Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk Men in China
Phase: NA
Conditions: HIV
Sponsor: Emory University

Title: Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services 
for High-Risk Men in China
Date: 05/08/2020
NCT#: NCT05484895

ANHUI MEDICAL UNIVERSITY 
INSTITUTIONAL REVIEW BOARD, HUMAN RESEARCH PROTOCOL 
PROJECT TITLE:  
Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for 
High-Risk Men in China 
PRINCIPAL INVESTIGATORS:  
Hongbo Zhang, PhD (Anhui Medical University), Don Operario, PhD (Brown University) 
Cui Yang PhD (Johns Hopkins University), Nickolas Zaller PhD (University of Arkansas) 
______________________________________________________________________ 
SUMMARY 
In this 5-year NIH-funded research project (current NIH grant # R01MH123352), we propose an 
intervention entitled “WeTest-WeLink” that aims to (i) promote uptake of HIV self-testing among 
MSM in China, and (ii) linkage to care for MSM who obtain preliminary positive HIV self-test 
results. This proposal builds on years of formative work with MSM in China conducted by this 
team of investigators (previous NIH grant # R34MH106349), demonstrating promising effects 
from a pilot RCT and strong indication of intervention acceptability, feasibility, and cultural 
sensitivity. The intervention uses the “WeChat” mobile app platform, which offers multiple features 
built into the app that facilitate health information delivery and communication channels (e.g., 
capacity for private texts, group chats, video sharing, GPS, instant messaging, real-time audio 
and visual communication). This protocol is funded by the US National Institutes of Health, and 
includes three phases of research activity over 5 years. Phase 1 (Year 1) involves use of online 
focus groups to refine the WeTest-WeLink intervention to incorporate additional and updated 
content regarding: the HIV care continuum, linkage to care for HIV-positive people and ART 
treatment; support and affirmation for those testing HIV-positive; and programming of GPS 
resources to assist participants in identifying care. Identification and incorporation of additional 
updated content will be guided by the Information-Motivation-Behavioral (IMB) theory of behavior 
change and Minority Stress Theory, and based on findings from focus groups to be conducted 
with MSM from study settings. Phase 2 (Years 2-4) is a prospective 2-group RCT of 1,800 MSM 
recruited from 3 sites: Chengdu, Suzhou, Wuhan. Participants will be randomized to the control 
group or to the WeTest-WeLink intervention. Primary and secondary outcomes include: i) repeat 
HST at 6, 12, and 18-month follow-up, ii) linkage to care for those who test HIV-positive. Additional 
analysis will explore effects on behavioral HIV risk, engagement in HIV community-based 
prevention services, and theoretical mechanisms of behavior change. Phase 3 (Year 5) involves 
qualitative examination with key constituents regarding implementation features specified within 
the CFIR. 

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RESEARCH PROTOCOL 
Title: Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services 
for High-Risk Men in China 
Specific Aims 
The overarching objectives for this R01 research project are to test the effectiveness of an 
mHealth intervention entitled “WeTest-WeLink” that will increase repeat HIV self-testing (HST) 
among MSM, and to examine the efficacy of “WeTest-WeLink” on linking individuals who test 
positive to HIV care. Based on a successful 3-year R34 NIMH-funded pilot study conducted in 
Hefei, Anhui Province, we established proof-of-concept for the use of the WeChat app to promote 
HIV self-testing with MSM. In the current 5-year R01 NIMH-funded research, we will employ a 
user-centered design process to refine and expand app features (e.g., app-based HIV and health 
promotion messages, videos, GPS maps, private groups and two-way communication channels) 
to support repeat HST uptake, behavioral risk reduction, stigma coping strategies, and self-
efficacy to link to HIV care. With the goal of increasing sustainable behavioral changes and 
examining the scalability of this proposed intervention, we will subsequently conduct a formative 
evaluation on the implementation of the intervention. The goal of this R01 application will be 
accomplished by using an Effectiveness-Implementation Hybrid Type 1 design consisting of a 
three site, 2-arm RCT to quantitatively test the intervention’s effects on primary and secondary 
outcomes (repeat HST, linkage to HIV-related care) as well as qualitative research to examine 
implementation and scalability. We will recruit 1,800 HIV negative MSM, who will be allocated to 
the intervention (access to the WeTest-WeLink app) or control group (basic information about 
HST and passive referral to HIV care for individuals who test HIV positive). We will assess 
participants at 6-, 12-, and 18 months to measure intervention effects on primary outcomes: use 
of HST (including photographic confirmation) and linkage to care for individuals who test HIV-
positive. Secondary outcomes include sexual risk behaviors and use of HIV prevention services, 
and we will conduct mediation analysis to examine theoretical mechanisms of behavior change. 
We will qualitatively assess intervention-related process characteristics that enable and/or 
impede implementation and scalability informed by the Consolidated Framework for 
Implementation Research (CFIR). 
The aims of this 5-year research program are the following: 
Specific Aim 1. To evaluate the effectiveness of the WeTest-WeLink intervention on HST 
behaviors 
Hypothesis 1: Greater proportion of HST every six months, confirmed by photographic 
evidence of test results, in the intervention vs control group  
Specific Aim 2. To evaluate the efficacy of the intervention on linkage to HIV related care 
Hypothesis 2. Greater proportion of participants who test HIV+ in the intervention will be linked 
to care vs control group  
Specific Aim 3. To inform broad scale implementation by assessing intervention barriers, 
facilitators, and potential adaptations for optimal uptake and sustainability 
Hypothesis 3. Key informants will identify key intervention features that can enhance 
subsequent implementation and scalability in real-world, ecological settings 

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Background 
Studies of MSM in China have found that stigma contributes to the underutilization of HIV 
prevention and testing services and to the underestimation of personal HIV risk behaviors. Many 
MSM refrain from accessing HIV prevention and testing offered through health clinics or local 
Centers for Disease Control (CDC) offices, out of fear of disclosing their same-sex behavior to 
physicians or CDC officials. A systematic review found that 62% of Chinese MSM had not been 
tested in the past 12 months and about half of them had never been tested for HIV in their lifetime. 
Low rates of testing and undiagnosed HIV infection pose substantial risks for furthering the growth 
of China’s HIV epidemic. Interventions are urgently needed to increase rates of HIV testing for 
MSM in China as well as to facilitate linkage to care for those who test positive in order to disrupt 
the expanding epidemic in this population. 
The use of mobile technologies to promote healthier behaviors (“mHealth”) opens new avenues 
for support the use of HST.  Emerging data suggest that delivery of HIV-prevention messages via 
mobile phone “apps” represents a feasible and acceptable way to encourage HIV testing and to 
lower HIV risk behaviors. In the context of HST, mobile phone apps can send text or video 
instruction on specimen collection and test result interpretation. In addition, automated app-
delivered messages can provide timely, confidential, and convenient information to motivate risk 
reduction, retesting, and necessary referrals to care.  
Preliminary Research 
In our prior 3-year NIMH-funded project, we developed and pilot-tested the WeTest intervention 
to provide proof-of-concept for the use of WeChat to promote HIV self-testing. Development of 
WeTest involved iterative rounds of quantitative and qualitative research with MSM in China to 
identify intervention targets and MSM-sensitive delivery processes for app-based HIV 
communication, messaging, and referrals. WeChat development was based on the Information-
Motivation-Behavior (IMB) theory, a widely accepted, evidence-based approach to promoting 
HIV-related behavior change. In accordance with this theory, WeChat provided accurate and up-
to-date HIV prevention information (about HIV transmission, prevention strategies, testing 
recommendations, living with and treatment for HIV, local HIV epidemiology in MSM populations), 
messages and stories to motivate risk reduction, and guidance and self-efficacy to engage in risk 
reduction behaviors. In addition, WeChat was informed by Minority Stress Theory, a framework 
that explicates the role of social stigma as a factor contributing to maladaptive health behaviors, 
including risk for HIV transmission in MSM. In accordance with this theory, WeChat included 
messages and short articles (vignettes, first-person narratives) to support participants’ MSM 
identities and affirm their same-gender sexuality, used empowering language, and provided 
information/referrals regarding local MSM-serving NGOs that advocate for the needs of this 
population. WeChat offered standard content – videos, fact sheets, local linkage/referral 
information, two-way communication feature – which was permanently available on the main 
WeChat landing page. WeChat also sent two additional weekly messages to participants’ 
“message feed” – including brief informational articles about HIV, STIs, and HIV testing; first-
person stories about people living with HIV; local data about HIV and STI infections among MSM; 
news about national policies related to HIV; and stories about general health concerns of MSM – 
drawn from a library of pre-prepared messages/stories for this project.   
Over a 3-month outreach and recruitment period, the study team recruited and enrolled 100 MSM 
participants into the pilot RCT and examined the acceptability, feasibility, and 6-month outcomes 
on HIV testing and condom use. All participants enrolled (100%) were retained at 6-month follow-
up. At follow-up, participants in the intervention group had increased uptake of oral HST following 
baseline procedures (adj. RR=2.17, 95%CI: 1.08-4.37) and increased trust in use of oral HST 
(adj. RR=2.28, 95%CI: 1.15-4.51), compared to the control. Nearly all (98%) of those who 
reported using HIV self-test kits uploaded and submitted photographic confirmation of their test 

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results to study staff via the secure WeChat project portal. This high submission rate is indicative 
of the potential utility for remote health workers to counsel, refer, and provide linkages to care for 
people who test positive. Overall, 10 individuals tested positive and all received immediate 
linkages to care. In qualitative exit interviews, intervention participants commented favorably 
about app-based approach for supporting HST and prevention, the ability to communicate with 
online remote counselors for questions and referrals, the discrete nature of the app as a way to 
avoid uncomfortable disclosure, and the focus on MSM-based support and identity affirmation. 
These results provide compelling support for the feasibility and acceptability of WeTest, and 
demonstrate the team’s ability to recruit and implement a mHealth intervention for this population. 
Methods 
This 5-year project involves 3 phases of research. 
Phase 1 involves use of online focus groups to refine the WeTest-WeLink intervention to 
incorporate additional and updated content regarding: the HIV care continuum, linkage to care for 
HIV-positive people and ART treatment; support and affirmation for those testing HIV-positive; 
and programming of GPS resources to assist participants in identifying care. Phase 2 is a 
prospective 2-group RCT of 1,800 MSM. Participants will be randomized to the control group or 
to the WeTest-WeLink intervention Primary and secondary outcomes include: i) repeat HST at 6, 
12, and 18-month follow-up, ii) linkage to care for those who test HIV-positive. Additional analysis 
will explore effects on behavioral HIV risk, engagement in HIV community-based prevention 
services, and theoretical mechanisms of behavior change. Phase 3 involves qualitative 
examination with key constituents regarding implementation features of the program. 
Recruitment and retention: 
We will recruit participants using the following strategies: 
1. In-person Recruitment. Study staff will approach men in known venues identified in previous
research where the target population congregates (e.g., bars, cafes, bookstores). They will take 
individual men aside and tell them about the study, provide small study cards or fliers to interested 
individuals, and encourage them to contact the study office if interested. If an individual is 
interested and wants to set up an appointment, study staff will schedule a time for the intake.  
2. Online Recruitment. Study recruitment staff will create profiles on known websites in China
where members of the local target population spend time (e.g., Blued, Aloha), following 
recruitment procedures used successfully in the team’s previous research with MSM in China. 
They will identify themselves as conducting a men’s health study. If a member of the target 
population approaches study staff online, they will explain the project, and will offer to do a 
screener over the phone. If the potential participant is eligible, they will schedule an intake 
appointment with a member of the study staff. 
3. Community-based Referrals. Study recruitment staff will make presentations about the
study to staff at relevant community-based organizations and service agencies in each target city. 
They will discuss the general study, and will also leave recruitment materials. They will ask staff 
to refer potential participants to the study by giving men the recruitment materials and 
encouraging them to contact study staff if interested. 
Phase 1 (Year 1): Intervention update and refinement. 
The purpose of Phase 1 is to update and refine the intervention content using focus groups, 
which will allow us to expand app features (e.g., app-based HIV and health promotion messages, 
videos, GPS maps, private groups and two-way communication channels) to support uptake and 
repeat use of HST, behavioral change, stigma coping strategies, and self-efficacy to link to HIV 
care. All focus group discussions will be conducted using remote online procedures (via WeChat 
or Zoom). 
Participants. We will conduct 12 focus groups total – 4 focus groups per research site 
(Chengdu, Suzhou, Wuhan). (i) We will conduct 6 focus groups with HIV-positive MSM (2 focus 

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5
groups per site; n=4 participants per group). (ii) We will also conduct 6 focus groups with HIV-
negative MSM (2 focus per groups; n=4 per group) (48 Phase 1 participants total). Due to 
concerns related to COVID-19, focus groups will occur via the Internet.  
Participants must be: aged 18 years or older; possess a mobile “smart” phone; experienced 
using WeChat; had condomless anal sex with another man in the past 6 months; reside in the 
site for at least 6 months. HIV-positive MSM focus groups will discuss their experiences receiving 
an HIV-status diagnosis, linkage to care, stigma coping and support needs. HIV-negative MSM 
focus groups will discuss anticipated challenges in repeat HST, anticipated barriers to care, risk 
reduction, and stigma coping and support needs. Additional focus groups may be held depending 
on need for data saturation. We will attempt to maximize diversity within focus groups in order to 
represent MSM of varying ages, education levels, and prior engagement in HIV 
prevention/testing. Eligible participants will receive a detailed description about the study and 
complete informed consent procedures. HIV-positive participants will be informed that 
participation will involve discussing their HIV status in the presence of other HIV-positive MSM; 
they will be given the option to complete individual interviews upon request.  
Procedures. Individuals who respond to recruitment efforts will be screened by a project staff 
member, using either the WeChat calling feature or at an in-person meeting at a collaborating 
NGO project office. Those ineligible will be excused and receive an electronic link or physical 
brochure with referrals to health services and recommendations about HIV prevention and testing. 
Those eligible will continue with the procedures described here. Focus groups participants will be 
sent an invitation to a secure online/internet platform. We will begin focus groups with a 
demonstration of two videos that will be provided as standard content in the WeChat-WeLink app 
group. The first brief video, developed for use in the R34 pilot study, demonstrates use of the 
locally manufactured HIV-1/2 oral self-test test kits (ABON Biopharm Co. Ltd, in Hangzhou). 
ABON oral HIV self-test kits have 100% initial sensitivity and 99.7% specificity, and are endorsed 
for use by USAID and the Global Fund. The video demonstrates how to self-administer the testing 
device (using an oral swab, no blood required); the importance of checking for expiration date 
(typically two years from purchase); how to interpret the test results; what to do if results are 
positive; how to safely dispose of the testing device (a package for safely disposing the device is 
included in the kit). We will provide a second brief video demonstration about the importance of 
linking to an HIV care site after testing HIV-positive. This video addresses myths and stigma about 
receiving an HIV-positive diagnosis, and emphasizes linkage to care as a step toward obtaining 
ART medication and achieving viral suppression. The video will clarify that ART is provided free 
through the local CDC, and will underscore the importance of communication with providers, 
medication adherence, attendance at follow-up clinic appointments and the importance of viral 
suppression to minimize risk of transmission to others.  
Focus group discussions will explore the appropriateness, relevance, and fit of the videos to 
population experiences and needs. Additional aspects of the WeChat platform and library of pre-
prepared content will be presented: local linkage/referral information to MSM-affirming NGOs and 
health promotion sites; brief informational articles about HIV, STIs, and HIV testing; first-person 
stories about people living with HIV; local data about HIV and STI infections among MSM; news 
about national policies related to HIV; and stories about general health concerns of MSM. Focus 
group facilitators will encourage participants to consider strategies for improving and updating the 
video content, and will solicit input on additional videos, brief messages, fact sheets, 
vignettes/stories, and referral sites. We will demonstrate the two-way communication features, 
which will facilitate engagement with a study staff member for deeper advice or support, and we 
will demonstrate the GPS feature, which will facilitate location of and linkage to CDC offices and 
care clinics, local MSM-affirming NGOs, and other HIV prevention/education sites. We will ask 
focus group participants to consider the necessary forms of information, motivation, and 
behavioral skills as well as stigma coping strategies to support repeated HST and linkage to care. 
Focus groups facilitated by trained members of co-I Dr. Zhang’s study team, will be audio 
recorded and participants will be compensated with 150 RMB (approximately 20 USD). An 
additional trained staff member will observe the discussions and take detailed notes from the 

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6
focus groups sessions, which will be summarized to reflect preferences and recommendations 
about message content, components, and delivery.  
Qualitative Analysis. Audio recordings will be transcribed into Mandarin and translated into 
English by professional translation services. Following Braun and Clarke’s thematic analysis 
framework, a team of coders will independently read the transcripts  and convene regularly to 
discuss emerging themes. The coding process will begin with the team reading each participant 
interview multiple times in order to become familiar with the data. This will be followed by indexing 
themes and categories. All the data relevant to each category will be identified and labelled to 
establish categories using a systematic approach. MAXQDA software will be used for cross-
indexing, sharing, and managing the data. At the conceptual level, analysis involves identification 
and summarizing patterns of experience related to HST self-administration, perceived facilitators 
and barriers to linkage to care, and preferences regarding app-based messages. At the 
descriptive level, the analysis involves identifying a diverse range of brief messages that can be 
delivered via mobile apps for motivating and encouraging repeat HIV testing and linkage. In 
addition, multiple coders will analyze subsets of the data and inter-rater reliability will be assessed; 
discrepancies will be resolved with discussion.  
Based on findings from focus groups, we will update/enhance WeChat content, 
create/program new content, and compile additional resources that support repeat HST, linkage, 
and risk reduction.  
Potential Risks and Benefits 
1. There is a risk of loss of privacy or confidentiality of data, including sensitive data on
sexual behaviors and psychological characteristics. We take this risk seriously, and we
will take steps to protect participants' confidential data and anonymity. We will ensure
that personal identifiers are removed from the data and any publications arising from the
study. The informed consent documents will bring confidentiality risks to participants'
attention. We will encourage participants to not disclose any content of the focus group
discussions.
2. Participants may experience psychological discomfort while completing qualitative
procedures, which will involve discussion or disclosure about HIV testing, sexual
behavior, HIV status, and physical health. We will take steps to minimize any
psychological discomfort. Research staff members will prepare a list of referrals to
address potential psychological problems in the target populations.
3. The risk of loss of privacy will be controlled (as described above) by using unique
participant ID numbers on all data rather than participant names. During the focus groups,
participant will be informed that they can use a pseudonym in order to keep their
identity/name unknown in the group discussions. We will develop a MOU with a
professional transcription agency to assure that all names or identifiers are omitted from
the transcripts, and that security protocols of all data recordings are maintained.
Research staff be trained on confidentiality issues. Only essential staff members will have
access to data and research files.
4. Participants may not receive any benefit for participating in this research project other
than having the opportunity to learn more about HIV self-testing and HIV-related sex risk
behaviors. This may lower their chance of exposure to HIV and other sexually transmitted
infections in the future.

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Inclusion of Women and Minorities 
All (100%) of the participants will be males ages 18 and over. In accordance with the research 
aims, 100% of participants will be non-White racial/ethnic minority individuals. All (100%) of the 
participants will be Chinese (Asian). 
Confidentiality 
In order to protect study participants from potential risks related to the breach of confidentiality, 
the following steps will be taken: 1) All information provided by the participant will be referenced 
to a participant ID# and will be kept in locked file cabinets. The patient’s ID# can be connected to 
the participant’s name only through a single master file, accessible only to authorized senior 
research staff and kept locked in a file separate from the data files. All data files entered on 
computers will be protected by passwords and computer disks will be maintained in locked file 
cabinets. 2) All research staff will be trained in the importance of maintaining confidentiality of the 
information obtained from patients and will undergo the mandatory NIH training in protection of 
human research participants. 3) All data collected from the participants will be presented in 
aggregate form and no participants will be identified individually. 
Audiorecordings will be identified only by participant ID# and interviewer. All digital 
audiorecordings will be stored in password-protected computer files. Participants will be made 
aware of the use of audiorecording during the informed consent process.  Audiorecordings will be 
destroyed following completion of primary analyses. Transcriptions will be stored in secure, locked 
computer files indefinitely. 

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Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk 
Men in China 
Informed Consent to Participate in Research 
Study Phase 1 
Introduction/Objective: You are being invited to participate in a research study conducted by 
Anhui Medical University. Collaborators for this project are Brown University, University of 
Arkansas Medical Sciences, and Johns Hopkins University (USA). The objectives of this research 
are to learn how to use WeChat to support people who use HIV self-test kits, and to provide 
linkage to care for people with HIV-positive self-test results. We are inviting participants who are: 
(a) male, (b) ages 18 years or older, (c) have had anal sex without a condom with another man in 
the past 6 months, (d) own a “smart” phone, (e) comfortable using WeChat.   
Procedures: If you agree to participate, the following will happen: 
• 
You will participate in an online focus group discussion  
• 
You will observe two video demonstrations about how to use the HIV self-test kit, 
and about the importance of HIV care for people with positive test results. 
• 
You will participate in a group discussion about your opinions of the videos, and 
provide feedback about how to use WeChat to improve HIV self-testing and linkage 
to HIV care for MSM. If you do not want to participate in a group discussion, you 
can choose to participate in an individual interview instead. 
• 
We will be recording the focus group discussion and we will transcribe the 
recordings. We will remove any personal identifying information from transcripts to 
protect your and others’ privacy and confidentiality. Members of the research team 
will analyze the written transcripts.  
Benefits: There is not a direct benefit for you for participating in this research project. If you agree 
to participate, you will be collaborating with Anhui Medical University and their partners to 
research how to improve HIV testing among men who have sex with men in China.  
Potentials Risks/Discomforts: Some of the questions ask about sensitive issues, which might 
be uncomfortable or embarrassing for you. You have the right to not answer any question if you 
do not want to. You can stop participation in the study at any time and for any reason. You do not 
have to provide a reason for skipping a question or stopping the study early. 
Compensation: You will receive 150 RMB for your participation in this study. 
Confidentiality: Your participation in this study will be entirely anonymous. We will not record 
your name. You do not have to sign any forms.  Your answers to the questions in the interview, 
which we will record and transcribe, will be used solely for the purpose of this study. No names 
will be reported to anyone.  
Voluntary Participation/Withdrawal: Your participation in this research is absolutely voluntary. 
You are free to change your mind about participating or withdraw your participation at any time.  
Contact Information: If you have any question or concern with respect to the project, please 
communicate with Zhang Hongbo, the Principal Investigator in charge of the project, at the 
following telephone number: 0551-5161169-8201 between 10:00 a.m. to 6:00 p.m.  

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If you agree to participate in the research study, you will receive a copy of this information sheet 
with all this information in case you have some concerns or questions about this study.  
CONSENT 
You will be given a copy of this consent form to keep. 
Your signature below shows that you have read and understood the information in this 
document, and that you agree to volunteer as a research participant for this study.  
Printed Participant Name (Optional) 
Signature of Participant (Optional) 
_______ 
Date 

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Recruitment information 
(for social media and internet sites) 
Volunteers Needed to Participate in a Research Project. 
We want your help to develop an effective program to reduce HIV and promote health for 
tongzhi (local word for men who have sex with men). 
Volunteers will participate in a confidential small-group discussion over the internet. Volunteers 
will watch brief videos about HIV testing and health services, and they will learn more about the 
intervention program.  Volunteers’ will provide feedback to help improve the intervention 
program. 
Volunteers will receive 150 RMB for their participation. 
Please email XXXXX or call XXXXX if you are interested. 

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WeTest – WeLink Focus Group Discussion Guide 
Welcome and thank you for volunteering to take part in this focus group. You have been asked to provide feedback 
on a new WeChat public account /公众号 “WeTest-WeLink” we are developing to promote HIV self-testing and to 
assist linkage to HIV care or prevention services.  We want to sincerely express our appreciation for your time and 
input.  
Introduction: This focus group discussion is designed to gather your thoughts and feelings regarding “WeTest-
WeLink”. We will show you various components of “WeTest-WeLink” and ask your feedback regarding content, 
applicability, features, and visual attractiveness. The primary purpose of this discussion is to capture feedback from 
potential users like you, and thus all candid feedback is appreciated. This focus group discussion will take no more 
than 90 minutes. As we informed you earlier, we would like to record this audio component of this discussion to 
help us remember and review comments from this group discussion. If anyone has a concern with recording. We 
will not be recording the visual component of this discussion. If anyone has concerns about recording the audio 
discussion, please use the Zoom/WeChat function to notify the research assistant, and that person will discuss your 
concerns privately. (Switch on the recorder on Zoom/WeChat for all members who remain in the discussion). 
Confidentiality:  Despite being audio recorded, I assure you that the discussion will be confidential. The recording 
will be stored in a highly secured server until it is transcribed word for word, and then it will be destroyed. 
Recordings will be accessed only by the study team through secure means. The transcribed notes of the focus group 
will contain no information that would allow individual participants to be linked to specific statements. You should 
try to answer and comment as accurately and truthfully as possible. I and the other focus group participants would 
appreciate it if you would refrain from discussing the comments of other group members outside the focus group. If 
there are any questions or discussions that you do not wish to answer or participate in, you do not have to do so; 
however, we certainly welcome all feedback you may have during the course of the discussion. 
Ground rules 
•
The most important rule is that only one person speaks at a time. There may be a temptation to
jump in when someone is talking but please wait until they have finished.
•
There are no right or wrong answers.
•
You do not have to speak in any particular order.
•
When you do have something to say, please do so. There are many of you in the group and it is
important that I obtain the views of each of you, if you want to contribute.
•
You do not have to agree with the views of other people in the group.
Does anyone have any questions? (answers) OK, let’s begin. 

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Warm up 
First, I’d like everyone to briefly introduce themselves. Can you tell us your given name (not your family name) or a 
nickname and tell us about one thing about yourself that you want to share with the group, such as your hobby.   
WeTest WeLink Demonstration – First Round: 
I am going to show you some sample content and layout of the content as it currently exists. I am going to show 
each feature, along with content examples in their entirety. Then, we will individually go through each feature and 
content example.  
During this first round, I would like you to pay attention to the content, features, and layout. 
(go over the “WeTest-WeLink” account) 
First Round Discussion Questions: Overall Impression 
•
What are your general impressions of the content after seeing it for the first time?
•
What do you think of the current layout?
•
Are there features that quickly caused a positive reaction when you saw them?
•
Are there features that gave you pause when you saw them?
•
After seeing it for the first time, how many of you would be excited to start using it?
•
Do you anticipate challenges or difficulties in using this account? If yes, what challenges do you
anticipate? [continue with follow-up questioning to individuals/group members].
•
What would make the account more ideal for promoting HIV self-testing and assisting people
who need to access HIV care or prevention services?
Second Round Discussion Questions  
OK, let’s go through the demonstration a second time, but we will pause after each feature is shown. 
1.
HIV self-testing demonstration video
Guiding Questions: 
•
What do you think of the video?
o
Usability
o
Positive/negative aspects of content
o
Understandability of the content
2.
HIV linkage to care demonstration video
Guiding Questions: 

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•
What do you think of the video?
o
Usability
o
Positive/negative aspects of content
o
Understandability of the content
3.
Other content: The account will house content in different forms of media (e.g. video, short
readings, memes, or short mentoring vignettes)
Showing content is designed to provide information relevant to: 
a.
Knowledge of HIV (e.g. details regarding HIV testing,
effectiveness of condom use, risk associated with multiple
partners, pre-exposure prophylaxis, treatment as prevention etc.)
b.
Linking to HIV care (e.g, details regarding CDC locations,
intake and registration, confidentiality, ART medications,
regular appointments, ongoing clinical assessments)
c.
Linking to HIV prevention services (e.g. resources for testing
sites, counseling and support services, behavioral prevention,
biomedical prevention).
Guiding questions: 
•
What do you think of the types of content you viewed?
•
What do you think of the specific content examples we provided?
o
Positive/negative reaction and reasoning
o
Suitability
o
Clarity
o
Relatability
•
Are there other occurrences where you think receiving a notification might
be needed or useful?
Wrap-up questions 
•
Of all the things we’ve seen and discussed today, what would you say are the most important issues you
would like to express as the WeTest-WeLink” development process moves forward? 
Conclusion 
•
Thank you for participating. This has been a very successful discussion.
•
Your opinions will be a valuable asset to the study.
•
We hope you have found the discussion interesting.
•
I would like to remind you that any comments featuring in the report coming from this discussion will be
anonymous. What you shared in this discussion will only be shared with the research and app development 
teams.  

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14
Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk 
Men in China 
Informed Consent to Participate in Research 
Study Phase 2 
Introduction/Objective: You are being invited to participate in a research study conducted by 
Anhui Medical University. Collaborators for this project are Brown University, University of 
Arkansas Medical Sciences, and Johns Hopkins University (USA). The objectives of this research 
are to use WeChat to support people who use HIV self-test kits, and to provide linkage to care for 
people with HIV-positive self-test results. We are inviting participants who are: (a) male, (b) ages 
18 years or older, (c) have had anal sex without a condom with another man in the past 6 months, 
(d) own a “smart” phone, (e) comfortable using WeChat.   
Procedures: If you agree to participate, the following will happen: 
• 
You will complete a survey to assess  
• 
You will observe two video demonstrations about how to use the HIV self-test kit, 
and about the importance of HIV care for people with positive test results. 
• 
You will participate in a group discussion about your opinions of the videos, and 
provide feedback about how to use WeChat to improve HIV self-testing and linkage 
to HIV care for MSM. If you do not want to participate in a group discussion, you 
can choose to participate in an individual interview instead. 
• 
We will be recording the focus group discussion and we will transcribe the 
recordings. We will remove any personal identifying information from transcripts to 
protect your and others’ privacy and confidentiality. Members of the research team 
will analyze the written transcripts.  
Benefits: There is not a direct benefit for you for participating in this research project. If you agree 
to participate, you will be collaborating with Anhui Medical University and their partners to 
research how to improve HIV testing among men who have sex with men in China.  
Potentials Risks/Discomforts: Some of the questions ask about sensitive issues, which might 
be uncomfortable or embarrassing for you. You have the right to not answer any question if you 
do not want to. You can stop participation in the study at any time and for any reason. You do not 
have to provide a reason for skipping a question or stopping the study early. 
Compensation: You will receive 150 RMB for your participation in this study. 
Confidentiality: Your participation in this study will be entirely anonymous. We will not record 
your name. You do not have to sign any forms.  Your answers to the questions in the interview, 
which we will record and transcribe, will be used solely for the purpose of this study. No names 
will be reported to anyone.  
Voluntary Participation/Withdrawal: Your participation in this research is absolutely voluntary. 
You are free to change your mind about participating or withdraw your participation at any time.  
Contact Information: If you have any question or concern with respect to the project, please 
communicate with Zhang Hongbo, the Principal Investigator in charge of the project, at the 
following telephone number: 0551-5161169-8201 between 10:00 a.m. to 6:00 p.m.  

Last updated 5/08/2020 
15
If you agree to participate in the research study, you will receive a copy of this information sheet 
with all this information in case you have some concerns or questions about this study.  
CONSENT 
You will be given a copy of this consent form to keep. 
Your signature below shows that you have read and understood the information in this 
document, and that you agree to volunteer as a research participant for this study.  
Printed Participant Name (Optional) 
Signature of Participant (Optional) 
_______ 
Date