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

NCT05803538 | Unknown DMC

• 1 other identifier: ETDU005
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Measles

Keywords

Participant Centered Active Surveillance; Adverse Event; Measles Immunization

Outcome Measures

Primary Outcomes (1)

• Response rate

  To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance

  7 days

Secondary Outcomes (1)

• AEFI's reported from each group and feasibility of participant centered AEFI active surveillance

  7days

Study Arms (4)

SMS

EXPERIMENTAL

Device: SMS, telephone interview or diary card

Telephone interview

EXPERIMENTAL

Device: SMS, telephone interview or diary card

Diary card

EXPERIMENTAL

Device: SMS, telephone interview or diary card

Usual Care

ACTIVE COMPARATOR

Device: SMS, telephone interview or diary card

Interventions

SMS, telephone interview or diary card DEVICE

SMS, telephone interview or diary card

Diary card; SMS; Telephone interview; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent because of cognitive impairment.
• Those who are both illiterate and don't have mobile phone.

Sponsors & Collaborators

• Dilla University: lead

Study Sites (1)

Dilla University

Awasa, Snnpr, 419, Ethiopia

Location

Related Publications (1)

• Assefa DG, Tesefaye T, Bekele E, Geberemickeal G, Mebratu A, Ejigu AG, Nigatu T, Zeleke ED. Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia. Int Health. 2025 Mar 4;17(2):195-204. doi: 10.1093/inthealth/ihae040.

  PMID: 38828522 DERIVED

MeSH Terms

Conditions

Measles

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: May 15, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 30, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

ET (1)