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PRIMM Trial (Phone Reminder for IMMunization)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02819895
Enrollment
600
Registered
2016-06-30
Start date
2016-07-31
Completion date
2018-06-30
Last updated
2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunization

Keywords

Phone Appointment Reminder, Immunization Rates, mHealth

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.

Interventions

OTHERA 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.

Sponsors

Thrasher Research Fund
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Immunization Rates at 14 weeks14 WeeksTo 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

MeasureTime frameDescription
Immunization Rates at 14 Months14 MonthsTo 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.
Timeliness of Immunization Receipt14 MonthsTo 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.

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026