HCVHepPEdNCT05942937
National Prisons Hepatitis Education Project: Research Evaluation
A study testing Education Intervention (The HepPEd Program) in people with HCV, run by Kirby Institute at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HCV
- What is being tested?
- Education Intervention (The HepPEd Program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesAustralia
- Study dates
- 4 Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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:
- 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.
Healthcare providers and correctional officers must meet the following inclusion criteria to be eligible to participate in the survey component:
- be currently working in a participating correctional centre.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Risdon Prison Complex
Hobart, Tasmania, 7016
Deb Siddall
- Recruiting
Capricornia Correctional Centre
Rockhampton, Queensland, 4702
Tahnee Gardiner
About this study
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.
Read the 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.
- Conditions
- HCV
- Being tested
- Education Intervention (The HepPEd Program)
- Keywords
- Hepatitis C, Public Health, Health Service, Prison, Education
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Intervention (The HepPEd Program)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Whole-of-prison education intervention | Experimental | The HepPEd Program will saturate the entire prison during a 3-month intervention phase. Receives: Other: Education Intervention (The HepPEd Program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months from baseline
Secondary outcomes (4)
The proportion of prisoners tested for HCV before and after the education intervention.
This will be measured by calculating the change in HCV testing rates before and after the education intervention.
Measured: 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.
This will be measured by assessing the change in health literacy before and after the education intervention.
Measured: 9 months from baseline
The acceptability, utility, and impact of the HepPEd Program.
This is measured by surveys, before and after the education intervention.
Measured: 9 months from baseline
The dose, reach, and fidelity of the HepPEd Program.
This is measured by surveys, before and after the education intervention.
Measured: 9 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start4 Sep 2023
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- Australasian Society for HIV Viral Hepatitis and Sexual Health Medicine (ASHM), Justice health, corrections, and hepatitis and drug-user organisations in each Australian state and territory
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942937
- Sponsor's protocol ID
- VISP2101
- Acronym
- HepPEd
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prisons Hepatitis Education Project: Research Evaluation
- ClinicalTrials.gov ID
- NCT05942937
- Acronym / sponsor ID
- HepPEd / VISP2101
- Conditions
- HCV
- Keywords
- Hepatitis C, Public Health, Health Service, Prison, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- Australasian Society for HIV Viral Hepatitis and Sexual Health Medicine (ASHM), Justice health, corrections, and hepatitis and drug-user organisations in each Australian state and territory
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Whole-of-prison education intervention | Experimental | Other: Education Intervention (The HepPEd Program)The HepPEd Program will saturate the entire prison during a 3-month intervention phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Whole-of-prison education intervention |
Primary outcome
The change in the proportion of prisoners treated for HCV before and after the education intervention.
Time frame: 9 months from baseline
This will be measured by calculating the change in HCV treatment rates before and after the education intervention.
4 secondary outcomes
The proportion of prisoners tested for HCV before and after the education intervention.
Time frame: 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.
Time frame: 9 months from baseline
The acceptability, utility, and impact of the HepPEd Program.
Time frame: 9 months from baseline
The dose, reach, and fidelity of the HepPEd Program.
Time frame: 9 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention (The HepPEd Program) in people with HCV, run by Kirby Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Lloyd (02 9385 2534, a.lloyd@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the proportion of prisoners treated for HCV before and after the education intervention. (time frame: 9 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.