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

Study Overview
=================
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.

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

Conditions
-----------------
Gonorrhea

Intervention / Treatment
-----------------
* Behavioral: Standard Pay-it-forward
* Behavioral: Community Engaged Pay-it-forward
* Other: Control arm


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: hybrid effectiveness-implementation study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Pay-it-forward<br>free gonorrhea/chlamydia testing minimal engagement | Behavioral: Standard Pay-it-forward<br>* 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).<br>|
| Experimental: Community engaged Pay-it-forward<br>Free gonorrhea/chlamydia testing Stronger engagement | Behavioral: Community Engaged Pay-it-forward<br>* 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)<br>|
| Other: Control arm<br>Test available for a fee No engagement | Other: Control arm<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gonorrhea, sexually transmitted infection (STI), gonorrhea testing among men who have sex with men