Timeliness of Immunization and Compliance Assessment Study

NCT ID: NCT03428776

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2065 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2019-09-25

Brief Summary

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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

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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.

Conditions

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Vaccinations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded prospective study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Controls

Self returns

Group Type SHAM_COMPARATOR

Record keeping

Intervention Type OTHER

Electronic immunization records on cloud-based software platform and use of biometric identification

Standard Compliance-linked incentives

Standard mobile-phone reminders and compliance-linked incentives

Group Type ACTIVE_COMPARATOR

Standard Compliance-linked incentives

Intervention Type BEHAVIORAL

Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

Intelligent Compliance-linked incentives

Intelligent mobile-phone reminders and compliance-linked incentives

Group Type ACTIVE_COMPARATOR

Intelligent Compliance-linked incentives

Intervention Type BEHAVIORAL

Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

Interventions

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Standard Compliance-linked incentives

Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

Intervention Type BEHAVIORAL

Intelligent Compliance-linked incentives

Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification

Intervention Type BEHAVIORAL

Record keeping

Electronic immunization records on cloud-based software platform and use of biometric identification

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Mother (or caregiver) with one or more children ≤24 months in their family will be enrolled
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Bal Umang Drishya Sanstha (BUDS), India

OTHER

Sponsor Role collaborator

Royal Datamatics Pvt. Ltd. (RDPL), India

UNKNOWN

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjay K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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BUDS

Haryāna, , India

Site Status

Countries

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India

Other Identifiers

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IRB00161339

Identifier Type: -

Identifier Source: org_study_id

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