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

NCT06470919 | Completed

• 1 other identifier: HUM00237101
• Study Type: interventional
• Target: 3,522
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Vaccines

Keywords

Kenya; Uganda; Vaccine coverage; Vaccine completion; Vaccine timeliness; Digital health interventions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Bacillus Calmette-Guerin (BCG) coverage

  18 months of the intervention period (full intervention period)

• Measles coverage

  9 months of the intervention period (second half of the intervention)

• Completion of basic immunizations

  9 months of the intervention period (second half of the intervention)

• Dropout rate from DPT1 to Measles

  9 months of the intervention period (second half of the intervention)

• Timeliness of BCG vaccination

  18 months of the intervention period (full intervention period)

Study Arms (2)

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

EXPERIMENTAL

Other: SMS reminders for upcoming vaccination(s)

Pre-intervention cohort

NO INTERVENTION

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

Interventions

SMS reminders for upcoming vaccination(s) 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.

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

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• day to 24 months old

You may not qualify if:

• Sites not included in the study

Sponsors & Collaborators

• University of Michigan: lead
• African Population and Health Research Center: collaborator

Study Sites (2)

African Population and Health Reseach Center

Nairobi, Kenya, 10787-00100, Kenya

Location

Uganda Christian University

Kasese, Uganda, Uganda

Location

Study Officials

• Emily Treleaven, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Gershim Asiki, MBChB, MSc, PhD

  African Population and Health Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: November 6, 2024
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); KE (1)