The objective of this study was to assess whether introducing dried blood spot testing can increase hepatitis C virus (HCV) diagnostic testing. A cluster randomized controlled trial was conducted. Sites were matched into pairs, with one site in each pair randomly allocated to receive the intervention (training and use of dried blood spot). Data were collected from all sites for 6 months before and 6 months after the start of the intervention. The participants were 22 specialist drug clinics and six prisons in England and Wales. The main outcome measure of this study was percentage point difference in individuals tested for HCV (the difference between the percentage of patients tested 6 months after and 6 months before the introduction of dried blood spot tests). Before the trial, 8% of patients at control and intervention sites had been tested for HCV, with 16 sites testing less than 5% of their caseload. The average percentage point difference between intervention and control sites was 14.5% (95% CI 1.3-28%, paired t-test, P = 0.03); with 13 of the 14 pairs contributing to the positive effect of the intervention (Wilcoxon matched-pairs signed-rank-test, P = 0.002). The size of the difference between intervention and control sites varied considerably. The study provides preliminary supporting evidence that dried blood spot testing may increase the uptake of HCV diagnostic testing, by increasing the opportunity for patients to be offered testing. Additional trials with a larger number of sites are justified, ideally in the context of drug and treatment policies that gave clearer priority (and targets) to infection control and testing.
National regulatory authorities (NRAs) are the gatekeepers of the supply chain of medical products, and they have a mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products, medical devices, including diagnostics and traditional, or herbal medicines. However, the majority of the world's regulators are still struggling to reach a level of maturity, whereby they have a stable, well-functioning and integrated regulatory system. The World Health Organization (WHO) has developed a Global Benchmarking Tool (GBT) as part of its five-step capacity building program to assist NRAs, using the tool, they can benchmark their own strengths and areas of weakness, and then engage in a formal benchmarking process together with WHO and international experts in order to formulate an effective and workable institutional development plan. The GBT is comprehensive across the entire product life cycle and allows benchmarking to be customized to the needs of the NRA. It has evolved from decades of experience using a variety of benchmarking tools, within WHO and other stakeholder organizations. By the end of December 2019, 26 countries had undergone formal benchmarking, and a further 54 countries had used the GBT to conduct self-benchmarking exercises assisted by WHO.
The high prevalence of HIV, and a recent increase in HIV detected through routine screening tests since 2000, suggests that an explosive epidemic has occurred among IDU in Togliatti City. In the face of currently inadequate HIV prevention coverage among IDU, this has urgent implications for maximizing the distribution of sterile injecting equipment as well as for enhancing sexual risk reduction. Recognizing that it is likely that similar explosive epidemics are taking place in other Russian cities, we recommend community-wide HIV prevention coverage supported by city and state policies oriented to harm reduction.
More than 200 confirmed cases of infection with the novel coronavirus have emerged in China, including three deaths and cases outside the city of Wuhan, in central Hubei province, where it was first identified.
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