Mobile Phone Reminders (and Photovoice) for Routine Immunization in Nigeria - The MOPING Study (MOPING)

EFFICACY OF MOBILE PHONE REMINDERS (AND PHOTOVOICE) IN IMPROVING CHILDHOOD IMMUNIZATION UPTAKE AND REDUCING INCIDENCE OF VACCINE-PREVENTABLE DISEASES - A RANDOMIZED CONTROLLED TRIAL AMONG POSTPARTUM MOTHERS AND CAREGIVERS IN NIGERIA

This study aims to implement and test the efficacy of photovoice, Short Messaging Service (SMS) and phone call reminders in improving childhood immunization coverage (uptake, timeliness and completion rates) and reducing incidence of vaccine-preventable diseases (VPDs) among infants in Nigeria

Study Overview

• Status: Unknown
• Conditions: Immunization; Infection
• Intervention / Treatment: Behavioral: Reminder module (SMS and Phone call); Behavioral: Photovoice

Detailed Description

This will be a single-blind three-arm cluster randomized controlled trial involving post-partum mothers and/or caregivers of infants (age 0-12months) attending immunization clinics in 12 randomly selected Primary Health Care Centres (clusters) across Sokoto, Jigawa, Kano, Ogun, Oyo and Lagos States of Nigeria. Additionally, a photovoice methodology will be implemented in 6 community clusters (one in each State) involving group discussions between community members (pregnant women in their third trimester, parents/caregivers of infants age 0-12 months), community leaders, service providers and policy makers on benefits of timely immunization and consequences of non-vaccination. Parent-infant pairs will be followed up for 12 months during which SMS and phone call immunization clinic appointment reminders will be provided to mothers and/or caregivers in intervention arm 1, and photovoice intervention provided at study commencement to participants in intervention arm 2. Respondents in the control group would receive standard care (routine paper-based appointment scheduling alone). The investigators will document and compare immunization uptake (all doses and vaccines), timeliness of receipt and completion rates of scheduled immunization between the three groups, as well as incidence of VPDs between the groups using multivariate statistical analyses.

• Study Type: Interventional
• Enrollment (Anticipated): 1813
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mothers/caregivers of healthy infants (age 0 - 12 months) who:

  1. Have a mobile phone access
  2. Received antenatal care and/or delivered their babies in a hospital
  3. Plans to receive immunizations at the selected PHCs
• Purposively-selected community sample of pregnant women in their third trimester, parents/caregivers of infants, providers, community gatekeepers and policy makers

Exclusion Criteria:

1. Parents of infants requiring hospital admission due to significant illness, congenital deformity/malformation and prematurity
2. Foreigners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reminder module (SMS and Phone call); Intervention will consist of a "Reminder module" delivered via SMS and telephone calls by an automated, customized software application. This will include standardized SMS reminder 3 days prior to scheduled immunization clinic appointments, telephone call reminders a day prior to scheduled clinic appointment (4 to 6pm) (in addition to standard care - routine paper-based appointment scheduling and counselling by care providers) for routine immunization. Reminders will be provided consistently for all immunization clinic appointments until the child turns 12 months of age.	Behavioral: Reminder module (SMS and Phone call); Same as described under arm/group descriptions
Experimental: Photovoice; In two small groups of 15 participants each per state, purposively selected pregnant women in their third trimester and parents of infants aged 0-12 months in the community, as well as community leaders, service providers and policy makers will be exposed to photographs (taken from other sources) of debilitating consequences of non-immunization, which will form the basis of the group discussions, knowledge sharing and consensus-building sessions, each lasting about 45 minutes to 1 hour. Each community cluster will be linked to a PHC.	Behavioral: Photovoice; Same as described under arm/group descriptions
No Intervention: Control; Respondents in control clusters will receive standard care only - comprising routine paper-based appointment scheduling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunization coverage	Proportion of randomized infants who received birth doses of BCG and OPV (overall), and complete doses of each vaccine as scheduled	12 months
Timeliness of receipt of scheduled immunization	Proportion of infants receiving scheduled immunization within 1 week of schedule	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of any childhood vaccine-preventable disease	Risk ratio of vaccine-preventable disease between intervention and control groups	12 months

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Collaborators: RCSI & UCD Malaysia Campus
• Investigators: Principal Investigator: Surajudeen A Abdulrahman, MBBS, PhD, RCSI & UCD Malaysia Campus; Study Director: Niyi Osamiluyi, Premier Medical Systems

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MOPING/V2/07/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No