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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05942937




Registration number
NCT05942937
Ethics application status
Date submitted
21/04/2023
Date registered
12/07/2023

Titles & IDs
Public title
National Prisons Hepatitis Education Project: Research Evaluation
Scientific title
National Prisons Hepatitis Education Project: Research Evaluation
Secondary ID [1] 0 0
VISP2101
Universal Trial Number (UTN)
Trial acronym
HepPEd
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HCV 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Education Intervention (The HepPEd Program)

Experimental: Whole-of-prison education intervention - The HepPEd Program will saturate the entire prison during a 3-month intervention phase.


Other interventions: Education Intervention (The HepPEd Program)
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in the proportion of prisoners treated for HCV before and after the education intervention.
Timepoint [1] 0 0
9 months from baseline
Secondary outcome [1] 0 0
The proportion of prisoners tested for HCV before and after the education intervention.
Timepoint [1] 0 0
9 months from baseline
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
9 months from baseline
Secondary outcome [3] 0 0
The acceptability, utility, and impact of the HepPEd Program.
Timepoint [3] 0 0
9 months from baseline
Secondary outcome [4] 0 0
The dose, reach, and fidelity of the HepPEd Program.
Timepoint [4] 0 0
9 months from baseline

Eligibility
Key inclusion criteria
All healthcare providers, correctional officers, and people in prison at the participating prison sites are anticipated to be exposed to the various HepPEd Program resources during the 3 month education intervention phase.

Participating prison sites must meet the following inclusion criteria to be eligible to participate in the study. Participating prison sites must have:

* a prisoner population of 400-600 inmates (assumed mean 500); and
* an existing prison-based hepatitis service undertaking both HCV testing and treatment.

Prisoners must meet the following inclusion criteria to be eligible to participate as peer educators. Prisoners must:

* 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.

Correctional officers must meet the following inclusion criteria to be eligible to participate as peer champions. Correctional officers must:

* be currently working in a participating correctional centre; and
* be considered as capable and willing, and well-respected amongst their peers.

Prisoners must meet the following inclusion criteria to be eligible to participate in the interview-style survey and dried blood spot (DBS) testing component:

1. be over the age of 18 years;
2. be currently incarcerated in a participating correctional centre;
3. have sufficient English comprehension skills to understand the survey questions; and
4. be willing and able to provide written informed consent.

Healthcare providers and correctional officers must meet the following inclusion criteria to be eligible to participate in the survey component:

1) be currently working in a participating correctional centre.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS
Recruitment hospital [1] 0 0
Capricornia Correctional Centre - Rockhampton
Recruitment hospital [2] 0 0
Risdon Prison Complex - Hobart
Recruitment postcode(s) [1] 0 0
4702 - Rockhampton
Recruitment postcode(s) [2] 0 0
7016 - Hobart

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Society for HIV Viral Hepatitis and Sexual Health Medicine (ASHM)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Justice health, corrections, and hepatitis and drug-user organisations in each Australian state and territory
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Lloyd
Address 0 0
Country 0 0
Phone 0 0
02 9385 2534
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05942937