IGHID 12118 - Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China: The PIONEER Pragmatic Randomized Controlled Trial
Phase: NA
Conditions: Gonorrhea, Chlamydia
Sponsor: University of North Carolina, Chapel Hill

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Pay-it-forward gonorrhea and chlamydia testing among men in China: The PIONEER 
pragmatic randomized controlled trial 
 
Study Protocol Version 4.0 
Version date 15Nov022 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Background: Gonorrhea is one of the most common sexually transmitted diseases (STDs) 
among men who have sex with men in China. Past studies have shown that pay-it-forward 
(PIF) approaches premised on upstream reciprocity theory have been associated with a 
substantial increase in gonorrhea test uptake compared to standard of care. We propose the 
Pay-It-forward gONorrhEa tEsting randomized controlled trial (PIONEER) to examine the 
effectiveness of two implementation strategies involving different levels of community 
engagement to translate the generosity created by the pay-it-forward approach into test-taking 
action. 
Methods: PIONEER will be a three-arm, programmatic cluster randomized controlled trial 
(RCT) to compare effectiveness of the three implementation strategies, followed by a mixed-
methods implementation evaluation study. For the cluster RCT, we will enroll 12 diverse 
clinics which will be randomly assigned to one of the intervention arms for delivering 
gonorrhea testing: a standard pay-it-forward implementation strategy with minimal 
encouragement to get tested, a community-engaged pay-it-forward strategy, and a control 
arm in which men pay for their own STD test. The primary outcome of the RCT will be 
gonorrhea test uptake and secondary outcomes will include chlamydia testing, syphilis 
testing, STD treatment among those with infection, amount donated, 100% condom use, and 
antimicrobial resistance. A sequential explanatory mixed methods design will be used to 
evaluate the implementation process. Data sources will include survey data on acceptability 
of intervention, intervention appropriateness, feelings and attitudes towards interventions 
among participants, administrative data about test uptake, treatment rate, and donations, as 
well as qualitative data to gain insights about men’s perceptions and attitudes towards the 
pay-it-forward interventions strategies, mechanisms driving uptake and donating behaviors. 
Both survey and qualitative interviews with implementers and organizers about fidelity and 
adherence to protocol, intention to continue and maintain a pay-it-forward intervention, and 
barriers and facilitators of implementing the intervention will be conducted. 
Discussion: PIONEER will substantially increase gonorrhea testing among MSM in China, 
providing an innovative new financial mechanism to sustain STD screening among sexual 
minorities in low- and middle-income countries. This study will answer compelling scientific 
questions about how best to implement pay-it-forward and the individual and organization 
characteristics that moderate it. 
 
Contributions to the literature 
• This cluster randomized controlled trial aims to examine the effectiveness of two 
implementation strategies involving different levels of community engagement to 
translate the generosity created by the pay-it-forward approach into test-taking action. 
• A sequential explanatory mixed methods design will be used to evaluate the 
implementation process to determine mechanisms by which pay-it-forward motivates 
testing and donations across the two intervention arms, and how these are moderated 
by individual and organizational characteristics.  

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• This study will answer compelling scientific questions about how best to implement 
pay-it-forward and the individual and organization characteristics that moderate it. 
 
 

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Background 
Gonorrhea is common among MSM in China. Gonorrhea is one of the most common 
sexually transmitted diseases (STDs) worldwide and in China. The World Health 
Organization estimated that there were 87 million  new cases of gonorrhea among people 15-
49 years old based on a global systematic review5. The prevalence of gonorrhea among MSM 
in southern China has been reported as high as 12.5%6-7. Gonorrhea is known to increase the 
risk of HIV acquisition and transmission, but is often asymptomatic at extragenital sites. 
Gonorrhea testing rates among MSM are low. World Health Organization9 and United States 
Centers for Disease Control and Prevention guidelines10 recommend routine gonorrhea 
testing for sexually active MSM. Studies in different provinces of China consistently report 
less than half of MSM have ever been tested for gonorrhea11-12. Low testing rates are 
problematic because this allows onward gonorrhea transmission 
Low testing rates likely related to fees and minimal community engagement. User fees are 
common in many low and middle-income countries for STD testing and discourage test 
uptake12, decreasing opportunities for prompt treatment and public health interventions11,13. 
Gonorrhea testing in China is expensive, not covered by health insurance, and not covered by 
other social support systems. This decreases access to routine gonorrhea testing14. Some 
young MSM may opt to self-pay for STD services in order to decrease the risk of parents, 
insurance providers, or others knowing about their need for services15. In addition to 
financing problems, community engagement in STD testing is often weak.58 Many MSM 
campaigns for STD testing are driven by public health authorities and have limited authentic 
input from local end-users16. This limited participation may then diminish STD test uptake. In 
response to these financial and community barriers to STD testing, our team developed a pay-
it-forward approach to gonorrhea testing for MSM. 
Pay-it-forward has a person receive a free gonorrhea test from the local community and then 
decide to donate money to support subsequent testers (Figure 1)17,18. Pay-it-forward fits 
within the broader field of behavioral economics which uses multiple disciplines to 
understand human decision making. Pay-it-forward chains of giving are sometimes driven by 
unconnected generous individuals18, but more often organized by a group with a common 
purpose19,20. Studies have shown that pay-it-forward can be sustainable and promote 
generosity21.  
 
Figure 1. Overview of pay-it-forward. *Participatory activities such as open calls to create 
handwritten messages in the community-engaged implementation strategy. Warm glow refers to 

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a positive feeling after receiving a gift. 
 
Our previous pay-it-forward research showed that it was associated with a substantial 
increase in gonorrhea test uptake compared to standard of care22,23. However, these studies 
have several limitations. First, the projects were mostly, although not entirely, implemented 
at MSM-led clinics. These clinics serve MSM who are more likely to disclosure their sexual 
orientation compared to MSM who present to public clinics. Alongside the MSM volunteers 
at MSM-led clinics, these sites are likely in a better position to organize MSM community 
engagement activities15. In addition to MSM-led clinics, public clinics also provide gonorrhea 
testing and treatment for MSM. Public clinics include HIV testing sites and STD clinics that 
receive support from public health authorities. Public clinics have higher rates of linkage to 
care and are more likely to have antibiotic therapy on-site. Second, MSM included in these 
two studies were mostly younger, better educated, higher income, and more willing to donate. 
The pay-it-forward intervention needs to be evaluated in additional cities and different types 
of clinic (i.e., both MSM-led and public clinics). Last, the previous study showed that pay-it-
forward was effective compared to standard of care, but for scale up, explicit and intentional 
support for implementation is needed.  Lack of implementation evaluation limits our 
understanding of the implementation process and community-engaged strategies are needed 
to maximize the efficiency and effectiveness. These underscore the importance of 
implementation research to inform contextually appropriate strategies to implement pay-it- 
forward most effectively at scale.  
We propose the Pay-It-forward gONorrhEa tEsting randomized controlled trial (PIONEER) 
to examine the effectiveness of two implementation strategies involving different levels of 
community engagement to translate the generosity created by the pay-it-forward approach 
into test-taking action. In the standard approach, men receive the gift of a free test and view 
messages promoting testing. In the community-engaged approach, men receive gifts, view 
tailored messages, are encouraged to create tailored messages of their own and are invited to 
become part of a community of collaborators engaged in promoting gonorrhea testing.  
Community-engaged approaches are important for enhancing contextual appropriateness of 
public health interventions and possibility of success.1 The objectives of the study are 
threefold:   
1) To compare point-of-care gonorrhea test uptake in a standard pay-it-forward 
implementation strategy arm, a community-engaged pay-it-forward implementation 
strategy arm, and a control arm using a three-arm cluster randomized controlled trial. 
2) To determine mechanisms by which pay-it-forward motivates testing and donations 
across the two intervention arms, and how these are moderated by individual and 
organizational characteristics.  
 
Theories informing the PIONEER intervention 
Our trial design and pay-it-forward strategies were informed by two theories/principles. First, 

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the pay-it-forward is a novel concept embedded in upstream reciprocity theory. Upstream 
reciprocity is defined as individuals helped by someone are more likely to help other 
unspecified people.  
Upstream reciprocity theory has been used to understand the mechanism of pay-it-forward 
within a community. The idea is that if someone is generous to you, it generates a “warm 
glow” that encourages you to be generous to others. In the context of pay-it-forward, the 
hypothesis is that someone receiving a gift feels an obligation to be generous to the 
community by getting tested, and also by contributing a gift in return.  
Principles guiding the design of community engagement elements  
Our implementation strategies were developed based on community -based participatory 
research (CBPR)26.   Community participation is essential to the acceptance and contextual 
appropriateness of an intervention strategy.1 This is especially important for hard-to-reach 
sexual minority groups. CBPR involves having the target community participating in several 
phases of the research process to address a health research question26. CBPR is appealing as it 
generates community engagement and amplifies voices of neglected populations in service 
delivery strategy designs. It is a bottom-up, user-centered approach which leads to the 
development of culturally appropriate intervention strategies.   Evidence has shown 
community engagement in developing intervention strategies is associated with better 
acceptance, adherence, and effectiveness of the interventions in changing behaviors in a 
favorable way. We will use CBPR to guide following activities: 1) organizing a co-creation 
group to co-create the community-engaged pay-it-forward strategy and forming shared 
leadership; 2) guiding the design of community engagement elements of the community-
engaged strategy; 3) involving key stakeholders in various stages of the project to enhance 
appropriateness, acceptability and feasibility.  
Effectiveness-implementation (EI) hybrid trial design  
Hybrid effective-implementation study designs are emerging as a useful research method to 
examine not only the intervention outcomes but also the implementation process that may 
affect the intervention effectiveness to various degrees. Evaluating the implementation 
outcomes collects evidence about the intervention delivery process which can inform future 
evidence-based practices, facilitate replication or scale-up, and translate research findings to 
routine practices. We define our trial as a hybrid implementation-effectiveness design in 
which we aim to identify an optimal pay-it-forward delivery strategy (ie, community-engaged 
pay-it-forward versus standard pay-it-forward strategies and a control arm without pay-it-
forward components) by comparing effectiveness of these three strategies, and in the 
meantime, examine the implementation process of the two pay-it-forward strategies guided 
by RE-AIM framework.  
Implementation evaluation framework 
Finally, we used the RE-AIM evaluation framework to define outcomes in the five key 
domains for evaluating the implementation process and how different factors may affect 
intervention effectiveness. The RE-AIM framework is one of the most commonly used 

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frameworks to evaluate implementation of an intervention. It guides the development of 
implementation-focused outcomes to better understand mechanisms and factors influencing 
behavioral changes as a result of the interventions. Evaluation of the five key domains of the 
implementation process will provide evidence for future scale up of the intervention and 
facilitate evidence-based practices. These domains are reach of the three implementation 
strategies within the target MSM population, effectiveness of the intervention itself and of the 
strategies that aim to enhance and optimize intervention delivery, factors affecting adoption 
of the implementation strategies, fidelity and adherence to standard operation protocol for 
implementation, maintenance and sustainability.  
 
Methods/design 
Design overview 
Our trial will use a hybrid effectiveness-implementation study design which values both 
intervention effectiveness and implementation process. Specifically, the PIONEER trial will 
be a three-arm, programmatic cluster randomized controlled trial (RCT), followed by a 
mixed-methods implementation evaluation study. The cluster RCT aims to compare 
effectiveness of the three implementation strategies and the implementation evaluation will 
look into other domains of the implementation process guided by the RE-AIM framework.  
For the cluster RCT, we will enroll 12 diverse clinics (i.e., MSM-led and public sexual health 
clinics) and the clinics will be randomly assigned to one of the intervention arms for 
delivering gonorrhea testing: a standard pay-it-forward implementation strategy with minimal 
encouragement to get tested, a community-engaged pay-it-forward strategy, and a control 
arm in which men pay for their own STD test. The standard strategy, which was developed 
through our previous pay-it-forward research, will have men who enter the clinic be provided 
a free gonorrhea test alongside handwritten postcards from other MSM in the local 
community. The community-engaged strategy will include all elements of the standard 
strategy, in addition to the following key community engaging activities, which may include 
gift recipients will be invited to submit handwritten postcards of their own, print images from 
instant cameras, or create videos promoting gonorrhea testing (to be viewed at the same 
clinic); men who agree to participate will  be invited to a hybrid digital and in-person pay-it-
forward event where they meet other people who have donated and to related participatory 
activities organized by the local clinic to promote gonorrhea testing.  
Mixed methods will be used to evaluate the implementation process with project 
implementers, organizers, and participants. Data sources will be multiple which will include 
survey data on acceptability of intervention, intervention appropriateness, feelings and 
attitudes towards interventions among participants, administrative data about test uptake, 
treatment rate, and donations, as well as qualitative data to gain insights about men’s 
perceptions and attitudes towards the pay-it-forward interventions strategies, mechanisms 
driving uptake and donating behaviors. Both survey and qualitative interviews with 
implementers and organizers about fidelity and adherence to protocol, intention to continue 
and maintain a pay-it-forward intervention, and barriers and facilitators of implementing the 

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intervention will be conducted.  
Study setting and population 
We will implement the study in Guangdong cities that have either (or both) public STD and 
MSM-led clinics. Examples include Zhuhai, Foshan, Jiangmen, Shenzhen, Zhanjiang, 
Dongguan, and Yunfu. These clinics were chosen because respective cities have a higher 
burden of STDs, and findings would be potentially relevant in many cities. Each of the clinics 
sees both MSM and non-MSM and only MSM who meet screening criteria will be 
approached to learn more about the study. Each of the clinics have dual chlamydia/gonorrhea 
point-of-care testing available.  
The study settings between public clinics and MSM-led clinics would be different. One key 
obstacle for recruiting MSM at public STD clinics is that MSM usually may not want to 
disclose their sexual identities due to justifiable fears about risks of stigma and discrimination 
from other men and health workers. Therefore, in order to avoid indirect sexual orientation 
disclosure and feeling of discrimination, public STI clinic recruitment will be extended to 
include all men regardless sexual orientation visiting the public clinic setting. This will lower 
the risk of being unnecessarily ‘targeted’ and accidental sexual orientation disclosure. 
The inclusion criteria at public clinics include men who at least 18 years old; have had sex 
over the past year; have not been tested for gonorrhea and chlamydia in the past year; reside 
in the city in the past three months; speak Mandarin Chinese or Cantonese; mentally capable 
to provide informed consent to test for gonorrhea and chlamydia; and owning a mobile 
phone.  
The inclusion criteria at MSM-led clinics include men who had anal sex with another man; at 
least 18 years old; have had anal sex over the past year; have not been tested for gonorrhea 
and chlamydia in the past year; reside in the city in the past three months; speak Mandarin 
Chinese or Cantonese; mentally capable to provide informed consent to test for gonorrhea 
and chlamydia; and owning a mobile phone. In China, over 90% of MSM own a mobile 
phone.  
Development of intervention and formative research 
Approach and study team 
A key innovation of this trial study, relative to past pay-it-forward research, is the 
development and evaluation of the community-engaged approach as an additional 
intervention arm. While upstream reciprocity is hypothesized to promote the pay-it-forward 
mechanism in our proposed trial, simulation models of the upstream reciprocity process show 
that by itself, the “warm glow” does not guarantee sustainability. In contrast, there is 
evidence to show that when combined with network reciprocity where acts of altruism are 
reinforced by a community of collaborators, the probability of cooperation increases.72 The 
two arms of our trial are designed to test these two hypotheses. The standard pay-it-forward 
arm evaluates the hypothesis that the upstream reciprocity created by a pay-it-forward 
approach will increase testing adoption with minimal implementation support, while the 
community-engaged arm tests the hypothesis that pay-it-forward needs to be reinforced by an 

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implementation strategy based on network reciprocity to enhance its effectiveness. 
The study will be managed through a consortium involving two academic centers, the 
University of North Carolina in Chapel Hill and the Southern Medical University 
Dermatology Hospital in Guangzhou, as well as a non-profit community-based organization 
who will organize community engagement activities, the Social Entrepreneurship to Spur 
Health (SESH). The SESH team has strong track record of community engagement and 
organizing research studies focused on sexual health, including pay-it-forward programs in 
Beijing and Guangzhou. The study team comprises representatives from the academic centers 
and SESH who have complementary expertise in community mobilization, implementation 
science, epidemiology, health economics, biostatistics, and social science.  
A co-creation group will be appointed and will comprise MSM representatives, clinicians and 
nurses, communication officer, co-chaired by members of SESH and a local MSM 
community-based organization. Co-creation groups serve as a source of shared leadership in 
CBPR-premised research, and its members typically reflect the community of interest. This 
co-creation group will be consulted on a quarterly basis to provide input on the study design, 
implementation, and dissemination activities. 
Site Selection, training and trial registration 
We will implement the study in Guangdong cities that already have MSM-led clinics: 
Guangzhou, Shenzhen, Zhuhai, Jiangmen, Foshan, and Dongguan. These clinics were chosen 
because respective cities have a higher burden of STDs, they include the two major service 
delivery approaches (MSM-led clinics and public clinics) in China, and findings would be 
potentially relevant in many cities have dual chlamydia/gonorrhea point-of-care testing 
available in addition to ceftriaxone and azithromycin. These clinics have also been selected to 
ensure that there is a stable supply chain for ceftriaxone and azithromycin. 
Each of the clinical sites will receive Good Clinical Practice (GCP) training for new 
personnel, regulatory assessment, and related trial requirements. Representative from each of 
the participating clinics will be invited to attend a single training workshop in Guangzhou to 
introduce the study protocol, local implementation workflows, point-of-care diagnostics, 
gonorrhea treatment, and resistance testing processes. We will register the RCT on 
ClinicalTrials.gov prior to the commencement of the trial.  
Developing standard strategy and the community-engaged strategy 
This three-arm cluster randomized controlled trial will compare gonorrhea test uptake in a 
standard pay-it-forward implementation strategy arm, a community-engaged pay-it-forward 
implementation strategy arm, and a control arm.  Our implementation strategies are 
summarized in Table 1. 
Table 1. Overview of the three study arms. 
Trial Arm 
Financial Component of Gonorrhea 
Testing* 
Community Engagement 

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Standard Pay-it-
forward arm 
Free point-of-care gonorrhea testing 
Passive: viewing postcards and 
materials written by others 
encouraging gonorrhea testing 
Community-
engaged Pay-
it-forward arm 
Free point-of-care gonorrhea testing 
Active: multi-stakeholder 
co-creation activities to 
develop essential 
components of the 
intervention and 
implementation 
strategies; writing 
postcards; opportunity to 
donate to support others 
Control arm 
Fee-based point-of-care gonorrhea 
testing (approximately 20 USD 
None 
*Note that all MSM found to have gonorrhea will receive free treatment according to WHO 
guidelines. 
 
In the standard strategy/arm, MSM who enter the clinic will be provided with a free 
gonorrhea test alongside handwritten postcards from other MSM in the local community. Our 
previous RCT has already created standard operating procedures, survey instruments, and 
educational materials for this intervention. The postcards will be generated through an open 
call for suggestions about tailored, hand-written messages that are clinic specific and locally 
appropriate. We will use standardized methods developed by the World Health Organization 
to design the open call. Briefly, this will involve creating a steering committee, promoting the 
open call, judging submissions, recognizing excellent submissions, and implementing 
selected ideas. 
In contrast, the community-engaged strategy/arm will include all elements of the standard 
strategy, in addition to the following key components: gift recipients will be invited to submit 
handwritten postcards of their own, print images from instant cameras, or create videos 
promoting gonorrhea testing (to be viewed at the same clinic); men who agree to participate 
will be invited to a pay-it-forward event where they will meet other people who have 
donated, and will also be invited to related participatory activities organized by the local 
clinic to promote gonorrhea testing.  
In the control arm, MSM will be informed about the importance of gonorrhea testing but will 
not receive handwritten postcards or other community engagement activities. Among men 
who choose to receive gonorrhea testing, they will have access to the same diagnostics, 
treatment, and follow-up provided in the other two arms. Donations in the two pay-it-forward 
arms will be organized using WeChat, a hybrid between Twitter and Facebook that allows 
micro-payments.  
We will use intervention mapping27, a method used in public health to design these 

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components in a way that is tailored to the local context and facilitates their implementation. 
We will be guided by several behavior change taxonomies that have been developed by 
implementation scientists to assist in the development of implementation interventions2 3 
Briefly, examples include categories of behavioral change techniques that focus on changes 
to increase knowledge, changes to awareness and risk perception, and changes to social 
influence.  
Formative testing, finalization of interventions, and development of instruments 
Formative Digital Qualitative (n=50) 
To further develop and fine-tune our implementation strategies in preparation for the RCT, 
we will conduct a series of digital qualitative research activities. These activities will explore 
the perceptions of men who have sex with men (MSM) in Guangzhou, Shenzhen, Zhuhai, 
Jiangmen, Foshan, and Dongguan on HIV and other STI testing, with a focus on barriers and 
facilitators to testing for HIV and other STI (especially Gonorrhea and Chlamydia), 
perceptions of public STI clinics, perceptions of MSM-led clinics, as well as perceptions of 
community-engagement in the MSM community. First, we will recruit up to 50 people to 
participate in an online chat-based focus group discussion (FGD) on WeChat. The SESH 
team will disseminate a call for participation over social media. Participants who are 
interested to participate will provided with a link to the participant information sheet and 
consent form, and following their consent, will be directed to an enrollment survey. Personal 
identifiers will never be shared with anyone outside of the research team. 
There will be no more than eight participants per FGD. In order to participate in this focus 
group discussion (FGD), individuals must meet the following criteria: Age 18 years or older 
(Age of majority in China); Sex assigned male at birth; Have had anal sex with a man at least 
once; Speaks Mandarin Chinese or Cantonese; and currently living in Guangzhou, Shenzhen, 
Zhuhai, Jiangmen, Foshan, and Dongguan. Second, we may follow up with no more than 25 
participants for further in-depth interviews conducted over voice call on WeChat. Third, we 
will conduct digital ethnographic activities on digital spaces and sites mentioned by 
participants throughout the course of the study, to articulate stakeholders associated with such 
spaces, and describe how community identities, interactions, and engagement occur in these 
spaces. 
Formative Quantitative (n = 350) 
We will field test our two implementation strategies at several MSM-led clinics and public 
clinic in Guangzhou, China. We will recruit a total of 350 participants. The eligibility criteria 
include at least 18 years old and mentally capable to provide informed consent to test for 
gonorrhea; men who have had anal sex with another man over the past year; have not been 
tested for gonorrhea in the past year; reside in the city in the past three months; speak 
Mandarin Chinese or Cantonese; and owning a mobile phone. This will allow us to improve 
the strategies using learning evaluation methods30 that involve iterative Plan-Do-Study-Act 
cycles based on user feedback. We will also develop and fine-tune our process evaluation 
instruments for fidelity assessment31, gratitude assessment32, 34, and organizational readiness35 
at this stage of research. 

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Formative Qualitative (n = 50) 
We have developed an interview guide as part of formative testing. Main topics in the 
interview guide will include the following: (1) reasons for getting tested; (2) understanding 
and perception of the pay-it-forward concept; (3) specific questions about emotions of 
gratitude after receiving a test that is supported by another community member; and (4) self-
identity in the MSM community and level of integration within a community; (5) intention 
and motivation to initiating and mediating helping behaviors within the community. We will 
obtain a recorded verbal informed consent from all interviewees before the commencement of 
the interview. Interviews will last about one hour and will take place either in person or over 
the phone based on participant preference. 
Interviews will be audio-recorded and personal information will not be recorded. 
Unintentional recording of personal information will otherwise be redacted before 
transcription. Each participant will receive a small monetary incentive of ¥50 (7.50 USD) for 
their participation. All recorded interviews will be transcribed, and transcripts will be 
checked by one research staff member. Summaries of interviews will be written up for 
preliminary data analysis. In addition, we will collect anonymized text from handwritten 
postcards and other community engagement activities.  
Pragmatic Programmatic cluster RCT 
Sample size and power considerations  
We used a binary outcome cluster RCT design for sample size calculation where the unit of 
randomization is the clinic. In order to achieve a 90% power and allow for 0.05 type-I error, 
12 overall clusters (4 in each arm) are needed. Thus, the sample size includes a total of 12 
clusters and 1200 participants (100 per cluster), based on cluster randomized trial sample size 
calculation principles. We expect this study will have 85% power to detect a 10% difference 
in azithromycin resistance between intervention arms and routine gonorrhea antibiotic 
surveillance data from other cities in the same province. Nevertheless, further calculations 
will be made following formative research endeavors that will estimate the prevalence of 
these outcomes. The calculation would be performed using the software PASS (version 15) 
with the formulas developed by Hussey and colleagues.36 
Randomization  
Figure 2 shows the cluster RCT design flowchart. We will assign clinics to study arms on a 
1:1:1 basis using covariate constrained randomization. We will use covariate constrained 
randomization to decrease potential bias associated with unbalanced study arms. We will 
balance the number of MSM-led and public clinics in each arm because these are unique 
implementation structures. All men recruited via one clinic will be assigned to one arm. We 
will recruit and screen men until we meet our sample size of 1200 men. 
 

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Figure 2. Pragmatic RCT flowchart. Each city will have one MSM-led clinic and 
one public clinic participating. 
 
Intervention delivery strategies 
The duration of the intervention is one year at each clinic, with the potential to continue 
based on local commitments. All clinics will have dual gonorrhea/chlamydia point-of-care 
molecular tests on-site. This diagnostic is approved by the US FDA and the Chinese national 
regulatory authority. Men who agree to be tested will have specimens collected from 
pharyngeal, rectal, and urethral sites. Specimens will be pooled based on excellent sensitivity 
and specificity. Turnaround time for test results will depend on the local clinic. Surveys will 
be done online in order to facilitate implementation. All participants diagnosed with 
gonorrhea will receive ceftriaxone and azithromycin in accordance with WHO 
recommendations for first-line gonorrhea therapy. 
Outcome measures 
The primary outcome of the RCT will be gonorrhea test uptake ascertained by administrative 
review from participating clinics. We used this same primary outcome in previous quasi-
experimental and RCT trials evaluating pay-it-forward. Secondary outcomes will include 
syphilis testing, amount donated towards pay-it-forward, antimicrobial resistance measures, 
positive tests for gonorrhea and chlamydia, measures of gratitude and community solidarity, 

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and per unit costs associated with the intervention (Table 2) .     
Table 2. Secondary outcomes of the cluster RCT 
Outcome  
Time Frame 
Ascertainment 
Syphilis testing 
During enrollment visit 
Administrative data 
Amount donated 
During enrollment visit 
Administrative data 
Azithromycin resistance based on culture 
and molecular methods 
During enrollment visit 
Laboratory result 
Ceftriaxone resistance based on culture 
and molecular methods 
During enrollment visit 
Laboratory result 
The number of participants who tested 
positive for Gonorrhea 
During enrollment visit 
Laboratory result 
The number of participants tested positive 
for chlamydia 
During enrollment visit 
Laboratory result 
Cost per test1 
During enrollment visit 
Costing data collection 
Adapted gratitude scale 
During enrollment visit 
Self-report 
Community solidarity scale4 
During enrollment visit 
Self-report2 
1Cost per test is defined as the cost associated with respective interventions (development, start-up, 
implementation, intervention) per individual who reported testing for gonorrhea and chlamydia following the 
intervention; economic test and financial cost are reported separately. 
2Community solidarity involves engagement, social network support, and a sense of belonging. These items 
were used in our previous pay-it-forward research study.4 
 
Data analysis 
The primary outcome will be gonorrhea test uptake among MSM. Generalized mixed effects 
models will be used to examine two main hypotheses: one comparing the superiority of the 
community- engaged strategy compared to the standard pay-it-forward strategy; and another 
comparing the superiority of the standard pay-it-forward strategy to the control arm. The 
estimated intervention effects will be reported with 95% CIs and p values. Descriptive 
analysis will be used to summarize the characteristics and behaviors of the participants in 
each arm. 
We will include participants diagnosed with gonorrhea whose isolates can be cultured and 
calculate the minimum inhibitory concentrations (MICs) for specific antibiotics. MICs will be 
described as geometric means, and the distributions among gonorrhea strains in the 
intervention arm will be compared to surveillance data using a Mann-Whitney test. We will 
use the midpoint between the specific value and the next higher or lower dilution value to 
calculate the mean for MICs above or below the pre-specified thresholds. We will calculate 
the prevalence rates and 95% confidence intervals of gonorrhea resistance and decreased 
susceptibility to pre-specified antibiotics. Bivariate analyses and multinomial logistic 
regression will be used to determine the variables associated with infection with resistant or 
decreased susceptible strains of antibiotics. We will compare the frequency of resistant 
strains in the three arms using a chi-squared test for trend. 
Oxytocin sub-study 
One community-engaged MSM-led clinic and one control MSM-led clinic will be selected to 
conduct a pilot quasi-experimental study to assess the impact of the community-engaged 
intervention on measures of salivary oxytocin. We aim to recruit 100 participants from each 

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site (n=200) for this sub-study. This sub-study aims to investigate the use of oxytocin as an 
objective biomarker to reflect feelings of warm glow. Oxytocin is a hormone produced in the 
hypothalamus and associated with trust and altruism measures.37-39 Studies have also 
administered intranasal oxytocin to study its effect on gratitude and pro-social actions.39 We 
aim to measure salivary oxytocin before and after the intervention to ascertain if such 
changes may be attributable to the intervention. Changes in oxytocin levels will also be 
measured against changes in levels of warm glow and other baseline characteristics to 
ascertain the relationship between these factors. Collected saliva samples will be stored at -40 
degree Celsius for a minimum of 6 months after collection and disposed of following the 
standard laboratory protocol per study site. 
Implementation evaluation 
The RE-AIM framework has been extensively used in implementation research to evaluate 
the implementation of evidence-based interventions. At this stage, we will evaluate the other 
dimensions of the implementation of the standard pay-it- forward and the community-
engaged pay-it-forward arms with a view to understand both the factors that influence men to 
get tested and those that motivate men to donate. Given the novelty of pay-it-forward to raise 
fund, its sustainability partly depends on men willing to donate. Understanding the drivers of 
financial sustainability across individuals and clinics may help inform policy makers and 
interested researchers in resource-limited settings about the potential of using the strategy to 
promote underfunded public health services.  
We will use a sequential explanatory mixed methods design.93 In this design, quantitative 
data is followed up with qualitative methods to expand or explain the quantitative results. The 
quantitative component of our design will measure reach, implementation, adoption and 
maintenance by adapting validated implementation research instruments to assess 
acceptability and appropriateness at the individual level (related to adoption) and fidelity and 
organizational readiness at the clinic level (related to implementation). We will also 
administer a gratitude questionnaire that has already been validated in China to test upstream 
reciprocity (related to maintenance). Details of these instruments are provided in Table 3 
below. The qualitative data will use in-depth interviews grounded in upstream and social 
reciprocity theories to explore the processes and mechanisms that affect the results, and how 
these differ by individual (geography and socioeconomics) and organizational (geography 
and readiness) characteristics. Our mixed methods study will be conducted during and after 
the RCT. 
Quantitative surveys  
Surveys with clinics, project implementers and participants will be conducted. We will 
administer an organizational readiness survey in all clinics in the standard and community-
engaged arms. All clinic staff involved in the implementation of the pay-it-forward 
intervention will be encouraged to take the survey which will assess the motivation and 
capabilities of their clinic. Every month, in each clinic in the standard and community- 
engaged arms, a convenience sample of 10 men will be selected and a member of the 
Guangdong Provincial STD Control Center staff will assess the extent to which pay-it-

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forward is implemented in accordance with the protocol. All recruited participants in the 
study in all clinics in the standard and community-engaged arms will be asked to take a brief 
survey assessing their perceptions of acceptability and appropriateness of pay-it-forward and 
the relevant implementation strategy. They will also complete a pay-it-forward-specific 
adapted version of the Gratitude Questionnaire-6 (GQ-6). 
Qualitative interviews 
MSM and pay-it-forward organizers will be recruited for in-depth interviews. We will recruit 
MSM in the clinic, immediately following participation in the RCT. Purposive sampling 
strategies will be used to recruit MSM who are involved in each implementation strategy 
arm, those who participate and those who do not, and those who provide a higher donation 
and lower donation. Among organizers, we will recruit them by sending a text message to a 
purposive sampling of organizers. This will include those at MSM-led clinics and public 
clinics, organizers who identify as gay and those who do not, and other key characteristics. 
We will develop a topic guide to guide the MSM interviews based on the literature review, 
fieldnotes and reflections during the implementation of RCT.  
Main topics will include the following: (1) reasons for getting tested; (2) understanding and 
perception of the pay-it-forward concept; (3) specific questions about emotions of gratitude 
after receiving a test that is supported by another community member; and (4) self-identity in 
the MSM community and level of integration within a community; (5) intention and 
motivation to initiating and mediating helping behaviors within the community. We will 
obtain a recorded verbal informed consent from all interviewees before the commencement of 
the interview. Interviews will last about one hour and will take place either in person or over 
the phone based on participant preference. 
Interviews will be audio-recorded and personal information will not be recorded. 
Unintentional recording of personal information will otherwise be redacted before 
transcription. Each participant will receive a small monetary incentive of ¥50 (7.50 USD) for 
their participation. All recorded interviews will be transcribed, and transcripts will be 
checked by one research staff member. Summaries of interviews will be written up for 
preliminary data analysis. In addition, we will collect anonymized text from handwritten 
postcards and other community engagement activities.  
Sample size and power considerations  
A total of 25 MSM participants and 25 pay-it-forward organizers will be recruited for 
individual interviews. Enrollment will cease when no new themes and sub-themes emerge, 
inferring data saturation. All eight participating clinics that are implementing the pay-it-
forward intervention (both standard strategy and community-engaged strategy) will be invited 
to respond to questions related to implementing the intervention (see Table 3). All 
participating clinics will be invited to answer questions related to organizational 
implementation and maintenance. Operational definitions and example measures of the five 
dimensions of RE-AIM adapted for the study are shown in Table 3.  
Outcome measures 

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The outcomes will include (1) primary RE-AIM data comparing differences between the 
community-engaged pay-it-forward strategy and the standard pay-it-forward strategy; (2) 
qualitative data describing mechanisms related to test uptake and donation decisions, 
respectively.  
Data analysis  
Thematic analysis will be used to analyze qualitative data. A codebook will be developed by 
a senior qualitative researcher. Two research assistants will then code the transcripts based on 
the codebook. NVivo version 12 (Nvivo, Columbus, OH) will be used for qualitative data 
analysis. Descriptive data analyses, independent sample t tests and chi-square tests will be 
used to compare differences in RE-AIM measures between pay-it-forward and standard-of-
care arms. We will generate a global implementation score and scores of separate dimensions 
and convert to a z-score. Correlates of global implementation and implementation dimensions 
will be examined using general linear mixed models (GLMM). In addition, qualitative data 
on social networks will be applied to disentangle the connection between an individual’s 
gratitude and position within a network comprised of helping relationships (both direct and 
indirect relationships). Finally, we will use linguistic inquiry word count to analyze textual 
information gathered as part of community engagement activities. 
Safety management plan 
Criteria for withdrawal: if participants want to quit the study for any reasons; Data and safety 
monitoring will be done by project implementers. 
Data management information 
For the surveys and demographic questionnaires, all data are directly entered into computers 
at UNC Project China office as participants complete the surveys. Programs to ensure 
accuracy, completeness, and internal consistency are automated. Data can be readily 
downloaded and converted to the format of commercially available statistical software. 
During collection of the online portion of the study, all data will be transmitted securely using 
SSL (TLS) 128-bit encryption across the Internet (HTTP). SSL provides users with the 
assurance of access to a valid, “non-spoofed” site, and prevents data interception or 
tampering with sensitive information. The SSL certificate that will be used for this project 
will use 128-bit encryption, the preferred security level of government and financial 
institutions. 128-bit encryption offers protection that is virtually unbreakable. For example, if 
a hacker could crack a standard 40-bit SSL session in a day, it is estimated that it would take 
well beyond a trillion years to accomplish the same thing against a 128-bit SSL session. A 
dedicated server, which eliminates security issues involved with shared hosting environments 
where hundreds of websites and users reside on one shared web server as well as ensuring 
both physical and network security, will be used to house the data. Data will then be stored in 
a secured server at Dermatology Hospital, Southern Medical University. The server will be 
configured with redundant hard drive array to ensure reliability. Access to the data will be 
password protected within the server’s firewall. Only the PI and a designated senior staff 
member will have the password to access to the “key” that links the non-descript identifier to 
personally identifiable information. IP addresses of participant's computers will not be 

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collected at any time. Cookies will not be used in any way to track participant activity. A 
quick link will exist on each survey page to provide participants a rapid way to switch to an 
innocuous website if their privacy is interrupted while completing the survey.  
For participants’ urine testing results and clinical outcomes, the data will be recorded directly 
input into Health Information System (HIS) at Dermatology Hospital, Southern Medical 
University.  Data will be downloaded and stored the same way as the survey data. 

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Table 3. Dimensions of RE-AIM in implementation research adapted for pay-it-forward.28 
Dimensions 
Level 
Operational definitions 
Measurement method 
Reach  
Individual 
• Proportion of MSM who enter the clinic who 
are screened for eligibility 
• Percent of MSMs who visit the clinic 
compared to the MSM in the catchment area 
Administrative data will be collected on the 
demographics, socioeconomics and geographic 
location (zip code or equivalent level) of those 
enrolled in pay-it-forward to test if there are 
differences in the characteristics of those who get 
tested and those who do not. 
Population of MSMs will be collected from public 
data to assess the potential reach of the pay-it-
forward intervention within the overall MSM 
population in the area. 
Effectiveness 
 
Individual 
• How effective are the two implementation 
strategies in promoting    gonorrhea test 
uptake? 
• Does pay-it-forward influence secondary 
outcomes (chlamydia testing, treatment and 
prevention outcomes)? 
The primary outcome is gonorrhea test uptake 
from the RCT which will be measured using 
administrative data from participating clinics. 
Other secondary indicators are test uptake, 
treatment rate among those infected, azithromycin 
resistance, ceftriaxone resistance, and 100% 
condom use. 
Adoption  
Individual 
• Do the participants find pay-it-forward 
acceptable and appropriate? 
• Is there a relationship between acceptability 
and appropriateness and testing outcomes? 
• What are the demographic, socioeconomic and 
geographic differences between those who 
found 
pay-it-forward 
acceptable 
and 
appropriate and those who did not? 
Quantitative data will be collected using an 
adapted 
version 
of 
the 
Acceptability 
of 
Intervention Measure (AIM) and the 
Intervention Appropriateness Measure (IAM). 
Qualitative data will be collected from interviews 
to gain additional insights about the results from 
these instruments. 
Organizational 
• How do feelings of gratefulness contribute to 
test adoption and donation behaviors? 
The R=MC2 instrument will be adapted for use in 
clinics. 

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Implementation 
Organizational 
• What is the extent to which local staff 
implement the pay-it-forward according to the 
SOP, and the extent to which legitimate 
adaptations are needed? 
Fidelity checklists (as specified by Carroll et al.) 
will be used to measure adherence to protocol 
related to content and dose. 
Interviews with clinic staff will be used to 
determine reasons for deviation from protocol and 
to track and document legitimate adaptation. 
Maintenance 
Individual 
• What is the average donation per participant in 
each arm? 
• Is there a relationship between testing and 
donations? 
• What are the facilitators and barriers of 
donation? 
• What are the demographic, socioeconomic and 
geographic differences between those who got 
tested after receiving the gift relative to those 
who were not? 
Tracking donations stratified by testing status, 
socioeconomics and demographics. Interviews 
with participants will examine the individual 
context of donating. 
Organizational 
• What is the average donation per clinic in each 
arm? 
• Is organizational readiness associated with 
higher donation rates? 
• What are resource commitments from the 
public health sector, MSM organizations, and 
others to sustain pay-it-forward? 
Administrative data will be used to track 
donations at the clinic level. 
Interviews with organizers who are able to 
continue the program after the 12-month RCT 
phase will examine facilitators and barriers of 
maintaining the intervention. 
*Maintenance data will be collected for an additional 12 months (following the RCT) at selected clinics. 
 

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Discussion 
Pay-it-forward is a novel behavioral and financial model. Our previous studies showed that it is 
cost-effective but the study findings have limited representativeness due to the primary 
involvement of MSM-led clinics but an exclusion of public clinics are a major provider for STD 
testing in the Chinese setting. There is also a lack of understanding the implementation process 
and a missed opportunity of optimizing the implementation strategy. By enhancing the 
community engagement components of the strategy, our trial aim to test the effectiveness of an 
enhanced pay-it-forward implementation strategy in comparison to the standard pay-it-forward 
approach and a control arm.  We propose a programmatic cluster RCT to document high-quality 
evidence on the effectiveness of different pay-it-forward implementation strategies and to better 
understand the real-world practices. The proposed study will provide an evidence base on 
whether community-engaged pay-it-forward implementation can strengthen effectiveness and to 
inform future expansion of pay-it-forward intervention strategies to improve gonorrhea testing 
and treatment for MSM in diverse clinic settings in China.  
This study has important implications for evidence-based practices for delivering important but 
underfunded public health services in a novel and efficient way. Hybrid implementation study 
designs focus not only on effectiveness but also assessing implementation outcomes. Generating 
evidence on the implementation itself will inform evidence-based practices and enable us to tap 
into the potential of normalizing or integrating the pay-it-forward interventions into existing 
programs to promote gonorrhea testing among a key community. Our hybrid implementation-
effectiveness design has a primary focus on testing two pay-it-forward implementation strategies 
as well as evaluating other domains including reach, adoption, implementation, and maintenance. 
These will help inform what is possible in routine practices, translate researching findings into 
practices and scale up the strategy in gonorrhea testing service delivery and beyond. 
Our trial will also have added value to the current body of literature on altruism and generosity 
research in changing behaviors. Our implementation evaluation will underscore the individual 
and organizational-level mechanisms affecting test uptake and donating behaviors in the pay-it-
forward arms. We will test against the upstream reciprocity theory and measure whether 
generosity is associated with uptake and donating behaviors. This evidence will be relevant to 
interested health researchers, program implementers and public health authorities to leverage 
human kindness and warm glow to promote healthy behaviors, engage key stakeholders.  
We anticipate that this novel financing model may also have policy implications for transitioning 
fee-based to subsidized health services in China and beyond. Pay-it-forward is effective in 
pooling small funds for essential services to support other service users in the community. Such 
pro-social behaviors could potentially be contagious when managed well. In addition, if proven 
practically more cost-effective, it is also possible to use pay-it-forward strategies to mobilize 

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microdonations from economically better off areas to cover essential health services in places 
that are underdeveloped.  
 
References 
1. 
Kirkcaldy RD, Weston E, Segurado AC, Hughes G. Epidemiology of gonorrhoea: a 
global perspective. Sexual health 2019; 16(5): 401-11. 
2. 
Ye X, Liu J, Yi Z. Trends in the Epidemiology of Sexually Transmitted Disease, 
Acquired Immune Deficiency Syndrome (AIDS), Gonorrhea, and Syphilis, in the 31 Provinces 
of Mainland China. Med Sci Monit 2019; 25: 5657-65. 
3. 
Wi T, Lahra MM, Ndowa F, et al. Antimicrobial resistance in Neisseria gonorrhoeae: 
global surveillance and a call for international collaborative action. PLoS medicine 2017; 14(7): 
e1002344. 
4. 
Wang C, Tang W, Zhao P, et al. Rapid increase of gonorrhoea cases in Guangdong 
Province, China, 2014–2017: a review of surveillance data. BMJ open 2019; 9(11): e031578. 
5. 
Rowley J, Vander Hoorn S, Korenromp E, et al. Chlamydia, gonorrhoea, trichomoniasis 
and syphilis: global prevalence and incidence estimates, 2016. Bulletin of the World Health 
Organization 2019; 97(8): 548. 
6. 
Chen X-S, Peeling RW, Yin Y-P, Mabey DC. The epidemic of sexually transmitted 
infections in China: implications for control and future perspectives. BMC Medicine 2011; 9(1): 
111. 
7. 
Yang LG, Zhang XH, Zhao PZ, et al. Gonorrhea and chlamydia prevalence in different 
anatomical sites among men who have sex with men: a cross-sectional study in Guangzhou, 
China. BMC infectious diseases 2018; 18(1): 675. 
8. 
Detels R, Green AM, Klausner JD, et al. The Incidence and Correlates of Symptomatic 
and Asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae Infections in Selected 
Populations in Five Countries. Sexually transmitted diseases 2011; 38(6): 503-9. 
9. 
World Health Organization. Prevention and Treatment of HIV and Other Sexually 
Transmitted Infections Among Men Who Have Sex With Men and Transgender People: 
Recommendation for a Public Health Approach Geneva, Switzerland WHO Document 
Production Services; 2011. 
10. 
CDC. 2015 Sexually Transmitted Diseases Treatment Guidelines. 2015. 
https://www.cdc.gov/std/tg2015/screening-recommendations.htm. 

v4 2022-11-15 
Page 23 of 25 
 
11. 
Wu D, Li KT, Tang W, et al. Low chlamydia and gonorrhea testing rates among men 
who have sex with men in Guangdong and Shandong Provinces, China. Sexually transmitted 
diseases 2019; 46(4): 260-5. 
12. 
Lin L, Nehl EJ, Tran A, He N, Zheng T, Wong FY. Sexually transmitted infection testing 
practices among ‘money boys’ and general men who have sex with men in Shanghai, China: 
objective versus self-reported status. Sexual health 2014; 11(1): 94-6. 
13. 
World Health Organization. Global Health Sector Strategy on Sexually Transmitted 
Infections 2016-2021. 2016. 
14. 
Zheng N, Guo Y, Padmadas S, Wang B, Wu Z. The increase of sexually transmitted 
infections calls for simultaneous preventive intervention for more effectively containing HIV 
epidemics in China. BJOG 2014; 121 Suppl 5: 35-44. 
15. 
Tucker JD, Muessig KE, Cui R, et al. Organizational characteristics of HIV/syphilis 
testing services for men who have sex with men in South China: a social entrepreneurship 
analysis and implications for creating sustainable service models. BMC infectious diseases 2014; 
14: 601. 
16. 
Tucker J, Fenton K, Peckham R, Peeling R. Social entrepreneurship for sexual health 
(SESH): a new approach for enabling delivery of sexual health services among most-at-risk 
populations. PLoS Med 2012; 9(7): e1001266. 
17. 
Hyde CR. Pay It Forward. New York, NY: Simon & Schuster; 1999. 
18. 
Murphy K. Ma'am, Your Burger Has Been Paid For. The New York Times. 2013 October 
19, 2013. 
19. 
Cueva M. Thanks, au lait: 750 pay it forward at Starbucks location. CNNcom. 2014 
August 22, 2014. 
20. 
Wegert T. JetBlue Pays It Forward Through a Social Storytelling Campaign With No End 
in Sight. The Content Strategist. 2014 November 13th, 2014. 
21. 
Jung MH, Nelson LD, Gneezy A, Gneezy U. Paying more when paying for others. 
Journal of personality and social psychology 2014; 107(3): 414. 
22. 
Li KT, Tang W, Wu D, et al. Pay-it-forward strategy to enhance uptake of dual gonorrhea 
and chlamydia testing among men who have sex with men in China: a pragmatic, quasi-
experimental study. The Lancet Infectious diseases 2019; 19(1): 76-82. 
23. 
Yang F, Zhang TP, Tang W, et al. Pay-it-Forward Gonorrhea and Chlamydia Testing 
Among Men Who Have Sex With Men in China: A Randomized Controlled Trial. The Lancet 

v4 2022-11-15 
Page 24 of 25 
 
Infectious diseases 2020. 
24. 
US Department of Health and Human Services. Principles of Community Engagement. 
Second Edition. 2015. 
https://www.atsdr.cdc.gov/communityengagement/pdf/PCE_Report_508_FINAL.pdf (accessed 
20th Aug 2018). 
25. 
Nowak MA, Roch S. Upstream reciprocity and the evolution of gratitude. Proceedings of 
the royal society B: Biological Sciences 2007; 274(1610): 605-10. 
26. 
Wallerstein NB, Duran B. Using community-based participatory research to address 
health disparities. Health promotion practice 2006; 7(3): 312-23. 
27. 
Fernandez ME, Ruiter RA, Markham CM, Kok G. Intervention mapping: theory-and 
evidence-based health promotion program planning: perspective and examples. Frontiers in 
public health 2019: 209. 
28. 
Kok G, Gottlieb NH, Peters G-JY, et al. A taxonomy of behaviour change methods: an 
intervention mapping approach. Health psychology review 2016; 10(3): 297-312. 
29. 
Presseau J, Ivers NM, Newham JJ, Knittle K, Danko KJ, Grimshaw JM. Using a 
behaviour change techniques taxonomy to identify active ingredients within trials of 
implementation interventions for diabetes care. Implementation Science 2015; 10(1): 1-10. 
30. 
Balasubramanian BA, Cohen DJ, Davis MM, et al. Learning evaluation: blending quality 
improvement and implementation research methods to study healthcare innovations. 
Implementation Science 2015; 10(1): 1-11. 
31. 
Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for 
implementation fidelity. Implementation science 2007; 2(1): 1-9. 
32. 
Kong F, You X, Zhao J. Evaluation of the Gratitude Questionnaire in a Chinese Sample 
of Adults: Factorial Validity, Criterion-Related Validity, and Measurement Invariance Across 
Sex. Frontiers in Psychology 2017; 8(1498). 
33. 
Zeng Y, Ling Y, Huebner ES, He Y, Lei X. The psychometric properties of the 5-item 
gratitude questionnaire in Chinese adolescents. Journal of Psychiatric and Mental Health Nursing 
2017; 24(4): 203-10. 
34. 
Wei C, Wu H, Kong X-n, Wang H. Revision of Gratitude Questionnaire-6 in Chinese 
adolescent and its validity and reliability. Chinese Journal of School Health 2011; 32(10): 1201-
2. 
35. 
Lehman WE, Greener JM, Simpson DD. Assessing organizational readiness for change. 

v4 2022-11-15 
Page 25 of 25 
 
Journal of substance abuse treatment 2002; 22(4): 197-209. 
36.  
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. 
Contemp Clin Trials 2007; 28(2): 182-91. 
37.  
Zak PJ, Kurzban R, Matzner WT. Oxytocin is associated with human trustworthiness. 
Hormones and Behavior 2005; 48(5): 522-7. 
38. 
Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in 
humans. Nature 2005; 435(7042): 673-6. 
39. 
Barraza JA, McCullough ME, Ahmadi S, Zak PJ. Oxytocin infusion increases charitable 
donations regardless of monetary resources. Horm Behav 2011; 60(2): 148-51.