Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial

Abstract

IntroductionCombination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV).Pharmacovigilance—monitoring the effects of medicines—is essential for understanding real-world drug safety. In Uganda, pharmacovigilance systems have only recently been developed, and rates of ADR reporting for cART are very low. Thus, the safety profile of medicines currently used to treat HIV and tuberculosis in our population is poorly understood.The Med Safety mobile application has been developed through the European Union’s Innovative Medicines Initiative WEB-Recognising Adverse Drug Reactions project to promote digital pharmacovigilance. This mobile application has been approved for ADR-reporting by Uganda’s National Drug Authority. However, the barriers and facilitators to Med Safety uptake, and its effectiveness in improving pharmacovigilance, are as yet unknown.Methods and analysisA pragmatic cluster-randomised controlled trial will be implemented over 30 months at 191 intervention and 191 comparison cART sites to evaluate Med Safety. Using a randomisation sequence generated by the sealed envelope software, we shall randomly assign the 382 prescreened cART sites to the intervention and comparison arms. Each cART site is a cluster that consists of healthcare professionals and PLHIV receiving dolutegravir-based cART and/or isoniazid preventive therapy. Healthcare professionals enrolled in the intervention arm will be trained in the use of mobile-based, paper-based and web-based reporting, while those in the comparison arm will be trained in paper-based and web-based reporting only.Ethics and disseminationEthical approval was given by the School of Biomedical Sciences Research and Ethics Committee at Makerere University (SBS-REC-720), and administrative clearance was obtained from Uganda National Council for Science and Technology (HS1366ES). Study results will be shared with healthcare professionals, policymakers, the public and academia.Trial registration numberPACTR202009822379650.

Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study

“…We therefore plan a two-armed (mobile app, no mobile app) cluster-randomised controlled trial (RCT). Based on our experience, during rollout of the RCT [ 26 ]; (1) mobile wireless routers should be supplied to field teams for internet hotspots to health workers at intervention sites, (2) power banks should be made available to circumvent the challenge of low phone battery charge, (3) wherever possible, software upgrades should be applied to older compatible smartphones that have technical support, (4) phone space should be created to ensure the successful download of Med Safety and, (5) for the first 6 months, monthly reminders to report ADRs should be sent to health workers to be enrolled in the large-scale RCT, e.g., by SMS and WhatsApp [ 27 ].…”

“…To promote the recognition and reporting of ADRs, health workers should be routinely trained to use the Ministry of Health (MoH) screening tool for active pharmacovigilance of ADRs to dolutegravir and IPT [ 27 ]. Uganda’s MoH consolidated HIV/TB prevention and treatment guidelines mandate screening for ADRs in every person living with HIV at each clinic visit [ 28 ].…”

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

“…Mobile apps are used increasingly in health data collection and information provision, due to their adaptability to user requirements, proximity to the patients and their HCPs and high configurability. Mobile apps are thus important sources of safety data that bring value to conventional methods and tools 51,52 …”

“…Mobile apps are thus important sources of safety data that bring value to conventional methods and tools. 51,52 New digital platforms such as social media, chatrooms and EHRs have been used from some years to share safety-relevant information;…”