Tunatar da ni. The Immunization Reminder and Information SMS System (IRISS)

NCT04001322 | Completed

• 1 other identifier: IRB00008732
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In 2016, only 33% of Nigerian children aged 12-23 months had been vaccinated with the 3rd dose of the pentavalent vaccine. Lack of knowledge was the leading reason for non-vaccination. To overcome this knowledge gap, this project, "Tunatar da ni", will deliver targeted text messages to community leaders and individualized text messages to parents and caregivers in Kebbi state, Northwest Nigeria, a state with very low coverage of immunization (19% penta 3 coverage in 2018). These text messages, also known as Short Messaging System (SMS) messages will be managed, scheduled and sent from a purpose-built, cloud-based Immunization Reminder and Information SMS System (IRISS). The messages will be deployed in three ways, as:

1. 1.General broadcast of messages on the importance of immunization to all active mobile phone subscribers in the intervention area.
2. 2.Targeted educational, informational, normative and motivational messages on immunization, and reminders on the local immunization clinic schedules, to community members who voluntarily registered into IRISS for these messages, and to traditional and religious leaders who then share these information with their communities.
3. 3.Individualized reminders of a child's immunization due dates and local clinic schedule to parents who voluntarily registered their child's information on IRISS in order to receive these reminders.

Conditions

Low Immunization Uptake

Outcome Measures

Primary Outcomes (1)

• Difference in proportion of infants appropriately vaccinated for age

  At end line, the proportion of children 0-11 months who had received all age-appropriate vaccines by the time of the survey will be compared between intervention and control LGAs

  9 months

Secondary Outcomes (2)

• Difference in the reach of the immunization SMS messages

  9 months

• Difference in proportion of zero dose infants

  9 months

Study Arms (2)

14 Intervention LGAs

EXPERIMENTAL

Various target beneficiaries will receive broadcast, targeted and individualized SMS messages on immunization.

Other: Community engagement; Other: IRISS advert for opt-in; Other: One-time SMS broadcast on immunization; Other: Scheduled weekly SMS reminder of health facility RI schedule to community leaders; Other: Scheduled bi weekly RI messages to community leaders; Other: Responsive individualized child vaccination schedule reminder to caregivers who opt-in

7 Control LGAs

OTHER

This arm will not receive any SMS messages on immunization

Other: Community engagement; Other: Responsive one-time SMS message on hand washing to those that erroneously register on IRISS

Interventions

Community engagement OTHER

The government will conduct a cascade of sensitization meetings with traditional leaders at all levels to promote newborn line listing (birth registration), reconciliation of child's vaccination status and defaulter tracking (home-based follow up of children who have missed their vaccination doses) by health providers and community leaders

14 Intervention LGAs; 7 Control LGAs

IRISS advert for opt-in OTHER

A module to advertise and demonstrate how individuals can opt-in to IRISS to receive the messages will be included in the community engagement sensitization meetings.

14 Intervention LGAs

One-time SMS broadcast on immunization OTHER

General broadcast of SMS messages on the importance of immunization to all active mobile phone subscribers in the intervention LGAs

14 Intervention LGAs

Scheduled weekly SMS reminder of health facility RI schedule to community leaders OTHER

Traditional and religious leaders who have a phone or access to a phone and have been registered on IRISS will receive SMS messages on the immunization session schedule of the health facilities in their communities, so they can disseminated the information through their town announcers to inform parents and caregivers. For example, "Ribah clinic is holding a vaccination session tomorrow from 8am to 2pm. Please take your child there to vaccinate them and encourage your neighbors to vaccinate their children."

14 Intervention LGAs

Scheduled bi weekly RI messages to community leaders OTHER

Traditional and religious leaders who own or have access to a phone and have been registered on IRISS will receive SMS messages on immunization, to share same with community members. The message categories are: 1) Educational messages that provide facts and increase knowledge, e.g. "Have you heard of Penta vaccine? It protects against 5 diseases: they are diphtheria, whooping cough, tetanus, HiB and Hepatitis B." 2) Informative messages that dispel myths about immunization, e.g. "Getting more than one vaccine at the same time does not harm a child. It is very important to completely receive all vaccine doses for full protection." 3) Normative messages to promote positive norms, e.g. "Our religious leaders have immunized their children, what are we waiting for"? 4) Motivational messages to inspire action, e.g. "Each visit to the health center for vaccination will reap many health benefits. Say YES to good health, be on time and complete your child's vaccination."

14 Intervention LGAs

Responsive individualized child vaccination schedule reminder to caregivers who opt-in OTHER

Parents and caregivers who voluntarily registered their child's information into IRISS will receive a reminder, a day before, about their child's due vaccines and the schedule of vaccination sessions in the health facilities within their locality (wards), e.g. "Greetings! Amina is due for Penta 1 tomorrow, kindly visit Ribah clinic. They vaccinate on Mondays and Thursdays."

14 Intervention LGAs

Responsive one-time SMS message on hand washing to those that erroneously register on IRISS OTHER

If individuals from control LGAs encounter IRISS adverts inadvertently and erroneously register into IRISS expecting a message, to avoid a loss in trust if no message is sent, they will receive a one-time general message about the importance of hand-washing, e.g. "Wash your hand with soap and water every time you finish from to the toilet, to maintain clean hands and avoid germs that make you sick."

7 Control LGAs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General broadcast: active phone owners living within the 14 intervention LGAs.
• Targeted broadcast: community leaders or other individuals who:
• own or have access to a phone
• live within the 14 intervention LGAs.
• Individualized broadcast: parents or caregivers of children aged 0-11 months who:
• own a phone or have access to a phone
• live within the 14 intervention LGAs

You may not qualify if:

• Not owning or having access to a phone that can receive text messages

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator
• Direct Consulting and Logistics: collaborator

Study Sites (1)

State Primary Health Care Development Agency

Birnin Kebbi, Kebbi, Nigeria

Location

Study Officials

• Chizoba B Wonodi, MD,MPH,DrPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Alain Labrique, MD,MHS,PHD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Local government area (LGA) is the unit of assignment. The study state (Kebbi) has 21 LGAs. Of these, 14 will be assigned to receive the intervention while the remaining seven will serve as control.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: June 15, 2019
• Primary Completion: October 30, 2020
• Study Completion: November 29, 2020
• Last Updated: October 7, 2022

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)