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

Not Applicable

Completed

Conditions: Gonorrhea

Interventions: Behavioral: Standard Pay-it-forward
Behavioral: Community Engaged Pay-it-forward
Other: Control arm

Registration Number: NCT05723263

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 1200

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Pay-it-forward	Standard Pay-it-forward	* free gonorrhea/chlamydia testing * minimal engagement
Community engaged Pay-it-forward	Community Engaged Pay-it-forward	* Free gonorrhea/chlamydia testing * Stronger engagement
Control arm	Control arm	* Test available for a fee * No engagement

Primary Outcome Measures

Name	Time	Method
Number of Participants Testing for Gonorrhea	During enrollment visit	PIONEER is a three-arm, programmatic, cluster-randomized controlled trial (RCT) that compared the effectiveness of pay-it-forward strategies in increasing gonorrhea and chlamydia testing uptake among men in China, with standard-of-care, followed by a mixed-methods implementation evaluation study. The test uptake rate was defined as the total number of eligible participants who provided self-collected samples for gonorrhea and chlamydia testing, out of the total number of eligible participants offered testing.

Secondary Outcome Measures

Name	Time	Method
Mean Self Reported Community Engagement Score	Baseline	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)
Donation Amount	Baseline	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.
Internalized Homophobia and Self-identification	Baseline	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)
Number of Participants Who Test Positive for Gonorrhea	Within 2 weeks of enrollment	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.
Number of Participants Who Test Positive for Chlamydia	Within 2 weeks of recruitment	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 gonorrhea. Test results were obtained from validated laboratory diagnosis reports based on PCR testing.
Cost Per Test Per Individual	Baseline - During enrollment visit	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.
Mean Self Reported Gratitude Score	During enrollment visit	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).
Mean Community Connectedness and Cohesion Score	Baseline	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)

Trial Locations

Locations (1): Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China
🇨🇳
Guangzhou, Guangdong, China