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

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.

Study Overview

• Status: Completed
• Conditions: Vaccines
• Intervention / Treatment: Other: SMS reminders for upcoming vaccination(s)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3522
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kenya
    • Nairobi, Kenya, Kenya, 10787-00100
      • African Population and Health Reseach Center
• Uganda
  • Uganda
    • Kasese, Uganda, Uganda
      • Uganda Christian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1 day to 24 months old

Exclusion Criteria:

• Sites not included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s)	Other: 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.
No Intervention: Pre-intervention cohort; This group will be compared to the post-intervention group to assess the digital vaccine card.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage	Percent (%) of all children born in the intervention period that received the first dose of DPT vaccine (Continuous measure, 0-100%).	18 months of the intervention period
Diphtheria, pertussis, and tetanus first dose (DPT3) coverage	Percent of all children born in the first 15 months of the intervention period that received the third dose of DPT vaccine (Continuous measure, 0-100%).	15 months of the intervention period (last 15 months of the intervention period)
Dropout rate from DPT1 to DPT3	Difference in the proportion of children born in the first 15 months of the intervention period that received the first and third doses of the DPT vaccine (Continuous measure, 0-100%)	15 months of the intervention period (last 15 months of the intervention period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacillus Calmette-Guerin (BCG) coverage	Percent of all children born in the intervention period that received the BCG vaccine (Continuous measure, 0-100%).	18 months of the intervention period (full intervention period)
Measles coverage	Percent of all children born in the first 9 months of the intervention period that received the Measles vaccine (Continuous measure, 0-100%).	9 months of the intervention period (second half of the intervention)
Completion of basic immunizations	Percent of all children born in the first 9 months of the intervention period that received all basic recommended immunizations (BCG, oral polio vaccine (OPV), DPT1, DPT2, DPT3, OPV1, OPV2, OPV3, Pneumococcal Conjugate (PCV)1, PCV2, PCV3, rotavirus (Rota)1, Rota2, Rota3, Measles)	9 months of the intervention period (second half of the intervention)
Dropout rate from DPT1 to Measles	Difference in the proportion of children born in first 9 months of the intervention period that received the first dose of the DPT vaccine and the Measles vaccine (Continuous measure, 0-100%)	9 months of the intervention period (second half of the intervention)
Timeliness of BCG vaccination	Percent of all children born in the intervention period that received the BCG vaccine by 4 weeks (Continuous measure, 0-100%).	18 months of the intervention period (full intervention period)
Timeliness of DPT1 vaccination	Percent of all children born in the intervention period that received the first dose of DPT vaccine by 10 weeks (Continuous measure, 0-100%).	15 months of the intervention period (last 15 months of the intervention period)
Timeliness of DPT3 vaccination	Percent of all children born in the intervention period that received the third dose of DPT vaccine by 18 weeks (Continuous measure, 0-100%).	15 months of the intervention period (last 15 months of the intervention period)
Timeliness of Measles vaccination	Percent of all children born in the intervention period that received the Measles vaccine by 10 months (Continuous measure, 0-100%).	9 months of the intervention period (second half of the intervention)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: African Population and Health Research Center
• Investigators: Principal Investigator: Emily Treleaven, PhD, MPH, University of Michigan; Principal Investigator: Gershim Asiki, MBChB, MSc, PhD, African Population and Health Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): October 29, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Kenya; Uganda; Digital health interventions; Vaccine completion; Vaccine coverage; Vaccine timeliness
• Other Study ID Numbers: HUM00237101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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