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

November 25, 2025 updated by: Emily Treleaven, University of Michigan
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3522

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Emily Treleaven, PhD, MPH
  • Phone Number: 734-764-7737
  • Email: treleav@umich.edu

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage
Time Frame: 18 months of the intervention period
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
Time Frame: 15 months of the intervention period (last 15 months of the intervention period)
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
Time Frame: 15 months of the intervention period (last 15 months of the intervention period)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bacillus Calmette-Guerin (BCG) coverage
Time Frame: 18 months of the intervention period (full intervention period)
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
Time Frame: 9 months of the intervention period (second half of the intervention)
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
Time Frame: 9 months of the intervention period (second half of the intervention)
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
Time Frame: 9 months of the intervention period (second half of the intervention)
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
Time Frame: 18 months of the intervention period (full intervention period)
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
Time Frame: 15 months of the intervention period (last 15 months of the intervention period)
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
Time Frame: 15 months of the intervention period (last 15 months of the intervention period)
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
Time Frame: 9 months of the intervention period (second half of the intervention)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
African Population and Health Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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