study objectives and procedures (in which the study will be referred to 
generically as a “healthcare services survey”) and obtained verbal confirmation of 
their understanding of the following study activities and expectations: 1) 
permission for study staff to approach individual providers in their facility for 
recruitment; 2) access by study staff to names and contact information of all 
providers; 3) for access to facility-level data (e.g. clinic size, average salary, etc.) 
to be used in the final analysis; and 4) for facilities randomized to the treatment 
arm to invite providers to participate in the hybrid intervention workshop. Given 
the burden of work on one person (Dr. Ligang Yang), these verbal confirmation 
procedures were conducted over the phone and via Wechat messaging. Content 
of the conversation and items discussed were documented on a per-call basis 
using the template in Appendix 2.  
In a second recruitment round, study staff approached providers in person at 
consenting facilities to conduct individual level recruitment. Suitable times to 
visits providers (e.g. during lunch time, at the end of day) were discussed in 
advance with facility directors. Once at the clinic, study staff described the study 
objectives—described once more as a “healthcare services survey”)—and 
sought written consent to 1) administer an face-to-face survey during the same 
visits; 2) to receive an SP visits at some time over the next 3 to 6 months; and 3) 
among providers at facilities randomized to the treatment condition to take part in 
a hybrid professional skills building workshop. Providers were assured that their 
participation in any part of the study would be fully voluntary and that neither their 
decision to participate nor their study data would be shared in any form with their 
clinical director. Providers who could not be reached in person at the time of staff 
visits to the facility were contacted by phone using contact information provided 
during facility-level recruitment procedures. The names of providers who declined 
to give their consent for study participation were included on a secure list in order 
to inform SP-facilitator teams of specific providers to avoid during unannounced 
visits. Assignment to a specific provider usually takes place during intake 
procedures, at which point SPs were able to avoid seeing a particular provider 
either by expressing a preference for a different provider, not recording 
information during the visit, or terminating the visit if necessary.  
Both clinic directors and provider participants themselves were provided contact 
information to follow up with the study team if needed. For this role we relied on 
Dr. Cheng Wang who oversees epidemiological research at the GDCDC. He is of 
equal rank to Drs. Ligang Yang and Bin Yang who both oversee clinical care 
standards, but is also seen as independent of the other two administrators so can 
therefore be a resource for participants in the event of concerns or questions. Dr. 
Wang is also well versed in the details of this study and well positioned to answer 
questions. To maximize security of the email account which participants may use 
to contact Dr. Wang, we used the following ProtonMail account, 
GDDH@protonmail.com. ProtonMail is a secure email service with end-to-end 
encryption and is HIPAA compliant (see https://protonmail.com/hipaa-
compliance). This email has been monitored by Dr. Wang as well as the two co-
PIs, Drs. Kumi Smith and Sean Sylvia. 
Though not considered study subjects, two CABs were also assembled to 
provide key input into the design and conduct of our research. One is composed 
of providers and another of MSM. Each CAB is composed of 5-10 members. 

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Providers were recruited (after sampling selection of study facilities) by the 
GDCDC from among providers not in consenting facilities but providing 
outpatient care for STIs elsewhere in Guangdong. To ensure that provider CAB 
members feel free to share their opinions freely, we recruited members of 
equivalent or similar professional rank. Members of the MSM CAB were recruited 
with the help of Zhitong LGBT Center, a community organization serving MSM in 
Guangdong. The former director of operations at Zhitong, Danyang Luo, is now a 
study team member for this grant. With Mr. Luo’s guidance, Zhitong solicited 
candidates through postings on social media (internal to Zhitong members) and 
by word-of-mouth. Those expressing interest were then followed up by study staff 
via phone to explain study objectives, CAB member responsibilities, and 
expenses covered by the study (travel, lodging per diem). Candidate members 
were individuals active in the MSM community with experience in areas such as 
community organizing, health promotion, LGBT advocacy, or research. We 
purposively recruited at least 1/3 of members from the community of people living 
with HIV (PLWH) so as to ensure their input into the design of the study and 
intervention which ultimately seeks to improve outcomes for this group. Those 
who are living with HIV were informed in advance that participation in the CAB 
could entail disclosing their status to other members. We did not anticipate this to 
be a deterrent for participation, as other candidate CAB members are all MSM 
active in this space and who therefore are deeply familiar and sympathetic to the 
issues and concerns of HIV+ MSM in their community. 
SPs for the qualitative sub-study will be approached by study staff via Wechat 
message which is the primary form of communication for most study affairs 
between study staff and SPs. The study will be introduced as a sub-study to 
learn more about their experiences as individuals taking part in an SP study. 
They will be told the duration of the study: 2 interviews, each no longer than an 
hour, taking place once after completion of training and once after completion of 
the baseline round of visits. They will be informed that each interview is voluntary 
and that participation – whether in both, one, or neither interview – will not affect 
their work as an SP. 
 
12.2 Source of Participants:  
Provider participants are any clinical staff licensed to provide 
dermatovenerological care in China. Because this is a cluster randomized trial 
and study eligibility is initially assessed at the facility level, these institutions have 
been the primary source of participants.  
SPs for the qualitative sub-study will include any of the SPs already hired, 
trained, and actively working for the study. Those who leave the study early will 
still be approached for interview opportunities.  
 
12.3 Identification of Potential Participants:  
Study practices were sampled from the 46 STD practices across the Guangzhou 
metro area and which met our inclusion criteria as described in section 12.1. 
Potential members for the provider CAB were identified by co-GDCDC co-
investigators who maintain regular communication with directors of all member 
practices within the provincial STD clinical network. Potential members of the 

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MSM CABs were identified and approached by Mr. Luo of the Zhitong LGBT 
Center, then followed up by study staff using the same procedures as with 
providers. 
12.4 Recruitment Materials: 
Recruitment materials pertaining to the Preparatory phase of the project included 
1) script to be read by Dr. Ligang Yang in the process of obtaining verbal 
confirmation of study procedures from facility directors and 2) script to be read by 
study staff in the process of in person recruitment and consenting of providers. 
According to our decision to use the modified Zelen design for our RCT (see 
details in Section 22.0), details of the recruitment text varied slightly depending 
on whether recruitment is occurring at a facility randomized to the treatment 
versus the control condition. 
12.5 Payment:  
In phase II, providers who are randomized to the treatment arm will take part in a 
professional skills building workshop as part of the intervention condition. All 
costs associated with workshop participation including lodging will be covered by 
the study budget. In addition to these costs, participants of the workshop will be 
provided study compensation for completing the pre-workshop videos, and 
attending the in-person training (42 dollars / 300 RMB compensation for each 
participant). These compensation amounts have been deemed necessary by the 
local team members based on historic challenges of sustaining adequate 
attendance by providers who have many competing demands for their time. 
Immediately after the intervention, staff will conduct clinic visits to survey the 
provider participants. Both control and treatment arms participants who finish the 
follow-up survey will receive 50 RMB (about 7 USD) compensation. 
SPs for the qualitative sub-study will receive 150 RMB (about 24 USD) for the 
first round of interviews and 50 RMB (about 7 USD) for the second round. 
 
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances 
Any participant wishing to withdraw from the study for any reason is permitted to 
do so at any point in the study. 
13.2 
Withdrawal Procedures 
Once intention to withdraw or to be withdrawn has been confirmed, study staff 
will initiate discussion with participants about their wishes regarding retention of 
data they have already contributed to the study. Withdrawing participants will be 
offered a choice between having their data retained or discarded from the 
remainder of study proceedings. They will also be informed that aggregate 
information about the facility at which they work or about colleagues working at 
the same facility will still be used as part of the planned analysis.  
13.3 
Termination Procedures 
We do not anticipate many circumstances in which study investigators would 
need to terminate a participant from the study. Barring any harm to participants, 
termination may also be considered if participant continuation threatens 
Commented [KS1]: Add compensation for completing the 
intervention training. 

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successful implementation of the study. The most plausible scenario for which 
our team will be prepared are cases when a provider, suspecting a certain 
patient is an SP, may choose to confront the SP during an unannounced clinic 
visit. This would not directly harm the provider nor the SP, but may signal to the 
study team that the provider’s participation may be jeopardizing the quality of 
care received by the provider’s other patients. In such an event the SP and the 
co-PIs will discuss the episode and it’s possible effects on the participant and 
those around him/her. A final decisions around termination will be jointly made 
by the co-PI’s, who may also consult the provider CAB for guidance in the 
matter if deemed necessary. As with withdrawal procedures, terminated 
participants will be offered a choice between having their data retained or 
discarded from the remainder of study proceedings. They will also be informed 
that aggregate information about the facility at which they work or about 
colleagues working at the same facility will still be used as part of the planned 
analysis. 
 
14.0 Risks to Participants 
14.1 
Foreseeable Risks:  
Provider participants in our study may be considered a group with a justified fear 
of negative consequences for not participating in the research. As in other 
professions, medicine in China is a relatively hierarchical field in which junior 
level physicians generally follow orders of their superiors. Therefore if a facility 
director has issued consent for his/her facility to take part in the study, some 
providers may sense unspoken pressure to take part in the study even if against 
their will. Some may fear retribution (e.g. pay cut, demotion) from their superiors 
for refusal to participate in research. To ensure that our providers are protected 
from either of these risks we have and will continue to take the precautions listed 
in Section 10.2. 
 
An additional factor that may make our provider participants vulnerable is the fact 
that our study collects data on their behaviors including potentially discriminatory 
or stigmatizing behavior towards patients. If data on these adverse interactions 
are leaked, this could generate negative press for the provider or the facility and 
even form grounds for a medical malpractice suit. 
Details on the measures to be taken to minimize these risks are detailed in 
Section 10.2. 
Foreseeable risks to SPs taking part in the qualitative sub-study may include 
psychological duress experienced from recalling unpleasant experiences during 
their participation in this study or in recalling experiences of discrimination from 
their personal life.  
 
14.2 
Reproduction Risks:  
N/A 
14.3 
Risks to Others:  

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There is a possibility that providers working at facilities randomized to the control 
arm may perceive an inequity in their assignment and alter the quality of care 
they provide to their patients. To minimize this risk we have adopted the modified 
Zelen design in which participants randomized to the control arm are not 
informed of their assignment or that the study is a randomized trial. Conversely 
patients of providers randomized to the treatment arm may receive better-than-
standard care quality as a result of their providers’ awareness of the study 
objectives. This may ultimately result in an unintended benefit for these patients. 
To minimize the impact of such effects on the unbiased estimation of program 
impact, however, we are taking many precautions to mask the true objectives of 
the study from participants and rather describe it as generic research on “health 
services.”  
 
15.0 Incomplete Disclosure or Deception 
15.1 
Incomplete Disclosure or Deception:  
In order to preserve the scientific validity of our main study outcome (stigma) and 
to minimize risk of unintended behavior change in the control group due to 
knowledge of the treatment condition, our consent procedures involved the two 
distinct forms of deception detailed below. Guided by the principles of respect for 
persons and beneficence from the Belmont Report, we centered our design  on 
the goal of maintaining minimum necessary levels of deception and prioritizing 
participant well-being in all study procedures. 
In order to preserve the integrity of our primary outcome measure—HIV and 
sexual stigma on the part of medical providers towards their patients—we hav 
and will continue to abstain from any reference to stigma in all participant 
interactions. Instead, all reference to the study and its objectives has been and 
will continue to be couched in the language of generic research on “patient-
centered care.” The justification for this approach is to avoid alerting participants 
to the notion of healthcare stigma, which could induce altered behaviors under 
observation. Doing so would not only undermine our ability to observe and learn 
from typical clinical behaviors but would also interfere with our ability to conduct  
an unbiased evaluation of our stigma reduction intervention. In addition, SP visits 
to observe provider behaviors are only partially unannounced; that is, providers 
are informed of the time range during which an SP visit will happen but not of the 
exact day or which patient is an SP. The justification for this approach is to 
reduce risk of SP discovery by providers and maximize our ability as researchers 
to observe true clinical behaviors. Providers are given opportunities at the end of 
the study to guess which patients may have been SPs in order to test the validity 
of our stigma measure. Past uses of the unannounced SP visit model by co-PI 
Dr. Sean Sylvia have reported discovery rates of 7%. 
A second instance of deception in this study is the masking of the randomized 
nature of the study to facilities and providers in the control arm. This approach, 
the modified Zelen design,37,38 can be considered ethical in instances when the 
intervention is not considered to be therapeutic or potentially life-saving. It can be 
also be considered justifiable if used to mitigate inadvertent altering of behaviors 
by individuals in the control arm due to their awareness of the treatment 
condition. Moreover if these altered behaviors have the potential to disadvantage 
their patients in terms of the quality of care they receive during the study, the 

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modified Zelen is even further justified. At the close of the study we will refrain 
from revealing the randomized nature of the study in order to preserve ideal 
conditions an anticipation of a fully powered RCT to follow this pilot study. In the 
event that control arm providers learn of the intervention (a hybrid professional 
skills building workshop) through their personal networks and confront study 
investigators or coordinators, the event will be explained to them as an 
experimental training that the GDCDC is piloting for potential future scale up. 
 
16.0 Potential Benefits to Participants 
Provider participants randomized to the treatment arm will benefit from the 
opportunity to take part in the stigma reduction intervention. Those randomized to 
the control arm will not access this benefit. However they may gain indirect 
benefits in the form of contributing the development and evaluation of an 
intervention to reduce the incidence of stigmatizing and discriminatory behavior 
towards PLHA and MSM in Chinese medical settings. If found effective, the 
intervention developed in the course of this study may be adopted by provincial 
policy makers (our co-investigators at the GDCDC) and incorporated into 
routinized clinical training throughout the provincial network of DV practices. The 
model for measuring and addressing enacted healthcare stigma developed in the 
course of this study will also be documented and disseminated with the intention 
for it to be replicated in other settings, particularly in low/middle-income settings 
that bear the greatest burden of HIV worldwide and where stigma is most severe.  
SPs taking part in our qualitative sub-study may benefit from the interviews by 
having an opportunity to share their personal experiences with the study team or 
air any grievances about study conduct.  
 
17.0 Data Management 
17.1 Data Analysis Plan:  
The primary goal of the study is to estimate the impact of healthcare stigma—in 
particular stigma directed at patients living with HIV (HIV stigma), patients who 
have same sex behaviors (homophobia), and patients with both attributes 
(intersectional stigma) on the quality of sexual healthcare they receive. Stigma is 
quantified as the difference in the mean healthcare quality index across the four 
case scenarios. Patterns of stigma occurrence are also assessed by stratifying 
results across key attributes such as tier of care (e.g. county hospital versus 
township clinic), rural/urban region, provider sex, and provider professional rank in 
order to illuminate provider subgroups of interest to inform tailored intervention 
design. A secondary analytical goal of this study is to assess the preliminary effect 
of the intervention on healthcare quality by comparing the same healthcare quality 
index across treatment arms. Details in the power analysis (section 17.2) and 
statistical analysis (section 17.3) sections are described separately for these two 
gaols. 
For the qualitative sub-study analysis, data from debrief session conducted with 
SPs following each clinic visits will be transcribed and translated into English by 
study staff and spot checked by the co-PIs for transcription accuracy by bilingual 

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study staff. Co-PIs will oversee analysis  by study staff including coding of 
transcripts and identification and interpretation of emergent themes. 
17.2 Power Analysis:  
Stigma Quantification: The primary objective of this pilot study is to estimate the 
extent to which stigma towards PLWH (HIV stigma) and towards MSM 
(homophobia) contribute to the deterioration of healthcare quality relative to 
straight people without HIV. A total sample size of 160 standardized patient (SP) 
interactions would provide 80% power (alpha=0.05) to detect a minimum effect 
size of 0.18 standard deviation. This calculation is conservative in that it does not 
account for blocked randomization of the SP cases within practices, which will lend 
additional power to each comparison. Two-sided tests will be needed to detect 
differences across the four case scenarios in order to separately quantify HIV, 
sexual, and intersectional stigma, for which the same assumptions will provide the 
same amount of power to identify a minimum effect size of 0.17 standard deviation 
between any 2 pairwise comparisons of scenarios. As recruitment will take place at 
the clinic level, the number of participants that will be needed to be recruited to the 
study will depend on estimates of the average numbers of eligible providers that 
our team can reasonably expect to recruit at each clinic. Preliminary data suggest 
that clinics in our study region employ an average of 5 eligible providers, of whom 
we conservatively expect to recruit 70% or 3.5 per clinic. Each provider will receive 
3 unannounced visits from a standardized patient, yielding a final estimated pool of 
56 providers for this study. 
 
Preliminary intervention effects: A secondary goal of the RCT is to estimate the 
preliminary effect of the intervention on quality of care index observed by SPs. 
Though this is only a secondary goal, we determine that it is plausible that the 
target enrollment of 20 clinics randomly allocated to treatment and control in a 1:1 
manner could yield sufficient power to detect reasonably small effects on the 
primary outcome measure. That is, with an alpha level of 0.05 for a one-sided test, 
an intra-cluster coefficient of 0.07, and a baseline prevalence of standardized 
quality of care index (with mean of 0 and standard deviation of 1), a sample size of 
160 SP clinic visits (8 visits per clinic on average) would provide 80% power to 
detect a reduction in EOC scores due to the intervention as small as 0.17 standard 
deviations. 
17.3 Statistical Analysis:  
Stigma Quantification: Each of the four SP scenarios will be coded across two 
binary variables (“MSM” and “HIV”) that will separately account for whether same-
sex behaviors, HIV+ status, or both were announced by the SP during the provider 
visit. The scenarios will then be regressed on the quality of care index to assess 
the excess erosion of care observed in visits where SPs present as both HIV 
infected and as MSM, beyond the simple sum or product of the erosion 
experienced with only one of the attributes. Specifically, we will estimate: 
𝜃𝜃𝑖𝑖𝑖𝑖𝑖𝑖= 𝛼𝛼+ 𝛽𝛽1𝐻𝐻𝐻𝐻𝑉𝑉𝑖𝑖𝑖𝑖+ 𝛽𝛽2𝑀𝑀𝑀𝑀𝑀𝑀𝑖𝑖𝑖𝑖+ 𝛽𝛽3(𝐻𝐻𝐻𝐻𝑉𝑉𝑖𝑖𝑖𝑖∗𝑀𝑀𝑀𝑀𝑀𝑀𝑖𝑖𝑖𝑖) + 𝛾𝛾𝑗𝑗+ 𝜂𝜂𝑠𝑠+ 𝜀𝜀𝑖𝑖𝑖𝑖𝑖𝑖 
where θijs is the quality of care index as measured in SP interaction i in facility j 
conducted by SPs; HIVij is an indicator for the HIV status of the SP scenario in that 
given provider encounter; MSMij an indicator for the MSM status of the SP scenario 
in that given provider encounter; γj is a vector of facility fixed effects; and ηs is a 
vector of fixed effects for SPs. Here, β1 and β2 provides an estimate of HIV and 

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MSM stigma respectively, and β3 the estimate of stigma due to the presence of 
both HIV and MSM status. 
Preliminary intervention effects: We will estimate the main intention-to-treat (ITT) 
impact of the training intervention using the Ordinary Least Squares (OLS) 
regression: 
θ𝑖𝑖𝑖𝑖𝑖𝑖= β0 + β1𝑇𝑇𝑐𝑐+ β2θ𝑑𝑑𝑑𝑑(𝑡𝑡−1) + γ𝑋𝑋𝑖𝑖𝑖𝑖+ εidc 
where  θ𝑖𝑖𝑖𝑖𝑖𝑖 is the healthcare quality index from SP interaction i with doctor d in 
clinic c measured at follow-up, 𝑇𝑇𝑐𝑐 is a dummy variable that takes the value of 1 if 
the clinic was randomized to be offered training and 0 if in the control group. The 
coefficient of interest is 𝛽𝛽1, which captures the ITT effect of training on the quality 
of care. We control for the average quality index from all SP interaction with doctor 
d at baseline, 𝜃𝜃𝑑𝑑𝑑𝑑(𝑡𝑡−1), as well as a vector of SP and disease script type (varying 
HIV and MSM status) fixed effects. 𝜀𝜀𝑖𝑖d𝑐𝑐 represents the idiosyncratic error, which we 
cluster at the clinic, the level of randomization. 
The ITT impacts reflect the effect of physicians being offered an opportunity to 
participate in training, not the causal effect of training itself. We therefore also 
estimate the effect of participating in training using the model 
  
𝜃𝜃𝑖𝑖𝑖𝑖𝑖𝑖= π0 + 𝜋𝜋1𝐴𝐴𝑑𝑑𝑑𝑑+ 𝜋𝜋2𝜃𝜃𝑑𝑑𝑑𝑑(𝑡𝑡−1) + 𝜑𝜑𝑋𝑋𝑖𝑖𝑖𝑖+ 𝜈𝜈𝑖𝑖d𝑐𝑐 
where 𝐴𝐴𝑑𝑑𝑑𝑑is a measure of whether or not doctor d in clinic c attends the training 
and other variables are defined as above. We fit this equation by two-stage least 
squares (2sls) using the following first-stage equation: 
 
𝐴𝐴𝑑𝑑𝑑𝑑= 𝛿𝛿0 + 𝛿𝛿1𝑇𝑇𝑐𝑐+ 𝛿𝛿2𝜃𝜃𝑑𝑑𝑑𝑑(𝑡𝑡−1) + 𝜁𝜁𝑋𝑋𝑖𝑖𝑖𝑖+ 𝜇𝜇𝑖𝑖d𝑐𝑐 
where the excluded instrument is the treatment assignment of doctor d’s clinic, 𝑇𝑇𝑐𝑐. 
We interpret the coefficient 𝜋𝜋1 as the local average treatment effect, or LATE, of 
participating in training on the quality of care provided.  
While the analysis outlined above provides estimates of the effect of the training (or 
offer of training) on the quality of care provided to SPs presenting with cases of 
presumptive syphilis, the goal is to estimate the effect of the training on enacted 
stigma. That is, rather than the overall effect on the level of healthcare quality, we 
are primarily concerned with observing how the training affects the difference in the 
quality of care received by patients presenting as MSM or HIV-positive vs. those 
not, all else equal. Our two levels of randomization (SP-doctor interactions disease 
script types and clinics to treatment or control) allow us to estimate the causal 
effect of training offer (or participation) by estimating regressions analogous to the 
above, but interacting the dummy clinic treatment allocation with dummy variables 
for each SP script type. For ITT effects, we estimate 
𝜃𝜃𝑖𝑖𝑖𝑖𝑖𝑖=  𝛼𝛼0+  𝛼𝛼1𝑇𝑇𝑐𝑐+  𝛼𝛼11𝑇𝑇𝑐𝑐× 𝑉𝑉𝐻𝐻𝐻𝐻𝐻𝐻+,𝑀𝑀𝑀𝑀𝑀𝑀−+  𝛼𝛼12𝑇𝑇𝑐𝑐× 𝑉𝑉𝐻𝐻𝐻𝐻𝐻𝐻−,𝑀𝑀𝑀𝑀𝑀𝑀+ +  𝛼𝛼13𝑇𝑇𝑐𝑐× 𝑉𝑉𝐻𝐻𝐻𝐻𝐻𝐻+,𝑀𝑀𝑀𝑀𝑀𝑀+
+ 𝛼𝛼2𝜃𝜃𝑑𝑑𝑑𝑑(𝑡𝑡−1) + 𝛾𝛾Γ𝑖𝑖𝑖𝑖+ 𝜀𝜀𝑖𝑖d𝑐𝑐 
Where 𝑉𝑉 are dummy variables for three of the four script variations (leaving out the 
HIV-, MSM- variation). Γ𝑖𝑖𝑖𝑖 is a vector of SP fixed effects. The coefficients  𝛼𝛼11–  𝛼𝛼13 
represent the effect of training offer on the difference in healthcare quality provided 

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to SPs presenting as {HIV+,MSM-}, {HIV-,MSM+}, and {HIV+,MSM+} compared to 
{HIV-,MSM-}.  
17.4 Data Integrity:  
Protocols will be in place to ensure the quality of the data collected. First, all survey 
data, whether from face-to-face interviews with providers or in the process of post-
visits data collection with SPs, will be collected using Wenjuanxing 
(https://www.wjx.cn ), a free data collection software program widely used in social 
science research in China. The program is optimized for Chinese language display 
and for administration using either desktop, tablet, or mobile devices. It features 
built in quality control mechanisms including skip patterns and answer validation. 
Although the team used Survey Solutions, a free program developed by the World 
Bank in the first round, several issues with program glitches led to local experts to 
advise our migration to Wenjuanxing instead.  
Regardless of the software program, use of computer-assisted personal 
interviewing (CAPI) techniques reduces errors in data collection by automating skip 
patterns and allowing for the pre-specification of rules to reduce the incidence of 
implausible and missing values. CAPI also improves data quality by eliminating 
errors that occur when data are input from physical forms. 
Second, all enumerators will be extensively trained using well-defined data 
collection protocols. Enumerator training aims to standardized survey protocols 
including the presentation of questions to reduce variability due to differences in 
survey  administration. 
Finally, data management protocols are specified to ensure data integrity after 
collection. These include specified conventions for storage & backup, database 
construction, naming conventions, and documentation. 
 
18.0 Confidentiality 
18.1 Data Security:  
Since provider names, place of employment, and other indirect identifiers (medical 
training, age, sex) will be collected, there is a risk that a breach of data security 
could lead to identification of study participants. To minimize the risk of 
confidentiality breaches in the course of data collection on providers and patients 
(aggregate clinic-level testing volume), all study staff will receive training on data 
security methods. All data will be collected on encrypted tablet computers and 
transferred via encrypted connection to Box Secure Storage, a secure environment 
featuring encryption, activity logging, Duo Two-Factor Authentication, and access 
controls such as view-only access. Created by the Center of Excellence for HIPAA 
Data and supported by the University of Minnesota, access to relevant Box storage 
files will maintained by co-PI Dr Kumi Smith and granted to authorized study staff. 
In addition  
All study information will be stripped of direct identifiers as soon as possible, and 
we will consult with data curators at the University of Minnesota for support to 
minimize presence of indirect identifiers. No individually identifiable data will be 
collected in the course of CAB proceedings. Data from provider surveys and SP 
interactions will be de-identified once survey and SP interaction data have been 
merged by replacing provider names with identification codes (names are required 

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to verify the merge). In addition results of a HIPCO Compliance Review Survey 
have been completed and submitted to the IRB of the University of Minnesota.  
Privacy laws in China are not anticipated to impact protections of our study data 
given the local legal context and the lack of local legal enforcement capacity. We 
will instead rely on our local site PI Dr. Bin Yang in her capacity as head of the 
provincial STD health authority (as well as her colleagues in the provincial health 
bureau) to adjudicate privacy issues raised in the course of study procedures. 
Audio recordings of in-depth interviews collected from SPs as part of our 
qualitative sub-study will be stored on password protected study devices before 
being uploaded to the Box cloud. Recordings will be transcribed by study staff, 
after which audio recordings will be destroyed. All digital files will be stored with 
study-specific identification numbers; files containing participant names will be 
stored separately in a password protected file. 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
19.1 
Data Integrity Monitoring.  
 
Study implementation will be monitored by the MPIs and the primary GDCDC Co-I. 
Study monitors will conduct reviews at each study phase to: 
• 
Assess adherence to the study protocol including implementation, recording, and 
reporting; 
• 
Verify compliance with human subjects and other research regulations and 
guidelines; 
• 
Confirm the quality and accuracy of information collected at the study site and 
recording in the study database. 
At each study milestone, the three monitors will meet to review protocol 
compliance and data integrity. During study implementation the GDCDC co-I will 
conduct monitor onsite. Any deviations from protocol will be documented in a 
report at each study milestone. In addition to noting protocol deviations, this report 
will describe actions taken to respond to deviations. These actions will be 
determined by the MPIs on a case-by-case basis. Monitoring documents will be 
kept as part of the permanent study record. 
19.2 Data Safety Monitoring.  
The study will not entail continuous data collection on participants. As such no 
protocols for continuous data safety monitoring are believed necessary.  
 
20.0 Provisions to Protect the Privacy Interests of Participants 
20.1 Protecting Privacy:  
We will take several measures to ensure the privacy of providers receiving SP 
visits. Data collected during visits will be identified by a study ID only, and the key 
linking the study ID to direct identifiers (e.g. name) or indirect identifiers (i.e. 
combination of variables such as facility name, provider age and sex) will be stored 
in separate password protected documents stored on encrypted tablet or laptop 
computers and transferred only on encrypted USB drives. Direct and indirect 
identifying information regarding providers will only be used to navigate logistical 
procedures during SP visits and will be destroyed following the follow-up SP visits. 

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In addition, debriefing sessions conducted between SPs and facilitators after each 
clinic visit will be conducted in a private location such as hired car or park bench 
away from the facility. 
To maintain the privacy of CAB participants, meetings will take place in private 
locations and meeting transcriptions will not include any information linking 
statements or ideas expressed to individual CAB members. Within 72 hours 
following each session, two study team members will review meeting notes and 
verify content against recordings where necessary. Following this review, session 
recordings will be destroyed/permanently deleted. In addition, prior to the start of 
each meeting, principles of conduct including the importance of privacy and 
confidentiality will be emphasized to all participants. If so desired, participants of 
any of the CABs will also be invited to pick a pseudonym for use for the duration of 
their CAB participation for the protection of their privacy within the group. 
20.2 Access to Participants: 
The research team will not access medical records or any other sources of private 
information about the participants.   
 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury:  
N/A 
21.2 Contract Language:  
N/A 
 
22.0 Consent Process 
22.1 Consent Process: 
All provider participants in this study were recruited, consented, and enrolled in the 
first phase of the study. Therefore no consent procedures are involved in this stage 
of the research. Upon administration of follow-up provider surveys and follow-up 
SP visits, however, we will seek permission from providers to share their de-
identified data as part of post-study data release procedures. Participants will be 
offered a tiered choice of data release procedures including a publicly available 
repository (i.e. the Data Repository of the U of M) or a repository where access is 
locked behind a vetting process regulated by the co-PIs (e.g. ICPSR or Dataverse). 
The justification for separating the consent procedures for study participation and 
data sharing permissions is in order to minimize the impact of decisions about data 
sharing on study participation. Documents pertaining to data permissions 
procedures will be added / modified at the commencement of the RCT phase of the 
project. 
Below is a description of the original consent procedures used in the first phase of 
the study: 
In order to minimize risk of unintended behavior change in the control group due to 
knowledge of the treatment condition, our consent procedures will involve a 
modified Zelen RCT design.39,40 A schemata of consent procedures for the entire 

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study (i.e. the Preparatory phase and RCT phase) are provided in Figure 1. Note 
that for the sake of context, the description below describes consent procedures for 
the entire study including both the preparatory and RCT phases; however, the 
protocol itself only pertains to the preparatory phase up until implementation of the 
intervention.  
Figure 1. Schemata for informed consent procedures in the context of study 
proceedings. 
 
 
According to the modified Zelen design, randomization will take place immediately 
after enumeration and sample selection, but before formal consent has been 
obtained. Following randomization, our collaborators at the GDCDC will implement 
verbal confirmation procedures with directors of eligible health facilities in both the 
control arm and treatment arms. In both arms, this consent process will involve 
explanation of study objectives and procedures (in which the study will be referred 
to generically as a “healthcare services survey”) and will seek explain the relevant 
study activities to which interested providers in their facility will be asked to consent 
(note that the list of activities described to control arm directors will not mention the 
intervention activities in line with the modified Zelen design). In addition, directors 
will be asked to provide our study stuff with names and contact information of all 
providers in their facility as well as access to facility-level data (e.g. clinic size, 
average salary, etc.) to be used in the final analysis. Verbal confirmation 
procedures with facility directors will be conducted by Dr. Ligang Yang, a co-
investigator on this study and Director of the STD Clinical Quality Control Program 
at the GDCDC. In his role as director he maintains regular contact with 
administrators of all eligible health facilities in Guangdong province in order to 
monitor clinical practice standards, arrange provider trainings, and address issues 
of clinical service delivery. In the event that Dr. Yang become unable to perform his 
duties, Dr. Yang Bin, the China site-PI for this grant and director of the entire 
GDCDC will assume his responsibilities. Given the burden of work for a single 
person, verbal confirmation procedures will be conducted over the phone or in 
person only if and when convenient. The script used for verbal confirmation 
procedures can be found in the document titled “Script for Facility-level Verbal 
Confirmation.” Conversations with facility directors will be documented in a formal 

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log maintained by Dr. Ligang Yang with support from study staff and will document 
the dates and times of calls, a checklist of minimally required  
Upon receipt of verbal confirmation from facility directors is confirmed, formal 
consent procedures will begin among the subset of facilities from which 
confirmation was obtained. Using the provider contact information obtained during 
verbal confirmation procedures, study staff will approach providers for individual-
level consent. In both control and treatment facilities study staff will explain the 
purpose of the study (which will be described as a generic “healthcare services 
survey”). They will also ask for consent to administer a face-to-face survey on 
demographics, professional rank, training history, and attitudes regarding specific 
medical procedures, as well as to receive an SP visits at some point in the next six 
months. According to the modified Zelen design, we will then seek consent only 
from providers in the treatment facilities to take part in the study intervention, a 
hybrid professional skills building workshop. Control arm participants will be aware 
that they are part of an observational study but not that they are in the control arm 
of an intervention study. Our justification for the Zelen design is to avoid artificially 
inducing changes to the standards of medical care in facilities randomization to the 
control arm, a common consequence in RCTs to evaluate population based 
services.38 Providers will be reminded their participation is entirely voluntary and 
that refusal to take part in any study activities will not impact their job security, 
salary, or any other aspect of their professional life. After initial discussion of the 
study design and procedures, providers will be given time to ask questions and if 
desired, to take the consent form home with them to have more time to make a 
final decision around study participation. Individual-level provider encounters will 
be conducted in person during which consent will be obtained. Consent procedures 
will entail study staff providing a print version of the consent on a study tablet for 
participants to read. They will also orally confirm relevant information including 
details on study scope, participant activities, duration of study, and risks and 
benefits. In light of preferences expressed by community members who wish to 
take part in the study but do not wish to sign their own names, we have sought a 
waiver of written consent. The consent form will include a statement that reads, “by 
completing this survey you are consenting to be in this study.” Participants who 
proceed with the survey will in this way be providing an alternative documentation 
of consent. Note that all verbal confirmation and consent procedures (both verbal 
and written aspects) will be conducted in participants’ native language of Mandarin 
Chinese. Both English and Chinese versions of the consent forms have been 
prepared for the purposes of ethical review in both the US (University of 
Minnesota) and China (the GDCDC). 
22.2 Waiver or Alteration of Consent Process:  
N/A  
22.3 Waiver of Written/Signed Documentation of Consent: 
Following early experiences with recruitment and consent, in January 2021, our 
team formally requested a waiver of written/signed documentation of consent. Our 
current consent procedures require a digital finger-drawn signature via tablet. The 
primary justification for this waiver request is due to the fact that a number of 
otherwise eligible participants have declined to take part in this study due to their 
reluctance to sign the consent form with their own names. These individuals 
indicated that they would have otherwise willingly taken part in the study. 

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We have reviewed the criteria for a waiver of written/signed documentation (From 
HRP-411) of consent and meet the following:  
• 
The research is not FDA regulated. 
• 
The written script of the information is to be provided both orally and for 
inspection and review by the participant using the study tablet used to 
administer the survey questionnaire. Each participant will be offered a printed 
copy of written information describing the research for their own keeping. They 
will not be required to accept a form.  
• 
The research presents no more than minimal risk to participants. 
• 
The research does not involve newborn dried bloodspots. 
• 
As detailed in Sections 12.1 and 18.1, study staff will maintain records of 
providers’ names to ensure that unannounced clinic visits do not take place 
with non-consenting providers. This is the only document that could link a 
participant with the research. Section 18.1 details the data security measures 
that will be taken to safeguard this information.  
• 
We have an appropriate alternative method of documenting that consent was 
obtained. The consent form will include a statement that reads, “by completing 
this survey you are consenting to be in this study.” Participants who proceed 
with the survey will in this way be providing an alternative documentation of 
consent. 
22.4 Non-English Speaking Participants:  
All field activities will be conducted in China. As such, enrollment and consent will 
be conducted in Mandarin Chinese, which is the native language of all potential 
participants.  
22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): 
                     N/A  
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: 
N/A  
22.7 Adults Unable to Consent: 
● 
Permission: N/A  
● 
Assent: N/A  
23.0 Setting 
23.1 Research Sites: 
All research activities involving human subjects have been and will continue to be 
conducted in Guangzhou, China in collaboration with the Guangdong STD Control 
Center (GDCDC). The protocol for the proposed research will be reviewed and 
monitored by the GDCDC (FWA number 00004801). All study staff have 
undergone training about human subjects and the study IRB protocol. The two 
phases of research have been and will continue to be overseen by study staff at 
the GDCDC. Key personnel oversee study staff in their primary responsibilities of 
engagement, recruitment, and consent procedures for all study participants. 
23.2 International Research:  

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Our team of investigators is evenly divided between local employees of the 
GDCDC and US-based investigators. The US based investigators including the 
two co-PIs collectively have decades of experience living, working, and conducting 
field research in China. They are all fluent in Mandarin Chinese and have fostered 
years long partnership with local researchers. Conversely researchers at the 
GDCDC have long international research experience and have administered and 
co-led multiple NIH funded studies on topics including HIV prevention, MSM heath, 
and syphilis microbiology.  
This study seeks to improve clinical behaviors of providers working DV clinics 
through job training. Such trainings are common in many clinical settings in China 
and so the risks associated with participation in this research are considered 
minimal, even in light of the local customs and norms. This study will take place 
locally and in a fully Chinese language environment, absolving us for the need for 
a local participant advocate. 
All non-Chinese researchers including students traveling to the study site in 
Guangzhou, China, will register their travel with their respective Travel Advisory 
Groups (e.g. for University of Minnesota, with the International Travel Risk 
Assessment and Advisory Committee). 
23.3 Community Based Participatory Research: 
The goal of this research is to reduce stigmatizing or discriminatory treatment of 
PLWH or MSM in clinical settings in China where this problem has been 
extensively documented. Participation and input from the PLWH and MSM 
communities is critical to the success of our research. To this end we formed a 
CABs of MSM to ensure that study procedures including the development of the 
SP training program, the stigma reduction intervention, and the overall study 
design is conducted in alignment with the values of these communities. The 
relationship between our study team and the community is supported by a long-
standing partnership between investigators at the University of Minnesota, 
University of North Carolina, the GDCDC, and the Zhitong LGBT Center. These 
groups have collaborated on numerous projects to address sexual health 
disparities in this community and to remove barriers to healthcare access. The joint 
establishment of a “gay-friendly clinic” by GDCDC and Zhitong is the best example 
of a mutually beneficial relationship which we hope will continue to motivate the 
CBPR elements of this research.  
We also formed a CAB of providers to similarly help us with our study design and 
implementation. Most stigma reduction programs to date rely on theoretical models 
to design interventions, which overlooks the opportunity to consult those closest to 
the problem: providers themselves. Past research has suggested that stigmatizing 
behavior is rarely driven by disgust or hatred but rather by ignorance, fear, and 
discomfort. By correctly identifying these drivers, our CAB members can help us 
build a more appropriate, specific, and ultimately effective intervention to reduce 
stigma.  
 
24.0 Multi-Site Research 
N/A 
 

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25.0 Resources Available 
25.1 Resources Available:  
We seek to recruit study facilities out of a possible 46 candidate facilities. Given 
our success in recruiting 10 clinics in the course of one week during our pilot 
activities we are confident that recruitment procedures are feasible and unlikely to 
take longer than one month. Though not considered participants, SP recruitment 
procedures are also anticipated to encounter few obstacles. In the course of pilot 
work for this project, the two co-PIs and staff at the Zhitong LGBT Center with 
whom we are partnering encountered high levels of community interest in the 
project and 4 SPs were recruited in the course of 2 days. The Zhitong LGBT 
Center maintains a corps of >200 in-person volunteers and with several hundred 
more MSM through online engagement. In the unlikely event that we face issues 
with recruitment we have allocated discretionary funds to take out an ad on a two 
popular web portals for MSM, www.danlan.org and the partner seeking app, BlueD  
Study activities have been and will continue to be based out of the local research 
site, the Guangdong Center for STD Control & Prevention (GDCDC). Co-PI Dr. 
Kumi Smith has maintained an active collaboration with the GDCDC for 5 years 
and is provided access to desk space, internet connectivity, access to printers, and 
basic office supplies while there. These same resources have been and will 
continue to extended to the other US-based investigators. 
Zhitong maintains an active hotline to provide psychosocial support to members of 
the LGBT community. Study participants experiencing emotional distress as a 
result of participating in our research activities have been and will continue to be 
referred to a trained Zhitong counselor. 
Members of our study team have been and will continue to meet on a weekly basis 
(in person or via conference call when members are in remote locations) to discuss 
research procedures, any issues arising in the course of research, and to discuss 
any anticipated activities that may require an amendment to the IRB. Any future 
study team members recruited to join this project will be onboarded by the study PI 
(Dr. Smith) to inform them of study protocol and their duties and responsibilities. 
 
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