Trial Outcomes & Findings for Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China (NCT NCT05723263)

NCT ID: NCT05723263

Last Updated: 2025-12-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1200 participants

Primary outcome timeframe

During enrollment visit

Results posted on

2025-12-03

Participant Flow

Participants were recruited based on physician referrals at six (6) public sexually transmitted infection (STI) and six (6) community-led clinics.

12 clinics in six cities were randomized to the three intervention arms in a 1:1:1 ratio, stratified by the 2023 GDP ranking. Each city had two clinics, and all clinics in the same city were assigned to the same intervention arm. Of the 1312 participants screened, 1200 met inclusion criteria and received the intervention assigned to the clinic. Reasons for exclusion were as follows: tested for gonorrhea in the last 12 months = 111, and disagreed to provide informed consent = 1

Unit of analysis: Clinic randomization in 1:1:1 ratio

Participant milestones

Participant milestones
Measure
Community-Engaged Pay-It-Forward
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Overall Study
STARTED
400 4
400 4
400 4
Overall Study
COMPLETED
400 4
400 4
400 4
Overall Study
NOT COMPLETED
0 0
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Community-engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S.Dollars (USD).
Total
n=1200 Participants
Total of all reporting groups
Age, Continuous
37.36 years
STANDARD_DEVIATION 12.54 • n=9 Participants
33.46 years
STANDARD_DEVIATION 12.49 • n=6 Participants
34.90 years
STANDARD_DEVIATION 11.12 • n=9 Participants
35.06 years
STANDARD_DEVIATION 10.23 • n=205 Participants
Sex: Female, Male
Female
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Sex: Female, Male
Male
400 Participants
n=9 Participants
400 Participants
n=6 Participants
400 Participants
n=9 Participants
1200 Participants
n=205 Participants
Race/Ethnicity, Customized
Chinese
400 Participants
n=9 Participants
400 Participants
n=6 Participants
400 Participants
n=9 Participants
1200 Participants
n=205 Participants
City of Enrollment
Dongguan
0 Participants
n=9 Participants
0 Participants
n=6 Participants
200 Participants
n=9 Participants
200 Participants
n=205 Participants
City of Enrollment
Foshan
200 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
200 Participants
n=205 Participants
City of Enrollment
Huizhou
200 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
200 Participants
n=205 Participants
City of Enrollment
Jiangmen
0 Participants
n=9 Participants
200 Participants
n=6 Participants
0 Participants
n=9 Participants
200 Participants
n=205 Participants
City of Enrollment
Zhanjiang
0 Participants
n=9 Participants
0 Participants
n=6 Participants
200 Participants
n=9 Participants
200 Participants
n=205 Participants
City of Enrollment
Zhuhai
0 Participants
n=9 Participants
200 Participants
n=6 Participants
0 Participants
n=9 Participants
200 Participants
n=205 Participants
Marital Status
Ever Married
201 Participants
n=9 Participants
133 Participants
n=6 Participants
190 Participants
n=9 Participants
524 Participants
n=205 Participants
Marital Status
Never Married
199 Participants
n=9 Participants
267 Participants
n=6 Participants
210 Participants
n=9 Participants
676 Participants
n=205 Participants
Sexual Behavior
MSM
194 Participants
n=9 Participants
230 Participants
n=6 Participants
197 Participants
n=9 Participants
621 Participants
n=205 Participants
Sexual Behavior
Non-MSM
206 Participants
n=9 Participants
170 Participants
n=6 Participants
203 Participants
n=9 Participants
579 Participants
n=205 Participants
Highest Level of Education
Below high school
118 Participants
n=9 Participants
87 Participants
n=6 Participants
80 Participants
n=9 Participants
285 Participants
n=205 Participants
Highest Level of Education
High school
119 Participants
n=9 Participants
89 Participants
n=6 Participants
141 Participants
n=9 Participants
349 Participants
n=205 Participants
Highest Level of Education
Bachelor's degree
136 Participants
n=9 Participants
186 Participants
n=6 Participants
130 Participants
n=9 Participants
452 Participants
n=205 Participants
Highest Level of Education
Postgraduate and above
27 Participants
n=9 Participants
36 Participants
n=6 Participants
49 Participants
n=9 Participants
112 Participants
n=205 Participants
Annual Income
< $49,670
100 Participants
n=9 Participants
120 Participants
n=6 Participants
102 Participants
n=9 Participants
322 Participants
n=205 Participants
Annual Income
$49,670 - $79,999
128 Participants
n=9 Participants
113 Participants
n=6 Participants
121 Participants
n=9 Participants
362 Participants
n=205 Participants
Annual Income
>/= $80,000
172 Participants
n=9 Participants
167 Participants
n=6 Participants
177 Participants
n=9 Participants
516 Participants
n=205 Participants
Previous Testing
Gonorrhea
58 Participants
n=9 Participants
51 Participants
n=6 Participants
35 Participants
n=9 Participants
144 Participants
n=205 Participants
Previous Testing
Chlamydia
63 Participants
n=9 Participants
50 Participants
n=6 Participants
36 Participants
n=9 Participants
149 Participants
n=205 Participants

PRIMARY outcome

Timeframe: During enrollment visit

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.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Number of Participants Testing for Gonorrhea and Chlamydia
390 Participants
361 Participants
12 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Per-protocol population (all participants recruited to the community-engaged and standard pay-it-forward groups and offered a chance to donate). This outcome does not apply to participants in the Control arm.

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.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Donation Amount
225.16 USD
Standard Deviation 37.53
382.61 USD
Standard Deviation 63.77

SECONDARY outcome

Timeframe: Within 2 weeks of enrollment

Population: Per-protocol population (all participants tested for gonorrhea with laboratory results available).

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.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=390 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=361 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=12 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Number of Participants Who Test Positive for Gonorrhea
10 Participants
12 Participants
1 Participants

SECONDARY outcome

Timeframe: Within 2 weeks of recruitment

Population: Per-protocol population (all participants tested for chlamydia with laboratory results available).

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.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=390 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=361 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=12 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Number of Participants Who Test Positive for Chlamydia
35 Participants
58 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline - During enrollment visit

Population: Per protocol analysis (cost of gonorrhea and chlamydia testing for each eligible participant who accepted and provided samples for dual gonorrhea and chlamydia testing in each study arm). Fraction for direct cost per test per individual = (total direct cost of laboratory tests paid - total amount donated by participants) / total number of participants tested.

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.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=390 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=361 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=12 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Cost Per Test Per Individual
14.10 USD
Standard Deviation 0.41
13.61 USD
Standard Deviation 0.75
20.18 USD
Standard Deviation 0

SECONDARY outcome

Timeframe: During enrollment visit

Population: Per-protocol population (all participants recruited to the pay-it-forward intervention group with average gratitude scores results available. Less than \<15% missing data for items in this scale was observed and average imputation was used). This outcome does not apply to participants in the Control arm.

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).

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Mean Self Reported Gratitude Score
5.81 score on a scale
Standard Deviation 1.04
6.21 score on a scale
Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline

Population: Less than \<15% missing data for items in this scale was observed and average imputation was used.

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)

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Mean Self Reported Community Engagement Score
0.21 score on a scale
Standard Deviation 0.29
0.27 score on a scale
Standard Deviation 0.31
0.32 score on a scale
Standard Deviation 0.34

SECONDARY outcome

Timeframe: Baseline

Population: Per-protocol population (all participants with average community connectedness and cohesion score results available. Less than \<15% missing data for items in this scale was observed and average imputation was used).

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)

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Mean Community Connectedness and Cohesion Score
3.27 score on a scale
Standard Deviation 0.67
3.02 score on a scale
Standard Deviation 0.72
2.66 score on a scale
Standard Deviation 0.83

SECONDARY outcome

Timeframe: Baseline

Population: Per-protocol population (All MSM participants with internalized homophobia assessment results available. Less than \<15% missing data for items in this scale was observed and average imputation was used). MSM referred to all eligible male participants who self-reported having ever engaged in anal intercourse with another man in the baseline survey.

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)

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=194 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=230 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=197 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Internalized Homophobia and Self-identification
3.61 score on a scale
Standard Deviation 0.89
3.34 score on a scale
Standard Deviation 0.95
3.44 score on a scale
Standard Deviation 0.84

OTHER_PRE_SPECIFIED outcome

Timeframe: During enrollment visit

Stratifies gonorrhea/chlamydia testing uptake between participants recruited in community-led clinics versus public STI clinics across the three intervention arms.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Gonorrhea and Chlamydia Testing Uptake by Clinic Type
Community-led Clinic
199 Participants
164 Participants
1 Participants
Gonorrhea and Chlamydia Testing Uptake by Clinic Type
Public STI Clinic
191 Participants
197 Participants
11 Participants
Gonorrhea and Chlamydia Testing Uptake by Clinic Type
Not Tested
10 Participants
39 Participants
388 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During enrollment visit

Stratifies gonorrhea/chlamydia testing uptake between MSM and non-MSM participants across the three intervention arms.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation
MSM
194 Participants
193 Participants
1 Participants
Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation
Non-MSM
196 Participants
168 Participants
11 Participants
Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation
Not Tested
10 Participants
39 Participants
388 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During enrollment visit

Stratifies gonorrhea/chlamydia testing uptake between participants aged 30 years and below and those above 30 years across the three intervention arms.

Outcome measures

Outcome measures
Measure
Community-Engaged Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary and/or handwritten message donations to support other participants.
Standard Pay-It-Forward
n=400 Participants
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants.
Control
n=400 Participants
Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD).
Gonorrhea and Chlamydia Testing Uptake by Age Group
30 years and below
143 Participants
178 Participants
4 Participants
Gonorrhea and Chlamydia Testing Uptake by Age Group
Not Tested
10 Participants
39 Participants
388 Participants
Gonorrhea and Chlamydia Testing Uptake by Age Group
Above 30 years
247 Participants
183 Participants
8 Participants

Adverse Events

Community Engaged Pay-it-forward

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Pay-it-forward

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Tucker, MD, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-2536

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place