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临床试验/NCT05479760
NCT05479760已完成不适用

Key Population-Led Same Day Test and Treat for Hepatitis C in Community-Based Organizations in Bangkok, Thailand: A Demonstration Project

Institute of HIV Research and Innovation Foundation, Thailand4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
4
主要终点
The proportion of eligible clients initiating DAAs

研究概览

简要总结

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.

详细描述

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.

  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.
  1. 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.
  1. 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligibility criteria for assessment of effectiveness outcomes:
  • Inclusion Criteria:
  • Thai citizen
  • 18 years or older
  • Signed informed consent
  • Tested anti-HCV positive

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: KP-Led HCV test and treat service (Other)

结局指标

主要结局

The proportion of eligible clients initiating DAAs

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • The fidelity of provider during the implementation(18 months)
  • Provider perception of KP-led HCV test and treat feasibility.(18 months)

研究者

发起方
Institute of HIV Research and Innovation Foundation, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (4)

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