Randomized Controlled Trial of Home-based Hepatitis C Self-testing for Key Populations in Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing
研究概览
简要总结
Self-testing with easy-to-use rapid diagnostic tests (RDTs) 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. 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 and men who have sex with men. In Malaysia, HIV self-testing has been shown to have moderate to high levels of acceptability, depending on the population, test used, and test delivery framework. In the present study we aim to evaluate the acceptability and impact of an online program enabling home-based hepatitis C virus (HCV) self-testing in Malaysia.
详细描述
Malaysia is an upper middle-income country with a population of more than 32 million, comprising thirteen states and three federal territories. It is estimated that the hepatitis C virus (HCV) seroprevalence in the general population of Malaysia is between 0.3% and 2.5%. In Malaysia, people who inject drugs represent just 0.24% (75 000) of the adult population; however, they are disproportionately affected by HCV, with an overall HCV prevalence of 67.5% to 89.9%. Other key populations in Malaysia at higher risk of HCV include 77 903 people living with human immunodeficiency virus (HIV, 0.24%), 221 698 men who have sex with men (0.69%), 22 000 female sex workers (0.069%), and 15 000 transgender sex workers (0.047%).
The major challenges faced by Malaysia in eliminating viral hepatitis have been under-screening, under-diagnosis and under-treatment. A high proportion of those infected with HCV remain undiagnosed and, until 2018, only a small proportion of those infected received treatment each year. Up until 2017, it is estimated that just 6.1% (23 258) of people infected with HCV were diagnosed.
Self-testing with easy-to-use rapid diagnostic tests (RDTs) 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. In the present study we aim to evaluate the acceptability and impact of an online program enabling home-based HCV self-testing in Malaysia.
FIND, in conjunction with the Malaysian AIDS Council (MAC) and the Ministry of Health (MOH) Malaysia, is evaluating HCV self-testing as a way to expand outreach, improve HCV testing rates, and increase linkage to care among HCV-infected individuals. The ability to utilize an existing online platform promoting HIV self-testing (JomTest) will enable us to examine how offering home-based HCV self-testing may help identify HCV-infected individuals and link them to care. *The online platform JomTest is currently hosting a research study with Medical Research Ethics Committee, University Malaya Medical Center MRECID No. 202013-8135, study title "Integrated HIV self-testing (HIVST) service delivery in Malaysia for policy and service development: JomTest online" and aims to assess the integrated HIVST service delivery in Malaysia for policy and service development through the platform.
This study will evaluate the impact of a home-based HCV self-testing program in Malaysia. We aim to describe the acceptability and impact of an online platform offering home-based HCV self-tests to key populations. 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
- •Eligible to access services on the JomTest online platform
- •Not known to be HCV antibody positive
- •Not tested for HCV within the last 6 months
- •Able to read and understand Bahasa Malaysia or English
- •Able to understand the scope of the study and provide online informed consent
排除标准
- •Self-reported previously confirmed positive HCV status (either antibody or RNA)
研究组 & 干预措施
Oral fluid-based HCV ST
In the intervention group, participants will receive a HCV self-test (ST) kit delivered in non-identifiable packaging to their home or a preferred mailing address. The kit will include the test, instructions for use, and information about additional supporting materials, such as access to live chat and a call center for questions about testing. In order to evaluate two sampling methods for HCV self-testing, the first 250 participants in the intervention group will receive an oral fluid-based HCV ST.
干预措施: OraQuick® HCV Self-Test (Diagnostic Test)
Blood-based HCV ST
In the intervention group, participants will receive a HCV self-test (ST) kit delivered in non-identifiable packaging to their home or a preferred mailing address. The kit will include the test, instructions for use, and information about additional supporting materials, such as access to live chat and a call center for questions about testing. In order to evaluate two sampling methods for HCV self-testing, the next 250 participants will receive a blood-based fingerstick HCV ST.
干预措施: First Response® HCV Self-Test (Diagnostic Test)
Control standard of care
In the control group, participants will receive information about standard of care HCV antibody testing available at local testing sites in their community and information about additional supporting materials, such as access to live chat and a call center for questions about testing.
结局指标
主要结局
To assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing
时间窗: Time Frame: 2 weeks to 2 months after enrollment
The number and estimate of the proportion of participants who report completing the HCV antibody testing in the intervention group vs the control group.
次要结局
- To assess the cost of HCV self-testing(entire duration of study, estimated 6 months)
- To assess the impact of HCV self-testing on treatment initiation in HCV RNA positive individuals eligible to start treatment(2 weeks to 6 months after enrollment)
- To assess the acceptability and feasibility of HCV self-testing at baseline and after study participation as assessed by responses to the questionnaire at baseline and after study participation(2 weeks to 3 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 6 months after enrollment)
- 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)