Chlamydia, Gonorrhea
Conditions
Keywords
gonorrhea, sexually transmitted infection (STI), gonorrhea testing among men who have sex with men, chlamydia
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.
Interventions
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).
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)
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
Sponsors
Study design
Intervention model description
hybrid effectiveness-implementation study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Testing for Gonorrhea and Chlamydia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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) |
| 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) |
| 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. |
| 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 chlamydia. Test results were obtained from validated laboratory diagnosis reports based on PCR testing. |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gonorrhea and Chlamydia Testing Uptake by Age Group | 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. |
| Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | During enrollment visit | Stratifies gonorrhea/chlamydia testing uptake between MSM and non-MSM participants across the three intervention arms. |
| Gonorrhea and Chlamydia Testing Uptake by Clinic Type | During enrollment visit | Stratifies gonorrhea/chlamydia testing uptake between participants recruited in community-led clinics versus public STI clinics across the three intervention arms. |
Countries
China
Participant flow
Recruitment details
Participants were recruited based on physician referrals at six (6) public sexually transmitted infection (STI) and six (6) community-led clinics.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 400 |
| 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. | 400 |
| Control Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S.Dollars (USD). | 400 |
| Total | 1,200 |
Baseline characteristics
| Characteristic | Control | Community-engaged Pay-It-Forward | Standard Pay-It-Forward | Total |
|---|---|---|---|---|
| Age, Continuous | 34.90 years STANDARD_DEVIATION 11.12 | 37.36 years STANDARD_DEVIATION 12.54 | 33.46 years STANDARD_DEVIATION 12.49 | 35.06 years STANDARD_DEVIATION 10.23 |
| Annual Income < $49,670 | 102 Participants | 100 Participants | 120 Participants | 322 Participants |
| Annual Income $49,670 - $79,999 | 121 Participants | 128 Participants | 113 Participants | 362 Participants |
| Annual Income >/= $80,000 | 177 Participants | 172 Participants | 167 Participants | 516 Participants |
| City of Enrollment Dongguan | 200 Participants | 0 Participants | 0 Participants | 200 Participants |
| City of Enrollment Foshan | 0 Participants | 200 Participants | 0 Participants | 200 Participants |
| City of Enrollment Huizhou | 0 Participants | 200 Participants | 0 Participants | 200 Participants |
| City of Enrollment Jiangmen | 0 Participants | 0 Participants | 200 Participants | 200 Participants |
| City of Enrollment Zhanjiang | 200 Participants | 0 Participants | 0 Participants | 200 Participants |
| City of Enrollment Zhuhai | 0 Participants | 0 Participants | 200 Participants | 200 Participants |
| Highest Level of Education Bachelor's degree | 130 Participants | 136 Participants | 186 Participants | 452 Participants |
| Highest Level of Education Below high school | 80 Participants | 118 Participants | 87 Participants | 285 Participants |
| Highest Level of Education High school | 141 Participants | 119 Participants | 89 Participants | 349 Participants |
| Highest Level of Education Postgraduate and above | 49 Participants | 27 Participants | 36 Participants | 112 Participants |
| Marital Status Ever Married | 190 Participants | 201 Participants | 133 Participants | 524 Participants |
| Marital Status Never Married | 210 Participants | 199 Participants | 267 Participants | 676 Participants |
| Previous Testing Chlamydia | 36 Participants | 63 Participants | 50 Participants | 149 Participants |
| Previous Testing Gonorrhea | 35 Participants | 58 Participants | 51 Participants | 144 Participants |
| Race/Ethnicity, Customized Chinese | 400 Participants | 400 Participants | 400 Participants | 1200 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 400 Participants | 400 Participants | 400 Participants | 1200 Participants |
| Sexual Behavior MSM | 197 Participants | 194 Participants | 230 Participants | 621 Participants |
| Sexual Behavior Non-MSM | 203 Participants | 206 Participants | 170 Participants | 579 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 400 | 0 / 400 | 0 / 400 |
| other Total, other adverse events | 0 / 400 | 0 / 400 | 0 / 400 |
| serious Total, serious adverse events | 0 / 400 | 0 / 400 | 0 / 400 |
Outcome results
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.
Time frame: During enrollment visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community-Engaged Pay-It-Forward | Number of Participants Testing for Gonorrhea and Chlamydia | 390 Participants |
| Standard Pay-It-Forward | Number of Participants Testing for Gonorrhea and Chlamydia | 361 Participants |
| Control | Number of Participants Testing for Gonorrhea and Chlamydia | 12 Participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Cost Per Test Per Individual | 14.10 USD | Standard Deviation 0.41 |
| Standard Pay-It-Forward | Cost Per Test Per Individual | 13.61 USD | Standard Deviation 0.75 |
| Control | Cost Per Test Per Individual | 20.18 USD | Standard Deviation 0 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Donation Amount | 225.16 USD | Standard Deviation 37.53 |
| Standard Pay-It-Forward | Donation Amount | 382.61 USD | Standard Deviation 63.77 |
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Internalized Homophobia and Self-identification | 3.61 score on a scale | Standard Deviation 0.89 |
| Standard Pay-It-Forward | Internalized Homophobia and Self-identification | 3.34 score on a scale | Standard Deviation 0.95 |
| Control | Internalized Homophobia and Self-identification | 3.44 score on a scale | Standard Deviation 0.84 |
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)
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Mean Community Connectedness and Cohesion Score | 3.27 score on a scale | Standard Deviation 0.67 |
| Standard Pay-It-Forward | Mean Community Connectedness and Cohesion Score | 3.02 score on a scale | Standard Deviation 0.72 |
| Control | Mean Community Connectedness and Cohesion Score | 2.66 score on a scale | Standard Deviation 0.83 |
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)
Time frame: Baseline
Population: Less than \<15% missing data for items in this scale was observed and average imputation was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Mean Self Reported Community Engagement Score | 0.21 score on a scale | Standard Deviation 0.29 |
| Standard Pay-It-Forward | Mean Self Reported Community Engagement Score | 0.27 score on a scale | Standard Deviation 0.31 |
| Control | Mean Self Reported Community Engagement Score | 0.32 score on a scale | Standard Deviation 0.34 |
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Mean Self Reported Gratitude Score | 5.81 score on a scale | Standard Deviation 1.04 |
| Standard Pay-It-Forward | Mean Self Reported Gratitude Score | 6.21 score on a scale | Standard Deviation 0.84 |
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.
Time frame: Within 2 weeks of recruitment
Population: Per-protocol population (all participants tested for chlamydia with laboratory results available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community-Engaged Pay-It-Forward | Number of Participants Who Test Positive for Chlamydia | 35 Participants |
| Standard Pay-It-Forward | Number of Participants Who Test Positive for Chlamydia | 58 Participants |
| Control | Number of Participants Who Test Positive for Chlamydia | 0 Participants |
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.
Time frame: Within 2 weeks of enrollment
Population: Per-protocol population (all participants tested for gonorrhea with laboratory results available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community-Engaged Pay-It-Forward | Number of Participants Who Test Positive for Gonorrhea | 10 Participants |
| Standard Pay-It-Forward | Number of Participants Who Test Positive for Gonorrhea | 12 Participants |
| Control | Number of Participants Who Test Positive for Gonorrhea | 1 Participants |
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.
Time frame: During enrollment visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | Above 30 years | 247 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | 30 years and below | 143 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | Not Tested | 10 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | Above 30 years | 183 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | 30 years and below | 178 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Age Group | Not Tested | 39 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Age Group | 30 years and below | 4 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Age Group | Not Tested | 388 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Age Group | Above 30 years | 8 Participants |
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.
Time frame: During enrollment visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Public STI Clinic | 191 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Community-led Clinic | 199 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Not Tested | 10 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Public STI Clinic | 197 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Community-led Clinic | 164 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Not Tested | 39 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Community-led Clinic | 1 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Not Tested | 388 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Clinic Type | Public STI Clinic | 11 Participants |
Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation
Stratifies gonorrhea/chlamydia testing uptake between MSM and non-MSM participants across the three intervention arms.
Time frame: During enrollment visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Non-MSM | 196 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | MSM | 194 Participants |
| Community-Engaged Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Not Tested | 10 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Non-MSM | 168 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | MSM | 193 Participants |
| Standard Pay-It-Forward | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Not Tested | 39 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | MSM | 1 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Not Tested | 388 Participants |
| Control | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Non-MSM | 11 Participants |