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GonorrheaNCT05723263

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

A study testing Standard Pay-it-forward and Community Engaged Pay-it-forward in people with Gonorrhea and Chlamydia, run by University of North Carolina, Chapel Hill at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Gonorrhea, Chlamydia
What is being tested?
Standard Pay-it-forward and Community Engaged Pay-it-forward
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
1 siteChina
Study dates
1 Apr 2023to 30 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 18 years of age

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510095

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions
Gonorrhea, Chlamydia
Being tested
Standard Pay-it-forward, Community Engaged Pay-it-forward, Control arm
Keywords
gonorrhea, sexually transmitted infection (STI), gonorrhea testing among men who have sex with men, chlamydia
Medical subject headings
Gonorrhea, Chlamydia Infections, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Pay-it-forwardBehavioural

    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).

  • Community Engaged Pay-it-forwardBehavioural

    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)

  • Control armOther

    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

Study groups in NCT05723263
Study groupRoleWhat they receive
Standard Pay-it-forwardExperimental* free gonorrhea/chlamydia testing * minimal engagement
Receives: Behavioral: Standard Pay-it-forward
Community engaged Pay-it-forwardExperimental* Free gonorrhea/chlamydia testing * Stronger engagement
Receives: Behavioral: Community Engaged Pay-it-forward
Control armOther* Test available for a fee * No engagement
Receives: Other: Control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During enrollment visit

Secondary outcomes (8)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Within 2 weeks of enrollment

  3. 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.

    Measured: Within 2 weeks of recruitment

  4. 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.

    Measured: Baseline - During enrollment visit

  5. 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).

    Measured: During enrollment visit

  6. 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)

    Measured: Baseline

  7. 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)

    Measured: Baseline

  8. 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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start1 Apr 2023
  3. Primary completion15 Jul 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
hybrid effectiveness-implementation study design
Masking
None (open label)
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723263
Sponsor's protocol ID
21-1667
Other IDs
R01AI158826
Status last verified
Mar 2025
First submitted
27 Jan 2023
Last updated
3 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41686825

  • 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.

    PubMed 37337181

Questions about this trial

What is this clinical trial studying?

A study testing Standard Pay-it-forward and Community Engaged Pay-it-forward in people with Gonorrhea and Chlamydia, run by University of North Carolina, Chapel Hill at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Testing for Gonorrhea and Chlamydia (time frame: During enrollment visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723263, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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