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KP-Led Same Day HCV Test and Treat Study

NCT05479760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • HCV, HIV

Interventions

OTHER

KP-Led HCV test and treat service

After completing informed consent procedures, screening procedures will take place to assess eligibility. Clients who are anti-HCV and HCV-RNA positive, but meet one/more ineligible characteristics for simplified treatment will be referred to a hepatologist for treatment initiation. Participants who are HCV-RNA positive and otherwise eligible will be offered to initiate DAAs at the CBO, followed by telehealth visits at week 4 and 8 and CBO visits at week 12, and week 24. If a visit is requested by the client, it can be conducted through telehealth or in-person at the clinic depending on client preferences. Substance use will be assessed using ASSIST, Retention in care, occurrence of adverse events during treatment, completion of treatment, and SVR achievement will be assessed. Clients who achieve SVR will be retested with HCV-RNA every 3 months to assess HCV re-infection. Clients who do not achieve SVR will be referred for further analysis and treatment.

Sponsors & Collaborators

  • Institute of HIV Research and Innovation Foundation, Thailand

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2025-02-15
Completion
2026-03-04

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05479760 on ClinicalTrials.gov