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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI158826 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pay-it-forward | Experimental |
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| Community engaged Pay-it-forward | Experimental |
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| Control arm | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Pay-it-forward | Behavioral | 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). |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph D Tucker, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China | Guangzhou | Guangdong | 510095 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41686825 | Derived | Liu Y, Zhou K, Li L, Salma G, Fitzpatrick T, Marley G, Zhu Z, Tang W, Tucker JD. Financing STI testing among men in China: A mixed-methods study of pay-it-forward monetary donations. PLoS One. 2026 Feb 13;21(2):e0342595. doi: 10.1371/journal.pone.0342595. eCollection 2026. | |
| 37337181 | Derived | 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. |
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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.
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9 to 36 months following publication
Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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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 were recruited based on physician referrals at six (6) public sexually transmitted infection (STI) and six (6) community-led clinics.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control | Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Men seeking HIV and STI care services at project public STI and community-led clinics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Pay-It-Forward |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During enrollment visit |
|
Baseline through follow-up (an approximate total of 3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Tucker, MD, PhD | University of North Carolina at Chapel Hill | 919-966-2536 | jdtucker@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan | Nov 15, 2022 | Oct 16, 2025 | Prot_SAP_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Amended Study Protocol and Statistical Analysis Plan | Dec 12, 2024 | Oct 16, 2025 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2023 | Oct 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| D002690 | Chlamydia Infections |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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hybrid effectiveness-implementation study design
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|
| Community Engaged Pay-it-forward | Behavioral | 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) |
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| Control arm | Other | 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 |
|
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 |
| 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 |
| 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 |
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 |
Participants received free gonorrhea and chlamydia testing donated by previous participants and were offered an opportunity to make monetary donations to support other participants. |
| BG002 | Control | Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S.Dollars (USD). |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| City of Enrollment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Sexual Behavior | Self-reported history of anal sex with other men. | Count of Participants | Participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Annual Income | United States Dollars (USD) | Count of Participants | Participants |
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| Previous Testing | Self-reported data on having ever tested for these sexually transmitted infections. Data was collected using a self-administered questionnaire at Baseline. | Count of Participants | Participants |
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| OG002 | Control | Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD). |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | USD | Baseline |
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| Secondary | 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. | Per-protocol population (all participants tested for gonorrhea with laboratory results available). | Posted | Count of Participants | Participants | Within 2 weeks of enrollment |
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| Secondary | 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. | Per-protocol population (all participants tested for chlamydia with laboratory results available). | Posted | Count of Participants | Participants | Within 2 weeks of recruitment |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | USD | Baseline - During enrollment visit |
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| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | During enrollment visit |
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| Secondary | 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) | Less than <15% missing data for items in this scale was observed and average imputation was used. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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) | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | 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) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Other Pre-specified | 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. | Posted | Count of Participants | Participants | During enrollment visit |
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| Other Pre-specified | Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation | Stratifies gonorrhea/chlamydia testing uptake between MSM and non-MSM participants across the three intervention arms. | Posted | Count of Participants | Participants | During enrollment visit |
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| Other Pre-specified | 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. | Posted | Count of Participants | Participants | During enrollment visit |
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| 0 |
| 400 |
| 0 |
| 400 |
| 0 |
| 400 |
| EG001 | 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. | 0 | 400 | 0 | 400 | 0 | 400 |
| EG002 | Control Arm | Participants received gonorrhea and chlamydia testing at an out-of-pocket cost of approximately $21 U.S. Dollars (USD). | 0 | 400 | 0 | 400 | 0 | 400 |
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| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002694 | Chlamydiaceae Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Not Tested |
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| Not Tested |
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| Not Tested |
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