Enhancing Health Care Access With Cellular Technology

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03180138
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH), Ministry of Science and Technology, India (Other), Bal Umang Drishya Sanstha (BUDS), India (Other), Royal Datamatics Pvt. Ltd. (RDPL), India (Other), St. Louis University (Other)
• Enrollment: 608
• Arms: 3
• Actual Duration (Months): 12.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination	Behavioral: Reminders alone; Behavioral: Compliance-linked incentives	N/A

Detailed Description

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.

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 608 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single blinded prospective studySingle blinded prospective study
• Masking: Single (Investigator)
• Masking Description: Study team members are blinded to group assignments.
• Primary Purpose: Health Services Research
• Official Title: Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations
• Actual Study Start Date: Jul 11, 2016
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Jul 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Controls
Active Comparator: Reminders alone	Behavioral: 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.
Active Comparator: Reminders + compliance-linked incentives	Behavioral: 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.; 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.

Outcome Measures

Primary Outcome Measures

1. Immunization Rate [12 months]

   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.

Secondary Outcome Measures

1. Timeliness of Vaccinations [12 months]

   The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins University
• National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Ministry of Science and Technology, India
• Bal Umang Drishya Sanstha (BUDS), India
• Royal Datamatics Pvt. Ltd. (RDPL), India
• St. Louis University

Investigators

• Principal Investigator: Sanjay K Jain, MD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 15, 2016

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03180138
• Other Study ID Numbers: IRB00086292; R03EB015955
• First Posted: Jun 8, 2017
• Last Update Posted: Jun 25, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Johns Hopkins University: mobile phone; Children's Health

Study Results

Participant Flow

Arm/Group Title	Controls	Reminders Alone	Reminders + Compliance-linked Incentives
Arm/Group Description	A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
Period Title: Overall Study
STARTED	204	201	203
COMPLETED	182	188	179
NOT COMPLETED	22	13	24

Baseline Characteristics

Arm/Group Title	Controls	Reminders Alone	Reminders + Compliance-linked Incentives	Total
Arm/Group Description	A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	Total of all reporting groups
Overall Participants	182	188	179	549
Age (Months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Months]	5	5	4	5
Sex: Female, Male (Count of Participants)
Female	95 52.2%	97 51.6%	90 50.3%	282 51.4%
Male	87 47.8%	91 48.4%	89 49.7%	267 48.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	182 100%	188 100%	179 100%	549 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Immunization Rate
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Controls	Reminders Alone	Reminders + Compliance-linked Incentives
Arm/Group Description	A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
Measure Participants	182	188	179
Median (Inter-Quartile Range) [Percentage of immunizations]	41.7	40.1	50.0

2. Secondary Outcome

Title	Timeliness of Vaccinations
Description	The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The events analyzed here are the total number of vaccines rather than subjects in each cohort. The outcome measure is the percent of the number of vaccines that were administrated in a timely manner divided by the total number of scheduled vaccines.

Arm/Group Title	Controls	Reminders Alone	Reminders + Compliance-linked Incentives
Arm/Group Description	A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.	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). Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
Measure Participants	182	188	179
Measure Vaccines	243	243	287
Number [Percentage of vaccines]	31.6	24.7	40.8

Adverse Events

Time Frame	1 year
Arm/Group Title	Controls		Reminders Alone		Reminders + Compliance-linked Incentives
Arm/Group Description	A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.		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). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.		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). Compliance-linked incentives: Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver). A cloud-based, biometric-linked software platform was used for positive identification, and record keeping.
All Cause Mortality
	Controls		Reminders Alone		Reminders + Compliance-linked Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/188 (0%)		0/179 (0%)
Serious Adverse Events
	Controls		Reminders Alone		Reminders + Compliance-linked Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/188 (0%)		0/179 (0%)
Other (Not Including Serious) Adverse Events
	Controls		Reminders Alone		Reminders + Compliance-linked Incentives
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/188 (0%)		0/179 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.