E = mc²: Education (E), medication (m), and conditional cash (c²) to improve uptake of antiseizure medications in a low-resource population: Protocol for randomized trial

Objective: Most people with epilepsy (PWE) could live seizure-free if treated with one or more antiseizure medications (ASMs). The World Health Organization (WHO) estimates that 75% of PWE in low-resource settings lack adequate antiseizure treatment. Limited education surrounding epilepsy and the out-of-pocket costs of ASMs in particular pose barriers to managing epilepsy in resource-poor, low-income settings. The aim of this study is to implement and test a novel strategy to improve outcomes across the epilepsy care cascade marked by (1) retention in epilepsy care, (2) adherence to ASMs, and (3) seizure reduction, with the measured goal of seizure freedom.Methods: A randomized, double-blinded clinical trial will be performed, centered at the Ignace Deen Hospital in Conakry, Republic of Guinea, in Western Sub-Saharan Africa. Two hundred people with clinically diagnosed epilepsy, ages 18 years and above, will receive education on epilepsy and then be randomized to (i) free ASMs versus (ii) conditional cash, conditioned upon return to the epilepsy clinic. Participants will be followed for 360 days with study visits every 90 days following enrollment.Significance: We design a randomized trial for PWE in Guinea, a low-resource setting with a high proportion of untreated PWE and a nearly completely privatized healthcare system. The trial includes a conditional cash transfer intervention, which has yet to be tested as a targeted means to improve outcomes for people with a chronic neurological disorder. The trial aims to provide an evidence base for the treatment of epilepsy in such settings.Plain Language Summary: We present a clinical trial protocol for a randomized, blinded study of 200 people with epilepsy in the low-resource African Republic of Guinea, providing an educational intervention (E), and then randomizing in a 1:1 allocation to either free antiseizure medication (m) or conditional cash (c2) for 360 days. Measured outcomes include (1) returning to outpatient epilepsy care, (2) adherence to antiseizure medications (ASMs), and (3) reducing the number of seizures. This study is an initial look at giving small amounts of cash for desired results (or "nudges") for improving epilepsy outcomes in the sub-Saharan African and brain disorder contexts.