Clinical trial NCT03428776: Timeliness of Immunization and Compliance Assessment Study
Official title: Timeliness of Immunization and Compliance Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccinations
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Bal Umang Drishya Sanstha (BUDS), India
name: Royal Datamatics Pvt. Ltd. (RDPL), India
name: St. Louis University
First posted: 2018-02-12
Enrollment: 2065
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded prospective study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although coverage for primary childhood immunizations has improved, a significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. While young children receive some primary vaccines, many are never fully vaccinated. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. Major challenges include maintaining immunization records linked to positive identification of the individual child, incentivizing follow-up and return immunizations and efficiently identifying and targeting non-compliant subjects. Mobile-phone costs have decreased dramatically in the developing world with rapid proliferation of web and mobile-phone connectivity. Novel approaches that integrate these modern technologies with existing resources in low and middle income countries can cost-effectively address these challenges. In this proposal, investigators will evaluate a novel software platform, utilizing biometric identification and of subjects, paired with intelligent and subject-aware, mobile-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children.

Detailed description: A cloud-based, biometric-linked vaccination record, mobile-phone reminder and compliance-linked incentive software platform to provide robust and universal access of vaccinations. The investigators will implement this platform in a low-resource settings with the following features: a) Cloud-based for robust and universal access. b) Biometric-linked for positive identification. c) Digital storage and reporting for transparent view of program operations. d) Global Positioning System (GPS)-linked, allowing rapid assessment of vaccination status of communities. e) Increasing vaccination uptake and coverage by intelligent and subject-aware automated reminders and compliance-linked incentives.

Eligibility criteria: Inclusion Criteria:

* Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
* There will be no exclusion criteria based on race, ethnicity or gender.

Exclusion Criteria:

- Participants unable or unwilling to comply with the protocol or with any other condition that would impede compliance or hinder completion of the study (e.g. no mobile-phone in the family), or failure to give informed consent would be the only exclusion criteria.

Primary outcomes:
measure: Timeliness of immunization
timeFrame: 12-15 months
Secondary outcomes:
measure: Immunization rate
timeFrame: 12-15 months
Other outcomes:
Locations:
city: Haryana
country: India
facility: BUDS
Study officials:
affiliation: Johns Hopkins University
name: Sanjay K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References: