Mhealth Supported Bundle to Improve Vaccination Completion

NCT05520736 | Completed

• 3 other identifiers: 15107KL2TR002530UL1TR002529
• Study Type: interventional
• Target: 2,855
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccination

Keywords

Vaccination; Childhood; Low- and middle-income country

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

Prospectively received appointment reminders, motivational interviews and targeted vaccine drives.

Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drives

Interventions

Appointment reminders, motivational interviewing and targeted vaccine drives BEHAVIORAL

Automated and real time phone call reminders, motivational interviewing and targeted vaccine drives applied in sequence

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Parents or caregivers not willing to participate.

Sponsors & Collaborators

• Indiana University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mother and Child Hospital Akure

Akure, Ondo State, 1111, Nigeria

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Osayame A Ekhaguere

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Cohort study

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 30, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Protocol: Within 6 month of study start Data set: After study completion.
• Access Criteria: One request

Locations

NG (1)