Exploring the behavioural determinants of adherence to prescription for acute febrile illnesses, and development of a training and communication clinical trial intervention: a description of research methods.

ObjectiveTo explore behavioural factors relating to prescription adherence and the communication of prescription adherence messages for patients with acute febrile illness, and to develop a Training & Communication (T&C) intervention to be delivered as part of a clinical trial. The clinical trial intervention package consists of improved diagnostic tools, clinical practices and the T&C package, for children, adolescents and adults presenting with fever symptoms at outpatient facilities in five LMICs. DesignContent analysis of primary, qualitative data collection, informed by the Capability, Opportunity, Motivation (COM-B) theory of behaviour, the Theoretical Domains Framework (TDF) and Behaviour Change Wheel (BCW) approach. SettingHealth facilities and local communities in five LMICs in Africa and Asia. ParticipantsHealth facility prescribers and local community adults. InterventionFebrile illness is a common presentation among adults and children in primary care settings, but diagnosing the cause of fever is challenging, especially in low-resource settings. Prescribers and patients behaviours underpin treatment practices, and antibiotics are the customary fallback choice for lack of better alternatives. However, in most cases antibiotics would not be required, do not cure the ongoing infection, and may have short-term (toxicity, costs) and long-term (drug resistance) untoward effects. Trialling new approaches including point-of-care tests and diagnostic algorithms alone would provide limited information on real-life applicability if behaviours are not accounted for. Accordingly, we designed an innovative, multiphase, mixed methods study, combining qualitative and behaviour approaches, with a quantitative two-arm, clinic based, randomised controlled trial. Qualitative and behavioural methods are used to: support the development of the Training & Communication component of the clinical trial, collect patient information on adherence, and support recommendations for future behaviour change interventions. This paper describes the qualitative research methods used to generate the clinical trial training and communication interventions, in support of adherence to prescriptions. Article SummaryO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LIThis is the first study we know of to explore the behavioural factors affecting prescription adherence and the communication of adherence messages in the LMIC study locations. C_LIO_LIThe use of behavioural frameworks to shape the design of data gathering topic guides has the potential to illuminate the drivers for antibiotic prescription adherence, and generate the knowledge needed to support the design of effective communication interventions. C_LIO_LIThe local nature of behavioural drivers means it is unlikely that the research findings will be generalisable and directly usable in other locations, however the process by which behavioural drivers are identified, and the process to convert to a training and communication package intervention, are applicable beyond the study sites. C_LIO_LIThe scope of the clinical trial intervention, of which the T&C package is one component, precludes a wider behaviour change intervention which may be beneficial to improving adherence. This will be explored in a set of intervention recommendations. C_LIO_LIBecause the T&C intervention is one component of the package of interventions for the clinical trial, we cannot rule out the influence of other intervention components (for example the use of an increased number of diagnostic tests) on prescription adherence. Similarly, due to the intervention package approach, we cannot conclude how much the T&C package contributed to patient recovery at Day7, the primary outcome. C_LI