Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

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

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.

Study Overview

• Status: Completed
• Conditions: Gonorrhea Male; Chlamydia;M
• Intervention / Treatment: Other: Pay-it-forward; Other: Pay-what-you-want

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • BlueD Danlan Happy Testing Office
  • Guangdong
    • Guangzhou, Guangdong, China
      • Southern Medical University
    • Guangzhou, Guangdong, China
      • Zhitong Guangzhou LGBT Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pay-it-forward; 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; 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.
EXPERIMENTAL: Pay-what-you-want; 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; Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.
NO_INTERVENTION: Standard of care; 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?

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: London School of Hygiene and Tropical Medicine; National Institute of Allergy and Infectious Diseases (NIAID); Yale University; National Institute on Aging (NIA); Southern Medical University, China; SESH (Social Entrepreneurship to Spur Health)
• Investigators: Principal Investigator: Joseph D Tucker, MD, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Li KT, Tang W, Wu D, Huang W, Wu F, Lee A, Feng H, Pan SW, Han L, Mak V, Yang L, Tucker JD. 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. Lancet Infect Dis. 2019 Jan;19(1):76-82. doi: 10.1016/S1473-3099(18)30556-5.
• Zhang TP, Liu C, Han L, Tang W, Mao J, Wong T, Zhang Y, Tang S, Yang B, Wei C, Tucker JD. Community engagement in sexual health and uptake of HIV testing and syphilis testing among MSM in China: a cross-sectional online survey. J Int AIDS Soc. 2017 Apr 3;20(1):21372. doi: 10.7448/IAS.20.01.21372.
• Yang F, Zhang TP, Tang W, Ong JJ, Alexander M, Forastiere L, Kumar N, Li KT, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Luo D, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial. Lancet Infect Dis. 2020 Aug;20(8):976-982. doi: 10.1016/S1473-3099(20)30172-9. Epub 2020 Apr 28.
• Zhang TP, Yang F, Tang W, Alexander M, Forastiere L, Kumar N, Li K, Zou F, Yang L, Mi G, Wang Y, Huang W, Lee A, Zhu W, Vickerman P, Wu D, Yang B, Christakis NA, Tucker JD. Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men in China: a study protocol for a three-arm cluster randomized controlled trial. Infect Dis Poverty. 2019 Aug 16;8(1):76. doi: 10.1186/s40249-019-0581-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2018
• Primary Completion (ACTUAL): September 2, 2019
• Study Completion (ACTUAL): September 2, 2019

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (ACTUAL): November 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: 18-2142; R01AI114310 (U.S. NIH Grant/Contract); 5P30AG034420-10 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No