PRIMM Trial (Phone Reminder for IMMunization)

PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria

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.

Study Overview

• Status: Completed
• Conditions: Immunization
• Intervention / Treatment: Other: A customized windows® software application

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ondo, Nigeria, 11111
    • Mother and Child Hospital Ondo
  • Ondo State
    • Akure, Ondo State, Nigeria, 11111
      • Mother and Child Hospital Ondo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Parents of healthy infants who have a cellular phone
2. Born at Mother and Child Hospital Ondo (Akure or Ondo Town)
3. Plans to receive immunizations at Mother and Child Hospital Ondo

Exclusion Criteria:

1. Parents of infants requiring hospital admission due to illness or prematurity.
2. Parents without a cellular phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: A customized windows® software application; A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunization Rates at 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.	14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunization Rates at 14 Months	To determine the effect of an automated customized phone and email immunization reminder system on the proportion of children completely immunized at 14 months among those who receive immunization reminders versus those who do not.	14 Months
Timeliness of Immunization Receipt	To determine if the proportion of infants who receive their immunizations within 1-week of its due date is higher in infants of parents who receive phone and email immunization reminders versus those who do not.	14 Months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Osayame Ekhaguere, MBBS, MPH, Children's Hospital of Philadelphia; Study Director: Andrew Steenhoff, MBBCh, Children's Hospital of Philadelphia; Study Director: Elizbeth Lowenthal, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Ekhaguere OA, Oluwafemi RO, Badejoko B, Oyeneyin LO, Butali A, Lowenthal ED, Steenhoff AP. Automated phone call and text reminders for childhood immunisations (PRIMM): a randomised controlled trial in Nigeria. BMJ Glob Health. 2019 Apr 3;4(2):e001232. doi: 10.1136/bmjgh-2018-001232. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 24, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: mHealth; Phone Appointment Reminder; Immunization Rates
• Other Study ID Numbers: 15-012572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO