Viral Hepatitis BDETECT-BNCT06403657
DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)
A study testing An enhanced model of hepatitis B testing and linkage to care in people with Viral Hepatitis B, run by Vietnam Viral Hepatitis Alliance.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Viral Hepatitis B
- What is being tested?
- An enhanced model of hepatitis B testing and linkage to care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Jul 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who visit the outpatient clinics at Le Van Thinh Hospital during the study period.
- Consent to use point-of-care HBsAg testing after being fully informed by the health care providers (this only applies during the last 4-month period where POC-HBsAg testing is introduced).
- Healthcare providers who work in the outpatient department and are involved in the enhanced model during the 12-month implementation period.
- Leaders who are involved in the enhanced model or make decisions or are authorized to to so relating to the enhanced model.
- Consent to join the in-depth interview or focus group after being fully informed by the study investigators.
- Exclusion criteria for healthcare providers and leaders: None
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Thanh Kim, MD contact
About this study
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
- 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,
- evaluate implementation fidelity, sustainability, and integration of the implementation study and
- analyze the costs and cost-effectiveness of the implementation study.
Read the 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:
- 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.
- 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.
- 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.
- Conditions
- Viral Hepatitis B
- Being tested
- An enhanced model of hepatitis B testing and linkage to care
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An enhanced model of hepatitis B testing and linkage to careOther
Implementing CME sessions (<50 attendees) at Le Van Thinh Hospital will focus on preventive strategies for hepatitis B (HBV). We'll collaborate with IT to integrate a Best Practice Advisory (BPA) system into the hospital's electronic records for hepatitis B testing reminders. The system prompts healthcare workers when a patient lacks HBV screening notes, ensuring timely education and testing. Also, we'll introduce Point-of-Care (POC) HBsAg testing using SD Bioline HBsAg WB® for efficient screening and counseling, with follow-up to ensure care linkage within two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Implementation of the enhanced model | Experimental | The enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA.
Since this implementation study is single-sited, the period before the implementation will be used as a control arm. Receives: Other: An enhanced model of hepatitis B testing and linkage to care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number or proportion HBsAg testing at primary care clinics between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.
The primary care clinics include general internal medicine clinics and family medicine clinics, located in the outpatient department.
Measured: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
Sustainability of the implementation of the enhanced model, as assessed by EPIS-based semi-structured/structured questionnaires.
This is a qualitative outcome. The information will be collected through focus group discussions or in-depth interviews on healthcare staff. The EPIS (Exploration-Preparation-Implementation-Sustainment) is a conceptual framework used to guide the questionnaire and the discussions/interviews
Measured: At Month 12 of the implementation period
Activity-based costs
The scope of the costing was limited to program implementation costs.
Measured: At Month 12 of the implementation period
Secondary outcomes (1)
Change in linkage to hepatitis B care between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.
Measured: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study startMay 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hepatitis BStudies 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
- Model description
- There are two periods - pre-implementation (used as control) and implementation. The enhanced model will be rolled out in the implementation phase. The change in hepatitis B testing will be evaluated for effectiveness. The enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vietnam Viral Hepatitis Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Le Van Thinh Hospital, University of Medicine and Pharmacy at Ho Chi Minh City
- Responsible party
- Principal investigator, Thanh Van Kim, Pham Ngoc Thach University of Medicine
- Investigators
- Thanh Kim, MD, Principal investigator, Pham Ngoc Thach University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403657
- Sponsor's protocol ID
- DETECT-B protocol
- Acronym
- DETECT-B
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEcentralize Testing, Education, and Linkage to Care by Using Electronic Best Practice Advisory for Hepatitis B (DETECT-B)
- ClinicalTrials.gov ID
- NCT06403657
- Acronym / sponsor ID
- DETECT-B / DETECT-B protocol
- Conditions
- Viral Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vietnam Viral Hepatitis AllianceUniversity, hospital or other
- Collaborators
- Le Van Thinh Hospital, University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- May 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 8 May 2024 (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.
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
- 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,
- evaluate implementation fidelity, sustainability, and integration of the implementation study and
- 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:
- 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.
- 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.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There are two periods - pre-implementation (used as control) and implementation. The enhanced model will be rolled out in the implementation phase. The change in hepatitis B testing will be evaluated for effectiveness. The enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA.
| Arm | Type | Receives |
|---|---|---|
| Implementation of the enhanced model | Experimental | Other: An enhanced model of hepatitis B testing and linkage to careThe enhanced model of hepatitis testing and linkage to care includes three implementation interventions: 1) continued medical education (CME) for primary health providers, 2) electronic health records-based best practice alerts (BPA) for chronic hepatitis B testing, 3) point-of-care HBsAg testing (POC). These implementation interventions will be introduced sequentially and cumulatively every four months for 12 months. For example, during the first 4-month period, only CME is implemented. In the next 4 months, BPA will be introduced, coupled with the ongoing CME. In the last 4 months, POC will be introduced, together with the ongoing CME and BPA. Since this implementation study is single-sited, the period before the implementation will be used as a control arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who visit the outpatient clinics at Le Van Thinh Hospital during the study period.
- Consent to use point-of-care HBsAg testing after being fully informed by the health care providers (this only applies during the last 4-month period where POC-HBsAg testing is introduced).
- Healthcare providers who work in the outpatient department and are involved in the enhanced model during the 12-month implementation period.
- Leaders who are involved in the enhanced model or make decisions or are authorized to to so relating to the enhanced model.
- Consent to join the in-depth interview or focus group after being fully informed by the study investigators.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| An enhanced model of hepatitis B testing and linkage to careImplementing CME sessions (<50 attendees) at Le Van Thinh Hospital will focus on preventive strategies for hepatitis B (HBV). We'll collaborate with IT to integrate a Best Practice Advisory (BPA) system into the hospital's electronic records for hepatitis B testing reminders. The system prompts healthcare workers when a patient lacks HBV screening notes, ensuring timely education and testing. Also, we'll introduce Point-of-Care (POC) HBsAg testing using SD Bioline HBsAg WB® for efficient screening and counseling, with follow-up to ensure care linkage within two weeks. | Other | Implementation of the enhanced model |
Primary outcome
Change in number or proportion HBsAg testing at primary care clinics between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.
Time frame: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
The primary care clinics include general internal medicine clinics and family medicine clinics, located in the outpatient department.
Sustainability of the implementation of the enhanced model, as assessed by EPIS-based semi-structured/structured questionnaires.
Time frame: At Month 12 of the implementation period
This is a qualitative outcome. The information will be collected through focus group discussions or in-depth interviews on healthcare staff. The EPIS (Exploration-Preparation-Implementation-Sustainment) is a conceptual framework used to guide the questionnaire and the discussions/interviews
Activity-based costs
Time frame: At Month 12 of the implementation period
The scope of the costing was limited to program implementation costs.
1 secondary outcome
Change in linkage to hepatitis B care between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital.
Time frame: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Thanh Kim, MD contact
Thanh Kim, MD principal investigator
Pham Ngoc Thach University of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing An enhanced model of hepatitis B testing and linkage to care in people with Viral Hepatitis B, run by Vietnam Viral Hepatitis Alliance.
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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanh Kim, MD (thanhkv@pnt.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number or proportion HBsAg testing at primary care clinics between pre- and implementation periods, extracted from electronic health records at Le Van Thinh hospital. (time frame: Up to 2 years (start one year before the implementation of the enhanced model and end one year after).). 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 8 May 2024.