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Completed

NCT Number: NCT03741725

Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

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.

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Key information

Age range

16 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Southern Medical University, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pay-it-forward

Other

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

Other

Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.

Primary outcomes

  1. Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm.

Secondary outcomes

  1. Number of Participants Tested Positive for Gonorrhea

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum.

  2. Number of Participants Tested Positive for Chlamydia

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    The is the number of men who tested positive for chlamydia through this study

  3. Cost Per Test

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    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.

  4. Cost Per Diagnosis

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    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.

  5. Number of Participants Reporting Community Engagement Activities

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    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

  6. Community Connectedness Scale Scores

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    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.

  7. Social Cohesion Scale Scores

    Time frame: During enrollment visit, an approximate total of 1.5 hours

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute on Aging (NIA)
  • Social Entrepreneurship to Spur Health
  • Southern Medical University, China
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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