Clinical trial NCT03482388: Crowdsourcing to Promote HBV and HCV Testing in China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis
Hepatitis B
Hepatitis C
Keywords: Hepatitis
Hepatitis B
Hepatitis C
Men who have sex with men
Crowdsourcing
China
Testing
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2018-03-29
Enrollment: 700
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned in a 1:1 ratio to the study intervention or control
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirmed HBV and HCV test uptake
timeFrame: enrollment - 4 weeks after enrollment
Secondary outcomes:
measure: Confirmed HBV test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Confirmed HCV test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Self-reported HBV test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Self-reported HCV test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: HBV vaccination uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: HBV vaccination uptake among men with confirmed susceptibility to HBV infection
timeFrame: enrollment - 4 weeks after enrollment
measure: HIV test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Chlamydia test uptake
timeFrame: baseline - 4 weeks after enrollment
measure: Gonorrhea test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Syphilis test uptake
timeFrame: enrollment - 4 weeks after enrollment
measure: Change in stigma toward people living with HBV
timeFrame: enrollment - 4 weeks after enrollment
measure: Visit with a physician after hepatitis test uptake
timeFrame: enrollment - 4 weeks after enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: UNC Project-China
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Joseph Tucker, MD, PhD, MA
role: STUDY_DIRECTOR
affiliation: Institute for Global Health and Infectious Diseases
name: Thomas Fitzpatrick
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
citation: Fitzpatrick T, Zhou K, Cheng Y, Chan PL, Cui F, Tang W, Mollan KR, Guo W, Tucker JD. A crowdsourced intervention to promote hepatitis B and C testing among men who have sex with men in China: study protocol for a nationwide online randomized controlled trial. BMC Infect Dis. 2018 Sep 29;18(1):489. doi: 10.1186/s12879-018-3403-3.