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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Confirmed HBV and HCV test uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •16 years of age or older
- •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
排除标准
- •previous HBV vaccination
- •previous HBV testing
- •previous HCV testing
研究组 & 干预措施
Crowdsourced intervention
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.
干预措施: Crowdsourced materials (Behavioral)
Control
No images or videos will be viewed, and suggestions for improving hepatitis testing materials will not be collected.
干预措施: Control (Other)
结局指标
主要结局
Confirmed HBV and HCV test uptake
时间窗: 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
次要结局
- Confirmed HBV test uptake(enrollment - 4 weeks after enrollment)
- Visit with a physician after hepatitis test uptake(enrollment - 4 weeks after enrollment)
- Self-reported HCV test uptake(enrollment - 4 weeks after enrollment)
- Change in stigma toward people living with HBV(enrollment - 4 weeks after enrollment)
- Confirmed HCV test uptake(enrollment - 4 weeks after enrollment)
- Self-reported HBV test uptake(enrollment - 4 weeks after enrollment)
- Chlamydia test uptake(baseline - 4 weeks after enrollment)
- HBV vaccination uptake(enrollment - 4 weeks after enrollment)
- Syphilis test uptake(enrollment - 4 weeks after enrollment)
- HBV vaccination uptake among men with confirmed susceptibility to HBV infection(enrollment - 4 weeks after enrollment)
- HIV test uptake(enrollment - 4 weeks after enrollment)
- Gonorrhea test uptake(enrollment - 4 weeks after enrollment)