A stepped wedge cluster randomized control trial of dried blood spot testing to improve the uptake of hepatitis C antibody testing within UK prisons

Abstract

Background: The prevalence of hepatitis C (HCV) is elevated within prison populations, yet diagnosis in prisons remains low. Dried blood spot testing (DBST) is a simple procedure for the detection of HCV antibodies; its impact on testing in the prison context is unknown. Methods: We carried out a stepped-wedge cluster-randomized control trial of DBST for HCV among prisoners within five male prisons and one female prison. Each prison was a separate cluster. The order in which the intervention (training in use of DBST for HCV testing and logistic support) was introduced was randomized across clusters. The outcome measure was the HCV testing rate by prison. Imputation analysis was carried out to account for missing data. Planned and actual intervention times differed in some prisons; data were thus analysed by intention to treat (ITT) and by observed step times. Results: There was insufficient evidence of an effect of the intervention on testing rate using either the ITT intervention time (OR: 0.84; 95% CI: 0.68–1.03; P = 0.088) or using the actual intervention time (OR: 0.86; 95% CI: 0.71–1.06; P = 0.153). This was confirmed by the pooled results of five imputed data sets. Conclusions: DBST as a stand-alone intervention was insufficient to increase HCV diagnosis within the UK prison setting. Factors such as staff training and allocation of staff time for regular clinics are key to improving service delivery. We demonstrate that prisons can conduct rigorous studies of new interventions, but data collection can be problematic. Trial registration: International Standard Randomized Controlled Trial Number Register (ISRCTN number ISRCTN05628482).

Active Case Finding for Communicable Diseases in Prison Settings: Increasing Testing Coverage and Uptake Among the Prison Population in the European Union/European Economic Area

“…The study quality was largely very low, with a few exceptions. For 8 studies, the level of evidence was classified as low ( 27 – 34 ); for additional 8, it was classified as moderate ( 16 , 35 – 41 ) ( Web Appendix 6, Web Tables 4–13 ).…”

Evidence-based interventions to enhance assessment, treatment, and adherence in the chronic Hepatitis C care continuum

“…The remaining 6 screening-related interventions (Table 1) demonstrate high rates of uptake and case-finding when interventions target high-risk individuals in specific settings, including PWID in NSPs (Aitken, Kerger, & Crofts, 2002), patients in a primary care clinic with certified methadone prescribers (Cullen et al, 2006), patients in specialty addiction treatment clinics and prison (Craine et al, 2014; Hickman et al, 2008), patients in a mobile medical clinic (Morano et al, 2014), and individuals with co-occurring substance use and serious psychiatric disorders in community mental health programs (Slade et al, 2013). The interventions described include free counseling and testing (Aitken et al, 2002), point-of-care testing (Morano et al, 2014), streamlined screen-test-immunize-reduce risk-refer protocols (Slade et al, 2013), dried blood spot testing (Craine et al, 2014; Hickman et al, 2008), and provider education with nursing support (Cullen et al, 2006). Programs were found to be generally effective at identifying new cases of chronic HCV and cost-effective when compared to treatment-as-usual, though often they required ancillary structural support to increase testing rates.…”

The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

“…Some studies have included both an analysis by the intention to treat schedule and by that which actually occurred. 24 Under the stepped wedge design the evaluation happens over a period of time, during which the proportion of clusters exposed to the intervention gradually increases. This means that unexposed observations will, on average, be from an earlier calendar time than exposed observations.…”