Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 4:11 PM
Study NCT ID:
NCT06403657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)
Sponsor:
Vietnam Viral Hepatitis Alliance
Organization:
Study Overview
Official Title:
DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT-B
Brief Summary:
The overarching goal of this implementation study is to determine if an enhanced model of hepatitis B testing and linkage to care could be integrated into a public healthcare facility. To answer this question, the investigators will
1. evaluate the effectiveness of the implementation program (overall impact or individual components) in increasing the use of testing services and linkage to hepatitis B care and treatment,
2. evaluate implementation fidelity, sustainability, and integration of the implementation study and
3. analyze the costs and cost-effectiveness of the implementation study.
1. evaluate the effectiveness of the implementation program (overall impact or individual components) in increasing the use of testing services and linkage to hepatitis B care and treatment,
2. evaluate implementation fidelity, sustainability, and integration of the implementation study and
3. analyze the costs and cost-effectiveness of the implementation study.
Detailed Description:
Chronic hepatitis B (CHB) poses a significant public health challenge, particularly in low-income countries like Viet Nam. Despite the development of various diagnostic and treatment tools for hepatitis B, the delivery of these services remains suboptimal.
In response, the investigators seek to assess the feasibility of integrating an enhanced model for hepatitis B testing and linkage to care within a public healthcare facility. The study aims to address this issue through several key objectives:
1. Effectiveness Evaluation: The investigators will evaluate the impact of the implementation program on increasing the utilization of testing services and linkage to hepatitis B care and treatment. This includes assessing the overall impact as well as the effectiveness of individual program components.
2. Implementation Fidelity and Sustainability: The investigators aim to evaluate the fidelity of implementation, examine how well the program is executed, and assess its potential for sustainability and integration into routine healthcare practices.
3. Cost and Cost-Effectiveness Analysis: The investigators will analyze the costs associated with the implementation of the program and its cost-effectiveness in improving hepatitis B testing and linkage to care.
The implementation study is based at Le Van Thinh Hospital in Thu Duc City, Ho Chi Minh City. This study is guided by the EPIS (Explore - Prepare - Implement - Sustain) conceptual framework, which informs our research development, implementation, and evaluation strategies.
A mixed-method quasi-experimental type II hybrid effectiveness-implementation design will be employed. This involves implementing various strategies to enhance hepatitis B testing sequentially over a 12-month period. Strategies include medical education for primary care providers, electronic medical record-based reminders for testing, and point-of-care testing for CHB.
Effectiveness will be assessed using interrupted time series analysis with electronic medical record data. Sustainability will be gauged through interviews or focus group discussions with healthcare providers and patients. Cost evaluation will utilize activity-based costing and cost-effectiveness analysis.
The study aims to generate evidence on the effectiveness and implementation of an enhanced model for hepatitis B screening and care linkage within a primary care setting at a public hospital. The findings are anticipated to be applicable to similar settings in Viet Nam and other lower-middle-income countries globally.
In response, the investigators seek to assess the feasibility of integrating an enhanced model for hepatitis B testing and linkage to care within a public healthcare facility. The study aims to address this issue through several key objectives:
1. Effectiveness Evaluation: The investigators will evaluate the impact of the implementation program on increasing the utilization of testing services and linkage to hepatitis B care and treatment. This includes assessing the overall impact as well as the effectiveness of individual program components.
2. Implementation Fidelity and Sustainability: The investigators aim to evaluate the fidelity of implementation, examine how well the program is executed, and assess its potential for sustainability and integration into routine healthcare practices.
3. Cost and Cost-Effectiveness Analysis: The investigators will analyze the costs associated with the implementation of the program and its cost-effectiveness in improving hepatitis B testing and linkage to care.
The implementation study is based at Le Van Thinh Hospital in Thu Duc City, Ho Chi Minh City. This study is guided by the EPIS (Explore - Prepare - Implement - Sustain) conceptual framework, which informs our research development, implementation, and evaluation strategies.
A mixed-method quasi-experimental type II hybrid effectiveness-implementation design will be employed. This involves implementing various strategies to enhance hepatitis B testing sequentially over a 12-month period. Strategies include medical education for primary care providers, electronic medical record-based reminders for testing, and point-of-care testing for CHB.
Effectiveness will be assessed using interrupted time series analysis with electronic medical record data. Sustainability will be gauged through interviews or focus group discussions with healthcare providers and patients. Cost evaluation will utilize activity-based costing and cost-effectiveness analysis.
The study aims to generate evidence on the effectiveness and implementation of an enhanced model for hepatitis B screening and care linkage within a primary care setting at a public hospital. The findings are anticipated to be applicable to similar settings in Viet Nam and other lower-middle-income countries globally.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: