Crowdsourcing to Promote HBV and HCV Testing in China

Not Applicable

Completed

• Conditions: Hepatitis C; Hepatitis B; Hepatitis
• Interventions: Other: Control; Behavioral: Crowdsourced materials

• Registration Number: NCT03482388
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This is an online randomized controlled trial (RCT) comparing men who have sex with men (MSM) exposed to a crowdsourced intervention to MSM who did not receive the intervention to determine the effect on Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) testing. Participants will be randomly assigned in a 1:1 ratio to intervention or control using a computer-based allocation system. Participants will be assessed for primary and secondary outcomes four weeks after randomization.

Detailed Description

700 MSM will be recruited through social media operated by gay organizations in China. Eligible participants will be born biologically male, age 16 years or older, report previous anal sex with another man, and reside in China. Men self-reporting previous HBV vaccination, HBV testing, or HCV testing will be excluded. After completing a baseline online survey, participants will be randomly assigned to intervention or control arms with a 1:1 allocation ratio. The intervention will include two components: (1) a multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. (2) A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images. The control arm will not view any images or videos and will not be invited to submit suggestions. All participants will be offered reimbursement for HBV and HCV testing costs. The primary outcome is HBV and HCV test uptake confirmed through electronic submission of test report photos within four weeks of enrollment. Secondary outcomes include self-reported HBV and HCV test uptake, HBV vaccination uptake, and change in stigma toward people living with HBV measured through a follow-up survey after four weeks. Men with primary and secondary outcomes will be calculated using intention to treat and as-exposed analyses and compared using two-sided 95% confidence intervals.

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Study Start: 2018-05-09
• Primary Completion: 2018-05-15
• Status Verified: 2018-06
• Study Completion: 2018-06-09
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 700

Inclusion Criteria

• 16 years of age or older
• male
• report having had anal sex with another man at least once in the past
• currently reside in China
• willing to provide working mobile phone number and WeChat account

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Exclusion Criteria

• previous HBV vaccination
• previous HBV testing
• previous HCV testing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
Crowdsourced intervention	Crowdsourced materials	A multimedia component will deliver two videos and two images promoting HBV and HCV testing developed through a crowdsourcing contest in China. A participatory component will invite men to submit suggestions for how to improve crowdsourced videos and images.

Primary Outcome Measures

Name	Time	Method
Confirmed HBV and HCV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had both HBsAg test uptake and anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test

Secondary Outcome Measures

Name	Time	Method
Confirmed HBV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had HBsAg test uptake through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test
Visit with a physician after hepatitis test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had HBV and/or HCV test uptake and saw a physician to discuss hepatitis test results within four weeks of enrollment, self-reported in follow-up survey
Self-reported HCV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had anti-HCV IgG uptake within four weeks of enrollment, self-reported in follow-up survey
Change in stigma toward people living with HBV	enrollment - 4 weeks after enrollment	Continuous variable, defined as difference between Toronto Chinese HBV Stigma Scale score assessed at follow-up and baseline. Stigma toward people living with HBV will be measured at baseline and follow-up using 20 survey items that are each on a five point Likert scale. The 20 items were originally developed as the Toronto Chinese HBV Stigma Scale (potential range of 20 - 100), which has been previously validated and correlated to HBV testing behaviors among Chinese populations. Decreased stigma toward people living with HBV will be defined as a mean composite score that is less at follow-up compared to baseline.
HBV vaccination uptake among men with confirmed susceptibility to HBV infection	enrollment - 4 weeks after enrollment	Defined as frequency of men with negative HBsAg and negative anti-HBs results confirmed through electronic submission of a test report photo showing serology results, who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey
HIV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey
Gonorrhea test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey
Syphilis test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey
Confirmed HCV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had anti-HCV IgG test uptake confirmed through electronic submission of a test report photo showing serology results, age of tester, sex of tester, and date of test
Self-reported HBV test uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had HBsAg uptake within four weeks of enrollment, self-reported in follow-up survey
Chlamydia test uptake	baseline - 4 weeks after enrollment	Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey
HBV vaccination uptake	enrollment - 4 weeks after enrollment	Defined as frequency of men who had receipt of at least a one dose of the HBV vaccine within four weeks of enrollment, self-reported in follow-up survey

Trial Locations

Locations (1)

UNC Project-China; 🇨🇳 Guangzhou, China