Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R03EB015955 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| Ministry of Science and Technology, India | OTHER_GOV |
| Bal Umang Drishya Sanstha (BUDS), India | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | No Intervention | ||
| Reminders alone | Active Comparator |
| |
| Reminders + compliance-linked incentives | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reminders alone | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Timeliness of Vaccinations | The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort. | 12 months |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjay K Jain, MD | Johns Hopkins University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32813276 | Derived | 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. | |
| 29540571 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Controls | A cloud-based, biometric-linked software platform was used for positive identification, and record keeping. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Controls | A cloud-based, biometric-linked software platform was used for positive identification, and record keeping. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Percentage of immunizations | 12 months |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls | A cloud-based, biometric-linked software platform was used for positive identification, and record keeping. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay K Jain | Johns Hopkins University | 4105028241 | sjain5@jhmi.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2016 | May 22, 2018 | Prot_SAP_000.pdf |
Not provided
| Royal Datamatics Pvt. Ltd. (RDPL), India |
| UNKNOWN |
| St. Louis University | OTHER |
Single blinded prospective study
Not provided
Not provided
Study team members are blinded to group assignments.
| Compliance-linked incentives | Behavioral | Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman. |
|
| Found to be >24 mon after randomization |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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. | 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. | Posted | Number | Percentage of vaccines | 12 months | Vaccines | Vaccines |
|
|
|
| 0 |
| 182 |
| 0 |
| 182 |
| 0 |
| 182 |
| EG001 | 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. | 0 | 188 | 0 | 188 | 0 | 188 |
| EG002 | 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. | 0 | 179 | 0 | 179 | 0 | 179 |
Not provided
Not provided