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Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

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ClinicalTrials.gov Identifier: NCT03741725
Recruitment Status : Completed
First Posted : November 15, 2018
Results First Posted : January 21, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Aging (NIA)
Southern Medical University, China
London School of Hygiene and Tropical Medicine
SESH (Social Entrepreneurship to Spur Health)
Yale University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 15, 2018
Results First Submitted Date  ICMJE January 6, 2020
Results First Posted Date  ICMJE January 21, 2020
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE December 8, 2018
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Dual Gonorrhea/Chlamydia Test Uptake [ Time Frame: study enrollment period ]
Dual gonorrhea/chlamydia test uptake as assessed by administrative records, divided by the number men in the respective arm
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Gonorrhea Testing by Administrative Record [ Time Frame: enrollment period ]
    Frequency of men, defined as the number of men who tested for gonorrhea (urine and/or anal swab) outside of the intervention, as confirmed by administrative record
  • Chlamydia Testing by Administrative Record [ Time Frame: enrollment period ]
    Frequency of men, defined as the number of men who tested for chlamydia (urine and/or anal swab) outside of the intervention, as confirmed by administrative record
  • Incremental Cost Per Test [ Time Frame: enrollment period ]
    Incremental cost, 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
  • Incremental Cost Per Diagnosis [ Time Frame: enrollment period ]
    Incremental cost, 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
  • Community Engagement [ Time Frame: enrollment period ]
    Frequency of men, defined as number of men who report awareness of and/or participation in MSM-related causes, organizations, or community events
  • Community Connectedness [ Time Frame: enrollment period ]
    Frequency of men, defined as number of men who report feelings of belonging to a larger MSM community (i.e., tongzhi circle, gay online networks or groups)
  • Social Cohesion [ Time Frame: enrollment period ]
    Frequency of men, defined as number of men who report feelings of being able to depend on a larger MSM community (i.e., tongzhi circle, gay online networks or groups)
  • Peers referred per participant [ Time Frame: enrollment period ]
    Number of men referred divided by the number of men who participated in each arm
  • Peers tested per participant [ Time Frame: enrollment period ]
    Number of referred men who tested for gonorrhea and chlamydia divided by the number of men who participated in each arm
  • New cases per participant [ Time Frame: enrollment period ]
    Number of referred men who tested positive for gonorrhea and/or chlamydia divided by the number of men who participated in each arm
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pay-it-forward RCT for Gonorrhea and Chlamydia Testing
Official Title  ICMJE Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3-arm superiority randomized controlled
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Gonorrhea Male
  • Chlamydia;M
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pay-it-forward
  • 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.
    Intervention: Other: Pay-what-you-want
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2020)
301
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
300
Actual Study Completion Date  ICMJE September 2, 2019
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 16 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741725
Other Study ID Numbers  ICMJE 18-2142
5P30AG034420-10 ( U.S. NIH Grant/Contract )
R01AI114310 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute on Aging (NIA)
  • Southern Medical University, China
  • London School of Hygiene and Tropical Medicine
  • SESH (Social Entrepreneurship to Spur Health)
  • Yale University
Investigators  ICMJE
Principal Investigator: Joseph D Tucker, MD, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP