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Completed

NCT Number: NCT05723263

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

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510095, China

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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)

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

Primary outcomes

  1. Number of Participants Testing for Gonorrhea and Chlamydia

    Time frame: 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 outcomes

  1. Donation Amount

    Time frame: 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.

  2. Number of Participants Who Test Positive for Gonorrhea

    Time frame: 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.

  3. Number of Participants Who Test Positive for Chlamydia

    Time frame: 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.

  4. Cost Per Test Per Individual

    Time frame: 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.

  5. Mean Self Reported Gratitude Score

    Time frame: 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).

  6. Mean Self Reported Community Engagement Score

    Time frame: 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)

  7. Mean Community Connectedness and Cohesion Score

    Time frame: 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)

  8. Internalized Homophobia and Self-identification

    Time frame: 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)

Other outcomes

  1. Gonorrhea and Chlamydia Testing Uptake by Clinic Type

    Time frame: During enrollment visit

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

  2. Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation

    Time frame: During enrollment visit

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

  3. Gonorrhea and Chlamydia Testing Uptake by Age Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

IGHID 12118 - Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China: The PIONEER Pragmatic Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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