Institute for Global Health & Infectious Diseases (IGHID) 11604 - Crowdsourcing to Promote HIV Testing: A Stepped Wedge Randomized Controlled Trial to Evaluate Promoting HIV Testing in China
Phase: NA
Conditions: HIV
Sponsor: University of North Carolina, Chapel Hill

 
1 
 
  
 
 
 
 
 
 
 
Crowdsourcing to Promote HIV Testing: A Pragmatic Stepped Wedge Randomized 
Controlled Trial to Evaluate Promoting HIV Testing in China 
 
Study Protocol  
1 March 2017 
Version 1.7  
NCT: NCT02796963 
 
 
 
 
 
 
 
 
 

 
2 
 
 
STUDY TEAM 
Partner Institutions: Guangdong Provincial Center for Skin Diseases and STI Control, 
University of North Carolina at Chapel Hill, University of California San Francisco, London 
School of Hygiene and Tropical Medicine, University of Bristol, Shandong University, 
Shandong Provincial CDC, Guangdong Provincial CDC, SESH Global 
  
PIs: Joseph D. Tucker, Chongyi Wei 
Survey development: Weiming Tang, Songyuan Tang, Chuncheng Liu, Haochu Li 
Statisticians: David Glidden, Chongyi Wei, Weiming Tang, Katie Mollan, Michael Hudgens 
MSM recruitment: Zihuang Chen, Chuncheng Liu, Larry Han 
Social media: Lisa Hightow-Weidman, Chongyi Wei, Kevin Fenton, Adam Saffer, Bolin Cao 
Modelling: Peter Vickerman, Kate Mitchell, Fern Terris-Prestholt, Kumi Smith, Jason  
Study design: Kumi Smith, Rosanna Peeling, Barry Bayus, Weiming Tang 
Guangzhou Team: Bin Yang, Shujie Huang, Weiming Tang, Songyuan Tang, Chuncheng 
Liu, Wei Zhang, Jessica Mao, Yilu Qin, Bolin Cao, Ligang Yang, Wang Cheng, Joseph 
Tucker, Rong Fu 
Jinan Team: Haochu Li, Wei Ma, Meizhen Liao, Dianmin Kang, Chongyi Wei 
Oversight: Bin Yang, Joseph Tucker 
External Advisory Board: Paul Volberding, George Rutherford, William Wong, Jinkou Zhao 
 
Funding support: National Institutes of Health (NIAID 1R01AI114310-01), UNC-South 
China STD Research Training Center (FIC 1D43TW009532-01), UNC Center for AIDS 
Research (NIAID 5P30AI050410), UCSF Center for AIDS Research (NIAID P30 
AI027763), NIMH (R00MH093201), UJMT Fogarty Fellowship (FIC R25TW0093), and 
SESH Global (www.seshglobal.org). Administrative assistance from the Guangdong 
Provincial Center for Skin Diseases and STI Control. UNC Chapel Hill, and UNC Project-
China in Guangzhou, China.  
 
 
 
 
 

 
3 
 
 
Addresses: 
Adam Saffer 
UNC School of Media and Journalism, Carroll Hall, CB 3365, Chapel 
Hill, NC 27599 
Barry Bayus 
McColl 4526, CB #3490, Chapel Hill, NC 
Chongyi Wei  
UCSF School of Medicine, Epidemiology & Biostatistics, 550 16th. 
Street, San Francisco CA 94158 
David Glidden 
Box 0560 , UCSF, San Francisco, CA 94143-0560 
Fern Terris-
Prestholt 
202 London School of Hygiene and Tropical Medicine, 15-17 
Tavistock Place, London, WC1H 9SH, UK 
Guangzhou Team1 
University of North Carolina Chapel Hill Project-China, No. 2 Lujing 
Road, Guangzhou, China, 510095 
Jason Ong 
Monash University, Wellington Rd & Blackburn Rd, Clayton VIC 
3800, Australia 
Jinan Team2  
 
School of Public Health, Shandong University, Baotuquan Campus, 
44 West Wenhua Road, Jinan, China, 250012 
Jinkou Zhao 
Nanjing Medical University, 140 Hanzhong Rd, Gulou, Nanjing, 
Jiangsu, China, 210029 
Joseph D. Tucker
 
 
University of North Carolina Chapel Hill Project-China, No. 2 Lujing 
Road, Guangzhou, China, 510095  
Kate Mitchell 
UG3, Norfolk Place, St Mary's Campus, Imperial College London, 
London, UK 
Katie Mollan 
UNC Center for AIDS Research, Lineberger Cancer Center, Chapel 
Hill, NC 27599 
Kevin Fenton 
Public Health England, Wellington House, 133-155 Waterloo Road, 
London, UK 
Lisa Hightow-
Weidman 
Division of Infectious Diseases, CB# 7030, Bioinformatics Building, 
130 Mason Farm Road, 2nd Floor, Chapel Hill, NC 
Michael Hudgens 
3107C McGavran-Greenberg Hall, CB #7420, Chapel Hill, NC 27599 
 
Paul Volberding 
George Rutherford 
UCSF School of Medicine, Epidemiology & Biostatistics, 550 16th. 
Street, San Francisco CA 94158 
 
Peter Vickerman 
Office OF21, Oakfield House, Oakfield Grove, Clifton BS8 2BN, UK 
Rosanna Peeling 
305b London School of Hygiene and Tropical Medicine, Keppel 
Street, London, WC1E 7HT, UK 
William Wong 
3/F., 161 Main Street,  
Ap Lei Chau Clinic, Ap Lei Chau, Hong Kong 
Zihuang Chen 
No. 2-B-028, Ping Guo She Qu, Bai Zi Wan Lu, Chaoyang, Beijing, 
China 
 
1Guangzhou team includes the following individuals: Weiming Tang, Songyuan Tang, 
Chuncheng Liu, Larry Han, Bolin Cao, Kumi Smith, Bin Yang, Shujie Huang, Wei Zhang, 
Jessica Mao, Yilu Qin, Ligang Yang, Wang Cheng, Rong Fu, Tiange Zhang 
2Jinan team includes the following individuals: Haochu Li, Wei Ma, Meizhen Liao, Dianmin 
Kang 
 
 

 
4 
 
Table of Contents 
1 List of Abbreviations ......................................................................................................... 5 
2 Summary ............................................................................................................................. 5 
3 Introduction ........................................................................................................................ 5 
3.1 Background.................................................................................................................. 5 
3.2 Specific Aims and Hypotheses ................................................................................... 6 
4 Trial Design ........................................................................................................................ 6 
4.1 Type of Trial ................................................................................................................ 6 
4.2 Rationale for Trial Design .......................................................................................... 7 
4.3 Randomization and Stratification ............................................................................. 7 
5 Trial Population and Measures ........................................................................................ 8 
5.1 Eligibility ...................................................................................................................... 8 
5.2 Recruitment ................................................................................................................. 8 
5.2.1 Online Recruitment ................................................................................................. 8 
5.2.2 CDC Data Collection .............................................................................................. 8 
5.3 Measures ...................................................................................................................... 9 
6 Intervention ........................................................................................................................ 9 
6.1 Intervention Development .......................................................................................... 9 
6.1.1 Crowdsourcing contest ............................................................................................ 9 
6.1.2 Designathon .......................................................................................................... 10 
6.2 Intervention Implementation ................................................................................... 11 
7 Statistical Considerations ................................................................................................ 12 
7.1 Primary Outcomes .................................................................................................... 12 
7.2 Secondary Outcomes................................................................................................. 13 
7.3 Sample Size Calculation ........................................................................................... 13 
7.4 Analysis Plan ............................................................................................................. 14 
7.4.1 Primary Outcome Analyses .................................................................................. 14 
7.4.2 Secondary Outcome Analyses .............................................................................. 15 
7.4.3 Sub-Analyses ........................................................................................................ 15 
8 Ethical approval ............................................................................................................... 15 
9 Trial status ........................................................................................................................ 15 
10 Appendix 1. Secondary outcomes measured as part of this RCT. ............................ 16 
11 References ....................................................................................................................... 18 
 
 
 
 

 
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1 List of Abbreviations 
CBO  
Community-based organization 
CDC  
Centers for Disease Control and Prevention 
CI 
 
Confidence interval 
GD 
 
Guangdong Province 
GEE 
 
Generalized estimating equations 
GLMM 
Generalized linear mixed models 
HIVST 
HIV self-testing 
MSM  
Men who have sex with men 
RCT 
 
Randomized controlled trial 
SD 
 
Shandong Province 
SESH  
Social Entrepreneurship for Sexual Health Group 
SMS  
Short Message Service text message 
2 Summary 
Crowdsourcing may be a useful tool for spurring innovation in HIV test promotion 
campaigns. Crowdsourcing is the process of shifting a task from an individual to a group, 
often in the form of an open contest. The purpose of this stepped wedge randomized 
controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting 
HIV testing among Chinese MSM.  The crowdsourced intervention will include an open 
contest, judging to determine finalists and prizes, a designathon, and contest-based MSM 
engagement.  The hypothesis is that a crowdsourced intervention will be superior to 
conventional HIV test uptake campaigns in eliciting HIV test uptake. 
3 Introduction 
3.1 
Background 
Key population HIV testing, especially among young key populations, is urgently needed.1 
However, many young key populations are not well reached by conventional HIV testing 
campaigns.  Operational research has demonstrated that many HIV testing campaigns do not 
reach them.2  This is the case in China where approximately 40% of men who have sex with 
men (MSM) have never received HIV testing.3  Low levels of MSM community engagement, 

 
6 
 
hesitancy to access facility-based services, and low trust in facility-based services all 
constrain MSM HIV testing programs in China.4 
 
Preliminary data from our team suggests that crowdsourcing may be a useful tool to 
overcome these challenges and increase HIV test uptake among MSM.5  An online RCT 
found that 37% of MSM without any HIV test experience who viewed a crowdsourced video 
subsequently reported receiving first-time HIV testing within one month.6  Qualitative data 
from our research group has shown that crowdsourcing contests empower individuals and 
result in a range of community engagement.7  
 
3.2 
Specific Aims and Hypotheses 
Specific Aim 1: To compare HIV test uptake associated with a crowdsourced intervention to 
that associated with conventional HIV test uptake campaigns.  
Hypothesis 1: A crowdsourced intervention is superior in eliciting HIV test uptake compared 
to conventional HIV test uptake campaigns. 
 
Specific Aim 2:  To compare secondary outcomes (including incremental cost, condom use, 
HIV testing social norms, syphilis testing, etc.) of a crowdsourced intervention to those of 
conventional HIV test uptake campaigns. 
Hypothesis 2: A crowdsourced intervention is superior in promoting a range of healthy 
behaviors and HIV testing social norms. 
4 Trial Design 
4.1 
Type of Trial 
This study will use an adaptation of the stepped wedge randomized controlled trial (RCT) 
design (Figure 1). In the stepped wedge RCT, study sites are randomized to begin the 
intervention at different times so that by the end of the study period all sites have initiated the 
intervention. A total of eight major metropolitan cities - four from Guangzhou Province 
(Guangzhou, Jiangmen, Zhuhai, Shenzhen) and four from Shandong Province (Yantai, Jinan, 
Qingdao, Jining) - will implement the crowdsourced intervention. These cities were chosen 
based on the following criteria: 1) previous CDC MSM sentinel surveillance site; 2) capacity 

 
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for campaign implementation; 3) capacity for intervention implementation at community 
level. Four cities (Guangzhou, Shenzhen in Guangdong Province, Qingdao, and Jinan in 
Shandong Province) will implement more intensive in-person events to promote engagement 
during the intervention development phase. Intervention development and implementation are 
described in detail in later sections.  
4.2 
Rationale for Trial Design 
A number of factors influenced our decision to adopt a pragmatic stepped wedge RCT 
design. Unlike a tightly controlled explanatory trial, a pragmatic trial evaluates an 
intervention in a real life context. We aim to understand whether crowdsourced interventions 
work in the range of local settings. A pragmatic design allows us to examine this intervention 
in eight different cities. In addition, two previous studies demonstrate that crowdsourcing can 
enhance HIV interventions among MSM.6,8 Given that we will recruit MSM with a known 
high risk of acquiring HIV infection, withholding our intervention to a subgroup of 
participants would be difficult. A stepped wedge RCT design addresses this ethical concern 
by ensuring all participants receive the intervention.  
4.3 
Randomization and Stratification 
The eight cities will be randomized to initiate intervention in groups of two at three-month 
intervals (Figure 1). The order of intervention implementation at four cities within each 
province (Guangdong and Shandong Provinces) will be randomized using SAS software. One 
city in Guangdong Province and one city in Shandong Province will then begin intervention 
simultaneously, i.e. city-level randomization will be stratified by province. While waiting to 
initiate the intervention, cities will continue conventional campaigns that are part of the 
routine activities of local CDC and CBOs.  
Figure 1.  Stepped-wedge study design 
Phase 
Prep. 
Intervention 
 
Months 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 11 12 13 14 15 16 
CDC surveillance survey 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop intervention and recruit online cohort in 8 cities  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Guangzhou (GD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Yantai (SD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Jiangmen (GD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Jinan (SD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Zhuhai (GD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Qingdao (SD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Shenzhen (GD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
Jining (SD) 
 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 
 
* 
 

 
8 
 
*represents online survey at baseline and every 3 months thereafter. Gray shading represents roll-out of the intervention. 8 
city clusters; 5 time periods; randomization stratified by 2 provinces (Guangdong, Shandong) 
5 Trial Population and Measures 
5.1 
Eligibility 
Eligibility criteria will include: currently living and planning to live in the eight cities for the 
next 12 months; not living with HIV; no HIV test in the past three months; born biologically 
male and identify as either male or transgender; had oral or anal sex with men at least once 
during their lifetime; 16 years and older; willing to provide cell phone number (for follow up 
and incentive delivery purposes); completed the informed consent document. MSM who meet 
all other eligibility criteria but received testing in the past three months or living with HIV 
will be invited to complete a single survey, but not followed over time in the cohort.  
5.2 
Recruitment 
5.2.1 Online Recruitment 
We will build our questionnaire on Sojump Survey Software (Sojump, Shanghai, China). 
Men will enter the study through website and social media banner/word advertisements, yet 
only those who lived in the 8 study cities could launch the questionnaire with the survey 
platform’s IP address restriction function. China’s largest gay app, BlueD, will be used to 
target recruitment within the eight cities. Eligible men will be invited to join the online 
cohort. No names or addresses will be collected from participants. In addition to the direct 
recruitment through websites and social media advertisements, participating individuals will 
be invited to refer up to three friends from their social networks, and 10 RMB will be given 
to them as incentive for each eligible participants they successfully invited. All individuals 
who enroll in the study will receive a 50 RMB (8.50 USD) pre-paid cell phone card for the 
first follow up and 50 RMB for each subsequent follow up.  Those who complete all surveys 
will be given an opportunity to win an iPad mini. Surveys will be given at baseline and every 
three months thereafter (Figure 1).  
5.2.2 CDC Data Collection 
MSM surveillance sites in each of the eight cities will have additional questions added about 
viewing SESH images, social media engagement with SESH, contributing to SESH contests, 

 
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exposure to other ongoing campaigns, HIV/syphilis testing, HIV/syphilis test results. All men 
who enter surveillance sites in these cities will also be invited to take part in the online 
cohort. Following informed consent, cell phone numbers will be used to link CDC and online 
survey data sets.    
5.3 
Measures 
Information on socio-demographics, sexual behaviors, and psychosocial conditions will be 
collected using standardized online survey tools. Socio-demographic characteristics include 
participants’ age, highest level of education completed, annual income, marital status, sexual 
orientation, and sexual orientation disclosure. Behavioral and psychosocial variables include 
self-reported HIV testing, syphilis testing, HIV self-testing, HIV test-associated stigma, 
frequency of sex, condom use (condomless sex, sex always with condom, and no sex), HIV 
testing social norms, HIV testing self-efficacy, community engagement, campaign 
engagement, MSM empowerment.  
6 Intervention 
6.1 
Intervention Development 
The intervention will be developed from a nationwide crowdsourcing contest and a 
designathon (Figure 2). The crowdsourcing contest will generate intervention materials that 
will later be packaged via the designathon into core elements of an HIV testing campaign. 
This ensures crowd wisdom is utilized through the entire intervention, from idea generation 
to campaign implementation.  
6.1.1 Crowdsourcing contest 
The first part of the crowdsourcing contest will be an open call for concepts (< 500 
characters) or images (photographs, posters, drawings, etc.) promoting HIV testing among 
young men in China. This open call will be announced on social media platforms nationwide. 
Social media promotion will include QQ, Weibo, WeChat announcements and short videos 
explaining the contest from SESH and our community partners in each city (CBOs and 
student groups interested in HIV testing). Social media will also serve as a channel for 
announcing prizes, deadlines, and other relevant information. Four cities (Guangzhou, 
Shenzhen in Guangdong Province, Qingdao, and Jinan in Shandong Province) will 

 
10 
 
implement in-person events in addition to social media promotion. In-person events will 
include community-based introductions, interactive feedback sessions, and community-
driven events (decided by community partners). Multiple incentives, including chances to 
win an iPad Mini, cash, post cards, etc., will be included to encourage contest participation.  
 
Crowdsourced entries will be evaluated by a crowd panel and an expert panel. The crowd 
panel consists of MSM from each of the eight cities while the expert panel consists of 
professionals from CDC, CBOs, and universities in the eight cities. These local panels 
increase the likelihood that local preferences would be incorporated, which may facilitate 
later implementation. The quality of crowdsourced ideas will be judged based on four 
established dimensions: novelty, relevance, feasibility, and elaboration. Judges will consider 
the four dimensions and score an entry on a 10-point scale. Given that a large number of 
judges evaluating a relatively small number of entries have been shown to be internally 
consistent and externally valid, each judge in our contest will evaluate no more than 20 
entries. Based on the number of entries, we will ensure enough judges are recruited so that 
each entry has at least three independent ratings. Following these judging criteria, all entries 
will first be screened to check for relevance to our contest and plagiarism. Next, 40 concepts 
and/or images will be identified by the crowd panel and expert panel. Scores from the expert 
panel will be used to announce contest winners. All 40 concepts and/or images will be 
recognized as finalist entries and be presented as materials for the designathon. The 
crowdsourcing contest and judging are planned to span a three-month period. 
6.1.2 Designathon 
The designathon will use finalist concepts and/or images to develop core elements of an HIV 
testing campaign. A designathon is similar to a hackathon,9,10 but focused instead on 
designing a campaign. Teams are formed with an emphasis on multi-sectoral partnership. 
Each team consists of one CDC worker and one MSM CBO leader from each of the eight 
cities as well as three participants selected from a nationwide application. A group of mentors 
from communication, design, social work, and public health background will also be 
available for consultation to all teams. Teams will have 72 hours to brainstorm and generate a 
written intervention plan that incorporates concepts and images from the crowdsourcing 
contest. A group of judges will evaluate team entries and select design elements to be 
included in a final, HIV test promotion campaign. Winners will be recognized with awards. 
 

 
11 
 
The final campaign will be implemented at both the individual and community levels using 
social media, in-person events, and other crowdsourced ideas for implementation. After the 
RCT is complete, we will launch an image bank that allows free access to 
images/taglines/concepts developed as part of the contest. 
6.2 
Intervention Implementation 
Phased implementation will be carried out in the eight cities following the stepped wedge 
RCT design (Figure 1). Implementation in each city will be locally adapted based on crowd 
feedback from the contest and the designathon. The intervention will be implemented at the 
individual level (via WeChat messages and SMS) and at the community level (via 
community partners including CDC, CBOs, and social media influencers) (Figure 2).  
 
For individual-level implementation, the campaign content (images and/or concepts) will first 
be shown to the online cohort at the end of the baseline survey, and then repeated once every 
two weeks for the next three months. Half of the online cohort will receive the campaign 
content via WeChat message while the other half will receive the campaign content via SMS 
text message. For community-level implementation, community partners in each city will 
facilitate the campaign using crowdsourced implementation ideas generated from the 
designathon.  
 
Figure 2. Schematic diagram of intervention development and implementation.   
 
*Finalist entries will be selected after an initial screening followed by crowd panel and expert panel judging (Detailed under 
“Crowdsourcing contest”). 
**Crowdsourcing contest winners will be selected based on expert panel scores. 
***Individual-level implementation will be divided based on delivery method into two groups: intervention via WeChat message vs. 
intervention via SMS text message. 
a: Crowd involvement in crowdsourcing contest consists of a nationwide, open call for submission of concepts and/or images related to 
promoting HIV testing among untested individuals. 

 
12 
 
b: Crowd involvement in designathon consists of multi-sectoral team members working with guidance from professionals to design an 
intervention plan. 
c: Crowd involvement in community-level implementation entails participation in contests and campaign events held by local CDC and 
CBOs.    
 
HIV self-testing intervention  
SESH implementation team will send out cohort participants an invitation of receiving free 
HIV testing kit through a confidential message on social media. Our research team had 
friended the participants on social media (WeChat) which allows private interaction with 
them. Individuals who would like to receive this test kit will be directed to an online form 
that allows them to provide an alias (not their real name), an address, and their cell phone 
number.  These three identifiers will be stored separately in Guangzhou in a locked cabinet. 
Our research assistant will identify the cohort participants by checking whether the mobile 
phone number is registered in our baseline survey. Men who provide their address will have a 
test kit mailed to them. The HIV self-testing package will be sent to participants. The HIV 
self-test kit is organized in partnership with Guangzhou Tongzhi (GZTZ), a local CBO. The 
test kits will be offered by SESH. The cover of the mail box will be labeled as “gift”. The 
mail boxes will be delivered by a courier service. Individuals will be able to implement and 
interpret the test wherever they want, but will be encouraged to send a photograph of the test 
result back to our research team through WeChat, which is convenient with a smartphone and 
has no cost. Individuals who have questions can also contact the study research office in 
Guangzhou over phone or through social media.  Individuals who have a positive test will be 
able to contact the study research office for information about linkage to care and counseling. 
 
7 Statistical Considerations 
7.1 
Primary Outcomes 
The primary outcome of this study will be HIV test uptake over the previous three months. 
This will be assessed by self-report during follow up survey and triangulated with HIV 

 
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testing surveillance data from the CDC. A difference of 10% in testing rate (assuming a 
proportion of HIV testing of 35% during the crowdsourced intervention period and 25% 
during the conventional intervention period) was chosen based on existing levels of HIV 
testing and what would be feasible and have public health importance in the Chinese context. 
The CDC measurement of the primary outcome will be the difference between HIV testing 
comparing the three months immediately prior to the intervention and the three months of the 
intervention.  
7.2 
Secondary Outcomes 
A number of secondary outcomes will also be measured. These include syphilis testing, 
condomless sex, community engagement, testing stigma, and others (Appendix 1). Outcomes 
will also be stratified based on the level of engagement in developing the intervention, and 
based on the personal level of engagement during the stage of intervention implementation. 
7.3 
Sample Size Calculation 
We used a binary outcome stepped-wedge randomized controlled trial design for sample size 
calculation. The required sample size is calculated for the primary outcome. To calculate 
sample size, we assumed that a crowdsourced intervention will be superior to a conventional 
method in promoting HIV testing among MSM who never tested for HIV. Assuming a 
proportion of HIV testing of 35% during the crowdsourced period and 25% during the 
conventional period, total number of clusters of eight, total number of time period for 
intervention of four, coefficient of variation of 0.4 (usually between 0.15 and 0.4), 2-sided 
alpha=0.05, 90% power, and 30% loss to follow up, then the total sample size will be 1040 
men (130 for each city). To further improve the power for sub-analysis and secondary 
outcomes, we will increase the sample size to 1280 men (160 for each city). The calculation 
was made using the formulas developed by Michael A. Hussey et al.11 
(http://faculty.washington.edu/jphughes/pubs.html).  
Table 2: sample size calculation 
Pi* Pc$ 
Number 
of 
clusters 
Number 
of time 
periods  
Coefficient 
of 
variation@ 
Alpha Power 
Sample 
size/no 
LTFU  
Loss 
to 
follow 
up 
Sample 
size for 
each 
cluster 
Total 
sample 
size (8 
clusters) 

 
14 
 
30 
20 
8 
5 
0.4 
0.05 
0.9 
80 
30% 
114  
912 
30 
20 
8 
5 
0.15 
0.05 
0.9 
71 
30% 
101  
808 
30 
15 
8 
5 
0.4 
0.05 
0.9 
31 
30% 
44  
352 
30 
15 
8 
5 
0.15 
0.05 
0.9 
26 
30% 
37  
296 
35 
25 
8 
5 
0.4 
0.05 
0.9 
91 
30% 
130  
1040 
35 
25 
8 
5 
0.15 
0.05 
0.9 
83 
30% 
119  
952 
35 
20 
8 
5 
0.4 
0.05 
0.9 
37 
30% 
53  
424 
35 
20 
8 
5 
0.15 
0.05 
0.9 
31 
30% 
44  
352 
40 
30 
8 
5 
0.4 
0.05 
0.9 
99 
30% 
141  
1128 
40 
30 
8 
5 
0.15 
0.05 
0.9 
93 
30% 
133  
1064 
40 
25 
8 
5 
0.4 
0.05 
0.9 
42 
30% 
60  
480 
40 
25 
8 
5 
0.15 
0.05 
0.9 
36 
30% 
51  
408 
45 
35 
8 
5 
0.4 
0.05 
0.9 
104 
30% 
149  
1192 
45 
35 
8 
5 
0.15 
0.05 
0.9 
99 
30% 
141  
1128 
45 
30 
8 
5 
0.4 
0.05 
0.9 
45 
30% 
64  
512 
45 
30 
8 
5 
0.15 
0.05 
0.9 
40 
30% 
57  
456 
 
Note: *Pi: probability of HIV testing during intervention period; $Pc: probability of HIV 
testing during control period; @ usually between 0.15-0.4. 
 
7.4 
Analysis Plan 
7.4.1 Primary Outcome Analyses 
The primary outcome will be self-reported HIV testing uptake in the past three months. We 
will examine the hypothesis comparing the superiority of the crowdsourced intervention 
compared to conventional HIV test uptake campaigns. In our study, since the outcome is 
binary, generalized linear mixed models (GLMM) and generalized estimating equations 
(GEE) can be used in our study for the primary outcome analysis. However, since we only 
have eight clusters, GLMM will be used for primary data analysis in our study; GLMM is 
preferred in studies with a small number of clusters12. The model will include intervention 
status and time as fixed effects and site and individuals as random effects. The estimated 
intervention effects will be reported with 95% CIs and p values. Descriptive analysis will be 

 
15 
 
used to summarize the characteristics and behaviours of the participants at baseline and 
follow-up surveys.  
7.4.2 Secondary Outcome Analyses 
Similar analyses will be conducted for binary secondary outcomes (continues variables will 
be categorized into binary variable), including frequency of syphilis testing, frequency of 
HIV testing (among those with previous HIV testing), condomless sex, community 
engagement, awareness of HIV status, empowerment and others. In addition, since four cities 
will implement more intensive in-person events to promote engagement (Guangzhou, 
Shenzhen, Qingdao, and Jinan) during intervention development, sub-analysis will be 
conducted to evaluate the potential effect of in-person events to promote HIV testing and 
other secondary outcomes among Chinese MSM. In addition, secondary analysis will 
investigate an interaction effect between intervention and community engagement (both for 
engagement during the intervention development stage and engagement during the 
intervention implementation stage, at personal level).  
7.4.3 Sub-Analyses 
Sub-analysis will also be conducted to compare the effect of the intervention in participants 
with different age (less than 30 versus 30 or older), and to compare two delivery methods for 
individual-level intervention: WeChat message vs. SMS text message.  
8 Ethical approval 
IRB approval will be obtained from the following institutional ethical review boards prior to 
study enrolment: Guangdong Provincial Center for Skin Diseases and STI Control, 
University of North Carolina at Chapel Hill, and University of California San Francisco.   
9 Trial status 
At the time of this draft, intervention development and participant recruitment have initiated. 
Study outcomes, data cleaning, and analysis are pending. The study is registered in the 
Clinical Trials.gov database (NCT02796963). 
 
 

 
16 
 
10 Appendix 1. Secondary outcomes measured as part of this RCT. 
Secondary Outcome 
Definition 
Incremental cost  
Incremental cost, defined as the cost associated with 
respective interventions (development, start-up, 
implementation, condom use, intervention per individual 
who reported no sex or sex with a condom during the 
follow-up period.) 
Condom use 
Frequency of men, defined as the number of men who 
reported increased condom use (in anal, vaginal, and/or 
oral sex with either male and female sex partners) 
comparing pre-intervention and post-intervention values 
HIV testing social 
norms 1 
Frequency of men, defined as number of men who report 
higher levels of social norms when comparing their pre-
intervention and post-intervention HIV testing norms 
HIV testing self-
efficacy 2 
Frequency of men, defined as number of men who had an 
increase in HIV testing self-efficacy when comparing 
their pre-intervention and post-intervention self-efficacy 
Community 
engagement/ MSM 
community affiliation 
Frequency of men, defined as an increase in closer 
affiliation with the MSM community (i.e., tongzhi circle, 
gay online networks or groups) when comparing their pre-
intervention and post-intervention engagement 
Campaign engagement Frequency of men, defined as number of men who had an 
increase in taking part in the HIV testing campaign when 
comparing their pre-intervention and post-intervention 
engagement 
HIV self-testing 
Frequency of men, defined as the number of men who 
reported being self-tested for HIV during the previous 
three months  
Anticipated HIV 
stigma 3 
Frequency of men, defined as number of men who report 
anticipated HIV stigma when comparing their pre-
intervention and post-intervention 
Syphilis testing  
Frequency of men, defined as the number of men who 
reported being tested for syphilis (excluding HIV) during 
the previous three months 
Weibo engagement 
Frequency of men, defined as the number of men who 
reported using Weibo in the past three months to give or 
receive information about HIV testing comparing their 
pre-intervention and post-intervention engagement 
(Except the intervention delivered by SESH) 
Wechat engagement 
Frequency of men, defined as the number of men who 
reported using Wechat in the past three months to give or 
receive information about HIV testing comparing their 
pre-intervention and post-intervention engagement 
(Except the intervention delivered by SESH) 
QQ engagement 
Frequency of men, defined as the number of men who 
reported using QQ in the past three months to give or 
receive information about HIV testing comparing their 

 
17 
 
pre-intervention and post-intervention engagement 
(Except the intervention delivered by SESH) 
Mobile app 
engagement 
Frequency of men, defined as the number of men who 
reported using mobile apps in the past three months to 
give or receive information about HIV testing comparing 
their pre-intervention and post-intervention engagement 
 
1 HIV testing social norms will be measured using six survey items that are each on a five point Likert scale.  Increased HIV testing social 
norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly (social norm 
change will be categorized into three groups: increased, stable and decreased social norm).  The HIV testing social norm outcome will be 
assessed in the entire group as well as the subgroup of men who were referred by their friends. This is adapted from Pettifor, A., MacPhail, 
C., Suchindran, S, & Delany-Moretlwe, S. (2015). Factors associated with HIV testing among public sector clinic attendees in Johanesburg, 
South Africa. AIDS and Behavior, 14, 913-921. 
2 Self-efficacy will be measured using six survey items that are each on a five point Likert scale.  Increased self-efficacy will be defined as 
having an increase from baseline in any two of these seven survey items and dichotomized accordingly (self-efficacy change will be 
categorized into three groups: increased, stable and decreased self-efficacy).  This is adapted from Gu, J., Lau, J. T. F., & Tsui, H. (2011). 
Psychological factors in association with uptake of voluntary counselling and testing for HIV among men who have sex with men in Hong 
Kong. Public Health, 125, 275-282. 
3 The Anticipated HIV Stigma will be assessed using 7 survey items that are each on a four point Likert scale. Reduced anticipated HIV 
stigma will be defined as having a decrease from baseline in the mean score (Continuous variable). This is adapted from Golub, S. A. & 
Gamarel, K. E. (2013). The impact of anticipated HIV stigma on delays in HIV testing behaviors: Findings from a community-based sample 
of men who have sex with men and transgender women in New York City. AIDS Patient Care and STDs, 27(11), 621-627. 
 
 
 
 
 

 
18 
 
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