Clinical trial NCT03741725: Pay-it-forward RCT for Gonorrhea and Chlamydia Testing
Official title: Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gonorrhea Male
Chlamydia;M
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute on Aging (NIA)
name: Southern Medical University, China
name: London School of Hygiene and Tropical Medicine
name: Social Entrepreneurship to Spur Health
name: Yale University
First posted: 2018-11-15
Enrollment: 301
Sex: MALE
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm superiority randomized controlled
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing
timeFrame: During enrollment visit, an approximate total of 1.5 hours
Secondary outcomes:
measure: Number of Participants Tested Positive for Gonorrhea
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Number of Participants Tested Positive for Chlamydia
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Cost Per Test
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Cost Per Diagnosis
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Number of Participants Reporting Community Engagement Activities
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Community Connectedness Scale Scores
timeFrame: During enrollment visit, an approximate total of 1.5 hours
measure: Social Cohesion Scale Scores
timeFrame: During enrollment visit, an approximate total of 1.5 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhitong Guangzhou LGBT Center
state: Guangdong
city: Beijing
country: China
facility: BlueD Danlan Happy Testing Office
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Joseph D Tucker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.