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

Gonorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723263
• Other study ID #: 21-1667
• Secondary ID: R01AI158826
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Joseph D Tucker, MD
• Phone: 919-966-2537
• Email: jdtucker[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Gonorrhea

Intervention

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).
• 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
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

Locations

Country	Name	City	State
China	Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants testing for gonorrhea	gonorrhea test uptake will be ascertained by administrative review of records from participating clinics	During enrollment visit
Secondary	Number of participants testing for syphilis	syphilis test uptake will be ascertained by administrative review of records from participating clinics	During enrollment visit
Secondary	Amount of money donated	the amount of money each participant donated towards the test of the next participant	During enrollment visit
Secondary	Number of participants with azithromycin resistance	laboratory culture results will be reviewed	During enrollment visit
Secondary	Number of participants with ceftriaxone resistance	laboratory culture results will be reviewed	During enrollment visit
Secondary	Number of participants who test positive for gonorrhea	laboratory results will be reviewed	During enrollment visit
Secondary	Number of participants who test positive for chlamydia	laboratory results will be reviewed	During enrollment visit
Secondary	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
Secondary	Self reported gratitude scale	10 Items; Lowest score of 10, highest of 70 (higher scores indicate higher levels of gratitude)	During enrollment visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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