Clinical trial NCT05723263: Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China
Official title: IGHID 12118 - Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China: The PIONEER Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gonorrhea
Keywords: gonorrhea
sexually transmitted infection (STI)
gonorrhea testing among men who have sex with men
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-02-10
Enrollment: 1200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hybrid effectiveness-implementation study design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Testing for Gonorrhea
timeFrame: During enrollment visit
Secondary outcomes:
measure: Donation Amount
timeFrame: Baseline
measure: Number of Participants Who Test Positive for Gonorrhea
timeFrame: Within 2 weeks of enrollment
measure: Number of Participants Who Test Positive for Chlamydia
timeFrame: Within 2 weeks of recruitment
measure: Cost Per Test Per Individual
timeFrame: Baseline - During enrollment visit
measure: Mean Self Reported Gratitude Score
timeFrame: During enrollment visit
measure: Mean Self Reported Community Engagement Score
timeFrame: Baseline
measure: Mean Community Connectedness and Cohesion Score
timeFrame: Baseline
measure: Internalized Homophobia and Self-identification
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China
state: Guangdong
Study officials:
affiliation: University of North Carolina
name: Joseph D Tucker, MD
role: PRINCIPAL_INVESTIGATOR
References: