Prevalence of Undiagnosed HCV Infections in HIV-negative MSM Visiting a Sexual Health Clinic.
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- HCV antibody prevalence
研究概览
简要总结
This study measures the prevalence of undiagnosed hepatitis C virus (HCV) infection in HIV-negative men-who-have-sex-with-men (MSM) visiting the sexual health clinics of public health services (in dutch: gemeentelijke gezondheidsdienst, GGD), in order to evaluate if systematic screening for HCV of HIV-negative MSM attending sexual health clinics in the Netherlands is needed.
详细描述
Until recently, sexually acquired HCV infections were thought to be limited to HIV-positive MSM. Yet, emerging data show that the prevalence of HCV among HIV uninfected MSM that opt-in for HIV pre-exposure prophylaxis (PrEP) is much higher. It was 5% (n=18/375) in Amsterdam and 2% (n=4/200) in Antwerp (Be-PrEP-ared; EudraCT2015-000054-37) (23).
This observation may be the result of the fact that PrEP users are, by definition, at risk for sexually transmitted infections because PrEP is only prescribed to those at risk for HIV. However, another explanation may be that in the new context of HIV "treatment as prevention" and the availability of PREP as a way to protect oneself against HIV, the incidence of HCV in HIV uninfected MSM is changing. Furthermore, if PrEP use would lead to an increase in sexual risk-taking, this may eventually lead to an increase in the incidence of HCV among HIV negative MSM on PrEP. If these HCV infections among HIV negative MSM remain unnoticed, they are a continuous source of HCV infections in HIV+MSM as well for the larger HIV-MSM community. Furthermore, PrEP as well as the very well-documented efficacy of HIV treatment as prevention can be expected to increase sexual mixing of HIV- and HIV+MSM.
Based on the observations described above, we hypothesize that undiagnosed HCV infections in HIV negative MSM are (or may become) an important source of HCV (re)infections in HIV+MSM as well as the larger HIV-MSM population.
Primary objectives:
- Measure the prevalence of HCV in a large group of HIV-negative MSM attending sexual health clinics in the Netherlands.
- Assess Risk Factors for HCV in order to validate the HCV-MOSAIC risk score in HIV-MSM, which may allow for a more cost-effective (=targeted) HCV testing of HIV-MSM in the future
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Self-identifying as a man-who-has-sex-with-men (MSM)
- •Willing to undergo HCV testing
排除标准
- •Clients known to be HIV positive
结局指标
主要结局
HCV antibody prevalence
时间窗: From start study to end of study, at least 2 years
Percentage of HCV IgG antibody positive clients per 1000 HIV-negative MSM tested
Value of HCV-MOSAIC risk score in HIV-negative MSM
时间窗: From start study to end of study, at least 2 years
Assess risk factors for a positive HCV IgG test in the study population according to the HCV-MOSAIC risk score, using sexual behavior questionnaires. The HCV-MOSAIC risk score is validated to identify HIV+MSM at risk for an acute HCV infection (Newsum et al, 2017). HCV-MOSAIC risk score: * Condomless receptive anal intercourse in the last 6 months - 1.1 * Sharing of sex toys in the last 6 months - 1.2 * Unprotected fisting in the last 6 months - 0.9 * Injecting drug use in the last 12 months - 1.4 * Sharing of straws when using nasally administered drug in the last 12 months - 1.0 * Ulcerative STI in the last 12 months - 1.4 Cut-off sum ≥2.0 = at risk for acute HCV infection
次要结局
- Proportion participating in study(From start inclusion to end of inclusion period, at least 1 year)
- HCV infection prevalence(From start study to end of study, at least 2 years)
研究者
Bart Rijnders
Principal Investigator
Erasmus Medical Center