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

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

Study Overview

• Status: Recruiting
• Conditions: Gonorrhea
• Intervention / Treatment: Other: Control arm; Behavioral: Standard Pay-it-forward; Behavioral: Community Engaged Pay-it-forward

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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph D Tucker, MD; Phone Number: 919-966-2537; Email: jdtucker@med.unc.edu

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Recruiting
      • Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China
      • Contact: Cheng Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Pay-it-forward; free gonorrhea/chlamydia testing; minimal engagement	Behavioral: Standard Pay-it-forward; 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).
Experimental: Community engaged Pay-it-forward; Free gonorrhea/chlamydia testing; Stronger engagement	Behavioral: Community Engaged Pay-it-forward; 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)
Other: Control arm; Test available for a fee; No engagement	Other: Control arm; 400 MSM at 4 clinics will be enrolled. The control arm will include a fee-based point-of-care gonorrhea testing (approximately 20 USD per test) and no community engagement component

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants testing for gonorrhea	gonorrhea test uptake will be ascertained by administrative review of records from participating clinics	During enrollment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants testing for syphilis	syphilis test uptake will be ascertained by administrative review of records from participating clinics	During enrollment visit
Amount of money donated	the amount of money each participant donated towards the test of the next participant	During enrollment visit
Number of participants with azithromycin resistance	laboratory culture results will be reviewed	During enrollment visit
Number of participants with ceftriaxone resistance	laboratory culture results will be reviewed	During enrollment visit
Number of participants who test positive for gonorrhea	laboratory results will be reviewed	During enrollment visit
Number of participants who test positive for chlamydia	laboratory results will be reviewed	During enrollment visit
Cost per test per individual	The cost associated with respective interventions per individual who reported testing for gonorrhea and chlamydia following the intervention	During enrollment visit
Self reported gratitude scale	10 Items; Lowest score of 10, highest of 70 (higher scores indicate higher levels of gratitude)	During enrollment visit
Self reported community engagement scale	6 Items; Lowest score of 0, highest of 6 (higher scores indicate higher levels of community engagement)	During enrollment visit
Self reported community connectedness scale	7 Items; Lowest score of 7, highest of 28 (higher scores indicate higher levels of community connectedness)	During enrollment visit
Self reported community cohesion scale	10 Items; Lowest score of 10, highest of 40 (higher scores indicate higher levels of community cohesion)	During enrollment visit
Self reported internalized homophobia scale	11 Items; Lowest score of 11, highest of 55 (higher scores indicate higher levels of internalized homophobia)	During enrollment visit

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Joseph D Tucker, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: gonorrhea; sexually transmitted infection (STI); gonorrhea testing among men who have sex with men
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Urogenital Diseases; Genital Diseases; Gonorrhea
• Other Study ID Numbers: 21-1667; R01AI158826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No