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A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study
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Highlights
• The proportion tested for HCV was higher in the intervention (99%) compared with the control phase (26%).
• The proportion treated for HCV was higher in the intervention (93%) compared with the control phase (22%).
• Median time from diagnosis to treatment initiation was shorter in the intervention than in the control phase (6 vs. 25 days).
• Combining all key HCV assessments into a single visit improved efficiencies and enhanced testing and treatment uptake.
• The Xpert HCV Viral load Fingerstick Assay requires a machine to process samples onsite which is expensive. The wait for the results are 45-60 minutes so a patient can wait for results & same day treatment can be provided along with other assessments including a Fibroscan to check for liver disease stage to prevent treating decompensated cirrhosis. Many clinicians call this a game changer.
A 'one-stop-shop' intervention incorporating point-of-care HCV RNA and HBsAg testing, fibro-elastography, nurse-led clinical assessment, and fast-tracked DAA prescription within a single visit was associated with increased HCV testing (99% vs. 26%) and treatment uptake (93% vs. 22%) compared with standard of care at a reception prison in Australia.
The dedicated study nurse and correctional officer likely facilitated throughput and retention in the care cascade. However, rather than any standalone element, the combined package of all 'one-stop-shop' elements was the likely contributor to facilitating enhanced treatment uptake.
Point-of-care testing overcame barriers such as the extended time to provision of laboratory results (several weeks with standard of care),and poor venous access common among people who inject drugs.
Participants completed a nurse-administered survey and received HCV testing and treatment as part of a 'one-stop-shop' intervention which incorporated HCV RNA point-of-care testing and other assessments in a single visit (Fig. 1). Participants initiating DAA treatment had follow-up visits at weeks 8 (treatment completion) and 20 (SVR12), involving point-of-care HCV RNA testing and a nurse-administered survey.
HCV RNA testing was performed using the Xpert® HCV Viral Load Fingerstick Assay (Cepheid, Sunnyvale, CA, USA) and HBsAg testing was performed using the Alere Determine 2 assay (Abbott, USA) - both from a capillary blood sample collected via finger prick. Liver fibrosis assessment was performed using transient fibro-elastography (FibroScan®; Echosens, Paris, France). Results for HCV RNA, HBsAg, and fibrosis status were provided to participants on the same day.
Eligible participants treated through the 'one-stop-shop' intervention were prescribed three fixed-dose combination tablets of glecaprevir (100 mg) and pibrentasvir (40 mg) administered orally once daily for 8 weeks received as monthly bottles for self-administered therapy (if permitted) or supervised daily dosing.
Point-of-care HCV RNA testing to detect current HCV infection within one hour has streamlined HCV care.
The Xpert® HCV Viral Load Fingerstick point-of-care test enables diagnosis and treatment in a single visit, increases testing acceptability, and reduces loss to follow-up, thereby enhancing treatment uptake. This assay has good technical accuracy (100% sensitivity/specificity), and results in high treatment uptake in needle and syringe programmes (81%), medically supervised injecting sites (89%), and mobile outreach models (74%). The improved timeliness, simplicity, and acceptability of point-of-care HCV RNA testing could overcome barriers to HCV testing and treatment in prison.
Previous studies evaluating point-of-care HCV RNA testing in prison are limited by a lack of comparator arms and small sample sizes.
This study aimed to evaluate the impact of an intervention integrating point-of-care HCV RNA testing, fibro-elastography, nurse-led clinical assessment, and fast-tracked direct-acting antiviral (DAA) prescription ('one-stop-shop' intervention) on HCV treatment uptake compared with standard of care among people recently incarcerated in Australia.
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