OAETanzania: Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area

Sponsor

Universiteit Antwerpen (Other)

Overall Status

Completed

CT.gov ID

NCT05749653

Collaborator

(none)

6,500

Enrollment

Location

Arm

59.1

Actual Duration (Months)

110

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Onchocerciasis Epilepsy	Drug: Bi-annual CDTI	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

population based studypopulation based study

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: bi-annual CDTI bi-annual CDTI with high coverage	Drug: Bi-annual CDTI Bi-annual CDTI

Arm

Intervention/Treatment

Other: bi-annual CDTI

bi-annual CDTI with high coverage

Drug: Bi-annual CDTI

Bi-annual CDTI

Outcome Measures

Primary Outcome Measures

Epilepsy incidence [3 years]
Number of new epilepsy cases per month

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: whole population -

Exclusion Criteria: No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Medical Research	Tanga		Tanzania

Sponsors and Collaborators

Universiteit Antwerpen

Investigators

Principal Investigator: Bruno Mmbando, PhD, National Institute of Medical Research, Tanga

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Colebunders, Emeritus professor, head NSETHIO research group, Global Health institute, Universiteit Antwerpen

ClinicalTrials.gov Identifier:

NCT05749653

Other Study ID Numbers:

B300201837863

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Onchocerciasis

Epilepsy

Study Results

No Results Posted as of Mar 1, 2023