Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area (OAETanzania)
Primary Purpose
Onchocerciasis, Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Bi-annual CDTI
Sponsored by
About this trial
This is an interventional prevention trial for Onchocerciasis
Eligibility Criteria
Inclusion Criteria: whole population - Exclusion Criteria: No -
Sites / Locations
- National Institute of Medical Research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
bi-annual CDTI
Arm Description
bi-annual CDTI with high coverage
Outcomes
Primary Outcome Measures
Epilepsy incidence
Number of new epilepsy cases per month
Secondary Outcome Measures
Full Information
NCT ID
NCT05749653
First Posted
February 17, 2023
Last Updated
February 28, 2023
Sponsor
Universiteit Antwerpen
1. Study Identification
Unique Protocol Identification Number
NCT05749653
Brief Title
Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area
Acronym
OAETanzania
Official Title
Impact of a Bi-annual Community-directed Treatment With Ivermectin Programme on the Incidence of Epilepsy in an Onchocerciasis-endemic Area of Mahenge, Tanzania: a Population-based Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Onchocerciasis is a neglected tropical disease associated with epilepsy, particularly in areas of high Onchocerciasis volvulus transmission. Onchocerciasis-associated epilepsy is characterised by seizures that start between the ages of five to 18 years. The tropical disease can be controlled through community-directed treatment with ivermectin (CDTi). Mahenge, in Tanzania, had a high prevalence of onchocerciasis and epilepsy despite more than 20 years of annual CDTi. Hence, the Tanzanian Neglected Tropical Diseases Control Programme has switched from annual to bi-annually CDTi since 2019. After this switch, the CDTi coverage increased and was sustained in both ivermectin rounds in 2021, and the number of new epilepsy cases decreased. The latter were persons who did not take ivermectin the year they had the first seizures. Hence, all ivermectin-eligible children at risk of onchocerciasis should take ivermectin at least annually. Overall, increasing the frequency and coverage of the CDTi programme should be considered in onchocerciasis-endemic areas with a high prevalence of epilepsy.
Detailed Description
Background: Community-directed treatment with ivermectin (CDTi) is used to eliminate onchocerciasis. However, despite 25 years of annual CDTi in Mahenge, Tanzania, the prevalence of onchocerciasis and onchocerciasis-associated epilepsy remained high in certain rural villages. Therefore, in 2019, bi-annual CDTi was introduced in the area. This study assessed the impact of the programme on the incidence of epilepsy in four villages.
Methodology: Door-to-door epilepsy surveys were conducted prior to (2017/18) and after (2021) implementing bi-annual CDTi. All household members were screened for epilepsy symptoms using a validated questionnaire, and suspected cases were examined by a medical doctor to confirm/reject the diagnosis of epilepsy. The prevalence and annual incidence of epilepsy, including nodding syndrome, were calculated with 95% Wilson confidence intervals with continuity correction. The latter was also done for CDTi coverage in 2021.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis, Epilepsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
population based study
Masking
None (Open Label)
Allocation
N/A
Enrollment
6500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bi-annual CDTI
Arm Type
Other
Arm Description
bi-annual CDTI with high coverage
Intervention Type
Drug
Intervention Name(s)
Bi-annual CDTI
Intervention Description
Bi-annual CDTI
Primary Outcome Measure Information:
Title
Epilepsy incidence
Description
Number of new epilepsy cases per month
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: whole population -
Exclusion Criteria: No
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Mmbando, PhD
Organizational Affiliation
National Institute of Medical Research, Tanga
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Medical Research
City
Tanga
Country
Tanzania
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After de-identification (text, tables, figures, and appendices), all individual participant data underlying the results reported in this article will be made available immediately and indefinitely via the Zenodo repository following publication for anyone who wishes to access the data for any purpose.
Learn more about this trial
Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area
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