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NCT04001322: IRISS
Tunatar da ni. The Immunization Reminder and Information SMS System (IRISS)
NA trial testing Community engagement in Low Immunization Uptake in 21 participants. Completed in 29 November 2020.
30 October 2020
Quick facts
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 21 |
| Start date | 15 June 2019 |
| Primary completion | 30 October 2020 |
| Estimated completion | 29 November 2020 |
| Sites | 1 location across Nigeria |
Drugs / interventions tested
- Community engagement
- IRISS advert for opt-in
- One-time SMS broadcast on immunization
- Scheduled weekly SMS reminder of health facility RI schedule to community leaders
- Scheduled bi weekly RI messages to community leaders
- Responsive individualized child vaccination schedule reminder to caregivers who opt-in
- Responsive one-time SMS message on hand washing to those that erroneously register on IRISS
Conditions studied
- Low Immunization Uptake — all drugs for Low Immunization Uptake →
Sponsor
Johns Hopkins Bloomberg School of Public Health
Who can join
Eligibility, any sex, with Low Immunization Uptake. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04001322 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health
- Last refreshed: 7 October 2022
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