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

NCT ID: NCT05803538

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 391 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-01-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

SMS

Group Type: EXPERIMENTAL

SMS, telephone interview or diary card

Intervention Type: DEVICE

SMS, telephone interview or diary card

Telephone interview

Group Type: EXPERIMENTAL

SMS, telephone interview or diary card

Intervention Type: DEVICE

SMS, telephone interview or diary card

Diary card

Group Type: EXPERIMENTAL

SMS, telephone interview or diary card

Intervention Type: DEVICE

SMS, telephone interview or diary card

Usual Care

Group Type: ACTIVE_COMPARATOR

SMS, telephone interview or diary card

Intervention Type: DEVICE

SMS, telephone interview or diary card

Interventions

SMS, telephone interview or diary card

SMS, telephone interview or diary card

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dilla University

OTHER

Sponsor Role: lead

Responsible Party

Dawit Getachew Getachew

Mr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dilla University

Awasa, Snnpr, Ethiopia

Countries

Ethiopia

Facility Contacts

Dawit G Assefa, MSc

Role: primary

dawitgetachewa@gmail.com

+251912820413

Role: backup

dawitgetachewa@gmail.com

References

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.

Reference Type: DERIVED

PMID: 38828522 (View on PubMed)

Other Identifiers

ETDU005

Identifier Type: -

Identifier Source: org_study_id