HCV, HIV479/65NCT05479760
KP-Led Same Day HCV Test and Treat Study
A study testing KP-Led HCV test and treat service in people with HCV, HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 4 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HCV, HIV
- What is being tested?
- KP-Led HCV test and treat service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesThailand
- Study dates
- 17 Aug 2023to 4 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thai citizen
- 18 years or older
- Signed informed consent
- Tested anti-HCV positive
- 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
Who cannot join
- Decline to participate in the research
- Eligibility criteria assessment of implementation outcomes:
- Do not provide informed consent to participate in the research
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Rainbow Sky Association of Thailand (RSAT)
Bangkok, Bangkapi, 10240
The Service Workers In Group Foundation (SWING)
Bangkok, Building 3, Patpong, Surawong Road, 10500
MPLUS Foundation (MPLUS)
Chiang Mai, 50100
Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
About this study
Official title: Key Population-Led Same Day Test and Treat for Hepatitis C in Community-Based Organizations in Bangkok, Thailand: A Demonstration Project
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.
Read the 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.
- Conditions
- HCV, HIV
- Being tested
- KP-Led HCV test and treat service
- Keywords
- HCV, HIV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-Led HCV test and treat serviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: KP-Led HCV test and treat service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (5)
The HCV re-infection rates
Proportion of clients with HCV-reinfection among those who had previously achieved SVR
Measured: 18 months
The duration to DAA initiation among clients with chronic HCV infection
Time from anti-HCV positivity to DAA initiation among clients with chronic HCV infection pre- compared to post-implementation
Measured: 18 months
The acceptability of KP-led HCV test and treat
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
Measured: 18 months
Provider perception of KP-led HCV test and treat feasibility.
The feasibility of providing KP-led HCV test and treat will be measured via survey and/or in-depth interviews with KP-lay providers.
Measured: 18 months
The fidelity of provider during the implementation
The KP-led HCV test and treat fidelity of KP-lay providers will be assessed through service delivery checklists and case report forms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start17 Aug 2023
- Primary completion15 Feb 2025
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV, HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479760
- Sponsor's protocol ID
- IHRI018
- Acronym
- 479/65
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Population-Led Same Day Test and Treat for Hepatitis C in Community-Based Organizations in Bangkok, Thailand: A Demonstration Project
- ClinicalTrials.gov ID
- NCT05479760
- Acronym / sponsor ID
- 479/65 / IHRI018
- Conditions
- HCV, HIV
- Keywords
- HCV, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation for anti-HCV reactive client | Experimental | Other: KP-Led HCV test and treat serviceAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Thai citizen
- 18 years or older
- Signed informed consent
- Tested anti-HCV positive
- Client level: Tested anti-HCV positive at one of the implementing CBOs
Key exclusion criteria (3 listed)
- Decline to participate in the research
- Do not provide informed consent to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KP-Led HCV test and treat serviceAfter 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. | Other | Implementation for anti-HCV reactive client |
Primary outcome
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.
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.
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.
5 secondary outcomes
The HCV re-infection rates
Time frame: 18 months
The duration to DAA initiation among clients with chronic HCV infection
Time frame: 18 months
The acceptability of KP-led HCV test and treat
Time frame: 18 months
Provider perception of KP-led HCV test and treat feasibility.
Time frame: 18 months
The fidelity of provider during the implementation
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KP-Led HCV test and treat service in people with HCV, HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible clients initiating DAAs (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.