Clinical trial NCT06470919: The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa
Official title: The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaccines
Keywords: Kenya
Uganda
Vaccine coverage
Vaccine completion
Vaccine timeliness
Digital health interventions
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: African Population and Health Research Center
First posted: 2024-06-24
Enrollment: 2700
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 1 day to 24 months old

Exclusion Criteria:

* Sites not included in the study

Primary outcomes:
measure: Diphtheria, pertussis, and tetanus first dose (DPT1) coverage
timeFrame: 18 months of the intervention period
measure: Diphtheria, pertussis, and tetanus first dose (DPT3) coverage
timeFrame: 15 months of the intervention period (last 15 months of the intervention period)
measure: Dropout rate from DPT1 to DPT3
timeFrame: 15 months of the intervention period (last 15 months of the intervention period)
Secondary outcomes:
measure: Bacillus Calmette-Guerin (BCG) coverage
timeFrame: 18 months of the intervention period (full intervention period)
measure: Measles coverage
timeFrame: 9 months of the intervention period (second half of the intervention)
measure: Completion of basic immunizations
timeFrame: 9 months of the intervention period (second half of the intervention)
measure: Dropout rate from DPT1 to Measles
timeFrame: 9 months of the intervention period (second half of the intervention)
measure: Timeliness of BCG vaccination
timeFrame: 18 months of the intervention period (full intervention period)
measure: Timeliness of DPT1 vaccination
timeFrame: 15 months of the intervention period (last 15 months of the intervention period)
measure: Timeliness of DPT3 vaccination
timeFrame: 15 months of the intervention period (last 15 months of the intervention period)
measure: Timeliness of Measles vaccination
timeFrame: 9 months of the intervention period (second half of the intervention)
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: African Population and Health Reseach Center
city: Kasese
country: Uganda
facility: Uganda Christian University
Study officials:
affiliation: University of Michigan
name: Emily Treleaven, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: African Population and Health Research Center
name: Gershim Asiki, MBChB, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: