Crowdsourcing to Promote HBV and HCV Testing in China

Hepatitis C Clinical Trial

Official title:

A Crowdsourced Intervention to Promote Hepatitis B and C Testing Among Men Who Have Sex With Men in China: a Nationwide Online Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482388
• Other study ID #: 18-0251
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: June 9, 2018

Study information

• Verified date: June 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 9, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Exclusion Criteria:

• previous HBV vaccination

• previous HBV testing

• previous HCV testing

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Intervention

Behavioral:
• Crowdsourced materials
Among participants randomized to the intervention arm, intervention images and videos promoting HBV and HCV testing will be delivered through the WeChat platform. Men will also be invited to submit suggestions for how to improve intervention videos and images.

Other:
• Control
Participants will not view any images or videos promoting HBV and HCV testing.

Locations

Country	Name	City	State
China	UNC Project-China	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Doris Duke Charitable Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed HBV and HCV test uptake	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	enrollment - 4 weeks after enrollment
Secondary	Confirmed HBV test uptake	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	enrollment - 4 weeks after enrollment
Secondary	Confirmed HCV test uptake	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	enrollment - 4 weeks after enrollment
Secondary	Self-reported HBV test uptake	Defined as frequency of men who had HBsAg uptake within four weeks of enrollment, self-reported in follow-up survey	enrollment - 4 weeks after enrollment
Secondary	Self-reported HCV test uptake	Defined as frequency of men who had anti-HCV IgG uptake within four weeks of enrollment, self-reported in follow-up survey	enrollment - 4 weeks after enrollment
Secondary	HBV vaccination uptake	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	enrollment - 4 weeks after enrollment
Secondary	HBV vaccination uptake among men with confirmed susceptibility to HBV infection	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	enrollment - 4 weeks after enrollment
Secondary	HIV test uptake	Defined as frequency of men who had HIV test uptake within four weeks of enrollment, self-reported in follow-up survey	enrollment - 4 weeks after enrollment
Secondary	Chlamydia test uptake	Defined as frequency of men who had chlamydia test uptake within four weeks of enrollment, self-reported in follow-up survey	baseline - 4 weeks after enrollment
Secondary	Gonorrhea test uptake	Defined as frequency of men who had gonorrhea test uptake within four weeks of enrollment, self-reported in follow-up survey	enrollment - 4 weeks after enrollment
Secondary	Syphilis test uptake	Defined as frequency of men who had syphilis test uptake within four weeks of enrollment, self-reported in follow-up survey	enrollment - 4 weeks after enrollment
Secondary	Change in stigma toward people living with HBV	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.	enrollment - 4 weeks after enrollment
Secondary	Visit with a physician after hepatitis test uptake	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	enrollment - 4 weeks after enrollment