Enhancing Health Care Access With Cellular Technology

NCT ID: NCT03180138

Last Updated: 2018-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

608 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2017-07-20

Brief Summary

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Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.

Detailed Description

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A web-based, biometric-linked vaccination record, cell-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) Web-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 automated text message reminders and compliance-linked incentives.

Conditions

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Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded prospective study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Study team members are blinded to group assignments.

Study Groups

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Controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Reminders alone

Group Type ACTIVE_COMPARATOR

Reminders alone

Intervention Type BEHAVIORAL

Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Reminders + compliance-linked incentives

Group Type ACTIVE_COMPARATOR

Reminders alone

Intervention Type BEHAVIORAL

Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Compliance-linked incentives

Intervention Type BEHAVIORAL

Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Interventions

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Reminders alone

Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Intervention Type BEHAVIORAL

Compliance-linked incentives

Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Mother-child (or caregiver-child) units with child \<2 years of age OR Pregnant women

Exclusion Criteria

Family does not have cell-phone OR cannot provide informed consent
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Ministry of Science and Technology, India

OTHER_GOV

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

References

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Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

Seth R, Akinboyo I, Chhabra A, Qaiyum Y, Shet A, Gupte N, Jain AK, Jain SK. Mobile Phone Incentives for Childhood Immunizations in Rural India. Pediatrics. 2018 Apr;141(4):e20173455. doi: 10.1542/peds.2017-3455. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29540571 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R03EB015955

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00086292

Identifier Type: -

Identifier Source: org_study_id

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