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Completed

NCT Number: NCT02819895

PRIMM Trial (Phone Reminder for IMMunization)

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.

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Key information

Conditions

Age range

1 day–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A customized windows® software application

Other

A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.

Primary outcomes

  1. 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

  1. Immunization Rates at 14 Months

    Time frame: 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.

  2. Timeliness of Immunization Receipt

    Time frame: 14 Months

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 30, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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