Hepatitis B, ChronicHBVNCT06658678
Linkage to Care and Treatment of Chronic HBV Patients
A study testing Receiving an educational intervention in people with Hepatitis B, Chronic, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Chronic hepatitis B remains the leading cause of liver related mortality and morbidity globally and locally. Countries have been formulating initiatives to meet the WHO target of eliminating viral hepatitis by 2030. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Receiving an educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Apr 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHB (HBV DNA+ or HBsAg+ for more than 6 months)
- Age >18
- Treatment naive at initial presentation
Who cannot join
- Prior HBV treatment
- Organ transplant or other immunosuppression
- HIV, HDV, HCV co-infection
- Decompensated or HCC patients
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital
Hong Kong
About this study
Official title: Achieving Linkage to Retention and Treatment After Territory-wide Screening and Care Referral for Chronic Hepatitis B Patients
Chronic hepatitis B remains the leading cause of liver related mortality and morbidity globally and locally. Countries have been formulating initiatives to meet the WHO target of eliminating viral hepatitis by 2030. However, data on the most important aspect of management of chronic hepatitis B, namely linkage to care and treatment, remains scarce. In order to achieve the WHO goal, treatment rate of eligible patients should reach 80%.
Read the detailed description
Diagnosing patients with chronic hepatitis B virus (HBV) infection and establishing linkage to treatment is important in achieving the World Health Organization (WHO) objectives in eliminating HBV as a public health threat by 2030. Global HBV diagnosis rates and treatment rates among eligible patients were 10% and 5% respectively. In Mainland China and Hong Kong, estimated diagnosis and treatment coverage were 19-27% and 11-22% respectively, similarly much lower than the WHO 2030 goals of 90% for diagnosis and 80% for treatment. A recent modeling study demonstrated that even if a modest 50% diagnosis rate was achieved in China, this will result in a 19% mortality decline, with 2.1 million deaths averted. Currently, HBV screening is recommended for persons born in regions with a HBV prevalence of 22%. This includes the vast majority of East Asian countries.
In the HBV care continuum, identifying patients and arranging linkage to care is only the first step. Long-term retention of patients is critical, especially since with disease progression, treatment eligibility rates can increase by 30% after 3 years of follow-up. Nonetheless, there has been a paucity of data on HBV care continuum retention rates after referrai and linkage. A US-based study did found that among diagnosed patients, only 63.2% achieved linkage to referral, and only 44.1% remained retained in clinical care after at least three clinic visits. Another study in Italy found a higher retention of 60% after 5 years; besides African ethnicity and concomitant HIV infection, the study failed to identify any predictors of retention failure, yet 74.8% of retained patients subsequently required treatment. There has been otherwise no published data on linkage to retention rates in endemic regions including East Asia, and on whether the care continuum cascade can successfully link referral to treatment.
Our center previously conducted a territory-wide prevalence study of HBV, and out of \>10,000 screened participants, the investigators identified 803 hepatitis B surface antigen (HBSAg)-positive individuals, with a mean age of 53.7 (135.8) years (36.7% male). As part of linkage to care, all patients were subsequently referred to their respective geographical cluster hospital. The investigators recently performed a follow-up telephone survey of the 803 patients, asking on their status of clinical follow-up and liver-related treatment. Our preliminary data found a retention rate of only 37.1% after 2 years post-referral. However, among retained patients, 51.2% were already started on anti-HBV treatment, suggesting that high rates of treatment eligibility may also exist in unretained patients. Hence, to enhance linkage to treatment, linkage to retention rates will need improvement.
There is emerging evidence on the effect of different interventions in improving the care continuum of viral hepatitis, although the majority of evidence is concentrated in hepatitis C virus and not HBV. Clinical reminders have been demonstrated to be the most effective method to improve testing rates; such reminders may also be useful to in improving clinic attendance and retention. On the other hand, the data on educational materials is less consistent. Data was concentrated in Asian migrants in North America, with some based on non-randomized studies, and could be susceptible to selection, attrition and reporting bias.
Interventions using social media and mobile technology may be promising. Experience from engaging patients with human immunodeficiency virus infection have found social media effective in reaching out to marginalized individuals, especially among those of a younger age. It would be interesting to see if educational videos disseminated on mobile devices via social media can improve linkage to retention and treatment for HBV.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Receiving an educational intervention
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving an educational interventionOther
Also called No educational intervention
Patient not receiving any educational intervention
| Study group | Role | What they receive |
|---|---|---|
| Receiving an educational intervention | Experimental | Receiving the educational video link on their mobile device Receives: Other: Receiving an educational intervention |
| No educational intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of education intervention on rate of retention in care in chronic hepatitis B patients identified from a territory wide screening program
Measured: 12 months
Secondary outcomes (4)
The treatment rate in chronic hepatitis B patients up to 5 years after diagnosis
Measured: 5 years
The rate of viral suppression in chronic hepatitis B patients up to 5 years after diagnosis
Measured: 5 years
The rate of complication in chronic hepatitis B patients up to 5 years after diagnosis
Measured: 5 years
Factors affecting rate of retention in care from patient perspective in the form of questionnaire survey
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start3 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wai-Kay Seto, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658678
- Sponsor's protocol ID
- HBVcare
- Acronym
- HBV
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Linkage to Retention and Treatment After Territory-wide Screening and Care Referral for Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT06658678
- Acronym / sponsor ID
- HBV / HBVcare
- Conditions
- Hepatitis B, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Oct 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.
Chronic hepatitis B remains the leading cause of liver related mortality and morbidity globally and locally. Countries have been formulating initiatives to meet the WHO target of eliminating viral hepatitis by 2030. However, data on the most important aspect of management of chronic hepatitis B, namely linkage to care and treatment, remains scarce. In order to achieve the WHO goal, treatment rate of eligible patients should reach 80%.
Detailed description
Diagnosing patients with chronic hepatitis B virus (HBV) infection and establishing linkage to treatment is important in achieving the World Health Organization (WHO) objectives in eliminating HBV as a public health threat by 2030. Global HBV diagnosis rates and treatment rates among eligible patients were 10% and 5% respectively. In Mainland China and Hong Kong, estimated diagnosis and treatment coverage were 19-27% and 11-22% respectively, similarly much lower than the WHO 2030 goals of 90% for diagnosis and 80% for treatment. A recent modeling study demonstrated that even if a modest 50% diagnosis rate was achieved in China, this will result in a 19% mortality decline, with 2.1 million deaths averted. Currently, HBV screening is recommended for persons born in regions with a HBV prevalence of 22%. This includes the vast majority of East Asian countries.
In the HBV care continuum, identifying patients and arranging linkage to care is only the first step. Long-term retention of patients is critical, especially since with disease progression, treatment eligibility rates can increase by 30% after 3 years of follow-up. Nonetheless, there has been a paucity of data on HBV care continuum retention rates after referrai and linkage. A US-based study did found that among diagnosed patients, only 63.2% achieved linkage to referral, and only 44.1% remained retained in clinical care after at least three clinic visits. Another study in Italy found a higher retention of 60% after 5 years; besides African ethnicity and concomitant HIV infection, the study failed to identify any predictors of retention failure, yet 74.8% of retained patients subsequently required treatment. There has been otherwise no published data on linkage to retention rates in endemic regions including East Asia, and on whether the care continuum cascade can successfully link referral to treatment.
Our center previously conducted a territory-wide prevalence study of HBV, and out of \>10,000 screened participants, the investigators identified 803 hepatitis B surface antigen (HBSAg)-positive individuals, with a mean age of 53.7 (135.8) years (36.7% male). As part of linkage to care, all patients were subsequently referred to their respective geographical cluster hospital. The investigators recently performed a follow-up telephone survey of the 803 patients, asking on their status of clinical follow-up and liver-related treatment. Our preliminary data found a retention rate of only 37.1% after 2 years post-referral. However, among retained patients, 51.2% were already started on anti-HBV treatment, suggesting that high rates of treatment eligibility may also exist in unretained patients. Hence, to enhance linkage to treatment, linkage to retention rates will need improvement.
There is emerging evidence on the effect of different interventions in improving the care continuum of viral hepatitis, although the majority of evidence is concentrated in hepatitis C virus and not HBV. Clinical reminders have been demonstrated to be the most effective method to improve testing rates; such reminders may also be useful to in improving clinic attendance and retention. On the other hand, the data on educational materials is less consistent. Data was concentrated in Asian migrants in North America, with some based on non-randomized studies, and could be susceptible to selection, attrition and reporting bias.
Interventions using social media and mobile technology may be promising. Experience from engaging patients with human immunodeficiency virus infection have found social media effective in reaching out to marginalized individuals, especially among those of a younger age. It would be interesting to see if educational videos disseminated on mobile devices via social media can improve linkage to retention and treatment for HBV.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receiving an educational intervention | Experimental | Other: Receiving an educational interventionReceiving the educational video link on their mobile device |
| No educational intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CHB (HBV DNA+ or HBsAg+ for more than 6 months)
- Age >18
- Treatment naive at initial presentation
Key exclusion criteria (4 listed)
- Prior HBV treatment
- Organ transplant or other immunosuppression
- HIV, HDV, HCV co-infection
- Decompensated or HCC patients
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 |
|---|---|---|
| Receiving an educational interventionAlso: No educational interventionPatient not receiving any educational intervention | Other | Receiving an educational intervention |
Primary outcome
The effect of education intervention on rate of retention in care in chronic hepatitis B patients identified from a territory wide screening program
Time frame: 12 months
4 secondary outcomes
The treatment rate in chronic hepatitis B patients up to 5 years after diagnosis
Time frame: 5 years
The rate of viral suppression in chronic hepatitis B patients up to 5 years after diagnosis
Time frame: 5 years
The rate of complication in chronic hepatitis B patients up to 5 years after diagnosis
Time frame: 5 years
Factors affecting rate of retention in care from patient perspective in the form of questionnaire survey
Time frame: 12 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 26 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving an educational intervention in people with Hepatitis B, Chronic, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 4 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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 effect of education intervention on rate of retention in care in chronic hepatitis B patients identified from a territory wide screening program (time frame: 12 months). 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 26 Oct 2024.