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OpenTrials
Completed

NCT Number: NCT06470919

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.

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Key information

Conditions

Vaccines

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

African Population and Health Reseach Center, Nairobi, Kenya

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1 day to 24 months old

Exclusion criteria

  • Sites not included in the study

Treatment and study plan

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.

Primary outcomes

  1. 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%).

  2. 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%).

  3. 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%)

Secondary outcomes

  1. 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%).

  2. 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%).

  3. 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)

  4. 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%)

  5. 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%).

  6. 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%).

  7. 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%).

  8. 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%).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • African Population and Health Research Center

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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