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

Not Applicable

Recruiting

• Conditions: Vaccines
• Interventions: Other: SMS reminders for upcoming vaccination(s)

• Registration Number: NCT06470919
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Study First Posted: 2024-06-24
• Status Verified: 2024-11
• Study Start: 2024-11-06
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• 1 day to 24 months old

Exclusion Criteria

• Sites not included in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Next Generation digital vaccine card with SMS reminders for upcoming vaccination(s)	SMS reminders for upcoming vaccination(s)	-

Primary Outcome Measures

Name	Time	Method
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage	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%).
Diphtheria, pertussis, and tetanus first dose (DPT3) coverage	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%).
Dropout rate from DPT1 to DPT3	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 Outcome Measures

Name	Time	Method
Measles coverage	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%).
Completion of basic immunizations	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)
Timeliness of BCG vaccination	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%).
Timeliness of DPT3 vaccination	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%).
Dropout rate from DPT1 to Measles	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%)
Timeliness of Measles vaccination	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%).
Bacillus Calmette-Guerin (BCG) coverage	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%).
Timeliness of DPT1 vaccination	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%).

Trial Locations

Locations (2)

African Population and Health Reseach Center; 🇰🇪 Nairobi, Kenya

Uganda Christian University; 🇺🇬 Kasese, Uganda