Reducing the Risk of Viral Hepatitis C and Other Sexually Transmitted Infections Among People Living With HIV Who Are Men Who Have Sex With Men: Efficacy of Serious Game Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,320
- 试验地点
- 1
- 主要终点
- HCV incidence
研究概览
简要总结
The study is aimed to provide high-risk, HIV-infection, men who have sex with men (MSM) with healthcare education regarding viral hepatitis C, through either serious game intervention or traditional online health education. After the education, each participants will be followed for 48 weeks and the change of risky sexual behaviors, acquisition of HCV and other STIs will be followed during the study periods.
详细描述
High-risk MSM living with HIV were participated in our study will be assigned (by randomization) to either:
- Serious game intervention: 1 single session of serious game for the participants to play (estimation to take 25-40 minutes). Hepatitis C virus (HCV)-related healthcare informations, including the severity of illness, route of transmission, preventive strategies and treatment options, would be embedded in the game.
- Traditional online health education (reading materials): 1 single session of healthcare education regarding HCV (with similar contents) will be provided.
After the healthcare intervention, each participants will be followed for 48 weeks. Assessment of risky sexual practice (by questionnaire), test of plasma HCV RNA and serological test of syphilis (optional), and detection of sexually-transmitted bacterial pathogens (optional) will be performed at the enrollment and then every 12 weeks during the observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •High-risk MSM living with HIV, defined as:
- •Had prior HCV infection, and had cleared HCV through treatment or spontaneously
- •Had any STI within the past 12 months
- •Had any unexplained elevation of liver transaminase in the past 6 months
- •Had at least 1 unprotected anal sex during the past 6 months
- •Being able to use mobile smartphone and understand study materials
- •Repeat entry of study is permitted, but the interval between health education intervention should >52 weeks.
排除标准
- •HCV RNA positive and yet clear virus (nor reaching SVR12).
- •Admission for any acute illness (including AIDS-defining conditions)
结局指标
主要结局
HCV incidence
时间窗: 48 weeks
The incidence rate of HCV acquisition between both arms. HCV RNA would be tested for each participants every 3 months during follow-up, and the incidence rate is calculated as following: new cases of HCV viremia / person-time of follow-up.
次要结局
- STI incidence(48 weeks)
- The frequency of condom use and sexualized drug use(At weeks 12, 24 and 48 of observation)