A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study.

BACKGROUND & AIMS: Prisons are key venues for scaling-up hepatitis C virus (HCV) testing and treatment. Complex clinical pathways and frequent movements of people in prison remain barriers to HCV care. This study evaluated the impact of a 'one-stop-shop' point-of-care HCV RNA testing intervention on treatment uptake compared with standard of care among people recently incarcerated in Australia. METHODS: PIVOT was a prospective, non-concurrent, controlled study comparing HCV treatment uptake during 'standard of care' (n = 239; November 2019-May 2020) and a 'one-stop-shop' intervention (n = 301; June 2020-April 2021) in one reception prison in Australia. The primary endpoint was uptake of direct-acting antiviral treatment at 12 weeks from enrolment. Secondary outcomes included the time taken from enrolment to each stage in the care cascade. RESULTS: A total of 540 male participants were enrolled. Median age (29 vs. 28 years) and history of injecting drug use (48% vs. 42%) were similar between standard of care and intervention phases. Among people diagnosed with current HCV infection (n = 18/63 in the standard of care phase vs. n = 30/298 in the intervention phase), the proportion initiating direct-acting antiviral treatment within 12 weeks from enrolment in the intervention phase was higher (93% [95% CI 0.78-0.99] vs. 22% [95% CI 0.64-0.48]; p <0.001), and the median time to treatment initiation was shorter (6 days [IQR 5-7] vs. 99 days [IQR 57-127]; p <0.001) compared to standard of care. CONCLUSIONS: The 'one-stop-shop' intervention enhanced treatment uptake and reduced time to treatment initiation among people recently incarcerated in Australia, thereby overcoming key barriers to treatment scale-up in the prison sector. IMPACT AND IMPLICATIONS: This study provides important insights for policymakers regarding optimal HCV testing and treatment pathways for people newly incarcerated in prisons. The findings will improve health outcomes in people in prison with chronic HCV infection by increasing testing and treatment, thereby reducing infections, liver-related morbidity/mortality, and comorbidities. The findings will change clinical practice, clinical guidelines, and international guidance, and will inform future research and national and regional strategies, in particular regarding point-of-care testing, which is being rapidly scaled-up in various settings globally. The economic impact will likely include health budget savings resulting from reduced negative health outcomes relating to HCV, and health system efficiencies resulting from the introduction of simplified models of care. CLINICAL TRIALS REGISTRATION: This study is registered at Clinicaltrials.gov (NCT04809246).

Understanding hepatitis C virus (HCV) health literacy and educational needs among people in prison to enhance HCV care in prisons.

BACKGROUND: Hepatitis C virus (HCV) is a significant concern within prison populations. Provision of HCV testing and treatment for people in prison is expanding and a key component of global elimination efforts. Despite growing service availability, several challenges remain in HCV testing and treatment engagement during incarceration. The PIVOT study demonstrated that a 'one-stop-shop' intervention (point-of-care HCV RNA testing, Fibroscan®, nurse-led clinical assessment, and fast-tracked direct-acting antiviral prescription) enhanced HCV testing and treatment at a reception prison in Australia. Utilising Squier et al's Health Literacy Skills Framework, this analysis aimed to understand HCV health literacy and educational needs among people at a reception prison in Australia. METHODS: Semi-structured interviews were conducted with twenty-four male PIVOT study participants. Purposive sampling ensured comparable representation of those with: 1) prior HCV testing history (standard pathology / no prior testing), and 2) injecting drug use history (IDU; ever / never). RESULTS: Varied HCV health literacy levels and educational needs were evident amongst people in prison. Whilst those with multiple incarceration episodes and IDU history (prior knowledge) appeared to have stronger HCV health literacy than those without, substantial gaps in HCV health literacy were evident. Knowledge of HCV transmission risks in prison was high, and most understood the importance of HCV testing and treatment in prison (comprehension), but ability to engage with HCV testing and treatment services, participation in safe injecting behaviours (health-related behaviours), and knowledge of re-infection and re-treatment, within the context of the prison environment, were suboptimal. There was a general desire for increased HCV education in prison. CONCLUSION: Gaps in HCV health literacy among people in prison were evident, indicating opportunities for improvement. A targeted HCV education program for people in prison, addressing the gaps identified in this analysis, may enhance HCV testing, treatment, and prevention by fostering stronger HCV health literacy among people in prison.

Reducing barriers to the hepatitis C care cascade in prison via point-of-care RNA testing: a qualitative exploration of men in prison using an integrated framework.

BACKGROUND AND AIMS: Hepatitis C virus (HCV) is highly prevalent within the prison setting. Although HCV testing and treatment are available within prisons, system barriers can impede progress along the HCV care cascade for those who are incarcerated. The PIVOT intervention used a 'one-stop-shop' model (i.e. point-of-care HCV RNA testing, Fibroscan-based liver disease assessment and treatment) at a reception prison in New South Wales, Australia. This analysis sought to understand the role of point-of-care HCV RNA testing at intake in reducing barriers to the HCV care cascade within the male prison setting. DESIGN AND SETTING: Qualitative analysis using semi-structured interviews in a reception prison in Australia. PARTICIPANTS: Twenty-four men enrolled in the PIVOT study; all participants had undergone HCV point-of-care testing in the intervention arm. MEASUREMENTS: Høj's Integrated Framework informed this analysis. FINDINGS: Participants widely expressed the view that point-of-care HCV RNA testing on entry was beneficial for care engagement. Point-of-care testing was perceived as timely (compared with standard pathology) and reduced opportunities for adjudication by correctional officers due to fewer clinic visits for testing and results. Adoption of routine opt-out testing at prison intake was regarded as an important strategy for normalising HCV testing (and likely to increase pathways to treatment uptake) and fostered patient candidacy (i.e. self-perceived eligibility to access care). CONCLUSION: Twenty-four men in prison in New South Wales, Australia, who underwent opt-out point-of-care HCV RNA testing on entry into prison, widely supported the programme as a means of overcoming barriers to HCV testing and treatment in the prison setting, as well as providing public health benefits through early detection of HCV infection among people entering into custody.

"That was quick, simple, and easy": Patient perceptions of acceptability of point-of-care hepatitis C RNA testing at a reception prison.

INTRODUCTION: Current diagnostic pathways require multiple healthcare provider visits and lead to a drop-off in the hepatitis C virus (HCV) testing and treatment care cascade. In prison settings, frequent transitioning between prisons and the community further reduces uptake of testing and treatment. The PIVOT study evaluated a 'one-stop-shop' intervention integrating point-of-care HCV RNA testing, Fibroscan®-based liver disease assessment, and treatment prescription at a reception prison in Australia. This qualitative sub-study was undertaken to assess patient acceptability of point-of-care HCV RNA testing in the reception prison setting. METHODS: Twenty-four men in prison enrolled in the PIVOT study participated in semi-structured interviews; all of whom had undergone point-of-care HCV RNA testing in the PIVOT study. Patients were purposefully selected to ensure comparable representation of people with and without a history of injecting drug use and people with and without prior HCV testing experience (standard venepuncture). Sekhon's Theoretical Framework of Acceptability, consisting of seven components (affective attitude, burden, ethicality, intervention coherence, opportunity cost, perceived effectiveness, and self-efficacy), informed this qualitative analysis. RESULTS: Acceptability of fingerstick point-of-care HCV RNA testing was evident across four components: affective attitude, burden, self-efficacy, and perceived effectiveness. Patients described point-of-care testing as "quick and easy" (affective attitude), while swift results were viewed as alleviating anxiety associated with long wait times for standard pathology (burden). Patients averse to venepuncture (e.g., fear of needles or poor vein health) found the fingerstick method accessible, thereby enabling participation in HCV screening (self-efficacy). Participants attributed confidence in test results predominantly due to trust in the healthcare system or trust in the personnel administering the test (perceived effectiveness). CONCLUSION: People entering custody perceive fingerstick HCV RNA point-of-care testing to be an acceptable method and preferred this method to standard HCV testing via venepuncture. In light of these findings, prison health authorities should consider the role of opt-out point-of-care HCV RNA testing upon prison entry.