The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa

NCT ID: NCT06470919

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2025-10-29

Brief Summary

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The research team of investigators from University of Michigan and the African Population and Health Research Center will implement and evaluate a newly-developed digital vaccine card and accompanying mobile application and electronic immunization registry. This will take place in rural Uganda and urban Kenya Health and Demographic Surveillance Systems (HDSS) and the study team will analyze its feasibility, impacts, cost through process, and economic evaluations. The study team will also assess the data quality and equity of the digital vaccine registry and card system.

Detailed Description

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This study design has three parts or aims for this project, however, only the third aim is considered to be the trial portion and is included in this registration.

Conditions

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Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mothers will be randomized to receive the digital vaccine card access with short message service (SMS) reminders versus mothers who did not receive digital vaccine card access with SMS reminders (treatment/control).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s)

Group Type EXPERIMENTAL

SMS reminders for upcoming vaccination(s)

Intervention Type OTHER

All parents/caregivers of children in participating villages will receive access to a digital vaccine card. This will be used for record-keeping application (digital vaccine registry). Selected parents/caregivers of children will receive SMS messages and reminders related to vaccination.

Pre-intervention cohort

This group will be compared to the post-intervention group to assess the digital vaccine card.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SMS reminders for upcoming vaccination(s)

All parents/caregivers of children in participating villages will receive access to a digital vaccine card. This will be used for record-keeping application (digital vaccine registry). Selected parents/caregivers of children will receive SMS messages and reminders related to vaccination.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1 day to 24 months old

Exclusion Criteria

* Sites not included in the study
Minimum Eligible Age

1 Day

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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African Population and Health Research Center

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Emily Treleaven

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Treleaven, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Gershim Asiki, MBChB, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

African Population and Health Research Center

Locations

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African Population and Health Reseach Center

Nairobi, Kenya, Kenya

Site Status

Uganda Christian University

Kasese, Uganda, Uganda

Site Status

Countries

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Kenya Uganda

Other Identifiers

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HUM00237101

Identifier Type: -

Identifier Source: org_study_id

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