Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial.

BACKGROUND: The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the 'just-in-case' use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? METHODS: We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. DISCUSSION: This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. TRIAL REGISTRATION: Clinicaltrials.gov NCT04081051 . Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019

COVID-19 Social Science and Public Engagement Action Research in Vietnam, Indonesia and Nepal (SPEAR): Protocol for a mixed methods study exploring the experiences and impacts of COVID-19 for healthcare workers and vulnerable communities

Background: When the novel coronavirus – SARS-CoV-2 – started to spread globally, there was a call for social and behavioral scientists to conduct research to explore the wider socio-cultural contexts of coronavirus disease 2019 (COVID-19), to understand vulnerabilities, as well as to increase engagement within communities to facilitate adoption of public health measures. In this manuscript, we describe the protocol for a study conducted in Indonesia, Nepal, and Vietnam. In the study, we explore how the COVID-19 pandemic is affecting individuals and their communities. We focus on the wider health and economic impacts of COVID-19, in particular emerging and increased burden on mental health, as well as new or deepened vulnerabilities in the communities. The introduction of vaccines has added another layer of complexity and highlights differences in acceptance and inequalities around access.  Methods: We use mixed methods, combining survey methods and social media surveillance to gain a picture of the general situation within each country, with in-depth qualitative methods to gain a deeper understanding of issues, coupled with a synergistic engagement component. We also include an exploration of the role of social media in revealing or driving perceptions of the pandemic more broadly. Participants include health workers and members of communities from 13 sites across the three countries. Data collection is spread across two phases. Phase 1 is concerned with exploring lived experiences, impacts on working lives and livelihoods, mental health and coping strategies. Phase 2 is concerned with acceptance of COVID-19 vaccines, factors that increase and reduce acceptance, and factors that influence access. Conclusions: We will disseminate findings in multiple ways including short reports and policy briefs, articles in peer-reviewed journals, and digital diaries will be edited into short films and uploaded onto social media sites.</ns3:p