Pay-it-forward RCT for Gonorrhea and Chlamydia Testing

NCT ID: NCT03741725

Last Updated: 2020-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-08

Study Completion Date

2019-09-02

Brief Summary

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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

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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.

Conditions

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Gonorrhea Male Chlamydia;M

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm superiority randomized controlled
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pay-it-forward

Intervention Type 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

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.

Group Type EXPERIMENTAL

Pay-what-you-want

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Social Entrepreneurship to Spur Health

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph D Tucker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Southern Medical University

Guangzhou, Guangdong, China

Site Status

Zhitong Guangzhou LGBT Center

Guangzhou, Guangdong, China

Site Status

BlueD Danlan Happy Testing Office

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30587296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28406270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32530426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31426869 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5P30AG034420-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AI114310

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-2142

Identifier Type: -

Identifier Source: org_study_id

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