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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,522
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.
African Population and Health Reseach Center
Nairobi, Kenya, Kenya
Uganda Christian University
Kasese, Uganda, Uganda
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%).
Time frame: 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%).
Time frame: 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%)
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Bacillus Calmette-Guerin (BCG) coverage
Percent of all children born in the intervention period that received the BCG vaccine (Continuous measure, 0-100%).
Time frame: 18 months of the intervention period (full intervention period)
Measles coverage
Percent of all children born in the first 9 months of the intervention period that received the Measles vaccine (Continuous measure, 0-100%).
Time frame: 9 months of the intervention period (second half of the intervention)
Completion of basic immunizations
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)
Time frame: 9 months of the intervention period (second half of the intervention)
Dropout rate from DPT1 to Measles
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%)
Time frame: 9 months of the intervention period (second half of the intervention)
Timeliness of BCG vaccination
Percent of all children born in the intervention period that received the BCG vaccine by 4 weeks (Continuous measure, 0-100%).
Time frame: 18 months of the intervention period (full intervention period)
Timeliness of DPT1 vaccination
Percent of all children born in the intervention period that received the first dose of DPT vaccine by 10 weeks (Continuous measure, 0-100%).
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of DPT3 vaccination
Percent of all children born in the intervention period that received the third dose of DPT vaccine by 18 weeks (Continuous measure, 0-100%).
Time frame: 15 months of the intervention period (last 15 months of the intervention period)
Timeliness of Measles vaccination
Percent of all children born in the intervention period that received the Measles vaccine by 10 months (Continuous measure, 0-100%).
Time frame: 9 months of the intervention period (second half of the intervention)
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