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Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

Por: Adams · N. · Stirrup · O. · Blackstone · J. · Krutikov · M. · Cassell · J. A. · Cadar · D. · Henderson · C. · Knapp · M. · Gosce · L. · Leiser · R. · Regan · M. · Cullen-Stephenson · I. · Fenner · R. · Verma · A. · Gordon · A. · Hopkins · S. · Copas · A. · Freemantle · N. · Flowers · P. · Sh
Introduction

Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes.

Methods and analysis

The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.

The trial will be delivered by a multidisciplinary research team through a series of five work packages.

The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers.

Ethics and dissemination

The study has been approved by the London—Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants.

Trial registration number

ISRCTN13296529.

Scabies outbreak management in refugee/migrant camps in Europe 2014-2017: a retrospective qualitative interview study of healthcare staff experiences and perspectives

Por: Richardson · N. A. · Cassell · J. A. · Head · M. G. · Lanza · S. · Schaefer · C. · Walker · S. L. · Middleton · J.
Objectives

Provide insights into the experiences and perspectives of healthcare staff who treated scabies or managed outbreaks in formal and informal refugee/migrant camps in Europe 2014–2017.

Design

Retrospective qualitative study using semistructured telephone interviews and framework analysis. Recruitment was done primarily through online networks of healthcare staff involved in medical care in refugee/migrant settings.

Setting

Formal and informal refugee/migrant camps in Europe 2014–2017.

Participants

Twelve participants (four doctors, four nurses, three allied health workers, one medical student) who had worked in camps (six in informal camps, nine in formal ones) across 15 locations within seven European countries (Greece, Serbia, Macedonia, Turkey, France, the Netherlands, Belgium).

Results

Participants reported that in camps they had worked, scabies diagnosis was primarily clinical (without dermatoscopy), and treatment and outbreak management varied highly. Seven stated scabicides were provided, while five reported that only symptomatic management was offered. They described camps as difficult places to work, with poor living standards for residents. Key perceived barriers to scabies control were (1) lack of water, sanitation and hygiene, specifically: absent/limited showers (difficult to wash off topical scabicides), and inability to wash clothes and bedding (may have increased transmission/reinfestation); (2) social factors: language, stigma, treatment non-compliance and mobility (interfering with contact tracing and follow-up treatments); (3) healthcare factors: scabicide shortages and diversity, lack of examination privacy and staff inexperience; (4) organisational factors: overcrowding, ineffective interorganisational coordination, and lack of support and maltreatment by state authorities (eg, not providing basic facilities, obstruction of self-care by camp residents and non-governmental organisation (NGO) aid).

Conclusions

We recommend development of accessible scabies guidelines for camps, use of consensus diagnostic criteria and oral ivermectin mass treatments. In addition, as much of the work described was by small, volunteer-staffed NGOs, we in the wider healthcare community should reflect how to better support such initiatives and those they serve.

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