KP-Led Same Day HCV Test and Treat Study

NCT05479760 | Completed

• 1 other identifier: IHRI018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

HCV, HIV

Outcome Measures

Primary Outcomes (3)

• The proportion of eligible clients initiating DAAs

  The proportion of eligible clients initiating DAAs in CBOs under KP-led HCV test and treat in CBOs as compared to pre-implementation.

  18 months

• The proportion of complete tretmented client

  The proportion of clients who complete 12 weeks of treatment under KP-led HCV test and treat in CBOs as compared to pre-implementation.

  18 months

• The proportion of SVR achieved client

  The proportion of clients who achieve SVR at 12 weeks after treatment completion under KP-led HCV test and treat in CBOs as compared to pre-implementation.

  18 months

Secondary Outcomes (5)

• The HCV re-infection rates

  18 months

• The duration to DAA initiation among clients with chronic HCV infection

  18 months

• The acceptability of KP-led HCV test and treat

  18 months

• Provider perception of KP-led HCV test and treat feasibility.

  18 months

• The fidelity of provider during the implementation

  18 months

Study Arms (1)

Implementation for anti-HCV reactive client

EXPERIMENTAL

All clients who test anti-HCV positive at the study CBOs will be assessed for the inclusion criteria. Eligible clients will be informed and offered to participate in the study.

Other: KP-Led HCV test and treat service

Interventions

KP-Led HCV test and treat service OTHER

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.

Implementation for anti-HCV reactive client

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thai citizen
• years or older
• Signed informed consent
• Tested anti-HCV positive

You may not qualify if:

• Decline to participate in the research
• Eligibility criteria assessment of implementation outcomes:
• 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
• Do not provide informed consent to participate in the research

Sponsors & Collaborators

• Institute of HIV Research and Innovation Foundation, Thailand: lead

Study Sites (4)

Rainbow Sky Association of Thailand (RSAT)

Bangkok, Bangkapi, 10240, Thailand

Location

Institute of HIV Research and Innovation

Pathum Wan, Bangkok, 10330, Thailand

Location

The Service Workers In Group Foundation (SWING)

Bangkok, Building 3, Patpong, Surawong Road, 10500, Thailand

Location

MPLUS Foundation (MPLUS)

Chiang Mai, 50100, Thailand

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 29, 2022
• Study Start: August 17, 2023
• Primary Completion: February 15, 2025
• Study Completion: March 4, 2026
• Last Updated: March 18, 2026

Record last verified: 2024-11

Locations

TH (4)