Clinical trial NCT02819895: PRIMM Trial (Phone Reminder for IMMunization)
Official title: PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Keywords: Phone Appointment Reminder
Immunization Rates
mHealth
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2016-06-30
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunization Rates at 14 weeks
timeFrame: 14 Weeks
Secondary outcomes:
measure: Immunization Rates at 14 Months
timeFrame: 14 Months
measure: Timeliness of Immunization Receipt
timeFrame: 14 Months
Other outcomes:
Locations:
city: Akure
country: Nigeria
facility: Mother and Child Hospital Ondo
state: Ondo State
city: Ondo
country: Nigeria
facility: Mother and Child Hospital Ondo
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Osayame Ekhaguere, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Andrew Steenhoff, MBBCh
role: STUDY_DIRECTOR
affiliation: Children's Hospital of Philadelphia
name: Elizbeth Lowenthal, MD, MSCE
role: STUDY_DIRECTOR
References:
citation: 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.