- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705455
Immunization Schedule Alert Platform (ISAP)
October 11, 2018 updated by: Dr.Ihedioha Emmanuel Chukwunwike, Lifespan Healthcare Resource Limited
Immunization Schedule Alert Platform: Determining ISAP SMS Efficacy in Improving Childhood Immunization Timeliness and Completeness in Nigeria
The ISAP study is investigating the efficacy of SMS messages in improving routine childhood Immunization timeliness and completeness in Nigeria.
Study Overview
Detailed Description
The ISAP - Immunization Schedule Alert Platform study is investigating the efficacy of ISAP SMS exposure to Caregivers with children( who have fulfilled our inclusion criteria) due for routine childhood Immunisation in influencing decision for timely and complete Immunization uptake.
ISAP SMS messages contains information on the Immunization appointment schedule, time ,vaccine to be administered and the address of the Immunization centre.
Study Type
Interventional
Enrollment (Anticipated)
1800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Enugu, Nigeria
- Nkanu East Health centre Immunization clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Caregiver with child due for birth dose vaccination or at 6weeks-OPV1,Penta1,PCV1,Rota1.
Exclusion Criteria: Caregiver with child who have already had OPV1,Penta1,PCV1and Rota1.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ISAP SMS
ISAP SMS will be sent to enrolled caregivers
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ISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic.
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No Intervention: No ISAP SMS
No ISAP SMS will be sent to enrolled caregivers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
Time Frame: 12 months
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Proportion of timely and complete vaccine uptake after ISAP SMS Intervention
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emmanuel Ihedioha, MBBS, Lifespan Healthcare Resource
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2018
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
October 9, 2018
First Submitted That Met QC Criteria
October 11, 2018
First Posted (Actual)
October 15, 2018
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 11, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- OPP1182651
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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