Prisons evaluation of a one-stop-shop InterVentiOn to scale-up hepatitis C testing and Treatment: the PIVOT study
University of New South Wales
720 participants
Oct 30, 2019
Interventional
Conditions
Summary
The main aim of the PIVOT study is to evaluate the effect of a simplified “one-stop-shop’ test and treat intervention on increasing the number of prisoners with hepatitis C (HCV) who initiate HCV therapy following reception. The study will be conducted in two phases: a control period and intervention period. The control period will allow observation of throughput in the HCV care cascade in the existing Justice Health & Mental Health Network (JH&FMHN) model of care. The intervention combines point-of-care finger-stick HCV testing (for HCV RNA, which tests for the virus indicating active infection), non-invasive liver fibrosis assessment (to check liver scarring), and treatment prescription (if HCV-positive), followed by linkage to ongoing hepatitis care all in the same 60-minute visit. The study will also evaluate the efficiency (time taken to each step of the care cascade) and acceptability (number of participants refusing to participate) of the intervention, as well as the rates of participants clearing the virus post-treatment, and treatment uptake. Participants will be recruited from new receptions to Mid North Coast Correctional Centre. The intervention method will be evaluated against the existing standard of care model for effectiveness, efficiency, and acceptability.
Eligibility
Inclusion Criteria9
- Potential participants will be eligible to participate in the trial if the subject:
- has provided written, informed consent to participate;
- is male and greater than or equal to 18 years of age on enrolment;
- has been incarcerated within the last six weeks.
- For HCV RNA positive participants commencing treatment:
- is HCV DAA treatment naïve;
- and if HIV-1 infected must also meet the following criteria:
- a. HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load; and
- b. be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the selected DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/ )
Exclusion Criteria9
- Potential participants will be excluded from participating in the trial if the subject:
- is unable or unwilling to provide informed consent or abide by the requirements of the study;
- is unable to gain an accurate reading on the fibroscan or the result is invalid;
- For HCV RNA positive participants commencing treatment, the subject will be excluded if they have:
- previous HCV DAA treatment experience;
- untreated HIV co-infection;
- chronic HBV co-infection;
- any clinically significant condition, history or concomitant medication known to contraindicate DAA therapy or would not be suitable for management within a prison-based treatment setting;
- known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (> 12.5 Kpa).
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Interventions
An interventional cohort study will be used to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, linkage to hepatitis care, non-invasive liver fibrosis assessment, and same-visit direct-acting antiviral (DAA) prescription, on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia. During the initial control period, all people who are newly incarcerated (in the previous six weeks) will be offered participation and will receive the standard of care with the current health service model. The control period will allow observation of throughput in the current health service model, which includes an initial reception interview for medical, psychiatric and substance abuse concerns (conducted within 24 hours of incarceration), which may be followed by referral for HCV screening by the Clinical Nurse Specialists. The Clinical Nurse Specialists are located in each prison and conduct risk assessments for blood borne virus infection, followed by laboratory testing, and then subsequent provision of results, and for those with chronic HCV an offer of referral for further assessment for DAA treatment. This referral is made to the Hepatitis Clinical Nurse Consultants who undertake structured clinical assessments (utilising structured proformas including a review of possible medication interactions with DAAs), further laboratory investigations, followed by fibro-elastography, and then case review with a specialist physician for DAA prescription. This model is associated with an estimated mean of 3-4 months between initial testing and engagement with the Hepatitis Service, and subsequent commencement of DAA therapy. After a control period of approximately 12 weeks (dependent on recruitment rate) to enrol n=240 individuals, all people who are newly incarcerated (in the previous six weeks) will be offered participation in the intervention period which will continue for approximately 24 weeks (dependent on recruitment rate) to enrol n=480 individuals. The intervention period will be based on establishment of a 'one-stop-shop' hepatitis clinic. During the intervention period participants will undertake an initial screening which includes study consent and questionnaire, followed by point-of-care HCV RNA testing, point-of-care hepatitis B surface antigen (HBsAg) testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography, and early DAA prescription followed by linkage to ongoing hepatitis care, all in the same 60-minute visit. A dedicated research nurse will perform all assessments and procedures in the 'one-stop-shop', followed by initiation of antiviral therapy for those eligible, and routine monitoring with point-of-care HCV RNA testing at end of treatment (ETR) and 12 weeks post treatment (SVR12).
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ACTRN12619001489189