Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

Study Overview
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Brief Summary
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This is a randomized controlled trial which will evaluate dual gonorrhea/chlamydia test uptake and other outcomes in men who have sex with men (MSM) in three trial arms - 1) a pay-it-forward testing arm, 2) a pay-what-you-want testing arm, and 3) standard of care arm.

Detailed Description
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At both of the program sites, MSM partaking in HIV and syphilis testing will be offered dual gonorrhea/chlamydia testing. First, all men will be provided a brief (5 minute) introduction to gonorrhea and chlamydia testing using a pamphlet. Program organizers will then explain the pay-it-forward program to each man separately. Briefly, men will be told that the hospital list price of gonorrhea and chlamydia testing was 150 RMB ($24 USD), but previous men attending the clinic had donated money to cover the cost of his test. Thus, each man could receive a free gonorrhea and chlamydia test, then decide whether to donate money (pay-it-forward) for future men to receive the same option. Men will be assured that donating is completely optional and advised to pay any amount that is feasible for them. Each man's gonorrhea and chlamydia test fees will be covered by a combination of the initial funding pool from the program organizers and the donations from previous participants. Men will also be shown a postcard with a message written by a previous pay-it-forward contributor. Messages will contain information encouraging men to be tested/slogans to promote sexual health and testing (i.e. taking ownership of their health). They will be told that they could also write a postcard message for a future participant. Men will then decide whether or not to receive combined urine gonorrhea/chlamydia testing. Program organizers will inform participants of their test results via WeChat. Patients with positive test results will be counseled and directed to the WeChat page of designated hospitals where they could make an appointment to receive treatment and follow-up.

Official Title
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Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial

Conditions
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Gonorrhea Male, Chlamydia;M

Intervention / Treatment
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* Other: Pay-it-forward
* Other: Pay-what-you-want


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: born biologically male age 16 years or older report previous anal sex with another man willing to provide mobile phone number for results notification Exclusion criteria: tested for both gonorrhoea and chlamydia in the past 12 months with no high-risk sexual behavior following testing previous participation in pay-it-forward program

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm superiority randomized controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pay-it-forward<br>First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option. | Other: Pay-it-forward<br>* Participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option.<br>|
| Experimental: Pay-what-you-want<br>First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test. | Other: Pay-what-you-want<br>* Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.<br>|
| No Intervention: Standard of care<br>First, participants will be provided a brief introduction to gonorrhea and chlamydia testing. Then, participants will be offered gonorrhoea and chlamydia testing at the standard patient price. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing | Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm. | During enrollment visit, an approximate total of 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Tested Positive for Gonorrhea | The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum. | During enrollment visit, an approximate total of 1.5 hours | 
| Number of Participants Tested Positive for Chlamydia | The is the number of men who tested positive for chlamydia through this study | During enrollment visit, an approximate total of 1.5 hours | 
| Cost Per Test | Cost per test, 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. | During enrollment visit, an approximate total of 1.5 hours | 
| Cost Per Diagnosis | Cost per diagnosis, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who tested positive for gonorrhea and/or chlamydia following the intervention. Cost using economic cost and financial cost were respectively reported. | During enrollment visit, an approximate total of 1.5 hours | 
| Number of Participants Reporting Community Engagement Activities | Number of participants who reported yes/no to specific questions on the awareness of and/or participation in MSM-related causes, organizations, or community events | During enrollment visit, an approximate total of 1.5 hours | 
| Community Connectedness Scale Scores | Community connectedness scales include six statements and Likert scale response ranging from 1= Strongly disagree, 2= Agree, 3= Disagree, and 4= Strongly agree. For each scale item, the range spans across 1 to 4, with higher score indicating more agreement with the statement and potentially higher community connectedness. | During enrollment visit, an approximate total of 1.5 hours | 
| Social Cohesion Scale Scores | Social cohesion is a scale made of seven statements and Likert response to them ranging from 1= strongly disagree, 2 = disagree, 3 = agree, and 4= strongly agree. Those questions asked about the feelings of being able to depend on a larger MSM community (i.e., tongzhi circle, gay online networks or groups). For each item, the range spans across 1 to 4. For items 1 to 5, the higher score, the more agreement with the statement and potentially the higher social cohesion. Item 6 and 7 are reversely scored, meaning that the higher the score, the lower social cohesion potentially. | During enrollment visit, an approximate total of 1.5 hours |