Clinical trial NCT05942937: National Prisons Hepatitis Education Project: Research Evaluation
Official title: National Prisons Hepatitis Education Project: Research Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HCV
Keywords: Hepatitis C
Public Health
Health Service
Prison
Education
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Australasian Society for HIV Viral Hepatitis and Sexual Health Medicine (ASHM)
name: Justice health, corrections, and hepatitis and drug-user organisations in each Australian state and territory
First posted: 2023-07-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: 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 broad goal of HepPEd: Research Evaluation is to measure the impact of a prison-specific hepatitis C (HCV) education program (the HepPEd Program) on enhancing HCV testing and treatment rates in Australian prisons. The HepPEd Program aims to improve HCV testing and treatment rates by enhancing the public health literacy of the prison sector regarding HCV in the prisons (that is the knowledge, attitudes and behaviours), and specifically targets the three key audience groups from the prison setting: healthcare providers, correctional officers, and people in prison.

The study will be conducted as a prison-level, controlled before-and-after trial with a primary objective of evaluating the impact of the HepPEd Program on HCV treatment uptake amongst people incarcerated in Australian prisons. Three to six Australian correctional centres will be selected to participate in the 9-month study. Each correctional centre will have a 3-month period of pre-intervention surveillance, involving monthly observation of HCV treatment uptake under existing operations. This will be followed by a three-month period of education delivery of the HepPEd Program (the 'education intervention'). The monthly surveillance data collection will continue during the intervention period. Finally, each correctional centre will have another 3-month period of post-intervention surveillance, again involving monthly surveillance of HCV treatment rates. Surveys will be conducted with members from each target audience group before and after the education intervention and dried blood spot testing will be conducted with members from the people in prison group to assess baseline HCV prevalence before the education intervention.

Eligibility 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.

Primary outcomes:
measure: The change in the proportion of prisoners treated for HCV before and after the education intervention.
timeFrame: 9 months from baseline
Secondary outcomes:
measure: The proportion of prisoners tested for HCV before and after the education intervention.
timeFrame: 9 months from baseline
measure: 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.
timeFrame: 9 months from baseline
measure: The acceptability, utility, and impact of the HepPEd Program.
timeFrame: 9 months from baseline
measure: The dose, reach, and fidelity of the HepPEd Program.
timeFrame: 9 months from baseline
Other outcomes:
Locations:
city: Rockhampton
country: Australia
facility: Capricornia Correctional Centre
state: Queensland
city: Hobart
country: Australia
facility: Risdon Prison Complex
state: Tasmania
Study officials:
References: