Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
Primary Purpose
Measles
Status
Not yet recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
SMS, telephone interview or diary card
Sponsored by
About this trial
This is an interventional other trial for Measles focused on measuring Participant Centered Active Surveillance, Adverse Event, Measles Immunization
Eligibility Criteria
Inclusion Criteria: Parents, care givers/guardians, whose child receive vaccine. ≥18 years of age. Willing to adhere to study procedures, which will include a randomization. Willing to participate Exclusion Criteria: Unable to give informed consent because of cognitive impairment. Those who are both illiterate and don't have mobile phone.
Sites / Locations
- Dilla University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
SMS
Telephone interview
Diary card
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Response rate
To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance
Secondary Outcome Measures
AEFI's reported from each group and feasibility of participant centered AEFI active surveillance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05803538
Brief Title
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
Official Title
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dilla University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles
Keywords
Participant Centered Active Surveillance, Adverse Event, Measles Immunization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
391 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMS
Arm Type
Experimental
Arm Title
Telephone interview
Arm Type
Experimental
Arm Title
Diary card
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SMS, telephone interview or diary card
Intervention Description
SMS, telephone interview or diary card
Primary Outcome Measure Information:
Title
Response rate
Description
To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance
Time Frame
7 days
Secondary Outcome Measure Information:
Title
AEFI's reported from each group and feasibility of participant centered AEFI active surveillance
Time Frame
7days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parents, care givers/guardians, whose child receive vaccine.
≥18 years of age.
Willing to adhere to study procedures, which will include a randomization.
Willing to participate
Exclusion Criteria:
Unable to give informed consent because of cognitive impairment.
Those who are both illiterate and don't have mobile phone.
Facility Information:
Facility Name
Dilla University
City
Hawassa
State/Province
Snnpr
ZIP/Postal Code
419
Country
Ethiopia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawit G Assefa, MSc
Phone
+251912820413
Email
dawitgetachewa@gmail.com
Email
dawitgetachewa@gmail.com
First Name & Middle Initial & Last Name & Degree
Dawit G Assefa, MSc
First Name & Middle Initial & Last Name & Degree
Tizalegn Tesefaye, MSc
First Name & Middle Initial & Last Name & Degree
Andualem Meberatu, MSc
First Name & Middle Initial & Last Name & Degree
Etaferaw Bekele, MSc
First Name & Middle Initial & Last Name & Degree
Genet Geberemickeal, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control Trial
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