NCT05942937

Brief Summary

The National Prisons Hepatitis Education Program (HepPEd Program) is a national, prison-based hepatitis C health literacy education program for healthcare providers, correctional officers, and people in prison. The HepPEd Program aims to improve the public health literacy of the prison sector regarding hepatitis C in prisons. The HepPEd: Research Evaluation aims to evaluate the impact of the HepPEd Program on HCV testing and treatment uptake amongst people incarcerated in Australian prisons, as well as changes in knowledge, attitudes, and capabilities of healthcare providers, correctional officers, and people in prison. The study is a controlled before and after study being conducted in 3-6 correctional centres in Australia.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

April 21, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Hepatitis CPublic HealthHealth ServicePrisonEducation

Outcome Measures

Primary Outcomes (1)

  • The change in the proportion of prisoners treated for HCV before and after the education intervention.

    This will be measured by calculating the change in HCV treatment rates before and after the education intervention.

    9 months from baseline

Secondary Outcomes (4)

  • The proportion of prisoners tested for HCV before and after the education intervention.

    9 months from baseline

  • The health literacy (knowledge, attitudes, and capabilities) amongst target audience groups (healthcare providers, correctional officers, and people in prison) before and after the education intervention.

    9 months from baseline

  • The acceptability, utility, and impact of the HepPEd Program.

    9 months from baseline

  • The dose, reach, and fidelity of the HepPEd Program.

    9 months from baseline

Study Arms (1)

Whole-of-prison education intervention

EXPERIMENTAL

The HepPEd Program will saturate the entire prison during a 3-month intervention phase.

Other: Education Intervention (The HepPEd Program)

Interventions

All healthcare providers, correctional officers, and people in prison (HepPEd Program target audience groups) at each participating site are anticipated to be exposed to the HepPEd Program over the course of the three-month education intervention phase. The HepPEd Program involves a suite of multi-modal resources targeting each target audience group and a peer education program (for correctional officer and people in prison groups only). The HepPEd Program resources will be delivered in an informal, mass education-style, as well as in peer to peer format.

Whole-of-prison education intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a prisoner population of 400-600 inmates (assumed mean 500); and
  • an existing prison-based hepatitis service undertaking both HCV testing and treatment.
  • be currently incarcerated in a participating correctional centre;
  • anticipate being in the participating correctional centre for \>12 months;
  • be considered as capable and willing, and well-respected amongst their peers; and
  • have approval from custodial authorities to participate as a peer educator.
  • be currently working in a participating correctional centre; and
  • be considered as capable and willing, and well-respected amongst their peers.
  • be over the age of 18 years;
  • be currently incarcerated in a participating correctional centre;
  • have sufficient English comprehension skills to understand the survey questions; and
  • be willing and able to provide written informed consent.
  • \) be currently working in a participating correctional centre.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Capricornia Correctional Centre

Rockhampton, Queensland, 4702, Australia

RECRUITING

Risdon Prison Complex

Hobart, Tasmania, 7016, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a single group, non-randomised, before-and-after trial of an education intervention being conducted in three to six selected prisons in Australia.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

July 12, 2023

Study Start

September 4, 2023

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations