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Trial record 52 of 661 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT04001322
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Direct Consulting and Logistics
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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

Study investigators hypothesize that providing community leaders with positive and actionable messages on immunization services will improve their understanding of the value of vaccines and provide them facts to drive discussions, build positive norms and increase acceptance of vaccination. Providing targeted reminders to parents about their child's vaccination due date and the schedule of their local vaccination clinics will motivate their timely action to seek vaccination services for their children.

Intervention will be evaluated using a two-arm cluster randomized controlled trial design. All 21 Local Government Areas (LGAs) in Kebbi state will be involved. Based on a 2:1 ratio, 14 LGAs will be randomly assigned to receive the SMS intervention while 7 LGAs will serve as controls.

The primary outcome measure will be the proportion of children aged 0-11 months who are appropriately vaccinated for age. The data to compare this outcome between the intervention and control arms, will be obtained from the quarterly lot quality assurance surveys done by the Nigerian government.


Condition or disease Intervention/treatment Phase
Low Immunization Uptake 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 Other: Responsive one-time SMS message on hand washing to those that erroneously register on IRISS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating SMS Messaging for Immunization Demand Generation in Nigeria
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: 14 Intervention LGAs
Various target beneficiaries will receive broadcast, targeted and individualized SMS messages on immunization.
Other: Community engagement
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

Other: IRISS advert for opt-in
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.

Other: One-time SMS broadcast on immunization
General broadcast of SMS messages on the importance of immunization to all active mobile phone subscribers in the intervention LGAs

Other: Scheduled weekly SMS reminder of health facility RI schedule to community leaders
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."

Other: Scheduled bi weekly RI messages to community leaders
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."

Other: Responsive individualized child vaccination schedule reminder to caregivers who opt-in
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."

7 Control LGAs
This arm will not receive any SMS messages on immunization
Other: Community engagement
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

Other: Responsive one-time SMS message on hand washing to those that erroneously register on IRISS
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."




Primary Outcome Measures :
  1. Difference in proportion of infants appropriately vaccinated for age [ Time Frame: 9 months ]
    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


Secondary Outcome Measures :
  1. Difference in the reach of the immunization SMS messages [ Time Frame: 9 months ]
    The proportion of parents of infants who receive SMS information on immunization and reminders about local vaccination schedules and services will be compared at end line between intervention and control LGAs.

  2. Difference in proportion of zero dose infants [ Time Frame: 9 months ]
    The proportion of children 0-11 months of age who received no routine immunization. This proportion will be compared at end line between intervention and control LGAs.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001322


Contacts
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Contact: Chizoba B Wonodi, MD,MPH,DrPH +2348100091910 chizobabw@gmail.com
Contact: Cristina Garcia, BSc,MSc,PhD +15127738029 cgarci15@jhu.edu

Locations
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Nigeria
State Primary Health Care Development Agency Recruiting
Birnin Kebbi, Kebbi State, Nigeria
Contact: Tobi Bamiduro, BSc    +2348145990328    tobi.bamiduro@dclnigeria.com   
Contact: Abubakar Muhammad, BSc       abubakarmuhammadarg@gmail.com   
Sub-Investigator: Chisom Obi-Jeff, BSc, MSc         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
Direct Consulting and Logistics
Investigators
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Principal Investigator: 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

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04001322     History of Changes
Other Study ID Numbers: IRB00008732
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs