Randomized Control Trial of Home-based Hepatitis C Self-testing in Key Populations in Georgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,250
- 试验地点
- 12
- 主要终点
- To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM
研究概览
简要总结
Self-testing with easy-to-use rapid diagnostic tests has been successfully used for diseases such as HIV. The availability of self-testing has been shown to increase testing rates and testing acceptability in diverse populations around the world, in large part due to its convenience and privacy advantages.7 Self-testing has also been effectively used to reach key populations who may not be covered by traditional healthcare programs, such as persons who inject drugs (PWID) and men who have sex with men (MSM). In Georgia, HIV self-testing has been offered to MSM through an online platform promoting their uptake.11-12 In the present study aims to evaluate the acceptability and impact of using an online platform to enable home delivery of HCV self-testing in Georgia for PWID and MSM.
详细描述
Georgia, a middle-income country with an estimated population of 3.7 million people, is among the world's highest-burden countries for HCV, with an estimated sero-prevalence of 7.7% in the general population and a higher burden of disease in high-risk populations such as persons who inject drugs. In 2015, Georgia embarked on an elimination program for HCV which includes the expansion of HCV testing, linkage to care, and treatment.
The country made a substantial progress in HCV testing, linkage to care and treatment during the last five years, but the gap still remains that needs to be addressed through testing of different screening modalities to reach marginalized groups of the population.
Self-testing with easy-to-use rapid diagnostic tests has been successfully used for diseases such as HIV. The availability of self-testing has been shown to increase testing rates and testing acceptability in diverse populations around the world, in large part due to its convenience and privacy advantages. The present study aims to evaluate the acceptability and impact of an online program enabling home delivery of HCV self-testing (HCVST) for people who inject drugs (PWID) and men who have sex with men (MSM) in Georgia.
The National Centres for Disease Control (NCDC) and FIND, in conjunction with the Georgian national HCV elimination program, Batumi Imedi, Equality Movement, Tanadgoma, and Tbilisi New Way are evaluating HCV self-testing as a way to expand outreach, improve HCV testing rates, and increase linkage to care among HCV-infected PWID and MSM. The ability to utilize an existing online platform promoting HIV self-testing, selftest.ge, will enable the study to examine how offering HCV self-testing may help Georgia reach its goal of nationwide elimination of HCV
The study aims to describe the acceptability and impact of an online platform offering home delivery of HCV self-tests to PWID and MSM. Since HCV self-tests detect the presence of antibodies to HCV, indicating exposure to HCV, any individual reporting a positive HCV self-test will be referred to HCV RNA confirmatory testing in order to identify active HCV infection. Those confirmed to have active HCV infection with a positive HCV RNA test will be linked to HCV treatment and care. Rates of testing and linkage to care will be measured, along with knowledge, attitudes, and practices around HCV testing and care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Able and eligible to access services on selftest.ge
- •Self-identify as a PWID and or MSM
- •Living in Batumi or Tbilisi
- •Able to understand the scope of the study and provide informed consent through online platform.
- •Able to read and understand Georgian
- •Unknown HCV serology status (i.e., never tested for HCV or tested HCV ab- in a most recent test performed no later than 6 months before enrolment)
排除标准
- •Self-reported previously confirmed positive HCV status (either Ab or RNA)
- •Un-eligible for Georgian National Hepatitis Elimination program
研究组 & 干预措施
MSM Postal delivery
Participants who identify primarily as MSM will receive a home delivered HCV self-test kit in non-identifiable packaging. The kit will include the test, instructions for use (IFU), and information about additional supporting materials, such as access to live chat and a call center for questions about testing
干预措施: (OraQuick® HCV Self-Test (Diagnostic Test)
MSM Peer delivery
Participants who identify primarily as MSM will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing
干预措施: (OraQuick® HCV Self-Test (Diagnostic Test)
MSM control
Participants who identify primarily as MSM will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing
PWID peer delivery
Participants who identify primarily as PWID will schedule a peer delivery of the HCV self-test kit and IFU. The peer will provide basic information about the test, what to do if the test is reactive, and how to access to live chat and a call center for questions about testing
干预措施: (OraQuick® HCV Self-Test (Diagnostic Test)
PWID control
Participants who identify primarily as PWID will receive information about standard of care HCV antibody testing available at local testing sites in their community. Participants will also have access to live chat and a call center for questions about HCV testing
结局指标
主要结局
To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSM
时间窗: 2 weeks to 2 months after enrollment
The number of participants who report completing the HCV antibody testing in the intervention group vs the control group
次要结局
- To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status(2 weeks to 2 months after enrollment)
- To assess the impact of HCV self-testing on linkage and completion of HCV RNA confirmatory testing in HCV antibody positive individuals(2 weeks to end of study)
- To assess the impact of HCV self-testing on treatment initiation in HCV RNA positive individuals eligible to start treatment(2 weeks to end of study)
- To assess the acceptability of HCV self-testing at baseline and after study participation.(2 weeks to 3 months after enrollment)
- To assess the cost of HCV self-testing(entire duration of study, estimated 6 months)