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

Primary Purpose

Gonorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard Pay-it-forward
Community Engaged Pay-it-forward
Control arm
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gonorrhea focused on measuring gonorrhea, sexually transmitted infection (STI), gonorrhea testing among men who have sex with men

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Standard Pay-it-forward

Community engaged Pay-it-forward

Control arm

Arm Description

free testing minimal engagement

Free testing Stronger engagement

Test available for a fee No engagement

Outcomes

Primary Outcome Measures

Number of participants testing for gonorrhea
gonorrhea test uptake will be ascertained by administrative review of records from participating clinics

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2023
Last Updated
January 27, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05723263
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonorrhea
Keywords
gonorrhea, sexually transmitted infection (STI), gonorrhea testing among men who have sex with men

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
hybrid effectiveness-implementation study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Pay-it-forward
Arm Type
Experimental
Arm Description
free testing minimal engagement
Arm Title
Community engaged Pay-it-forward
Arm Type
Experimental
Arm Description
Free testing Stronger engagement
Arm Title
Control arm
Arm Type
Other
Arm Description
Test available for a fee No engagement
Intervention Type
Behavioral
Intervention Name(s)
Standard Pay-it-forward
Intervention Description
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 testing).
Intervention Type
Behavioral
Intervention Name(s)
Community Engaged Pay-it-forward
Intervention Description
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; opportunity to donate to support others)
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants testing for gonorrhea
Description
gonorrhea test uptake will be ascertained by administrative review of records from participating clinics
Time Frame
During enrollment visit
Secondary Outcome Measure Information:
Title
Number of participants testing for syphilis
Description
syphilis test uptake will be ascertained by administrative review of records from participating clinics
Time Frame
During enrollment visit
Title
Amount of money donated
Description
the amount of money each participant donated towards the test of the next participant
Time Frame
During enrollment visit
Title
Number of participants with azithromycin resistance
Description
laboratory culture results will be reviewed
Time Frame
During enrollment visit
Title
Number of participants with ceftriaxone resistance
Description
laboratory culture results will be reviewed
Time Frame
During enrollment visit
Title
Number of participants who test positive for gonorrhea
Description
laboratory results will be reviewed
Time Frame
During enrollment visit
Title
Number of participants who test positive for chlamydia
Description
laboratory results will be reviewed
Time Frame
During enrollment visit
Title
Cost per test per individual
Description
The cost associated with respective interventions per individual who reported testing for gonorrhea and chlamydia following the intervention
Time Frame
During enrollment visit
Title
Self reported gratitude scale
Description
10 Items; Lowest score of 10, highest of 70 (higher scores indicate higher levels of gratitude)
Time Frame
During enrollment visit
Title
Self reported community engagement scale
Description
6 Items; Lowest score of 0, highest of 6 (higher scores indicate higher levels of community engagement)
Time Frame
During enrollment visit
Title
Self reported community connectedness scale
Description
7 Items; Lowest score of 7, highest of 28 (higher scores indicate higher levels of community connectedness)
Time Frame
During enrollment visit
Title
Self reported community cohesion scale
Description
10 Items; Lowest score of 10, highest of 40 (higher scores indicate higher levels of community cohesion)
Time Frame
During enrollment visit
Title
Self reported internalized homophobia scale
Description
11 Items; Lowest score of 11, highest of 55 (higher scores indicate higher levels of internalized homophobia)
Time Frame
During enrollment visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph D Tucker, MD
Phone
919-966-2537
Email
jdtucker@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D Tucker, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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