IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Phase: NA
Conditions: HIV, Pre-exposure Prophylaxis
Sponsor: University of North Carolina, Chapel Hill

 
The Development of a Mobile-based App to Increase Uptake of Pre-
Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China 
 
 
 
NCT number NCT04426656 
Document Date 09/02/2020 
 

IGHID # 120001 
PI:  Chunyan Li 
Version Date: Sept 2, 2020 
 
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The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) 
by Men Who Have Sex with Men in China 
Funding Sponsor: NIH National Institute of Allergy and Infectious Diseases (NIAID) 
 
 Funding Mechanism: R01- AI114310-S1 
NCT04426656  
 
 
Protocol Date: Sept 2, 2020 
 
Protocol Version: V3 
 
Study Sponsor and Principal 
Investigator:  
Chunyan Li, MSc 
Graduate Research Assistant 
Address: 135 Dauer Dr, 302 
Rosenau Hall, Chapel Hill, NC  
27599 
919-966-6695 (PHONE)  
E-mail: chunyli@live.unc.edu  
 
Co-Investigator(s):  
 
Kathryn Muessig, PhD 
Associate Professor 
Address: 306 Rosenau Hall 
CB# 7440 
Chapel Hill, NC 27599 
Email: kmuessig@med.unc.edu  
 
Joseph D. Tucker, MD, PhD 
Associate Professor 
Address: 130 Mason Farm Road, 
CB#7030, Chapel Hill, NC 27514  
E-mail: jdtuker@med.unc.edu   
 
 
Linghua Li, MD 
Professor 
Address: 627 Dongfeng Dong 
Road, Yuexiu District, 
Guangzhou, Guangdong, 510050, 
China,  
+96-13725297174(PHONE) 
llheliza@126.com  
 
 
 
 
 

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SIGNATURE PAGE  
The signature below documents the review and approval of this protocol and provides the necessary 
assurances that this study will be conducted according to the protocol, including all statements regarding 
confidentiality, and according to national, regional, and local legal and regulatory requirements. 
 
 
____________CHUNYAN LI___________________ 
Site Principal Investigator Name (Print)  
 
 
____________________________________________ 
Signature  
 
 
____________________________________________ 
Date  
 
 

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List of Abbreviations  
PrEP 
Pre-exposure prophylaxis 
MSM 
Men who have sex with men 
RCT 
Randomized controlled trial 
STI 
Sexually transmitted infections  
 
 
 
 
 
 

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Protocol Summary 
Protocol Title  
 
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure 
Prophylaxis (PrEP) by Men Who Have Sex with Men in China: Study Protocol 
Study Design 
 
The study consists of a formative research phase to develop a mobile phone-
based intervention, the mini-app, to increase individual knowledge, 
understanding and initiation of pre-exposure prophylaxis (PrEP) among HIV-
negative adult men who have sex with men (MSM) in Guangzhou, China, 
followed by a two-arm randomized control trial to test its efficacy.   
Study Population  
 
Individual who reported aged 18 and above, assigned male sex at birth, ever had 
anal sex with another man, HIV-negative, identifying as Chinese citizen, 
currently residing Guangzhou(only applicable in Aim 2), China, and able to and 
being willing to sign written informed consent and participate in the study as 
procedures required. 
Number of subjects  
 
Total sample size: N=110 
Aim 1 (in-depth interviews): n=40 
Aim 2 (two-arm RCT): n=70 (intervention arm n=40, control arm n=30)  
Number of sites  
 
1 
Estimated Start of 
Enrollment 
June 15, 2020 
 
Estimated Time to 
Completion 
June 15, 2021 
 
Protocol Duration 
Aim 1: 90 minutes 
Aim 2: Aim 2: 16 weeks (8-week active intervention and after-intervention 
follow-up at the 12th week. Participants in the intervention arm can have access 
to the intervention app up to 16 weeks.) 
Participants may choose to participate in either Aim 1 or Aim 2.  
Stratification 
Participants in Aim 1 will be stratified into three groups:  
(1) 5 current PrEP users 
(2) 30 people who have never used PrEP 
(3) 5 intermittent PrEP users (people who were on PrEP before but now off) 
Regimen or 
Intervention 
Aim 1: Formative research/in-depth interviews: no intervention 
Aim 2: Two-arm RCT: 70 participants will be randomized at enrollment into 
the intervention arm (n=40) or the standard of care control arm (n=30). All 70 
participants will pay an initial visit to the Guangzhou No.8 People’s Hospital to 
complete enrollment and a Web-based baseline assessment survey.  
• 
The standard of care control arm: during the initial visit, 
participants will receive written HIV prevention materials including 
basic facts of PrEP, recommendations for HIV/STIs testing and 
referrals to local HIV/STIs testing sites and prevention services.  
• 
 The intervention arm: In addition to the standard of care, 
participants in the intervention arm will have access to a mini-app-
based PrEP intervention for up to 16 weeks. The mini-app has four 
main functions: (1) a mini-classroom function that contains a series 
of HIV-, sexual health-, and PrEP-related educational articles in 
Chinese; (2) an HIV/Syphilis home-based test kit ordering system 
that allows users to order a finger-prick HIV rapid test toolkit and 
shipped to home for free (one piece at a time); (3) an asynchronous 

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message function that allows users to communicate with the study 
team; and (4) a user profile page where users can manage orders of 
HIV test kits.  
 
 
 

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Table of Contents 
1.0 
OBJECTIVE .................................................................................................................................9 
1.1 
HYPOTHESIS ............................................................................................................................................ 9 
1.2 
PRIMARY OBJECTIVE ................................................................................................................................. 9 
1.3 
SECONDARY OBJECTIVES ........................................................................................................................... 9 
2.0 
INTRODUCTION .........................................................................................................................9 
2.1 
BACKGROUND ......................................................................................................................................... 9 
2.2 
RATIONALE ........................................................................................................................................... 10 
3.0 
STUDY DESIGN ........................................................................................................................ 11 
4.0 
SELECTION AND ENROLLMENT OF PARTICIPANTS ..................................................................... 16 
4.1 
INCLUSION CRITERIA ............................................................................................................................... 16 
4.2 
EXCLUSION CRITERIA............................................................................................................................... 16 
4.3 
STUDY ENROLLMENT PROCEDURES ........................................................................................................... 17 
5.0 
STUDY TREATMENT (OR INTERVENTION) ................................................................................. 17 
6.0 
DATA COLLECTION .................................................................................................................. 19 
6.1 
DATA COLLECTION ACTIVITIES ................................................................................................................... 19 
6.2 
DATA MANAGEMENT ............................................................................................................................. 20 
6.3 
QUANTITATIVE OUTCOME MEASURES ....................................................................................................... 20 
6.4 
INCENTIVES ........................................................................................................................................... 20 
7.0 
PARTICIPANT WITHDRAW AND REPORT .................................................................................. 21 
8.0 
STATISTICAL CONSIDERATIONS ................................................................................................ 22 
8.1 
GENERAL DESIGN ................................................................................................................................... 22 
8.2 
ENDPOINTS ........................................................................................................................................... 22 
8.3 
RANDOMIZATION AND STRATIFICATION ..................................................................................................... 22 
8.4 
SAMPLE SIZE AND ACCRUAL ..................................................................................................................... 22 

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8.5 
MONITORING ........................................................................................................................................ 22 
8.6 
ANALYSES ............................................................................................................................................. 23 
9.0 
STUDY MANAGEMENT ............................................................................................................ 23 
9.1 
INSTITUTIONAL REVIEW BOARD (IRB) REVIEW AND INFORMED CONSENT ........................................................ 23 
9.2 
CRITERIA FOR DISCONTINUATION .............................................................................................................. 24 
9.3 
OBLIGATIONS OF INVESTIGATORS .............................................................................................................. 25 
9.4 
PARTICIPANT CONFIDENTIALITY ................................................................................................................ 26 
9.5 
STUDY DISCONTINUATION ....................................................................................................................... 26 
10.0 
BIOHAZARD CONTAINMENT .................................................................................................. 26 
REFERENCES .................................................................................................................................... 27 
 
 
 

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1.0 
OBJECTIVE 
1.1 
Hypothesis 
We hypothesize that in our study sample, adult men who have sex with men (MSM) in the 
intervention arm are more likely to report successful PrEP initiation at the end of trial, as 
compared to the control arm.   
1.2 
Primary Objective 
Our primary objectives include: 
(1) Conduct formative research to understand key barriers and facilitators for PrEP uptake among 
Chinese MSM and test the usability of a mobile-based mini-app intervention.  
(2) Conduct a two-arm pilot randomized control trial to test the efficacy of the mini-app in 
increasing PrEP uptake rates among Chinese adult MSM.  
1.3 
Secondary Objectives 
 
Secondary objectives include: in our study sample,  
(1) Test the efficacy of the mini-app in decreasing PrEP stigma and increasing PrEP use self-
efficacy at the individual level. 
(2) Identify the predictors associated with successful PrEP initiation during the study period.  
(3) Investigate the association between depression at baseline and successful PrEP initiation 
during the study period. 
(4) Assess PrEP use adherence among participants who successfully started PrEP during the 
study period.     
2.0 
INTRODUCTION 
2.1 
Background 
The prevalence of HIV among Chinese men who have sex with men (MSM) has steadily 
increased for the past decade. According to the National HIV Sentinel Surveillance System, the 
prevalence of HIV in Chinese MSM rose from 1.5% in 2005 to 8.0% in 2015.1 Overall, MSM 
comprise over a quarter of new HIV diagnoses in China, this greater than three times the rate in 
other countries.2 These trends continue to rise as China works to implement feasible and 
sustainable HIV prevention measures. 
Pre-exposure prophylaxis (PrEP) is a once daily oral fixed-dosed combination of two 
antiretroviral medications, tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) also 
referred to as TDF/FTC. Several clinical trials have demonstrated that PrEP is safe and 
significantly reduces the rate of HIV acquisition in MSM,3 heterosexual HIV sero-discordant 
couples,4 heterosexual individuals,5 and persons who inject drugs.6 Based on these studies, in 

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2014, the United States Centers of Disease Control and Prevention (CDC) issued 
recommendations for PrEP in MSM, high risk heterosexual men and women, and PWID. These 
recommendations were updated in 2017 with more trials further supporting PrEP use in these key 
populations.7 In 2014, the World Health Organization (WHO) recommended global access to 
PrEP for MSM which was then expanded in 2015 to include all populations at substantial risk of 
HIV infection.8 
Despite the current HIV landscape of China and the proven safety and efficacy of PrEP, uptake 
remains limited with only an estimated 400-600 current PrEP users in the country.9 The delay in 
PrEP expansion in China is likely multifactorial, including limited awareness of PrEP, HIV and 
sexuality-related stigma and discrimination, concerns of PrEP effectiveness and side effects, and 
financial concerns to afford PrEP.10–13 Initial PrEP demonstration projects in China were 
unsuccessful because of poor community engagement and lack of community ownership.11 
Bottom-up approaches such as challenge contests provide a tool for MSM to be more actively 
engaged in HIV service delivery.14 A recent multisite survey of urban Chinese MSM showed 
while nearly half of the respondents endorsed unprotected anal sex, less than a quarter had heard 
of PrEP.15 These studies indicate a need in using an MSM-friendly approach to promote PrEP 
uptake among this at-high-risk population and linking them to PrEP to help stem the ongoing 
epidemic. 
Mobile health (mHealth) intervention tools have become increasingly popular in HIV- and PrEP-
related research. Formative studies indicate that mHealth interventions are acceptable and 
effective in promoting HIV prevention practices in MSM and other young populations.16,17 
Among the few mHealth-based PrEP intervention studies, text messaging has been effective in 
improving PrEP adherence in MSM via reducing missed doses18 and increasing drug 
concentrations in blood.19 More mHealth PrEP uptake intervention studies are in the pipeline 
however all are based in the US.20–23 mHealth shows promise as an intervention tool in places like 
China where HIV risk factors and infection remains highly stigmatized.24 HIV-related and sexual 
health interventions delivered through Internet-enabled platforms are feasible and acceptable in 
Chinese settings,25 including interventions through websites, text message and mobile apps which 
have shown effectiveness in reducing HIV-related risk behaviors, increasing linkage to care, and 
medication adherence.26–28 
2.2 
Rationale 
While most of our previous knowledge about the acceptability of PrEP in China came from cross-
sectional survey studies, little is known from a qualitative perspective about the key concerns and 
thoughts that Chinese MSM are having of PrEP as an HIV prevention strategy. Further, either 
globally or in China, limited data exists on the efficacy of app-based interventions aimed to 
increase PrEP uptake and adherence. Given the gap in knowledge, this proposed study aims to 
deeply understand the key barriers and facilitators to PrEP uptake among Chinese MSM and their 
unmet needs in HIV prevention via in-depth interviews, followed by a two-arm pilot randomized 
controlled trail to test the efficacy of a mini-app in increasing their engagement for PrEP 
education and initiation. A prototype of the mini-app has been developed from an MSM-friendly 

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Doctor Finder hackathon contest (April 2019, Guangzhou) by a team of Chinese young MSM. 
Our study will provide preliminary data for a competitive R01 to fully develop and test this new 
evidence-based intervention to increase PrEP knowledge and actual uptake in China. If 
successful, this research will ultimately impact the PrEP/HIV prevention cascade in China by 
showing that an mHealth intervention can alleviate systemic and psychosocial barriers to HIV 
prevention services among young Chinese MSM. This research addresses a critical need as MSM 
bear a disproportionate burden of China’s HIV infections and remain underserved in the 
healthcare system. 
 
3.0 
STUDY DESIGN   
 
This study is designed to collect formative data and preliminary efficacy test result of a mini-app 
that will help inform a future full-scale intervention study to increase PrEP uptake in China. It 
consists of a formative phase using in-depths interviews (Aim 1, see Figure 1) and an 
experimental phase using a two-arm randomized controlled trial (RCT) design (Aim 2, see Figure 
2).  
Aim 1: Understand the key barriers and facilitators of using PrEP, and access the usability 
and acceptability of a mobile-based intervention mini-app for PrEP education and initiation 
among MSM in China via in-depth interviews with 40 HIV-negative young Chinese MSM 
(18 years old and above) in China. 
In Aim 1 we will assess unmet needs in HIV prevention, key barriers and facilitators of PrEP 
uptake among HIV-negative young MSM in China. We will conduct in-depth interviews with 40 
HIV-negative MSM including 30 people who have never used PrEP, 5 people who used PrEP 
before but are now off treatment, and 5 people who are current PrEP users. All potential 
participants will be verbally screened for eligibility during their initial contact with the study 
team. During the interview, participants will be asked to test use a mini-app prototype for 5 
minutes on their own smartphone, after a brief instruction on the purpose of the mini-app and 
how to use it. The mini-app is built in an existing popular social networking app (WeChat) that 
any user with a test link will be able to access the mini-app via WeChat without downloading 
additional installments. Then participants will be asked questions about their perceived feasibility 
and acceptability of the mini-app. A brief demographic survey will be administrated at the end of 
interview. The mini-app has four main functions: (1) a mini-classroom that contains a series of 
HIV-, sexual health-, and PrEP-related educational articles in Chinese; (2) an HIV/Syphilis duo 
self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and 
shipped to home for free (one kit per order); (3) an asynchronous message function that allows 
users to initiate a chat with a study staff; and (4) a user profile page where users can manage all 
HIV test orders. 

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Interviewees’ demographics and PrEP use history will be recorded in a spreadsheet in order to 
balance enrollment across all 3 groups (current PrEP users, people who never use PrEP, and 
intermittent PrEP users). We will use semi-structured interview guides with tailored questions for 
each group of the participants (see attached in-depth interview guide). In addition to discussing 
their knowledge, attitudes and willingness to use PrEP and PrEP use history, interviewees will be 
asked to describe their past pathways to HIV prevention services (e.g., HIV testing, counseling) 
including struggles and support resources they encountered. After test-using the mini-app, 
participants will be asked to comment on the design, contents and ease of use of the mini-app. 
Interviews will be conducted one-on-one in private spaces, last 60-90 minutes and will be audio 
recorded with participant's permission.  
 
 
 
 
 
Figure 1. Procedure of in-depth interview in Aim 1  
 
Aim 2: Evaluate the preliminary efficacy of the mini-app in changing PrEP perceptions and 
increasing PrEP uptake among young Chinese MSM (18 years old and above) in 
Guangzhou, China through a small pilot RCT (n=70), comparing the mini-app (n=40) to the 
standard of PrEP care (n=30). 
Before the start of Aim 2, we will refine the mini-app based on participants’ feedback in Aim 1. 
In Aim 2, we will conduct a pilot two-arm RCT to evaluate the feasibility and acceptability of the 
mini-app and examine its preliminary efficacy in changing PrEP-related perceptions and 
increasing actual PrEP initiation compared with a standard of care control group. All potential 
participants who show interest in participating the study need to complete a verbal eligibility 
screening during their initial contact with the study team. Those screened eligible and interested 
in participation will need to make an initial in-person or remote visit at the Guangzhou No.8 
People’s Hospital, during which they complete a baseline assessment survey after proceeding the 
full informed consent process. Only participants who express interest in using the mini-app for 
HIV prevention, meet the eligibility criteria, provide informed consent, and complete a baseline 
assessment will be assigned a final study ID and be eligible for randomization. 
Control: Standard of Care 
Interview: Past experience 
and needs in HIV 
prevention and care, and 
perceptions of taking 
medicines to prevent HIV 
(such as PrEP)  
Participant 
test use the 
mini-app  
Interview: Feedback on 
the mini-app, e.g., using 
experience, designs and 
contents, relevance, 
and suggestions for 
scaling up PrEP in China.   
Participant 
Complete a 
short app 
usability survey 

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In the standard of care control arm, participants will receive written HIV prevention materials 
(hard-copy at the clinic or electronic files) including basic facts of PrEP, recommendations for 
HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.  
Intervention: the mini-app 
The study intervention tool, a mini-app built within a chat-app (WeChat, available on both 
Android and iOS systems), serves as the primary participant-facing component of the 
intervention. The mini-app does not require users to download or install anything as long as they 
have WeChat installed on their phone. Participants in the intervention arm will be able to access 
full function of the mini-app for 8 weeks. The mini-app has four main functions: (1) a mini-
classroom that contains a series of HIV-, sexual health-, and PrEP-related educational articles in 
Chinese; (2) an HIV/syphilis home-based test kit ordering system that allows users to order a 
finger-prick HIV rapid test toolkit and ship to home for free (one toolkit per order allowed; 
participants can place more than one orders with no upper limit during the intervention period); 
(3) an asynchronous message function that allows users to communicate with the study team; and 
(4) a user profile page where users can manage orders of HIV/syphilis test kits. The mini-app is 
not able to collect or track any individual user information or user activity within the mini-app. It 
cannot initiate a chat with participants unless the participant requests a chat. 
Home-based HIV/Syphilis test kit 
The study will use a mail-based system to deliver free HIV/Syphilis test kits to participants upon 
request. We will use imported Abbott SD BIOLINE HIV/Syphilis Duo test kit that allows users 
to conduct finger-prick test at home. Participants will receive a plain box via standard mail that 
includes the test kit with instructions. Participants can also find the instruction of how to use the 
test kit in the mini-app. Participants do not need to send back any specimen or other material back 
to the study team, but they will be encouraged to report back test results to the study team via 
messaging through the mini-app. Testing experience and results will also be asked in the 
biweekly follow-up surveys.  
PrEP initiation 
Participants in both arms can choose to initiate PrEP at any time point since the initial visit until 
the end of 8th week. Participants can contact the study team via phone call, text messages or via 
the chat function in the mini-app to communicate their interest in PrEP initiation. If baseline 
assessment or follow-up survey results do not show contradictions to PrEP initiation, interested 
participants will be referred to the Department of Infectious Diseases at Guangzhou No.8 
People’s Hospital to consult a clinician regarding HIV risks and PrEP eligibility. As is standard of 
care for any patient starting PrEP, participants will take comprehensive physical examinations 
(including routine urine examinations, hepatic and renal function tests, blood glucose and lipids, 
and bone mineral density (BMD)). The study team will not have access to participants’ medical 
records (i.e. the physical examination results). Participants who are confirmed by the clinician 
HIV-negative, with no serious liver or kidney dysfunction and negative for HBs antigen, without 
serology indicating osteoporosis, without clinical signs or symptoms consistent with acute viral 

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infection, will be prescribed either 8-week daily oral TDF/FTC or event-driven oral TDF/FTC 
based on participants’ preference. The cost of physical examinations in order to get PrEP 
prescription will be covered by the study team. If a participant is eligible for starting PrEP and 
have been prescribed PrEP by a PrEP provider, the participant will get a 50% reimbursement of 
the cost for their first two months of PrEP doses (30 pills/month, up to 60 pills in total) filled at 
the in-house pharmacy of the study hospital (the Guangzhou Eighth People’s Hospital). 
Follow-up and Data collection 
The active intervention period will last for 8 weeks, but participants in the intervention arm can 
have access to the mini-app throughout the whole study period or until the end of their first two-
month PrEP use, which can be as long as 16 weeks.  Baseline assessments will be conducted at 
the enrollment visit, with follow-up assessments conducted at 2, 4, 6, 8, 12 (post-intervention). 
Participants from both arms will need to complete a self-administrated Web-based survey at each 
assessment time point.   
In addition to Web-based surveys, a subgroup of participants (n=20) from both the intervention 
arm and the control arm will receive up to two rounds of in-depth interviews, separately at the 4th 
and 8th week, to share their experience of using the app and changed perceptions and/or 
behaviors related to PrEP. Among the 20 participants, 15 will be recruited for interviews during 
the first and fourth weeks, who will receive two rounds of interviews. Another five participants 
will be recruited between the 4th and 8th week, who will be only interviewed once at the 8th 
week. Interview topics include participants’ experience of using the app and changed perceptions 
and/or behaviors related to PrEP and HIV prevention practices during the study period. 
Interviews will be conducted one-on-one in private spaces, last 60-90 minutes and will be audio 
recorded with participant's permission. 
Referrals 
In the case of an initial positive HIV test done through the study, participants who have initiated 
PrEP will be instructed to discontinue PrEP dosing. Participants testing positive will be referred 
to the Guangzhou No.8 People’s Hospital for confirmation test or other testing places if needed. 
The Guangzhou Center for Diseases Prevention and Control will be notified of confirmed 
positive results in accordance with China’s public health reporting laws, a procedure that will be 
explained to participants at consent. For positive syphilis testing results, participants will be 
referred to STI treatment at the Guangzhou No.8 People’s Hospital. The study team will follow-
up with participants testing positive for HIV or STIs to encourage participants to seek appropriate 
care. 
 
 

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Figure 2. Flowchart of Aim 2 study design 
 
Participant Recruitment  
Eligibility screening over phone/online survey 
Initial visit at Guangzhou No.8 People’s Hospital 
(Full consent procedure & baseline assessment) 
Mini-app arm (n=40) 
Standard of care arm (n=20) 
Participants 
interested in 
PrEP initiation 
No.8: Physical 
examinations 
PrEP 
prescription 
(8-week 
doses) 
4th week in-depth 
interview 
(10 from the app arm + 
 5 from the control arm) 
4th week survey 
6th week survey 
8th week survey 
8th week in-depth 
interview 
(same 15 participants 
from 4th week + another 
5 new participants) 
8-week  
intervention 
During the 
first 8-week  
period 
2nd week survey 
12th week survey 
After  
intervention 

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4.0 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 
Inclusion Criteria 
Aim 1 (in-depth interviews):  40 HIV-negative men who have sex with men (MSM): must self-
report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal 
sex with another man, currently reside in Guangzhou, China, identify as a Chinese citizen, able to 
being willing to sign written informed consent and participate in the study as procedures required. 
Aim 2 (randomized controlled trial, RCT): 70 HIV-negative MSM: same characteristics as in 
Aim 1. AND, they must report:   
• 
Having a smartphone with WeChat installed.  
• 
Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal 
sex with another man, currently reside in Guangzhou, China, identifying as a Chinese 
citizen, able to sign written informed consent and participate in the study as procedures 
require. AND 
• 
Not currently using any medicine as PrEP 
• 
At least one criterion associated with high risk of HIV infection in the past 6 months prior 
to enrollment as follows: 
o Unprotected (condomless) anal intercourse with male partner(s)  
o More than two male partners (regardless of condom use and HIV serostatus)  
o Reported STI, such as syphilis, HSV-2, gonorrhea, chlamydia, chancroid, or 
lymphogranuloma venereum. 
o Reported use of post-exposure prophylaxis (PEP) 
o Have a sexual partner living with HIV 
4.2 
Exclusion Criteria 
Aim 1: Individuals who report any following status will be excluded from participating Aim 1: 
• 
HIV-positive  
• 
Mental health issues which may compromise participant adherence or safety, including 
memory loss, cognitive impairment, intellectual disability, or communication disorders.  
Aim 2: Individuals who report any following status will be excluded from participating Aim 2 
• 
HIV-positive  
• 
Currently taking oral PrEP based on self-report  
• 
Symptoms of acute HIV infection within the prior 30 days  
• 
Contradictions to taking oral PrEP  
• 
Personal diagnosis or family history of hemophilia Chronic Hepatitis B (self-report) 
• 
Participating in another research study related to HIV and antiretroviral therapy or other 
intervention study  
• 
Having serious chronic disease, including metabolic diseases (such as diabetes), 
neurological, and psychiatric disorders  

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• 
Mental health issues which may compromise participant adherence or safety, including 
memory loss, cognitive impairment, intellectual disability, or communication disorders.  
4.3 
Study Enrollment Procedures 
Participant recruitment will be targeted to venues (health clinics, gay bar) and mediums (e.g. 
Internet, social media) that we have identified from past formative work to be frequented by 
MSM in Guangzhou, and specifically MSM who are seeking HIV testing or post-exposure 
prophylaxis.  
Aim 1: Potential participants will be verbally screened for eligibility during their initial contact 
with the study team, before proceeding to the full informed consent and enrollment in in-depth 
interviews. All enrolled participants will be given a unique ID number for identification purposes. 
Aim 2: Potential participants will be verbally screened for eligibility during their initial contact 
with the study team, before proceeding to the full informed consent and enrollment in the RCT. 
All enrolled participants will be given a unique ID number for identification purposes. 
We will conduct a simple randomization that randomly assign the 70 participants to either the 
mini-app arm (n=40) or the control arm (n=30). Based on the timing of enrolling the study, each 
participant will be assigned a two-digit study ID (e.g., the first enrolled participant will be ID01; 
the second will be ID02; the last one enrolled will be ID70). Before enrollment, the study team 
will use the Microsoft Excel program to randomly assign the 70 IDs into group A (the 
intervention arm) and group B (the control arm). Once enrolled, a participant will be 
automatically assigned to either the intervention arm or the control arm based on his ID. If a 
participant quitted the study because of non-PrEP-related reasons (e.g., seroconversion, moving 
to other cities) after enrollment, we will recruit a new participant for replacement.  
 
5.0 
STUDY TREATMENT (OR INTERVENTION) 
 
Aim 1: No study treatment or intervention. 
Aim 2: Participants will receive two types of study treatment: 
(1) Standard of Care 
During their initial visit at Guangzhou No.8 People’s Hospital (in-person or via 
videoconferencing systems), after enrollment, participants from both arms will receive written 
HIV prevention materials (hard-copy at the study clinic or electronic files)  including basic facts 
of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and 
prevention services.  
(2) The Mini-app Intervention 

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In addition to the standard of care, participants who are assigned to the intervention arm will 
receive a mini-app-based PrEP intervention for up to 16 weeks. The intervention tool is a mini-
app that is built in a popular Chinese social media mobile platform, WeChat, to increase the 
engagement for PrEP education and PrEP initiation among Chinese MSM.  
Right after enrollment, participants randomized to the intervention arm will be guided by study 
staff through the mini-app access process and given a tour to highlight features. A prototype of 
the mini-app has been developed from an MSM-friendly doctor finder hackathon contest (April 
2019, Guangzhou) by a team of Chinese young MSM. The mini-app will be refined in terms of 
prioritized topics, graphical designs and tones of language based on results from Aim 1 before 
starting trial in Aim 2. The overall goal of the mini-app is for PrEP education. It has four main 
functions: (1) a mini-classroom that contains a series of HIV-, sexual health-, and PrEP-related 
educational articles in Chinese; (2) an HIV/syphilis self-test toolkit ordering system that allows 
users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a 
time); (3) an asynchronous message function that allows users to chat with a trained PrEP 
counselor; and (4) a user profile page where users can manage all HIV test orders. The mini-app 
wireframe is presented in Figure 3.  
 
Figure 3. Wireframe of the mini-app PrEP intervention (Aim 2) 
Participants in the intervention arm will have access to the mini-app for up to 16 weeks since 
enrollment. Usage of the mini-app will at participants’ own discretion or preference. A one-
sentence weekly reminders that encourage participants to use the mini-app will be sent out 
through text messages. The mini-app will not be able to track any individual user information or 
user activity within the mini-app. Self-reported app usage will be assessed in bi-weekly follow-up 

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surveys and in-depth interviews. At 8th week, participants in the intervention arm will be allowed 
to continue using the mini-app, but will not no longer receive reminder messages.  
 
6.0 
DATA COLLECTION 
6.1 
Data collection activities 
Data collection activities will be described by study aims.  
Aim 1: Qualitative interviews  
One-on-one in-depth interviews will be conducted in multiple settings in Guangzhou, China 
including an HIV testing clinic, and private locations of the participants' choosing (e.g. private 
room in a tea shop, private office space). Each interview will last 60-90 minutes. Interviews will 
be audio taped, transcribed verbatim in Chinese, summarized in English for analysis. During the 
interview participants will also be required to complete a 5-point Likert usability scale and a brief 
demographic survey.  
Due to the social distancing requirement during the COVID-19 pandemic as well as to reduce 
health risks for both participants and research staff, in-depth interviews may be conducted via 
videoconferencing system (e.g., Zoom, WeChat video/audio call) depending on the participant’s 
preference.  
Aim 2: Two-arm RCT 
Data collection in Aim 2 include Web-based baseline and follow-up assessment surveys, and 
qualitative interviews.  
Web-based surveys 
Baseline assessment will be conducted at the initial enrollment visit, with follow-up assessments 
conducted at 2, 4, 6, 8, and 12 weeks. All Web-based survey will be self-administrated and 
collected through a Chinese professional secure electronic survey platform (www.wjx.cn). Survey 
links will be sent to participants via text message that participants can choose to finish the survey 
on their phone or computer.  
Qualitative interview 
Similar to in-depth interviews in Aim 1, in-depth interviews in Aim 2 will be conducted in 
multiple settings in Guangzhou, China including an HIV testing clinic, and private locations of 
the participants' choosing (e.g. private room in a tea shop, private office space). 
Due to the social distancing requirement during the COVID-19 pandemic as well as to reduce 
health risks for both participants and research staff, in-depth interviews and enrollment visit may 

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be conducted via videoconferencing system (e.g., Zoom, WeChat video/audio call) depending on 
the participant’s preference.  
 
6.2 
Data Management 
Only authorized users (PIs, faculty advisor), based on correct login will be able to access and 
open the study surveys and in-depth interview recordings and transcripts. In-depth interviews will 
be audio taped, transcribed verbatim (in Chinese), summarized in English and organized and 
managed using Dedoose cloud-based qualitative data analysis software (www.dedoose.com). 
Web-based survey will be collected through a Chinese professional secure electronic survey 
platform Wenjuanxing (www.wjx.cn). Survey data will be downloaded from Wenjuanxing and 
will be stored on password protected encrypted study computers along with other electronic study 
files. All study files will have a back-up copy stored on UNC secure server space that only study 
personnel will have access to. All information will be kept confidential, with responses labeled by 
an identification number available only to investigators in locked or password secured files. 
6.3 
Quantitative Outcome Measures 
Quantitative outcome measures will be assessed in Aim 2 through baseline and follow-up 
assessments.  
Primary Outcome Measures: The primary outcome is PrEP initiation, measured by the number 
of participants who successfully initiated PrEP during the 8-week intervention period.  
Secondary Outcome Measures: Secondary outcomes include self-report PrEP use self-efficacy, 
PrEP stigma, PrEP adherence (among those who are on PrEP), sexual risk behaviors, sexually 
transmitted infection incidence, general stress and HIV-related stress.  
6.4 
Incentives 
Aim 1: Remuneration will be provided at the end of each completed interview (total of three 
possible interviews) in the form of a 75-CNY (~ 10 USD) gift card or equivalent. The participant 
may opt to stop the interview at any time, however remuneration will only be provided for 
completed interviews. 
Aim 2: Participants in Aim 2 will receive up to 340 CNY in total, including a 50-CNY (~ 7 USD) 
gift card for the in-person initial visit or baseline assessment at Guangzhou No.8 People’s 
Hospital, and another 20-CNY (~3 USD) gift card for completing each Web-based long follow-
up survey at weeks 4, 8, and 12, and 5-CNY (~1 USD) gift card for complete each Web-based 
short survey at weeks 2 and 6. Participants who are selected for in-depth interviews will receive 
75-CNY (~10 USD) gift card for completing each interview (two interviews in total). 
Remuneration will be provided at the end of each completed session. The participant may opt to 
stop the interviews/baseline assessment/follow-up surveys at any time, however remuneration 
will only be provided for completed sessions. Participants who participate in all the required 
research activities will receive a bonus incentive of 50 CNY at the end of the study. 

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7.0 
PARTICIPANT WITHDRAW AND REPORT 
 
Participants may voluntarily withdraw from the study for any reason at any time. No further data 
collection will occur from the date the decision is made to permanently discontinue the 
participant from the study. The study investigators also may withdraw participants from the study 
in order to protect participant or staff safety. Study staff will record the reasons for all 
withdrawals. 
If a participant fails or is unable to comply with study procedures they will be withdrawn from 
the study. Participants will be withdrawn if they: 
• 
are noticeably intoxicated or on illegal drugs. 
• 
threaten a study staff member. 
• 
are mentally handicapped and unable to give full informed consent. 
• 
are incarcerated during course of study. 
• 
become HIV-positive during course of study. 
• 
reporting severe medication side effects after initiating PrEP and are advised to quit the 
study by a HIV specialist. 
Any enrolled participant who report any of the above-mentioned events will be immediately stop 
participation in the study, and study staff will complete a Study Stop form for participants who 
are discontinued. This form will include the date, last research activity completed, and reason for 
study discontinuation. These will be reported to the UNC IRB and the Guangzhou No.8 People’s 
Hospital IRB at the end of study. 
Reporting is required of all unanticipated problems to the UNC IRB, including those which may 
occur after the participant has completed or has withdrawn from the study, including after study 
closure.  
Unanticipated problems as defined by the UNC IRB: 
Unanticipated problems involving risks to participants or others” or “Unanticipated Problem” 
refers to any incident, experience, or outcome that: 
• 
is unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the characteristics 
of the participant population being studied;  
• 
is related or possibly related to a participant’s participation in the research; and  
• 
suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) related to the research than 
was previously known or recognized.  
 

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Unanticipated Problems that are serious adverse events should be reported to the UNC IRB ang 
Guangzhou No.8 People’s Hospital IRB within one (1) week of the investigator becoming aware 
of the event.  Any other Unanticipated Problem should be reported to the UNC IRB and 
Guangzhou No.8 People’s Hospital IRB within two (2) weeks of the investigator becoming aware 
of the problem.  If the Unanticipated Problem Report cannot be completed in its entirety within 
the required time period, a preliminary report should be submitted.  The Unanticipated Problem 
Report should be amended once the event is resolved and/or more information becomes available.  
 
8.0 
STATISTICAL CONSIDERATIONS 
 
This section is only applicable to Aim 2.  
8.1 
General Design 
Aim 2 include a two-arm unblinded RCT, testing the efficacy of a mini-app-based PrEP 
intervention in promoting PrEP uptake among Chinese MSM compared to standard of care 
control.  
8.2 
Endpoints 
The endpoint for primary outcome is successful initiation of PrEP.   
8.3 
Randomization and Stratification 
Participants will be simply randomized at initial enrollment visit into two arms (intervention=40, 
control=30). No stratification will be conducted. 
8.4 
Sample Size and Accrual 
This is a pilot study to test the preliminary efficacy of a WeChat-based mini-app in promoting 
PrEP uptake rates in an 8-week intervention. Inclusion of a control arm will allow estimation of 
an effective size to sufficiently power a future full-scale efficacy trial. The full-size intervention 
study will be designed as a two-arm RCT, following participants up to 12 months and use 
multilevel modeling methods to understand the association between intervention exposure, 
changed PrEP perceptions, PrEP initiation and long-term adherence. 
8.5 
Monitoring 
Data will be collected and stored by anonymous identification numbers by study investigators. 
Data will not be shared with third parties. Data will be discarded 2 years following study 
completion. 
Plans for monitoring participant safety and study progress 
The PIs will receive regularly bi-weekly updates from study personnel. In addition, study 
procedures are established that if at any time during the study a participant divulges that he is at 

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risk for harm, including but not limited to reporting severe medication side effects, being abused 
or experiencing violence, if harm is suspected or likely, or if the participant states he is 
suicidal/homicidal, the PIs will be notified immediately and measures will be taken to ensure the 
participant's safety. Reporting will be done as appropriate to the situation and the legal statutes, 
and referrals will be provided for appropriate support, counseling, or treatment resources. 
The full study team will hold bi-weekly conference calls to report progress on enrollment, data 
collection and data analysis. Any challenges that arise will be discussed during these calls and 
plans made to address. 
This study is expected to pose minimal risk. Nevertheless, any unanticipated problems will be 
recorded in a master log by the PIs and reported during bi-weekly updates (or immediately as 
described above). The master log will be reviewed during bi-weekly full study team conference 
calls. Participants may voluntarily withdraw from the study for any reason at any time. Detailed 
description of participant withdraw and report can be found in section 7.0 in this protocol.  
 
8.6 
Analyses 
Descriptive statistical analysis will be first conducted to report demographic characteristics of 
participants, PrEP uptake rates, PrEP-related perceptions, PrEP adherence, HIV/STI testing 
behaviors, prevalence of STIs, mini-app use behaviors at different time points throughout the 
study period. Statistical tests including Chi-Square tests and t-tests will be conducted to compare 
the preliminary intervention effects (i.e. the efficacy of mini-app in improving PrEP-related 
perceptions, increasing PrEP uptake rates and HIV/STI testing behaviors) between the 
intervention group and control group at each time point. Multivariate logistic regression models 
will be applied to estimate the association between intervention arm and the primary study 
outcome, PrEP initiation during the 8-week intervention period. If prognostic factors associated 
with the primary outcome remain insufficiently balanced through simple randomization, we may 
adjust for these factors in our models. Potential confounding factors that may be included are 
perceived HIV infection risk, PrEP self-efficacy and perceived PrEP stigma. 
 
9.0 
STUDY MANAGEMENT 
9.1 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol and the informed consent documents and any subsequent modifications 
(amendments) will be reviewed and approved by the UNC IRB and Guangzhou No.8 People’s 
Hospital IRB that are responsible for oversight of the study.  
It is expected that the IRB will have the proper representation and function in accordance with 
federally mandated regulations. The IRB should approve the consent form(s) and protocol. 

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In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) and to 
ethical principles that have their origin in the Declaration of Helsinki. 
Before recruitment and enrollment onto this study, the participant will be given a full explanation 
of the study and will be given the opportunity to review the consent form(s). Each consent form 
must include all the relevant elements currently required by the FDA Regulations and local or 
state regulations, which include elements such as the purpose of the study, the procedures to be 
followed, and the risks and benefits of participation.  Once this essential information has been 
provided to the participant and the investigator is assured that the participant understands the 
implications of participating in the study, the participant will be asked to give consent to 
participate in the study by signing an IRB-approved consent form. 
Prior to a participant’s participation in the trial, the written informed consent form(s) should be 
signed and personally dated by the participant or the participant’s legally authorized 
representative (legal guardian or person with power of attorney for participants who cannot 
consent for themselves), and by the person who conducted the informed consent discussion. 
A copy of the consent form will be given to the participant or legal guardian, and this fact will be 
documented in the participant’s record. 
9.2 
Criteria for Discontinuation 
9.2.3 Premature Study Discontinuation  
• 
Request by the participant to withdraw 
• 
Request of the primary care provider if s/he thinks the study is no longer in the best 
interest of the participant 
• 
Participant judged by the investigator to be at significant risk of failing to comply with 
the provisions of the protocol as to cause harm to self or seriously interfere with the 
validity of the study results 
• 
At the discretion of the ACTU, IRB, FDA, Office for Human Research Protections 
(OHRP), NIAID, investigator, or pharmaceutical supporters  
9.2.3 Deviations from the Protocol  
The investigator may implement a deviation from, or a change of, the protocol to eliminate an 
immediate hazard(s) to study participants without prior IRB/IEC approval/favorable opinion.  As 
soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the 
proposed protocol amendment(s) should be submitted to: 
a) IRB for review and approval 
b) to the sponsor for agreement and, if required 
c) to the regulatory authority(ies) 
9.2.4 
Required Documentation 
Before the study can be initiated at any site, the following documentation must be provided to the 
ACTU/CID/IGHID Office at the University of North Carolina. 

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• 
A copy of the official IRB approval letter for the protocol and informed consent(s) 
• 
IRB membership list 
• 
CVs for the principal investigator and any associate investigators who will be involved in 
the study 
• 
A copy of the IRB-approved consent form(s) 
9.2.5 
Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, and well-being 
of the study participant requires alternative treatment, the study shall be conducted exactly as 
described in the approved protocol.  Any deviation from the protocol must have prior approval by 
the Principal Investigator and must be recorded and explained. 
9.2.6 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated and 
documented by the Principal Investigator at UNC.  The written amendment will be sent to 
investigators and must be submitted to the IRB at the investigator's site for approval.  It should 
also be noted that when an amendment to the protocol substantially alters the study design or the 
potential risk to the participant, a revised consent form might be required. 
9.2.7 
Record Retention 
Study documentation includes all Case Report Forms, data correction forms or queries, source 
documents, Sponsor-Investigator correspondence, monitoring logs/letters, and regulatory 
documents (e.g., protocol and amendments, IRB correspondence and approval, signed participant 
consent forms). 
Source documents include all recordings of observations or notations of clinical activities and all 
reports and records necessary for the evaluation and reconstruction of the clinical research study. 
Government agency regulations and directives require that all study documentation pertaining to 
the conduct of a clinical trial must be retained by the study investigator.  In the case of a study 
with a drug seeking regulatory approval and marketing, these documents shall be retained for at 
least two years after the last approval of marketing application in an International Conference on 
Harmonization (ICH) region.  In all other cases, study documents should be kept on file until 
three years after the completion and final study report of this investigational study. 
9.3 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the site in 
accordance with Title 21 of the Code of Federal Regulations and/or the Declaration of Helsinki.  
The Principal Investigator is responsible for personally overseeing the treatment of all study 
participants.  The Principal Investigator must assure that all study site personnel, including co-
investigators and other study staff members, adhere to the study protocol and all FDA/GCP 
regulations and guidelines regarding clinical trials both during and after study completion. 
The Principal Investigator at each institution or site will be responsible for assuring that all the 
required data will be collected and entered onto the Case Report Forms (CRFs). Periodically, 

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monitoring visits will be conducted and the Principal Investigator will provide access to his/her 
original records to permit verification of proper entry of data.  Site monitors will visit 
participating sites to review the individual participant records, including consent forms, CRFs, 
supporting data, laboratory specimen records, and medical records (physicians’ progress notes, 
nurses’ notes, individuals’ hospital charts), to ensure protection of study participants, compliance 
with the protocol, and accuracy and completeness of records.  The monitors also will inspect 
sites’ regulatory files to ensure that regulatory requirements are being followed and sites’ 
pharmacies to review product storage and management.  At the completion of the study, all case 
report forms will be reviewed by the Principal Investigator and will require his/her final signature 
to verify the accuracy of the data. 
The site investigator will make study documents (e.g., consent forms, drug distribution forms, 
CRFs) and pertinent hospital or clinic records readily available for inspection by the local IRB, 
the site monitors, the FDA, the NIAID, the OHRP, and the pharmaceutical supporter or designee 
for confirmation of the study data.  
9.4 
Participant Confidentiality 
All evaluation forms, reports, and other records that leave the site will be identified by coded 
number only to maintain participant confidentiality.  All records will be kept locked.  All 
computer entry and networking programs will be done with coded numbers only. Participant 
information will not be released without written permission of the participant, except as necessary 
for monitoring by the ACTU, IRB, the FDA, the NIAID, the OHRP, or the pharmaceutical 
supporters or designee. 
9.5 
Study Discontinuation 
The study may be discontinued at any time by the ACTU, IRB, the NIAID, the pharmaceutical 
supporters, the FDA, the OHRP, or other government agencies as part of their duties to ensure 
that research participants are protected.  
 
10.0 BIOHAZARD CONTAINMENT 
No specimens will be collected or handled in this study.

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