Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-17 @ 4:08 AM
Study NCT ID:
NCT02819895
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRIMM Trial (Phone Reminder for IMMunization)
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: