Timeliness of Immunization and Compliance Assessment Study

NCT03428776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2065

Last updated 2019-09-27

No results posted yet for this study

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.

Conditions

  • Vaccinations

Interventions

BEHAVIORAL

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

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

OTHER

Record keeping

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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • Bal Umang Drishya Sanstha (BUDS), India

    collaborator OTHER
  • Royal Datamatics Pvt. Ltd. (RDPL), India

    collaborator UNKNOWN
  • St. Louis University

    collaborator OTHER
  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Sanjay K Jain, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2019-09-25
Completion
2019-09-25

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428776 on ClinicalTrials.gov