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Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

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ClinicalTrials.gov Identifier: NCT03741725
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : January 8, 2019
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

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.

Condition or disease Intervention/treatment Phase
Gonorrhea Male Chlamydia;M Other: Pay-it-forward Other: Pay-what-you-want Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3-arm superiority randomized controlled
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pay-it-forward Gonorrhea and Chlamydia Testing Among Men Who Have Sex With Men in China: a Cluster Randomized Controlled Trial
Actual Study Start Date : December 8, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741725


Contacts
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Contact: Tiange Zhang 18611636966 tiangezhang@wustl.edu

Locations
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China, Guangdong
Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Wenting Huang    18613067997      
Zhitong Guangzhou LGBT Center Recruiting
Guangzhou, Guangdong, China
Contact: Tiange Zhang    18611636966      
China
BlueD Danlan Happy Testing Office Recruiting
Beijing, China
Contact: Tiange Zhang    18611636966      
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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
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Principal Investigator: Joseph Tucker, MD, PhD University of North Carolina, Chapel Hill

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03741725     History of Changes
Other Study ID Numbers: 18-2142
5P30AG034420-10 ( U.S. NIH Grant/Contract )
R01AI114310 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections