PRIMM Trial (Phone Reminder for IMMunization)

Immunization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819895
• Other study ID #: 15-012572
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Week

Eligibility

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

Related Conditions & MeSH terms

• Immunization

Intervention

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.

Locations

Country	Name	City	State
Nigeria	Mother and Child Hospital Ondo	Akure	Ondo State
Nigeria	Mother and Child Hospital Ondo	Ondo

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Thrasher Research Fund

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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