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 6.0 
Version date 12 December 2024 
 
 
 
 
 
 
 
 
 
 
 

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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 the effectiveness of the three implementation strategies, followed by a 
mixed-methods implementation evaluation study guided by a transformative paradigm. 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 
public and MSM-led clinics in the same city will be randomized to the same study group to 
prevent contamination. The primary outcome of the RCT will be gonorrhea test uptake, and 
secondary outcomes will include chlamydia 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 the acceptability of the intervention, intervention 
appropriateness, feelings and attitudes towards the 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 
organizational characteristics that moderate it. 
 

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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 individual 
and organizational characteristics moderate these individual and organizational 
characteristics moderate these.  
• 
This study will answer compelling scientific questions about how best to implement 
pay-it-forward and the individual and organizational 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 87 million new cases of gonorrhea among people 15-49 years old based on a 
2016 global systematic review
5. 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 Organization
9 and United States 
Centers for Disease Control and Prevention guidelines
10 recommend routine gonorrhea 
testing for sexually active MSM. Studies in different provinces of China consistently report 
that less than half of MSM have ever been tested for gonorrhea
11-12. Low testing rates are 
problematic because this allows onward gonorrhea transmission. 
Low testing rates are 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 
uptake
12, decreasing opportunities for prompt treatment and public health interventions
11,13. 
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 testing
14. 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 services
15. In addition to 
financing problems, community engagement in STD testing is often weak.  Many MSM 
campaigns for STD testing are driven by public health authorities and have limited authentic 
input from local end-users
16. 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 gonorrhea test as a gift 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 individuals
18, but more often organized by a group with a 
common purpose
19,20. Studies have shown that pay-it-forward can be sustainable and 
promote generosity
21.  
 

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Figure 1. Overview of pay-it-forward. *Participatory activities such as open calls to create 
handwritten messages in the community-engaged implementation strategy. A warm glow 
refers to 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 care
22,23. 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 disclose 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 activities
15. 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 clinics (i.e., both MSM-led and public clinics). Last, the previous study 
showed that pay-it-forward was effective compared to the standard of care, but explicit and 
intentional support for implementation is needed for scale-up. Lack of implementation 
evaluation limits our understanding of the implementation process, and community-
engaged strategies are needed to maximize 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 the contextual 
appropriateness of public health interventions and the 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 

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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, 
the pay-it-forward is a novel concept embedded in upstream reciprocity theory. Upstream 
reciprocity is defined as individuals helped by someone who is more likely to help other 
unspecified people.  
Upstream reciprocity theory has been used to understand the pay-it-forward mechanism 
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 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 participate in several 
phases of the research process to address a health research question
26. CBPR is appealing as 
it generates community engagement and amplifies the voices of neglected populations in 
service delivery strategy designs. It is a bottom-up, user-centered approach that leads to the 
development of culturally appropriate intervention strategies.   Evidence has shown that 
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 the 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 (i.e., community-

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engaged pay-it-forward versus standard pay-it-forward strategies and a control arm without 
pay-it-forward components) by comparing the 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 
frameworks to evaluate the 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 the reach of the three implementation 
strategies within the target MSM population, the effectiveness of the intervention itself and of 
the strategies that aim to enhance and optimize intervention delivery, factors affecting the 
adoption of the implementation strategies, fidelity and adherence to standard operation 
protocol for implementation, maintenance and sustainability.  
Transformative Mixed Methods Paradigm 
A transformative paradigm was chosen to address issues of social justice and inform the 
methodological decisions of this study in ways that eventually ensure a strong link between 
the research and advancing a social justice agenda
27,28. In the context of this hybrid trial, the 
transformative paradigm has informed our research in several ways. First, acknowledging that 
there are multiple realities shaped by political, social, cultural, economic, gender, and sexual 
identities, we ensured that a participatory co-creation process involving diverse partners 
were adopted to develop trial components, lead implementation of the research, and 
provide input into the analysis and interpretation of our data. Second, beyond centering 
community voices in our research, a transformative paradigm will inform our qualitative 
implementation research with its focus on structural inequities and power structures that lead 
to the marginalization of MSM and limit access to healthcare in the population
29. Third, the 
research adopts a hybrid effectiveness-implementation trial design as its commitment to 
ensuring that effective, community-led solutions are scaled up and sustained in local health 
systems. This research ultimately hopes to bridge inequities in gonorrhea testing and 
treatment for the MSM population in China. 
 
Methods 
Design overview 
Our trial will use a hybrid effectiveness-implementation study design which values both 

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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 the 
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. Randomization will be based city 
economic status and stratified by clinic type. The standard strategy, which was developed 
through our previous pay-it-forward research, will have men who enter the clinic be 
provided with a free gonorrhea test and shown 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: the gift 
recipients will be invited to choose and keep one anonymously donated postcard,  submit 
handwritten postcards of their own, draw on plain fans, and decorate with stickers, send out 
messages that encourage testing on social media platforms or create videos promoting 
gonorrhea testing (to be viewed at the same clinic). Men who agree to participate in the 
community engagement activities 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.  
Data collection 
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 the acceptability of the 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.  
Study setting and population 
We will implement the study in Guangdong cities with either (or both) public STD and MSM-
led clinics. Examples include Zhuhai, Foshan, Jiangmen, Zhanjiang, Zhanjiang, Dongguan, and 
Huizhou. These clinics were chosen because respective cities have a higher burden of STDs, 
and findings would be potentially relevant in many cities. In MSM-led clinic, only MSM who 

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meet eligibility criteria will be included. In public STI clinics, all men will be recruited. The 
rationale for this is that many MSM do not identify as being attracted to other men.   
The study settings between public clinics and MSM-led clinics would be different. One key 
obstacle to 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,  to avoid indirect sexual orientation disclosure and 
feelings of discrimination, public STD clinic recruitment will be extended to include all men 
visiting the public clinic setting regardless of sexual orientation. This will lower the risk of 
being unnecessarily ‘targeted’ and accidental sexual orientation disclosure. 
The inclusion criteria at public clinics include men who are 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 
of providing 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; are 
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 of providing informed consent to test for 
gonorrhea and chlamydia; and owning a mobile phone. In China, over 95% 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 developing 
and evaluating 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 the “warm 
glow” does not guarantee sustainability. In contrast, evidence shows that the probability of 
cooperation increases when combined with network reciprocity where a community of 
collaborators reinforces acts of altruism.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 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 that will 

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organize community engagement activities, the Social Entrepreneurship to Spur Health 
(SESH). The SESH team has a 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 officers, and 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 with MSM-led clinics:  Huizhou, Zhuhai, 
Jiangmen, Foshan, Zhanjiang, 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 that have chlamydia/gonorrhea point-of-care testing available. 
Each of the clinical sites will receive Good Clinical Practice (GCP) training for new personnel, 
regulatory assessment, and related trial requirements. Representatives 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,  sample collection and testing, 
gonorrhea and chlamydia treatment, and the resistance testing processes. We registered the 
RCT on ClinicalTrials.gov (registration id: NCT05723263) 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 
Standard 
Pay-it-
forward arm 
Free gonorrhea/ chlamydia 
testing 
Passive: viewing 
postcards and materials 
written by others 
encouraging gonorrhea/ 
chlamydia testing 
Active: an opportunity 

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to donate to support 
others. 
Community-
engaged 
Pay-it-
forward arm 
Free gonorrhea/ chlamydia 
testing 
Active: multi-
stakeholder co-creation 
activities to develop 
essential components 
of the intervention and 
implementation 
strategies; writing 
postcards; designing 
fans with stickers,; 
sending out testing 
promotion messages 
on social media; an 
opportunity to donate to 
support others. 
Control arm 
Fee-based gonorrhea/ 
chlamydia testing 
(approximately 20 USD 
None 
*Note:  All participants who test positive for gonorrhea will receive a referral for AMR testing 
and treatment at the local public STD clinic. 
 
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 initial postcards were generated through 
an open call for suggestions about tailored, handwritten messages that are  clinic-specific 
and locally appropriate. We used the 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 select a 
handwritten postcard for keepsakes, submit handwritten postcards of their own, draw on and 
decorate plain hand fans with stickers, send out messages promoting gonorrhea/chlamydia 
testing on social media platforms, or create videos promoting gonorrhea testing (to be 
viewed at the same clinic). Men who agree to participate in the community-engagement 
activities 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, 

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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 mapping
30, a method used in public health, to design these 
components in a way that is tailored to the local context of each site and facilitates their 
implementation. We will be guided by several behavior change taxonomies developed by 
implementation scientists to assist in the designing of implementation interventions
2,3. 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 Huizhou, Zhanjiang, 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 in 
participating will be provided with a link to the participant information sheet and consent 
form, and will be directed to an enrollment survey after they provide informed consent. 
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 Huizhou, Zhanjiang, 
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 selected MSM-led clinics and public 
STD clinics in Guangdong province, China. We will recruit a total of 350 participants. The 

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eligibility criteria include at least 18 years old and mentally capable of providing 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 methods
31 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 assessment
32, gratitude assessment
33, 34, and 
organizational readiness
35 at this stage of research. 
Formative Qualitative (n = 50) 
We have developed an interview guide as part of formative testing. The 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 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 the 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 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 

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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 patients who accept testing will receive gonorrhea/ 
chlamydia PCR testing. 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 

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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, 
and per unit costs associated with the intervention (Table 2).     
Table 2. Secondary outcomes of the cluster RCT 
Outcome  
Time Frame 
Ascertainment 
Data Analysis 
Primary 
 
 
 
Gonorrhoea and Chlamydia 
test uptake 
 
Clinic 
administrative 
data 
Generalized 
mixed effects 
models 
(compare 
control arm to 
pay-it-forward 
intervention) 
Secondary  
 
 
 
Amount donated 
During enrollment 
visit 
Administrative 
data 
Descriptive 
analysis 
The number of participants 
who tested positive for 
Gonorrhea 
During enrollment 
visit 
Laboratory result 
Descriptive 
analysis 
The number of participants 
tested positive for 
chlamydia 
During enrollment 
visit 
Laboratory result 
Descriptive 
analysis 
The proportion of those who 
tested positive for 
Gonorrhea or Chlamydia 
who returned for referral 
treatment  
One month after 
receiving the 
results 
Self-reported 
follow-up survey 
(linkage to care, 
treatment) 
Descriptive 
analysis 
Cost per test1 
During enrollment 
visit 
Costing data 
collection 
Micro-costing 
approach 

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Adapted gratitude scale 
During enrollment 
visit 
Self-report 
T-test 
Community solidarity scale4 
During enrollment 
visit 
Self-report2 
T-test 
Community cohesion 
During enrollment 
visit 
Self-report 
T-test 
Internalized homophobia 
During enrollment 
visit 
Self-report 
T-test 
Subgroup analysis 
 
 
 
Gonorrhea and chlamydia 
testing uptake by clinic type  
During enrollment 
visit 
Administrative 
data at study site 
MSM-led clinic 
vs. public STD 
clinic 
Gonorrhea and chlamydia 
testing uptake by sexual 
orientation 
During enrollment 
visit 
Self-reported 
sexual 
orientation data 
from baseline 
survey 
Self-identified 
sexual minority 
vs. not 
Gonorrhea and chlamydia 
testing uptake by age group 
During enrollment 
visit 
Self-reported 
socio-
demographic 
data from 
baseline survey 
≤30years 
vs. >30years 
Gonorrhea and chlamydia 
testing uptake by PrEP 
eligibility 
During enrollment 
visit 
Self-reported 
frequency of 
condom use in 
during sexual 
intercourse in the 
past 3 months 
data from 
baseline survey 
Condom use vs. 
Condomless sex. 
‘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.. 
 
Data analysis 
Data will be analyzed using a transformative mixed method research approach. The primary 
outcome will be gonorrhea and chlamydia test uptake among MSM. Quantitative and 
qualitative data will be analyzed using a convergent parallel design (i.e., analyze quantitative 

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and qualitative data separately) and the results were interpreted together. 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% C.Is and p-
values. Descriptive analysis will be used to summarize the characteristics and behaviors of the 
participants in each arm. 
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 funds, its sustainability partly depends on men willing to donate. Understanding the 
drivers of financial sustainability across individuals and clinics may help inform  policymakers 
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. 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, at each site in the standard and community- 
engaged arms, a member of the research staff will assess the extent to which pay-it-forward 
is implemented in accordance with the protocol using a fidelity checklist. This checklist will 
document how often each step of the Pay-it-forward protocol (including screening, consent, 
explanation of study procedures and Pay-it-forward, sample collection, donation, and 

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community engagement activities) is implemented. Research staff will also document the 
sequence of the study procedures, site-specific adaptations, and any implementation 
challenges  that occur at each site visit.  
Qualitative interviews 
MSM, healthcare providers, and PIONEER organizers will be recruited for in-depth interviews. 
We will recruit MSM in the clinic, immediately following participation in the RCT. We will also 
recruit, and interview selected health professionals to explore their perspectives about 
generosity in clinical settings to contribute to the development of more generous health 
services and inform clinical innovations. Purposive sampling strategies will be used to recruit 
MSM  involved in each implementation strategy arm, those who participate and those who 
do not, those who provide a higher donation and lower donation, and healthcare providers. 
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 and healthcare provider 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. The healthcare provider interviews will 
explore their perceptions of the factors affecting generosity will be explored at both 
individual and collective levels, particularly in terms of cynicism and gratitude within the 
practitioner-patient relationship. Analysis will focus on how generosity may be demonstrated 
and received, expanded and restricted, and its impact on patient recipients, colleagues and 
the clinical settings, and implications for the wider social community beyond the clinic space. 
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, 27 healthcare providers, and 25 PIONEER organizers will be 

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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 
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; and 
(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 them 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 reason. Project 
implementers will do data and safety monitoring. 
Data management information 
For the surveys and demographic questionnaires, all data are directly entered into computers 
at the 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 the 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 

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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 a 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 the “key” that links the non-descript identifier to 
personally identifiable information. IP addresses of participant's computers will not be 
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 with 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 
and input into the Health Information System (HIS) at the  public STD clinic. 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.31 
Dimensions 
Level 
Operational definitions 
Measurement 
method 
Analysis 
Reach  
Individual 
• Proportion of MSM who 
enter the clinic and are 
screened for eligibility 
• Percent of MSMs who visit 
the clinic compared to the 
MSM in the catchment area 
RCT data 
Local CDC data 
Descriptive analysis 
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)? 
RCT data 
Covered in RCT analyses above 
Adoption 
Organizational 
• Is the organization ready to 
adopt pay-it-forward? 
ORIC survey – 
administer after 
piloting and again 
early during RCT  
Qualitative 
interviews 
Descriptive analysis 
Rapid or content analysis 
Implementation Organizational 
• Fidelity: what is the extent 
to which local staff 
implement the pay-it-
forward according to the 
SOP and how does this 
Fidelity checklist 
filled out by 
research staff 
member observing 
intervention 
Descriptive analysis 
T-test/regression for fidelity 
score and/or adaptations vs 
intervention effectiveness 
Time series of adaptation 

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impact effectiveness? 
• Adaptations: what 
adaptions are implemented 
and how do they impact 
effectiveness?  
Documentation of 
adaptation content 
and timing 
Interviews with 
clinic staff  
implementation 
Rapid or content analysis 
Maintenance 
Organizational 
• Donations over time during 
the intervention 
• Cost-effectiveness 
• What are the barriers and 
facilitators of maintenance? 
What do implementing 
partners need to sustain 
Pay-it-forward? 
Donation and 
costing data 
Qualitative 
interviews 
Descriptive analysis 
Time series 
Cost-effectiveness analysis 
Rapid or content analysis 
 

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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, which are the major provider 
of STD testing and treatment services in the Chinese setting. There is also a lack of 
understanding of the implementation process and a missed opportunity to optimize the 
implementation strategy. By enhancing the community engagement components of the 
strategy, our trial aims 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 the effectiveness and 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 on 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 research 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, and engage key stakeholders.  
We anticipate that this novel financing model may also have policy implications for transitioning 

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from 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 
microdonations from economically better-off areas to cover essential health services in places 
that are underdeveloped.  
Organizational structure/Study team 
Principal Investigator (PI) 
Dr. Joseph D. Tucker 
Email: jdtucker@med.unc.edu  
Co-PI 
Dr Weiming Tang 
Co-investigators (CIs) 
Dr Ramaswamy Rohit; Dr Wang Cheng; Dr Kurt Gray; Dr Sean 
S, Sylvia; Dr David Van Duin; Dr Zheng Heping; Dr Dan Wu; 
Dr Ligang Yang; Dr Bin Yang 
Post-docs: Dr Rayner K.J. Tan; Dr Gifty Marley; Dr Katherine 
Li; Dr Meredith Wang 
Research Assistants 
Zixuan Zhu 
Liyuan Zhang 
Danyang Luo  
Ye Liu 
Zhou Ke  
Ruby Wang 
Interns 
Dorian Ho,  
 
 
 

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