NCT03180138

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
608

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

June 5, 2017

Results QC Date

April 4, 2018

Last Update Submit

June 20, 2018

Conditions

Vaccination

Keywords

mobile phoneChildren's Health

Outcome Measures

Primary Outcomes (1)

  • Immunization Rate

    Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.

    12 months

Secondary Outcomes (1)

  • Timeliness of Vaccinations

    12 months

Study Arms (3)

Controls

NO INTERVENTION

Reminders alone

ACTIVE COMPARATOR
Behavioral: Reminders alone

Reminders + compliance-linked incentives

ACTIVE COMPARATOR
Behavioral: Reminders aloneBehavioral: Compliance-linked incentives

Interventions

Reminders aloneBEHAVIORAL

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 incentivesReminders alone
Compliance-linked incentivesBEHAVIORAL

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

Reminders + compliance-linked incentives

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Family does not have cell-phone OR cannot provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 32813276DERIVED

  • 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.

    PMID: 29540571DERIVED

Results Point of Contact

Title
Sanjay K Jain
Organization
Johns Hopkins University
sjain5@jhmi.edu
4105028241

Study Officials

  • Sanjay K Jain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Study team members are blinded to group assignments.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Single blinded prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2017

First Posted

June 8, 2017

Study Start

July 11, 2016

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

June 25, 2018

Results First Posted

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share