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Bridging the Childhood Epilepsy Treatment Gap in Africa

NCT04290975 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1672

Last updated 2026-02-20

Study results available
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Summary

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.

Conditions

Interventions

OTHER

Task-shifting epilepsy care to epilepsy-trained community health workers (CHWs)

Children with previously untreated epilepsy, identified via community-based screening and diagnositic evaluations, receive epilepsy care (including anti-seizure medication management) from epilepsy-trained community health workers (CHWs).

OTHER

Enhanced usual care for epilepsy (EUC)

Children with previously untreated epilepsy, identified via community-based screening and diagnostic evaluations, receive epilepsy care by physicians, as routinely done in Nigeria. The usual physician care is enhanced by community health workers (CHWs), who do not participate in the child's epilepsy care, but who help families navigate the healthcare system.

Sponsors & Collaborators

  • Aminu Kano Teaching Hospital

    collaborator OTHER

  • Ahmadu Bello University Teaching Hospital

    collaborator OTHER

  • Federal Neuro-Psychiatric Hospital, Kaduna

    collaborator UNKNOWN

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Edwin Trevathan, MD, MPH · Vanderbilt University Medical Center

  • Aminu Taura, MBBS · Aminu Kano Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2024-05-31
Completion
2025-07-15

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290975 on ClinicalTrials.gov