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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06470919
Enrollment
3522
Registered
2024-06-24
Start date
2024-11-06
Completion date
2025-10-29
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccines

Keywords

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

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.

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.

Interventions

OTHERSMS 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.

Sponsors

African Population and Health Research Center
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No

Inclusion criteria

* 1 day to 24 months old

Exclusion criteria

* Sites not included in the study

Design outcomes

Primary

MeasureTime frameDescription
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage18 months of the intervention periodPercent (%) of all children born in the intervention period that received the first dose of DPT vaccine (Continuous measure, 0-100%).
Diphtheria, pertussis, and tetanus first dose (DPT3) coverage15 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%).
Dropout rate from DPT1 to DPT315 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

MeasureTime frameDescription
Dropout rate from DPT1 to Measles9 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%)
Timeliness of BCG vaccination18 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%).
Measles coverage9 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%).
Timeliness of DPT3 vaccination15 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%).
Timeliness of Measles vaccination9 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%).
Timeliness of DPT1 vaccination15 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%).
Bacillus Calmette-Guerin (BCG) coverage18 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%).
Completion of basic immunizations9 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)

Countries

Kenya, Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026