Two-way risk communication mobile application versus traditional methods of adverse drug reaction reporting in Uganda: a randomized controlled trial
Medical Research Council
Makerere University
There is an urgent need to improve pharmacovigilance in Uganda. Despite efforts to improve reporting using web- and paper-methods, adverse drug reaction (ADR) reporting by healthcare professionals (HCPs) remains critically low. We aim to complete a cluster-randomised controlled trial to evaluate the effectiveness of a mobile application in addition to traditional web- and paper-based methods for ADR-reporting by HCPs. Our goal is to recruit 3820 HCPs from 382 ART-sites in Uganda to evaluate the Med Safety(R) mobile application, developed by the European Union WEB-RADR programme to embed digital PV in healthcare. Med Safety(R) is available in English and Luganda and has been implemented in limited settings in Uganda since February 2020. We aim to discover the barriers and facilitators to Med Safety(R) uptake, its effectiveness in improving PV, and the cost-effectiveness of rolling it out to HCPs at ART-sites. Our study will have two arms: HCPs enrolled at ART-sites in the intervention arm will be trained in the use of Med Safety(R), paper- and web-based ADR-reporting methods and those in the control arm will be trained in the use of paper- and web-based ADR-reporting only. HCPs will be encouraged to report ADRs through onsite awareness campaigns, reminder WhatsApp and mobile phone short messages. To-date we have enrolled 243 HCPs from 45 intervention sites and 386 HCPs from 41 control sites, using funding from Makerere University. We are requesting funds from the MRC to deliver the rest of this project. The work will deliver important insights into the practicality, acceptability and effectiveness of mobile application-driven ADR-reporting in a resource-limited setting and increase our knowledge of the safety of dolutegravir-regimens and isoniazid preventive therapy among people living with HIV in Uganda. This work underpins potential national roll-out of Med Safety(R) among HCPs in collaboration with Uganda's National Pharmacovigilance Centre.
7.3 Management and decision making / Research Grant