- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479760
KP-Led Same Day HCV Test and Treat Study (479/65)
Key Population-Led Same Day Test and Treat for Hepatitis C in Community-Based Organizations in Bangkok, Thailand: A Demonstration Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Implementation Effectiveness To assess effectiveness, an interrupted time series (ITS) design. The counterfactual scenario (under which KP-led HCV test and treat had not been implemented) will be determined using routine service data collected from 15 months prior to the study implementation, and will provide a comparison for the evaluation of the impact of KP-led HCV test and treat by examining any change occurring in the primary outcomes in the post-implementation period during the 15 months of the study.
Implementation Strategies To assess implementation, Proctor's model was used to guide the selection of relevant implementation outcomes, which during this stage of implementation are acceptability, feasibility, and fidelity. Socio-ecological level, framework, and relevant constructs for each outcome are outlined below and in table 1.
Acceptability of KP-led HCV test and treat Acceptability refers to the perception that the service is agreeable and satisfactory. It will be measured using surveys at four socio-ecological levels, informed by different frameworks according to relevance
- Clients, pre-implementation: The Health Belief Model (HBM) will be used to design a survey to assess determinants that drive the acceptability of HCV test and treat services at the CBO. The HBM is one of the first theories of health behavior, and addresses the individual's perception of the threat posed by a health problem and factors influencing the decision to act. This assessment will be conducted pre-implementation, and findings will inform the design of implementation strategies targeting clients
- Clients, during implementation: To assess the acceptability and satisfaction of the same day HCV test and treat service, clients who initiated DAA treatment at the CBO will be asked to complete a standard survey on acceptability and satisfaction
- Providers: The Theory of Planned Behavior (TPB) will be used to design a survey to assess factors that influence the acceptability of HCV test and treat among KP-lay providers. The TPB examines the relations between an individual's belief, attitudes, intentions, behavior, and perceived control over that behavior. This assessment will be conducted pre-implementation, and findings will inform the design of implementation strategies targeting providers.
- CBO leadership: The Theory of Planned Behavior (TPB) will also be used to design a survey to assess factors that influence the acceptability of HCV test and treat among CBO leaderships. This assessment will be conducted pre-implementation, and findings will inform the design of implementation strategies targeting CBO leadership.
- Policy makers: The Consolidated Framework for Implementation Research (CFIR) will be used to produce interview guides to assess the acceptability of the service among key government stakeholders and policy makers.
Feasibility of providing KP-led HCV test and treat by KP-lay providers in CBOs
Feasibility refers to the extent to which the service can be successfully delivered within the CBO setting. It will be measured at two socio-ecological levels:
- Providers: Training records, and surveys and in-depth interviews informed by CFIR.
- CBO leadership: CFIR will be used to design surveys to assess relevant domains and constructs, and in-depth interviews will be conducted to further explore survey findings.
- Fidelity of KP-led HCV test and treat implementation Fidelity refers to the extent to which the service was delivered as intended. It will be measured at the provider level using observation, checklists, and assessment of client records, guided by CFIR.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rena Janamnuaysook, MBA
- Phone Number: 6698 516 4562
- Email: rena.j@ihri.org
Study Contact Backup
- Name: Nittaya Phanuphak, MD,PhD.
- Phone Number: 6681 825 3544
- Email: nittaya.p@ihri.org
Study Locations
-
-
Bangkapi
-
Bangkok, Bangkapi, Thailand, 10240
- Recruiting
- Rainbow Sky Association of Thailand (RSAT)
-
Contact:
- Tanachai Chaisalee
- Phone Number: 6683 897 1691
- Email: tanachai@rsat.info
-
-
Bangkok
-
Pathum wan, Bangkok, Thailand, 10330
- Recruiting
- Institute of HIV Research and Innovation
-
Contact:
- Nittaya Phanuphak, MD.,Ph.D.
- Phone Number: +66 2 1605371
- Email: nittaya.p@ihri.org
-
Contact:
- Rena Janamnuaysook, MBA
- Phone Number: +66 2 1605371
- Email: rena.j@ihri.org
-
-
Building 3, Patpong, Surawong Road
-
Bangkok, Building 3, Patpong, Surawong Road, Thailand, 10500
- Recruiting
- The Service Workers In Group Foundation (SWING)
-
Contact:
- Surang Janyam
- Phone Number: 081 626 6538
- Email: surang.jan@swingthailand.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implementation for anti-HCV reactive client
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of eligible clients initiating DAAs
Time Frame: 18 months
|
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
Time Frame: 18 months
|
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
Time Frame: 18 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The HCV re-infection rates
Time Frame: 18 months
|
Proportion of clients with HCV-reinfection among those who had previously achieved SVR
|
18 months
|
The duration to DAA initiation among clients with chronic HCV infection
Time Frame: 18 months
|
Time from anti-HCV positivity to DAA initiation among clients with chronic HCV infection pre- compared to post-implementation
|
18 months
|
The acceptability of KP-led HCV test and treat
Time Frame: 18 months
|
The acceptability of KP-led HCV test and treat will be measured via survey and/or in-depth interviews with clients, providers, CBO leadership, and policymakers
|
18 months
|
Provider perception of KP-led HCV test and treat feasibility.
Time Frame: 18 months
|
The feasibility of providing KP-led HCV test and treat will be measured via survey and/or in-depth interviews with KP-lay providers.
|
18 months
|
The fidelity of provider during the implementation
Time Frame: 18 months
|
The KP-led HCV test and treat fidelity of KP-lay providers will be assessed through service delivery checklists and case report forms.
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IHRI018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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