Vaccination
Conditions
Keywords
mobile phone, Children's Health
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.
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. 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.
Interventions
BEHAVIORALReminders 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.
BEHAVIORALCompliance-linked incentives
Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.
Sponsors
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
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
Study team members are blinded to group assignments.
Intervention model description
Single blinded prospective study
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Controls A cloud-based, biometric-linked software platform was used for positive identification, and record keeping. | 182 |
| Reminders Alone 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. | 188 |
| Reminders + Compliance-linked Incentives 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. | 179 |
| Total | 549 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Found to be >24 mon after randomization | 3 | 0 | 3 |
| Overall Study | Mobile-phone could not be verified | 2 | 13 | 15 |
| Overall Study | No prior immunization records | 17 | 0 | 6 |
Baseline characteristics
| Characteristic | Controls | Reminders Alone | Reminders + Compliance-linked Incentives | Total |
|---|---|---|---|---|
| Age, Continuous | 5 Months | 5 Months | 4 Months | 5 Months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 182 Participants | 188 Participants | 179 Participants | 549 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 95 Participants | 97 Participants | 90 Participants | 282 Participants |
| Sex: Female, Male Male | 87 Participants | 91 Participants | 89 Participants | 267 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 182 | 0 / 188 | 0 / 179 |
| other Total, other adverse events | 0 / 182 | 0 / 188 | 0 / 179 |
| serious Total, serious adverse events | 0 / 182 | 0 / 188 | 0 / 179 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Controls | Immunization Rate | 41.7 Percentage of immunizations |
| Reminders Alone | Immunization Rate | 40.1 Percentage of immunizations |
| Reminders + Compliance-linked Incentives | Immunization Rate | 50.0 Percentage of immunizations |
Secondary
Timeliness of Vaccinations
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Controls | Timeliness of Vaccinations | 31.6 Percentage of vaccines |
| Reminders Alone | Timeliness of Vaccinations | 24.7 Percentage of vaccines |
| Reminders + Compliance-linked Incentives | Timeliness of Vaccinations | 40.8 Percentage of vaccines |