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

Study Overview
=================
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

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.

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

Conditions
-----------------
Immunization; Infection

Intervention / Treatment
-----------------
* Behavioral: Reminder module (SMS and Phone call)
* Behavioral: Photovoice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers/caregivers of healthy infants (age 0 - 12 months) who: Have a mobile phone access Received antenatal care and/or delivered their babies in a hospital 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: Parents of infants requiring hospital admission due to significant illness, congenital deformity/malformation and prematurity Foreigners
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reminder module (SMS and Phone call)<br>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)<br>* Same as described under arm/group descriptions<br>|
| Experimental: Photovoice<br>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<br>* Same as described under arm/group descriptions<br>|
| No Intervention: Control<br>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 |