Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China

IGHID 12118 - Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China: The PIONEER Pragmatic Randomized Controlled Trial

PIONEER is a three-arm, programmatic cluster randomized controlled trial (RCT) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

Study Overview

• Status: Completed
• Conditions: Chlamydia; Gonorrhea
• Intervention / Treatment: Behavioral: Standard Pay-it-forward; Behavioral: Community Engaged Pay-it-forward; Other: Control arm

Detailed Description

The study will be implemented at 12 clinics in Guangdong, China, which will be randomly assigned to one of the intervention arms for delivering gonorrhea testing: a standard pay-it-forward implementation strategy with minimal encouragement to get tested, a community-engaged pay-it-forward strategy, and a control arm in which men pay for their own sexually transmitted disease (STD) test. Data sources will include survey data on acceptability of intervention, intervention appropriateness, feelings and attitudes towards interventions among participants, administrative data about test uptake, treatment rate, and donations, as well as qualitative data to gain insights about men's perceptions and attitudes towards the pay-it-forward interventions strategies, mechanisms driving uptake and donating behaviors. Both survey and qualitative interviews with implementers and organizers about fidelity and adherence to protocol, intention to continue and maintain a pay-it-forward intervention, and barriers and facilitators of implementing the intervention will be conducted.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• at least 18 years old
• have had sex over the past year
• have not been tested for gonorrhea and chlamydia in the past year
• reside in the city in the past three months
• speak Mandarin Chinese or Cantonese
• mentally capable of providing informed consent to test for gonorrhea and chlamydia
• own a mobile phone

Exclusion Criteria:

• < 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Pay-it-forward; free gonorrhea/chlamydia testing; minimal engagement	Behavioral: Standard Pay-it-forward; 400 men who have sex with men (MSM) at 4 clinics will be enrolled. The standard pay-it-forward arm will include free point-of-care gonorrhea testing, as well as a passive community engagement component (such as viewing postcards and materials written by others encouraging gonorrhea/chlamydia testing).
Experimental: Community engaged Pay-it-forward; Free gonorrhea/chlamydia testing; Stronger engagement	Behavioral: Community Engaged Pay-it-forward; 400 MSM at 4 clinics will be enrolled. The community engaged pay-it-forward arm will include free point-of-care gonorrhea testing, as well as an active community engagement component (such as multi-stakeholder co-creation activities to develop essential components of the intervention and implementation strategies; writing postcards; designing fans with stickers; sending out testing promotion messages on social media; and opportunity to donate to support others)
Other: Control arm; Test available for a fee; No engagement	Other: Control arm; 400 MSM at 4 clinics will be enrolled. The control arm will include a fee-based point-of-care gonorrhea testing (approximately 20 U.S. Dollars (USD) per test) and no community engagement component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Testing for Gonorrhea and Chlamydia	Defined as the number of eligible participants who accepted and provided laboratory samples for gonorrhea and chlamydia PCR testing out of the total number of eligible participants recruited across the three study arms.	During enrollment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donation Amount	The response was defined as the total amount of money donated by participants in the pay-it-forward group to support testing for other participants. Self-reported via a self-administered survey and validated in donation receipt records.	Baseline
Number of Participants Who Test Positive for Gonorrhea	The response rate was defined as the number of participants who tested positive for gonorrhea out of the total number of participants tested for gonorrhea. Test results were obtained from validated laboratory diagnosis reports based on polymerase chain reaction (PCR) testing.	Within 2 weeks of enrollment
Cost Per Test Per Individual	The costs per test individual consist of the direct costs of PCR tests for gonorrhea and chlamydia for each individual tested at baseline. For the intervention arms, the estimate was calculated as the total direct cost paid to the laboratory minus the total amount donated by pay-it-forward arm participants in that intervention arm, divided by the total number of participants tested in that arm. The average exchange rate for the US dollar (USD) to RMB on March 31, 2025, was 1 USD = 7.22 RMB. Control arm participants paid the standard cost of 150 RMB (~20.18 USD) each for dual PCR testing at the clinic site out-of-pocket.	Baseline - During enrollment visit
Mean Self Reported Gratitude Score	The response rate was the average self-rated gratitude towards and about the pay-it-forward intervention. This was scored using a 10-item adapted gratitude survey on a 5-level Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Possible average scores ranged from 1 (lowest level of gratitude) to 7 (highest level of gratitude).	During enrollment visit
Mean Self Reported Community Engagement Score	The response rate was the average self-rated community engagement with the local and/or LGBTQ community before participating in the study, scored using a validated tool assessed on a 6-item Likert scale. Possible average scores ranged from 0 (no community engagement) to 6 (high community engagement)	Baseline
Mean Community Connectedness and Cohesion Score	The response rate was defined as the average self-rated community engagement score using a validated 11-item scale rated on a 4-level Likert scale. Possible average scores ranged from 1 (low community connectedness and cohesion) to 4 (high community connectedness and cohesion)	Baseline
Internalized Homophobia and Self-identification	The response rate was the average self-rated internalized homophobia and self-identification score assessed using a validated 9-item survey rated on a 1-5 Likert scale. Possible average scores ranged from 1 (low self-identification and high internalized homophobia) to 5 (high self-identification and low internalized homophobia)	Baseline
Number of Participants Who Test Positive for Chlamydia	The response rate was defined as the number of participants who tested positive for chlamydia out of the total number of participants who tested for chlamydia. Test results were obtained from validated laboratory diagnosis reports based on PCR testing.	Within 2 weeks of recruitment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gonorrhea and Chlamydia Testing Uptake by Clinic Type	Stratifies gonorrhea/chlamydia testing uptake between participants recruited in community-led clinics versus public STI clinics across the three intervention arms.	During enrollment visit
Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation	Stratifies gonorrhea/chlamydia testing uptake between MSM and non-MSM participants across the three intervention arms.	During enrollment visit
Gonorrhea and Chlamydia Testing Uptake by Age Group	Stratifies gonorrhea/chlamydia testing uptake between participants aged 30 years and below and those above 30 years across the three intervention arms.	During enrollment visit

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Joseph D Tucker, MD, University of North Carolina

Publications and helpful links

General Publications

• Marley G, Tan RKJ, Wu D, Wang T, Sun M, Sheng Q, Holly ME, Hlatshwako TG, Wang C, Tang W, Ramaswamy R, Yang L, Luo D, Sylvia SS, Gray K, Van Duin D, Zheng H, Tucker JD. Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol. BMC Public Health. 2023 Jun 20;23(1):1182. doi: 10.1186/s12889-023-16095-8.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: gonorrhea; sexually transmitted infection (STI); chlamydia; gonorrhea testing among men who have sex with men
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Chlamydia Infections; Gonorrhea
• Other Study ID Numbers: 21-1667; R01AI158826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No