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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

301

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach

1 country

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

November 12, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed

23 days until next milestone

Study Start

First participant enrolled

December 8, 2018

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed

5 months until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed

Last Updated

July 7, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

November 12, 2018

Results QC Date

January 6, 2020

Last Update Submit

July 2, 2020

Conditions

Gonorrhea Male Chlamydia;M

Outcome Measures

Primary Outcomes (1)

Number of Participants Who Received the Dual Gonorrhea/Chlamydia Testing
Dual gonorrhea/chlamydia test uptake as assessed by administrative records in each arm.
During enrollment visit, an approximate total of 1.5 hours

Secondary Outcomes (7)

Number of Participants Tested Positive for Gonorrhea
During enrollment visit, an approximate total of 1.5 hours
Number of Participants Tested Positive for Chlamydia
During enrollment visit, an approximate total of 1.5 hours
Cost Per Test
During enrollment visit, an approximate total of 1.5 hours
Cost Per Diagnosis
During enrollment visit, an approximate total of 1.5 hours
Number of Participants Reporting Community Engagement Activities
During enrollment visit, an approximate total of 1.5 hours
+2 more secondary outcomes

Study Arms (3)

Pay-it-forward

EXPERIMENTAL

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

Pay-what-you-want

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

Pay-it-forwardOTHER

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-it-forward

Pay-what-you-wantOTHER

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

Pay-what-you-want

Eligibility Criteria

Age16 Years - 99 Years

Sexmale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

born biologically male
age 16 years or older
report previous anal sex with another man
willing to provide mobile phone number for results notification

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of North Carolina, Chapel Hilllead
National Institute of Allergy and Infectious Diseases (NIAID)collaborator
National Institute on Aging (NIA)collaborator
Southern Medical University, Chinacollaborator
London School of Hygiene and Tropical Medicinecollaborator
Social Entrepreneurship to Spur Healthcollaborator
Yale Universitycollaborator

Study Sites (3)

Southern Medical University

Guangzhou, Guangdong, China

Location

Zhitong Guangzhou LGBT Center

Guangzhou, Guangdong, China

Location

BlueD Danlan Happy Testing Office

Beijing, China

Location

Related Publications (4)

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.
PMID: 30587296BACKGROUND
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.
PMID: 28406270BACKGROUND
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.
PMID: 32530426DERIVED
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.
PMID: 31426869DERIVED

Results Point of Contact

Title: Dr. Weiming Tang
Organization: University of North Carolina, Project-China

Study Officials

Joseph D Tucker, MD, PhD
University of North Carolina, Chapel Hill
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: SCREENING
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 15, 2018

Study Start

December 8, 2018

Primary Completion

September 2, 2019

Study Completion

September 2, 2019

Last Updated

July 7, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-01

Locations

CN(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (3)

Pay-it-forward

Pay-what-you-want

Standard of care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (4)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations