August 28, 2019

Principal Investigator: Edwin Trevathan, MD, MPH

About half of the world's children with epilepsy do not receive treatment – known as the epilepsy treatment gap – with significantly higher rates (67%-90%) in low- and middle-income countries (LMICs). We will conduct the first cluster-randomized clinical trial (cRCT) to determine the efficacy, implementation, and cost-effectiveness of a novel intervention shifting childhood epilepsy care to epilepsy-trained community health extension workers in an effort to close the epilepsy treatment gap. This research will provide information to help extend epilepsy treatment to children in LMICs and worldwide who suffer from untreated seizures.

Abstract: About half of the world's children with epilepsy are not receiving treatment – known as the epilepsy treatment gap, and largely due to the 67%-90% of children in low- and middle-income countries (LMICs) with epilepsy who do not receive treatment.

Task-shifting epilepsy care to community health extension workers (CHEWs) working in primary healthcare centers (PHCs) has been recommended by the World Health Organization, but evidence of efficacy for task-shifted epilepsy care is lacking, and large-scale task-shifted epilepsy care has not been implemented. In preparation for a first cluster-randomized clinical trial (cRCT) of task- shifted childhood epilepsy care, we developed and piloted in northern Nigeria (R21TW010899).

  • (a) a scalable epilepsy training program for CHEWs,
  • (b) an epilepsy community education program in the local language (Hausa), and
  • (c) an epilepsy data collection and management system. We also
  • (d) validated an epilepsy screening tool in this population and
  • (e) documented the feasibility of enrolling children into a study of task- shifted epilepsy care. We now propose this project, “Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)”, as the first cRCT of task-shifted childhood epilepsy care in Africa.

Sixty PHCs in three northern Nigeria cities (Kano, Zaria, and Kaduna) with an estimated epilepsy treatment gap of 70% will be randomly selected; 30 PHCs will provide task-shifted (to CHEWs) childhood epilepsy care, and 30 PHCs will provide enhanced usual care (EUC) (referral to a physician for epilepsy management plus primary care by an epilepsy- trained CHEW).

CHEWs with additional training in epilepsy will screen ~270,000 children ages 1-17, of which we estimate (based on preliminary data) 1700-2552 will have untreated epilepsy, 1530-2297 will enroll in the cRCT, and 1377-2067 will complete the 24-month cRCT. Assuming an equal proportion of children who are seizure-free for at least six months at 24 months follow-up in the two cRCT arms, we will achieve ≥ 80% power to determine an efficacy difference of 10% or greater between the arms.

Secondary outcomes of the cRCT will include the percent seizure reduction from enrollment baseline, time to next seizure after a 3-month period of seizure freedom, and accuracy of epilepsy diagnosis and seizure type classification, as determined by blinded physician epilepsy specialists.

Socio-behavioral and implementation outcomes will also be determined for the two arms of the cRCT, including acceptability, appropriateness, and feasibility among the healthcare providers and quality of life, epilepsy-associated stigma, and trust in healthcare providers among parents/guardians and enrolled patients (if age 15-17 years).

The cost-effectiveness of the task-shifted epilepsy care intervention will be determined in US dollars and Nigerian Naira per additional quality adjusted life year (QALY). This cRCT will inform the implementation of task-shifted care systems to address the childhood epilepsy treatment gap and establish a network of community-based clinical epilepsy research centers in northern Nigeria.

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