The SIMPLY-B Study

NCT05614466 | Unknown

• 1 other identifier: SIMPLY-B Study
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted in three parts: Part A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care settings before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package. Part B: A nested qualitative health services feasibility study using semi -structured interviews and thematic analysis

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention

  Number of patients previously diagnosed with chronic hepatitis B within each primary care clinic study site who have attended the clinic within the 36-month period prior to implementation of the intervention

  36 months prior to study

• Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP

  Number (proportion) of hepatitis B patients receiving guideline-based hepatitis B management by GP

  2 years

• Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting

  Number (proportion) of hepatitis B patients receiving specialist care in a hospital or private setting

  2 years

• Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care

  Number (proportion) of hepatitis B patients receiving treatment by the GP in primary care

  2 years

Secondary Outcomes (1)

• Acceptability and feasibility of using the Simply B package to facilitate hepatitis B management by GPs in primary care from health worker and patient perspectives.

  2 years

Study Arms (1)

Patients living with hepatitis B

EXPERIMENTAL

Patients living with hepatitis B will be managed at the GP clinic using the Simply B e-support package

Other: The Simply B Study

Interventions

The Simply B Study OTHER

This study will be conducted in three parts: Part A: A prospective open label pilot intervention study, comparing the proportion of people with hepatitis B who are managed by their GP in primary care clinics before, 12 months and 24 months after implementation of the Simply B electronic hepatitis B support package. Part B: A nested qualitative health services feasibility study using semi -structured interviews and thematic analysis Part C: A mathematical modelling study using a Markov model to determine cost effectiveness of Simply B for increasing hepatitis B treatment uptake compared to status quo of hospital care.

Patients living with hepatitis B

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years
• Attended participating primary care clinic in the preceding 36 months (June 1, 2019-June 30, 2022) or attended the clinic during the study period
• HBsAg positive
• Treatment naïve
• Not receiving specialist hepatitis B care

You may not qualify if:

• \< 18 years of age
• Already on hepatitis B treatment
• Already attending hepatitis B specialist care
• Hepatitis C or hepatitis D coinfection
• HIV coinfection
• Pregnant

Sponsors & Collaborators

• Nadine Barnes: lead

Related Publications (1)

• Moussa D, Wallace J, Manski-Nankervis JA, Doyle JS, Nguyen L, Boyle D, Stoove MA, Asselin J, Valaydon Z, Ahad M, Glasgow S, New K, Hocking JS, Sanci L, Thompson A, Hellard M, Howell J. Assessment of a primary care e-support package of automated case finding, simplified treatment algorithm and decision support to increase hepatitis B treatment uptake in primary care clinics in Australia (SIMPLY-B Study): protocol for a pilot evaluation. BMJ Open. 2023 Mar 16;13(3):e070663. doi: 10.1136/bmjopen-2022-070663.

  PMID: 36927591 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager, Research Grants and Research Integrity Office

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 14, 2022
• Study Start: April 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share