The Impact of Treatment for Chronic Hepatitis B Virus on Non-clinical Harms

NCT07053449 | Not Yet Recruiting

• 1 other identifier: 24HP005
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this qualitative study is to explore the impact of antiviral treatment, or none, for chronic hepatitis B virus on the non-clinical (social) harms experienced by migrant populations living in the UK. Two groups of participants living with hepatitis B virus will be interviewed, those taking the daily treatment, and those not prescribed any treatment.

Conditions

Hepatitis B Virus (HBV)

Keywords

Hepatitis B Virus; Qualitative; Lived Experience; Stigma

Outcome Measures

Primary Outcomes (1)

• The qualitative Interview Topic Guide Questionnaire will thematically measure patients' experience of treatment, or not having treatment, for chronic hepatitis B virus infection.

  A qualitative interview topic guide questionnaire on patient's experience of treatment, or no treatment, for hepatitis B virus infection. The coding scheme will be inductively derived by the study team and overarching themes that characterise patients' experiences will be determined.

  The outcome measure will be assessed and data collected for reporting on day 1

Study Arms (1)

HBsAg positive

Adult migrant populations living with chronic hepatitis B virus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults living with chronic hepatitis B virus infection

You may qualify if:

• Chronic HBsAg
• Able to give informed consent in English
• Able to converse in English
• Any migrant population member (non-UK) including if born overseas or in the UK
• Aged 18 years and over
• Has never taken antiviral treatment for HBV (12-15 participants)
• Prescribed and taking any oral treatment for HBV for a minimum of 12 months (12-15 participants)

You may not qualify if:

• Emotionally distressed due to HBV diagnosis
• Current episode of decompensated cirrhosis
• Current diagnosis of hepatocellular carcinoma

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Related Publications (16)

• Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023 Aug;20(8):524-537. doi: 10.1038/s41575-023-00760-9. Epub 2023 Apr 6.

  PMID: 37024566 BACKGROUND

• Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection [Internet]. Geneva: World Health Organization; 2024 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK614989/

  PMID: 40424433 BACKGROUND

• World Health Organisation. (2023) What is the WHO definition of health? Available at: Frequently asked questions (who.int)

  BACKGROUND

• World Health Organisation. (2016) WHO: Viral Hepatitis 2016-2021. June. https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf;sequence=1

  BACKGROUND

• Wallace J, Pitts M, Liu C, Lin V, Hajarizadeh B, Richmond J, Locarnini S. More than a virus: a qualitative study of the social implications of hepatitis B infection in China. Int J Equity Health. 2017 Aug 1;16(1):137. doi: 10.1186/s12939-017-0637-4.

  PMID: 28764768 BACKGROUND

• UK Health Security Agency (2024) Hepatitis B in the UK-2024 report. online available at: https://www.gov.uk/government/publications/hepatitis-b-in-england/hepatitis-b-in-england-2024#tab1

  BACKGROUND

• UK Health Security Agency (2023) Hepatitis B in the UK-2023 report. Online available at: Hepatitis B in England - 2023 report (publishing.service.gov.uk)

  BACKGROUND

• Tomar M, Sharma T, Prasad M. Social challenges experienced by Hepatitis B patients: A mixed method study. J Family Med Prim Care. 2023 Apr;12(4):748-755. doi: 10.4103/jfmpc.jfmpc_1575_22. Epub 2023 Apr 17.

  PMID: 37312795 BACKGROUND

• Sharma S, Carballo M, Feld JJ, Janssen HL. Immigration and viral hepatitis. J Hepatol. 2015 Aug;63(2):515-22. doi: 10.1016/j.jhep.2015.04.026. Epub 2015 May 8.

  PMID: 25962882 BACKGROUND

• Robertson, R., Williams, E., Buck., D., Breckwoldt, J. (2021). Ethnic health inequalities and the NHS: Driving progress in a changing system. Available at: https://www.nhsrho.org/wp-content/uploads/2023/05/Ethnic-Health-Inequalities-Kings-Fund-Report.pdf

  BACKGROUND

• Papathanassiou, I. et al. (2013). Holistic Nursing Care: Theories and Perspectives. American Journal of Nursing Science. Vol. 2, No. 1, 2013, pp. 1-5. doi: 10.11648/j.ajns.20130201.11

  BACKGROUND

• Oka T, Enoki H, Tokimoto Y, Kawanishi T, Minami M, Okuizumi T, Katahira K. Employment-related difficulties and distressed living condition in patients with hepatitis B virus: A qualitative and quantitative study. BMC Public Health. 2017 Jun 12;17(1):568. doi: 10.1186/s12889-017-4416-3.

  PMID: 28606133 BACKGROUND

• Hepatitis B (chronic): diagnosis and management. London: National Institute for Health and Care Excellence (NICE); 2017 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK553697/

  PMID: 32068988 BACKGROUND

• Fattovich G. Natural history of hepatitis B. J Hepatol. 2003;39 Suppl 1:S50-8. doi: 10.1016/s0168-8278(03)00139-9. No abstract available.

  PMID: 14708678 BACKGROUND

• European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.

  PMID: 28427875 BACKGROUND

• Adekanle O, Komolafe AO, Olowookere SA, Ijarotimi O, Ndububa DA. Hepatitis B Infection: A Mixed Methods of Disclosure Pattern and Social Problems in the Nigerian Family. J Patient Exp. 2020 Apr;7(2):208-216. doi: 10.1177/2374373519827965. Epub 2019 Mar 7.

  PMID: 32851142 BACKGROUND

MeSH Terms

Conditions

Hepatitis B; Social Stigma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Social Behavior; Behavior

Study Officials

• Kathryn E Jack, PhD

  NUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn E Jack, PhD

CONTACT

+447976243189; kathryn.jack@nhs.net

Stephen D Ryder, consultant

CONTACT

+44115 924 9924; stephen.ryder4@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: July 8, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share