NCT05803538

Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial

Status unknown NA Last updated 7 April 2023

What this trial tests

NA trial testing SMS, telephone interview or diary card in Measles in 391 participants. Status unknown.

Timeline

15 May 2023

Primary endpoint
20 December 2023

30 January 2024

Quick facts

Lead sponsor	Dilla University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	391
Start date	15 May 2023
Primary completion	20 December 2023
Estimated completion	30 January 2024
Sites	1 location across Ethiopia

Drugs / interventions tested

• SMS, telephone interview or diary card

Conditions studied

• Measles — all drugs for Measles →

Sponsor

Dilla University

Who can join

18 and older, any sex, with Measles. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Participant centered active adverse event following immunization (AEFI) surveillance can offer real time vaccine safety data and help in signal detection. Evidence showed that it is still difficult to get AEFI from passive reporting in Ethiopia. Vast novel method of enhanced AEFI surveillance has been practiced globally. However, those methods had serious limitations including the requirement of high resource and expertise. Hence, there is a need to find the most flexible low cost and integrated AEFI surveillance system. To the best of our knowledge, there has no published research in Ethiopia which compare Participant diary, SMS, and telephone interview for the purpose of active AEFI surveillance.

Objective: To assess participant centered active adverse event surveillance following measles immunization at Gedeo Zone health facilities, Ethiopia.

Method: An open randomized trial will be employed from October 1, 2022- December 1, 2023, at Gedio Zone health facilities. All parents, care givers/guardians whose child receive vaccine during the study period in the study site will be included in the study. A total of 391participants will be randomized to SMS, telephone interview or diary card group using random number generator on Excel. Every participant will be contacted on day seven to request them whether they experience any AEFI. Differences in proportions will compared using chi-square tests. A 0.05 level of significance will be used for all analyses. Independent sample t-tests will be used to compare the mean time (in days) required to collect complete AEFI data by SMS, telephone interview and diary card. Multinominal logistic regression analyses will be used assess the factors associated with effective use of tailored SMS, telephone interview and diary card for the AEFI active surveillance. To further investigate the association between the vaccine and the adverse events and factors associated with vaccine binary and multi variable logistic regression will be used.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.