An interventional study of SMS, telephone interview or diary card in Measles, sponsored by Dilla University. Status unknown at 1 site in Ethiopia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Dilla University · Not applicable, Interventional, and Other
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.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's planned enrollment of 391 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →Dilla University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: SMS, telephone interview or diary card
Device: SMS, telephone interview or diary card
Device: SMS, telephone interview or diary card
Device: SMS, telephone interview or diary card
SMS, telephone interview or diary card
Response rate
To compare response rate of tailored SMS, telephone interview and diary card for the AEFI active surveillance
Time frame: 7 days
AEFI's reported from each group and feasibility of participant centered AEFI active surveillance
Time frame: 7days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2023; primary completion for Dec 2023, 7 months later.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Dilla University