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CompletedNCT06658678HBVUpdated Oct 26, 2024

Linkage to Care and Treatment of Chronic HBV Patients

An interventional study of Receiving an educational intervention in Hepatitis B, Chronic, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Apr 2021, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
803
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 803 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • CHB (HBV DNA+ or HBsAg+ for more than 6 months)
  • Age >18
  • Treatment naive at initial presentation

Exclusion criteria

Exclusion Criteria:

  • Prior HBV treatment
  • Organ transplant or other immunosuppression
  • HIV, HDV, HCV co-infection
  • Decompensated or HCC patients
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
803 participants (actual)

Study arms

  • Experimental
    Receiving an educational intervention

    Receiving the educational video link on their mobile device

    Other: Receiving an educational intervention

  • No intervention
    No educational intervention

Interventions

  • OtherReceiving an educational intervention

    Patient not receiving any educational intervention

    Also known as: No educational intervention

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 5 years

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

    Time frame: 5 years

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

    Time frame: 5 years

  4. Factors affecting rate of retention in care from patient perspective in the form of questionnaire survey

    Time frame: 12 months

07

Study locations

1 site
  • Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06658678
Lead sponsor
The University of Hong Kong
Responsible party
Wai-Kay Seto (Clinical Professor, The University of Hong Kong) — Principal investigator
First posted
Oct 26, 2024
Start date
Apr 3, 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022
Last update
Oct 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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