Mhealth Supported Bundle to Improve Vaccination Completion

Implementing a Mobile Health Supported Bundle to Improve Routine Vaccination Completion Rate in a Low-resource Setting

Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drives

Detailed Description

Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.

• Study Type: Interventional
• Enrollment (Actual): 2855
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ondo State
    • Akure, Ondo State, Nigeria, 1111
      • Mother and Child Hospital Akure

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.

Exclusion Criteria:

• Parents or caregivers not willing to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Prospectively received appointment reminders, motivational interviews and targeted vaccine drives.	Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drives; Automated and real time phone call reminders, motivational interviewing and targeted vaccine drives applied in sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DPT3 vaccine completion rate	The proportion of enrolled subjects who complete the Diphtheria, pertussis, and tetanus vaccine (DPT3) vaccine series when assessed at 15 months of age.	15 Months
Measles vaccine completion rate	The proportion of enrolled subjects who complete the measles vaccine series when assessed at 15 months of age.	15 Months
Number of eligible subjects enrolled	Vaccine clinic records will be reviewed to identify the total number of eligible patients in the clinic (defined as those presenting to the vaccine clinic with a child receiving their first vaccine) and the number who agreed to participate during the study period.	15 Months
Project Cost	The cost of administering each component of the mHealth bundle will be documented, such as cost of targeted drive and cost of real time phone calls. This will assist in determining the cost to scale the project.	15 Months
Provider Adoption	A modified intervention acceptability, perception and system usability assessment using a Likert scale questionnaire.	15 Months
Protocol Adherence	The proportion of eligible subjects who received a real-time phone call reminder, counselling, and targeted vaccine drive when indicated	15 Months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Osayame A Ekhaguere, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Vaccination; Childhood; Low- and middle-income country
• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: 15107 (CTSRMC, Abramson Cancer Center, University of Pennsylvania); UL1TR002529 (U.S. NIH Grant/Contract); KL2TR002530 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publish a study protocol in an open access journal. Provider study data set on request.
• IPD Sharing Time Frame: Protocol: Within 6 month of study start Data set: After study completion.
• IPD Sharing Access Criteria: One request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No