Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011741472301 Date of Approval: 18/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Measures and new methods for addressing identification and management of epilepsy and other mental, neurological and substance use disorders in Kilifi, Kenya
Official scientific title Epilepsy Pathway Innovations in Africa (EPInA): Kilifi, Kenya- mental health Gap Action Programme-Intervention Guide (mhGAP-IG) substudy
Brief summary describing the background and objectives of the trial Epilepsy is one of the most common serious neurological conditions and is particularly widespread in sub-Saharan Africa (SSA). This high incidence is, in at least a quarter of cases, because of preventable factors, yet many people who may have had seizures are not diagnosed and even fewer receive appropriate treatments. These factors are compounded by enduring social stigma that can make it hard for people with epilepsy (PWE) in SSA to obtain employment, form relationships or feel valued. This is a mixed methods research including a stepped-wedge trial aimed at improving the rate of accurate diagnosis of epilepsy and other priority mental and neurological disorders by implementing the WHO mental health Gap Action Programme-Intervention Guide among primary healthcare workers. Other aims of the study are: to increase knowledge and awareness about epilepsy by engaging with community members, traditional health practitioners and health care providers; to improve the rate of accurate diagnosis of epilepsy in clinical community surveys by refining app-based technologies; to ensure an enduring, positive society change by improving public awareness and reducing the stigma experienced by PWE in SSA through interaction with primary health care workers (PHW) and traditional healers as well as county and national ministries of health and local epilepsy stakeholders and to conduct economic costing of epilepsy interventions. Throughout we will work closely with local communities, PWE, carergivers and NGOs to ensure that the projects are tailored to the individual environments. The principal impact will be to engage with local ministries of health in Kilifi and to task-shift the care of PWE in Kilifi through training PHWs and hopefully to scale up nationally.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) EPInA
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2021
Actual trial start date 16/08/2021
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 29/09/2023
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mental Health Gap Action Program Intervention Guide version 2 training Not applicable 17 months (including the baseline step) The intervention will be a five-day training of nurses, clinical officers and medical officers on the use of the mhGAP-IG V2 to diagnose and manage MNSD followed by monthly supervisory meetings for the duration of the study (18 months in total). All modules of the mhGAP-IG V2 will be implemented, except the child and adolescent module for which there is lack of expertise in this setting. The trainers will undertake the full mhGAP-IG V2 course, followed by an additional “training of trainers” and supervision course and a two-week practise and evaluation session before they are eligible to conduct the trainings. 128
Control Group No training 17 months The untrained facilities will act as controls to those that will have started the trainings 128 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Primary healthcare workers with no prior specialized training in mental health Primary healthcare workers with valid practicing licenses Primary healthcare workers with work contract with the same facility for the duration of the study Primary healthcare workers valid practicing license including interns, students and attaches, Primary healthcare workers on locum basis, Primary healthcare workers with contracts shorter than the study duration Primary healthcare workers who plan to retire or resign within the study period 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/08/2020 KEMRI Scientific and Ethics Research Unit
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road Nairobi 54840 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2021 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes from baseline in the proportions of mental, neurological and substance use disorders cases correctly diagnosed and treated by trained primary healthcare workers in participating health facilities. Baseline then monthly following the intervention
Secondary Outcome Changes in trainees’ level of knowledge Baseline, 3 months, 6 months and at one year following the intervention
Secondary Outcome Changes in the quality of life of patients managed by mhGAP-IG V2 trainees Baseline, then every two weeks for six months
Secondary Outcome Changes in levels of disability of patients managed by trained practitioners Baseline, then every month for six months
Secondary Outcome Changes in severity of illness of patients managed by trainees Baseline then at every visit by the trained attending nurse or clinician for the follow up period of six months.
Secondary Outcome Cost effectiveness of the intervention Throughout the study with analysis at the end of the study
Secondary Outcome Barriers and facilitators of successful implementation of the mhGAP-IG V2. 3 months, 6 months and 1 year after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI Wellcome Trust Research Programme Hospital Road Kilifi 230-80108 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health Research Enterprise Road Southampton SO16 7NS United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Oxford Wellington Square Oxford OX1 2JD United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
African Population and Health Research Center Kitusuru Nairobi 10787 Kenya
University of Ghana Legon Accra LG 25 Ghana
Ifakara Health Institute Kiko Avenue Mikocheni Dar es Salaam 78 373 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Symon Kariuki skariuki@kemri-wellcome.org +254723926339 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Public Enquiries Mercy Odhiambo matieno@kemri-wellcome.org +254723763073 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Programme
Role Name Email Phone Street address
Principal Investigator Charles Newton cnewton@kemri-wellcome.org +254709983000 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya KEMRI Wellcome Trust Research Program and University of Oxford
Role Name Email Phone Street address
Scientific Enquiries Mary Bitta mbitta@kemri-wellcome.org +254722205901 Hospital Road
City Postal code Country Position/Affiliation
Kilifi 230-80108 Kenya Study Investigator DPhil Candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data that underlie the results reported in this study will be available for sharing immediately following publication with researchers and investigators for use in approved proposals or for individual participant meta-analysis. Requests should be directed to skariuki@kemri-wellcome.org Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose to achieve aims in the approved proposal or for individual participant meta-analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information