KP-Led Same Day HCV Test and Treat Study (NCT05479760) | Clinical Trial Compass
CompletedNot Applicable
KP-Led Same Day HCV Test and Treat Study
Thailand200 participantsStarted 2023-08-17
Plain-language summary
This is a Hybrid design to primarily assess effectiveness, and to secondarily observe and collect data on the implementation of the service. This will allow the assessment of health-related outcomes and implementation outcomes to facilitate dissemination and replication if proven to be successful in other CBOs in Thailand, regionally, and globally.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility criteria for assessment of effectiveness outcomes:
Inclusion Criteria:
* Thai citizen
* 18 years or older
* Signed informed consent
* Tested anti-HCV positive
Exclusion Criteria:
* Decline to participate in the research
Eligibility criteria assessment of implementation outcomes:
Inclusion criteria:
* Client level: Tested anti-HCV positive at one of the implementing CBOs
* Provider level: KP lay providers providing KP-led Same Day HCV Test and Treat
* Leadership level: leadership of implementing CBOs
* Government level: involved in policy making related to HCV testing and treatment in key populations
Exclusion criteria:
* Do not provide informed consent to participate in the research
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of eligible clients initiating DAAs
Timeframe: 18 months
2
The proportion of complete tretmented client
Timeframe: 18 months
3
The proportion of SVR achieved client
Timeframe: 18 months
Trial details
NCT IDNCT05479760
SponsorInstitute of HIV Research and Innovation Foundation, Thailand