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Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

Primary Purpose

Gonorrhea Male, Chlamydia;M

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pay-it-forward
Pay-what-you-want
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Gonorrhea Male

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Southern Medical University
  • Zhitong Guangzhou LGBT Center
  • BlueD Danlan Happy Testing Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pay-it-forward

Pay-what-you-want

Standard of care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing
Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm.

Secondary Outcome Measures

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.
Number of Participants Tested Positive for Chlamydia
The is the number of men who tested positive for chlamydia through this study
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.
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.
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
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.
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.

Full Information

First Posted
November 12, 2018
Last Updated
July 2, 2020
Sponsor
University of North Carolina, Chapel Hill
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
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1. Study Identification

Unique Protocol Identification Number
NCT03741725
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 8, 2018 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
September 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonorrhea Male, Chlamydia;M

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3-arm superiority randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pay-it-forward
Arm Type
Experimental
Arm Description
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.
Arm Title
Pay-what-you-want
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pay-it-forward
Intervention Description
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 Type
Other
Intervention Name(s)
Pay-what-you-want
Intervention Description
Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.
Primary Outcome Measure Information:
Title
Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing
Description
Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm.
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Secondary Outcome Measure Information:
Title
Number of Participants Tested Positive for Gonorrhea
Description
The number of men who tested positive for gonorrhea through this study. Samples were collected either from urine or rectum.
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Number of Participants Tested Positive for Chlamydia
Description
The is the number of men who tested positive for chlamydia through this study
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Cost Per Test
Description
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.
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Cost Per Diagnosis
Description
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.
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Number of Participants Reporting Community Engagement Activities
Description
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
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Community Connectedness Scale Scores
Description
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.
Time Frame
During enrollment visit, an approximate total of 1.5 hours
Title
Social Cohesion Scale Scores
Description
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.
Time Frame
During enrollment visit, an approximate total of 1.5 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Tucker, MD, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Zhitong Guangzhou LGBT Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
BlueD Danlan Happy Testing Office
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30587296
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.
Results Reference
background
PubMed Identifier
28406270
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.
Results Reference
background
PubMed Identifier
32530426
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.
Results Reference
derived
PubMed Identifier
31426869
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.
Results Reference
derived

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Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

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