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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in 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.

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 groups in NCT06658678
Study groupRoleWhat they receive
Receiving an educational interventionExperimentalReceiving the educational video link on their mobile device
Receives: Other: Receiving an educational intervention
No educational interventionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. The treatment rate in chronic hepatitis B patients up to 5 years after diagnosis

    Measured: 5 years

  2. The rate of viral suppression in chronic hepatitis B patients up to 5 years after diagnosis

    Measured: 5 years

  3. The rate of complication in chronic hepatitis B patients up to 5 years after diagnosis

    Measured: 5 years

  4. 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.

  1. First posted26 Oct 2024
  2. Study start3 Apr 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2022

Resources

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)
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

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.

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