Time to Diagnosis of HCV Re-infection With the Use of a Self-test: A Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Change in time to HCV re-infection diagnosis with the intervention in MITT population
研究概览
简要总结
HIV+MSM (men who have sex with men) that have been cured of a hepatitis C viral infection (HCV) are at risk for HCV re-infection (5-10% per year). One intervention to reduce HCV incidence in this population may be to decrease the time to diagnosis of HCV re-infections in order to decrease the duration that these re-infected patients may transmit their HCV to sex partners. Diagnosis of HCV re-infection is followed by counseling on transmission risk in combination with prompt initiation of HCV therapy, which will prevent new HCV infections on the population level.
In this study the investigators evaluate the effect and feasibility of more frequent and home-based testing for HCV on the time to diagnosis and treatment of HCV re-infections.
详细描述
Elimination of HCV was recently formulated as a WHO target and was set for the year 2030. Globally, approximately 6.2% of HIV-infected patients are co-infected with HCV. Of the patients living with HIV, people who inject drugs (PWID) and men who have sex with men (MSM) are at particularly high risk of HCV co-infection. Until recently, the prevalence of chronic hepatitis C virus infection (HCV) in Dutch HIV+MSM was very high at 4,8% (compared with 0.2% in the Dutch population in general). After unrestricted availability of direct-acting antivirals since the end of 2015, the prevalence of chronic HCV in HIV+MSM decreased rapidly. A subsequent decrease in the incidence of HCV of 51% was observed in 2016, but no further decline was seen in 2017. Additionally, the incidence of HCV re-infections in HIV+MSM that were cured of a previous HCV infection continues to be high (5-10% per year).
The continuously high re-infection risk and the lack of a further decline in the HCV incidence after 2016 illustrates that universal DAA therapy for all patients diagnosed with a chronic HCV infection on its own will not result in HCV elimination. Other interventions are needed to reach the WHO goal of HCV elimination by 2030. One of these additional interventions may be decreasing the time to diagnosis of HCV re-infections in order to decrease the duration that these re-infected patients may transmit their HCV to sex partners.
Objective:
To assess the effectivity of HCV RNA self-testing in reducing the time to diagnosis of HCV re-infection in MSM previously cured of an HCV infection, compared to the current diagnostic standard of care.
To evaluate whether the uptake of self-testing is sufficient and warrants the use of HCV RNA self-testing in clinical practice.
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
盲法说明
No masking
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
- •Cured of HCV defined as an SVR (=documented negative HCV RNA test) at least 12 weeks after the end of DAA therapy and no new documented positive HCV RNA test after the date of the SVR
- •Spontaneous clearance of HCV infection defined as two consecutive negative HCV RNA tests at least 3 months apart after a positive HCV RNA test.
- •In care for an HIV infection in an HIV clinic in a study center or HIV negative and receiving PrEP at a PrEP clinic
- •Able and willing to perform the self-test at home after viewing the instruction video
- •Willing to fill out a questionnaire on risk behavior at the time of HCV self-testing
- •At risk of HCV re-infection according to a short questionnaire, in other words, patients should have one of the following risk factors:
- •Receptive unprotected (condomless) anal intercourse in the last 6 months
- •Fisting or being fisted without gloves in the last 6 months
- •Sharing toys in the last 6 months
- •Syphilis or LGV in the last 12 months,
- •Slamming (injecting drug use) in the last 12 months
- •Sharing sniffing straws or other objects to sniff drugs in the last 12 months
排除标准
- •Age < 18
- •Patients that are tested by HCV RNA as a standard of care test (e.g. in the context of PREP use) > 1x/year
- •Patients that are expected to be tested by ALT at their HIV or PREP clinic <1x/year
研究组 & 干预措施
HCV self-test intervention
Diagnostic intervention: participant performs capillary blood sampling at home in between outpatient clinic visits (3 months after) and sends the sample to the investigator's laboratory by regular post mail for HCV RNA analysis. This is on top of standard of care ALT measurement at every 6-monthly outpatient clinic visit, followed by HCV RNA testing if ALT is elevated. Follow-up period is 2 years, in which participants will perform and send in 4 self-tests, in combination with filling out 4 questionnaires into sexual risk behavior.
干预措施: HCV RNA self-test (Diagnostic Test)
结局指标
主要结局
Change in time to HCV re-infection diagnosis with the intervention in MITT population
时间窗: Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years)
Comparison of the time to HCV re-infection diagnosis in patients using the HCV RNA self-test (intervention) with the time to HCV re-infection diagnosis with the standard diagnostic approach (virtual control) in the modified intention to treat (MITT) population.
次要结局
- Change in time to HCV re-infection diagnosis with the intervention in PP(Last negative HCV test to first positive HCV test (from start study to first positive HCV test in up to 2 years))
- Acceptability of intervention in target population: percentage that accepted to participate and eventually self-collected and sent in at least one plasma sample(Through study process, from start screening to study completion, at least 3 years)
- HCV re-infection incidence in study population(During follow-up period of 2 years)
- HCV infections found at screening(At screening visit (T=0))
研究者
Bart Rijnders
Principal Investigator
Erasmus Medical Center