PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Immunization Rates at 14 weeks
Study Overview
Brief Summary
The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a customized automated telephone and email immunization reminder system will be feasible, acceptable, and significantly improve immunization utilization rates.
Detailed Description
Background: Worldwide, vaccine preventable diseases account for 29% of all deaths between 1 month and 5 years, underscoring the importance of immunizations. In Nigeria, routine childhood immunization rates are unacceptably inconsistent and low, ranging from 35-85% at 14 weeks and 10-37% for all routine immunizations at 12-24 months.
GAP: The feasibility, acceptability and utility of an automated phone immunization reminder system have never been explored in this rural setting of Nigeria.
HYPOTHESIS
Given ~90% of the adult population in Nigeria uses a mobile phone, a customized mHealth immunization reminder system will be feasible and acceptable; and will significantly improve immunization rates in this rural setting of Ondo State, Nigeria.
METHODS: A prospective randomized controlled trial study design will be utilized. This study will recruit parents of healthy newborn infants delivered at Mother and Child Hospital Ondo, who live in Akure or Ondo Town and plan to receive their immunizations at Mother and Child Hospital Ondo.
DATA ANALYSIS: The proportion of immunization visits between intervention and control groups will be compared using a two-sided, two sample test of proportions with p <0.05 being significant. Secondary analysis will focus on the predictive value of social demographic variables on immunization rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 1 Day to 1 Week (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Parents of healthy infants who have a cellular phone
- •Born at Mother and Child Hospital Ondo (Akure or Ondo Town)
- •Plans to receive immunizations at Mother and Child Hospital Ondo
Exclusion Criteria
- •Parents of infants requiring hospital admission due to illness or prematurity.
- •Parents without a cellular phone
Arms & Interventions
Intervention
Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive their usual care (an immunization card). In addition they will received automated text, calls and emails (if applicable) reminders through a customized windows® software application when their child's immunization visit is due.
Intervention: A customized windows® software application (Other)
Control
Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive usual care (an immunization card)
Outcomes
Primary Outcomes
Immunization Rates at 14 weeks
Time Frame: 14 Weeks
To determine if an automated customized telephone and email immunization reminder system can increase the 14-week immunization rates, by at least 10% among those who receive immunization reminders versus those who do not.
Secondary Outcomes
- Immunization Rates at 14 Months(14 Months)
- Timeliness of Immunization Receipt(14 Months)