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REASSURED evaluation of the Bioline HCV point-of-care testing for diagnosing hepatitis C virus infection in primary healthcare settings of Ghana: a study protocol
Introduction
Hepatitis C virus (HCV) infection is a silent epidemic that needs a comprehensive and contextualised approach to manage. Access to readily available, affordable and acceptable HCV point-of-care (POC) in vitro diagnostics (IVDs) is equally required to meet the global HCV goals. However, most guidelines for evaluating these IVDs such as the WHO prequalification process and country-specific standards disproportionately focus on diagnostic performance. The real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free or simplicity and deliverability to end-users (REASSURED) criteria provide a holistic and user-oriented evaluation of the IVDs in the populations they are meant to be used. Therefore, as part of a multinational study in sub-Saharan Africa, we will conduct an evaluation of the Bioline HCV POC test for diagnosing HCV infection in primary healthcare settings of Ghana using the REASSURED criteria.
Methods and analysis
This field evaluation will be conducted in three phases. The first phase will use a cross-sectional field evaluation study design to evaluate the diagnostic performance of the Bioline HCV POC test. The second phase will use mixed methods to ascertain operational characteristics and users’ perceptions. In the third phase, a cross-sectional survey will be used to estimate the costs of accessing HCV diagnostics services using three proposed HCV testing models to inform the affordability of the testing pathways and linkage to care in the primary healthcare clinics. This phase will run concurrently with the second phase of the study. Thematic content analysis and quantitative data analysis will be performed using ATLAS.ti V.23.0.6 and StataCorp LLC’s Stata statistical software V.16.0, respectively.
Ethics and dissemination
The study protocol has been reviewed and fully approved by the Faculty of Health Sciences Research Ethics Committee, University of Pretoria (281/2023) and the Ghana Health Service Ethics Review Committee (GHS-ERC013/08/23). This diagnostic trial has also been registered in the Pan African Clinical Trial Registry (PACTR202410837698664). The findings of the study will be presented in relevant peer-reviewed journals, at local and international conferences, and to all stakeholders involved.
Prevenzione infezioni da Hcv e Hiv, a Nisida 'Noi Ci siamo'
Da domani nel Lazio al via vaccinazioni anti-covid e influenza
Nei prossimi giorni disponibili servizi prenotazione on-line
Influenza: dalla Lombardia al Lazio, ecco le Regioni che vaccinano da inizio ottobre
Over 60 e fragili gratuitamente potranno vaccinarsi nei centri vaccinali, dal medico di famiglia o nelle farmacie
Influenza: dalla Lombardia al Lazio, ecco le Regioni che vaccinano da inizio ottobre
Over 60 e fragili gratuitamente potranno vaccinarsi nei centri vaccinali, dal medico di famiglia o nelle farmacie
Influenza: dalla Lombardia al Lazio, ecco le Regioni che vaccinano da inizio ottobre
Over 60 e fragili gratuitamente potranno vaccinarsi nei centri vaccinali, dal medico di famiglia o nelle farmacie
Influenza: dalla Lombardia al Lazio, ecco le Regioni che vaccinano da inizio ottobre
Over 60 e fragili gratuitamente potranno vaccinarsi nei centri vaccinali, dal medico di famiglia o nelle farmacie
Recompensation of Chronic Hepatitis C-related decompensated cirrhosis following direct-acting antiviral therapy: Prospective Cohort study from an HCV elimination program.
Chronic hepatitis C(CHC) related decompensated cirrhosis is associated with lower SVR-12 rates and variable regression of disease severity following direct-acting antiviral agents (DAAs). We assessed rates of SVR-12, recompensation (Baveno VII criteria), and survival in such patients.
Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol
Introduction
Previous studies have shown that substantial percentages of emergency department (ED) patients in the USA recommended for HIV or hepatitis C (HCV) decline testing. Evidence-based and cost-effective interventions to improve HIV/HCV testing uptake are needed, particularly for people who inject drugs (PWIDs) (currently or formerly), who comprise a group at higher risk for these infections. We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to agree to be tested. In this investigation, we will determine if the PHCI is more efficacious in convincing ED patients to be tested for HIV/HCV when delivered by a video or in person, and whether efficacy is similar among individuals who currently, previously or never injected drugs.
Methods and analysis
We will conduct a multisite, randomised controlled trial comparing PHCIs delivered by video versus in person by a health educator to determine which delivery method convinces more ED patients who had declined HIV/HCV testing instead to be tested. We will stratify randomisation by PWID status (current, former or never/non-PWID) to permit analyses comparing the PHCI delivery method by injection-drug use history. We will also perform a cost-effectiveness analysis of the interventions compared with current practice, examining the incremental cost-effectiveness ratio between the two interventions for the ED population overall and within individual strata of PWID. As an exploratory analysis, we will assess if a PHCI video with captions confers increased or decreased acceptance of HIV/HCV testing, as compared with a PHCI video without captions.
Ethics and dissemination
The study protocol has been approved by the institutional review board of the Icahn School of Medicine. The results will be disseminated at international conferences and in peer-reviewed publications.
Trial registration number
NCT05968573.
'Unusual HCV genotype subtypes: origin, distribution, sensitivity to direct-acting antiviral drugs and behaviour on antiviral treatment and retreatment
The high genetic diversity of hepatitis C virus (HCV) has led to the emergence of eight genotypes and a large number of subtypes in limited geographical areas. Currently approved pangenotypic DAA regimens have been designed and developed to be effective against the most common subtypes (1a, 1b, 2a, 2b, 2c, 3a, 4a, 5a and 6a). However, large populations living in Africa and Asia, or who have migrated from these regions to industrialised countries, are infected with ‘unusual’, non-epidemic HCV subtypes, including some that are inherently resistant to currently available direct-acting antiviral (DAA) drugs due to the presence of natural polymorphisms at resistance-associated substitution positions. In this review article, we describe the origin and subsequent global spread of HCV genotypes and subtypes, the current global distribution of common and unusual HCV subtypes, the polymorphisms naturally present in the genome sequences of unusual HCV subtypes that may confer inherently reduced susceptibility to DAA drugs and the available data on the response of unusual HCV subtypes to first-line HCV therapy and retreatment. We conclude that the problem of unusual HCV subtypes that are inherently resistant to DAAs and its threat to the global efforts to eliminate viral hepatitis are largely underestimated and warrant vigorous action.
Gastro Digest: Integrated telemedicine to treat HCV through opioid treatment programs
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Aggiornamento del bollettino del ministero della Salute
Hepatitis C risk score as a tool to identify individuals with HCV infection: a demonstration and cross-sectional epidemiological study in Egypt
Objectives
Hepatitis C virus (HCV) infection poses a global health challenge. By the end of 2021, the WHO estimated that less than a quarter of global HCV infections had been diagnosed. There is a need for a public health tool that can facilitate the identification of people with HCV infection and link them to testing and treatment, and that can be customised for each country.
Methods
We derived and validated a risk score to identify people with HCV in Egypt and demonstrated its utility. Using data from the 2008 and 2014 Egypt Demographic and Health Surveys, two risk scores were constructed through multivariable logistic regression analysis. A range of diagnostic metrics was then calculated to evaluate the performance of these scores.
Results
The 2008 and 2014 risk scores exhibited similar dependencies on sex, age and type of place of residence. Both risk scores demonstrated high and similar areas under the curve of 0.77 (95% CI: 0.76 to 0.78) and 0.78 (95% CI: 0.77 to 0.80), respectively. For the 2008 risk score, sensitivity was 73.7% (95% CI: 71.5% to 75.9%), specificity was 68.5% (95% CI: 67.5% to 69.4%), positive predictive value (PPV) was 27.8% (95% CI: 26.4% to 29.2%) and negative predictive value (NPV) was 94.1% (95% CI: 93.5% to 94.6%). For the 2014 risk score, sensitivity was 64.0% (95% CI: 61.5% to 66.6%), specificity was 78.2% (95% CI: 77.5% to 78.9%), PPV was 22.2% (95% CI: 20.9% to 23.5%) and NPV was 95.7% (95% CI: 95.4% to 96.1%). Each score was validated by applying it to a different survey database than the one used to derive it.
Conclusions
Implementation of HCV risk scores is an effective strategy to identify carriers of HCV infection and to link them to testing and treatment at low cost to national programmes.