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

Sponsor
Universiti Putra Malaysia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03402646
Collaborator
RCSI & UCD Malaysia Campus (Other)
1,813
3
19

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reminder module (SMS and Phone call)
  • Behavioral: Photovoice
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1813 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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, the investigators will be implementing a photovoice methodology 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.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, the investigators will be implementing a photovoice methodology 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.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
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
Anticipated Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Immunization coverage [12 months]

    Proportion of randomized infants who received birth doses of BCG and OPV (overall), and complete doses of each vaccine as scheduled

  2. Timeliness of receipt of scheduled immunization [12 months]

    Proportion of infants receiving scheduled immunization within 1 week of schedule

Secondary Outcome Measures

  1. Incidence of any childhood vaccine-preventable disease [12 months]

    Risk ratio of vaccine-preventable disease between intervention and control groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universiti Putra Malaysia
  • RCSI & UCD Malaysia Campus

Investigators

  • Principal Investigator: Surajudeen A Abdulrahman, MBBS, PhD, RCSI & UCD Malaysia Campus
  • Study Director: Niyi Osamiluyi, Premier Medical Systems

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Surajudeen Abiola Abdulrahman, Principal Investigator, Universiti Putra Malaysia
ClinicalTrials.gov Identifier:
NCT03402646
Other Study ID Numbers:
  • MOPING/V2/07/17
First Posted:
Jan 18, 2018
Last Update Posted:
Jan 18, 2018
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 18, 2018