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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03741725
Other study ID # 18-2142
Secondary ID 5P30AG034420-10R
Status Completed
Phase N/A
First received
Last updated
Start date December 8, 2018
Est. completion date September 2, 2019

Study information

Verified date January 2020
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date September 2, 2019
Est. primary completion date September 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China BlueD Danlan Happy Testing Office Beijing
China Southern Medical University Guangzhou Guangdong
China Zhitong Guangzhou LGBT Center Guangzhou Guangdong

Sponsors (7)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill London School of Hygiene and Tropical Medicine, National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA), SESH (Social Entrepreneurship to Spur Health), Southern Medical University, China, Yale University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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