The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa
NCT Number: NCT06470919
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vaccines
Interventions: OTHER: SMS reminders for upcoming vaccination(s)
Sponsor: University of Michigan
Collaborators: African Population and Health Research Center
Sex: ALL
Age: CHILD
Enrollment: 2700
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2024-12
Locations: African Population and Health Reseach Center, Nairobi, 10787-00100, Kenya|Uganda Christian University, Kasese, Uganda

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.

Primary Outcome Measures: 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%)., 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%)., 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%), 15 months of the intervention period (last 15 months of the intervention period)
Secondary Outcome Measures: Bacillus Calmette-Guerin (BCG) coverage, 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, 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, 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, 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, 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, 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, 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, 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)