Timeliness of Immunization and Compliance Assessment Study (TICA)

Johns Hopkins University

Status: Completed

Conditions: Vaccinations

Treatments: Behavioral: Intelligent Compliance-linked incentives; Behavioral: Standard Compliance-linked incentives; Other: Record keeping

Study type: Interventional

Funder types: Other

Identifiers

NCT03428776

IRB00161339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,065 patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,065 participants in 3 patient groups

Controls

Sham Comparator group

Description:

Self returns

Treatment:

Other: Record keeping

Standard Compliance-linked incentives

Active Comparator group

Description:

Standard mobile-phone reminders and compliance-linked incentives

Treatment:

Behavioral: Standard Compliance-linked incentives

Intelligent Compliance-linked incentives

Active Comparator group

Description:

Intelligent mobile-phone reminders and compliance-linked incentives

Treatment:

Behavioral: Intelligent Compliance-linked incentives