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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Emerging communication technologies, such as text messaging offer low-cost, scalable opportunities to improve health literacy and promote healthy behaviors, such as vaccination. While the investigators reported the success of text message vaccine reminders, effects were limited by their untailored approach. The trans-theoretical model of behavior change supports tailoring interventions to an individual's stage of decision-making. Human papillomavirus (HPV) is the most prevalent sexually transmitted virus in the U.S. and can lead to genital warts, and cervical, anal and penile cancer. The three-dose vaccine is 90-100% efficacious. Minorities are at greatest risk for such cancers but have low HPV vaccine completion rates. Limited health literacy regarding the vaccine can affect series completion. The investigators will compare the effects of enhancing text message vaccination reminders with interactive, vaccine health literacy-promoting information tailored to vaccine decision making-stage on HPV vaccine series completion. The effects of these messages represent a new paradigm in interactive health communications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Text Message | Experimental | Conventional text message reminder |
|
| Enhanced reminders | Experimental | Enhanced text message reminders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional text message reminder | Behavioral | Receipt of conventional text message notifying when due for next dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed HPV Vaccine Series | receipt of 3 doses of HPV vaccine by 12 months after initiation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time Between 1st and 2nd Dose | Time elapsed in days between first and second dose- for those in need of three doses | 12 months |
| Time Between 1st and 3rd Dose | Time elapsed (in days) between 1st and 3rd dose for those in need of three doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa S Stockwell, MD MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34958306 | Derived | Wynn CS, Catallozzi M, Kolff CA, Holleran S, Meyer D, Ramakrishnan R, Stockwell MS. Personalized Reminders for Immunization Using Short Messaging Systems to Improve Human Papillomavirus Vaccination Series Completion: Parallel-Group Randomized Trial. JMIR Mhealth Uhealth. 2021 Dec 27;9(12):e26356. doi: 10.2196/26356. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Text Message | Conventional text message reminder Conventional text message reminder: Receipt of conventional text message notifying when due for next dose |
| FG001 | Enhanced Reminders | Enhanced text message reminders Enhanced text message reminders: Receipt of enhanced text messages notifying when due for next dose coupled with educational information |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Text Message | Conventional text message reminder Conventional text message reminder: Receipt of conventional text message notifying when due for next dose |
| BG001 | Enhanced Reminders |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Number of Participants Who Completed HPV Vaccine Series | receipt of 3 doses of HPV vaccine by 12 months after initiation | Posted | Count of Participants | Participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Text Message | Conventional text message reminder Conventional text message reminder: Receipt of conventional text message notifying when due for next dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Stockwell | Columbia University | 2123425732 | mss2112@cumc.columbia.edu |
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| 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 | Jan 5, 2021 | Oct 15, 2024 | Prot_SAP_000.pdf |
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| Enhanced text message reminders | Behavioral | Receipt of enhanced text messages notifying when due for next dose coupled with educational information |
|
| 12 months |
Enhanced text message reminders
Enhanced text message reminders: Receipt of enhanced text messages notifying when due for next dose coupled with educational information
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Language | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time Between 1st and 2nd Dose | Time elapsed in days between first and second dose- for those in need of three doses | Posted | Mean | Standard Deviation | days | 12 months |
|
|
|
| Secondary | Time Between 1st and 3rd Dose | Time elapsed (in days) between 1st and 3rd dose for those in need of three doses | Posted | Mean | Standard Deviation | days | 12 months |
|
|
|
| 0 |
| 481 |
| 0 |
| 481 |
| 0 |
| 481 |
| EG001 | Enhanced Reminders | Enhanced text message reminders Enhanced text message reminders: Receipt of enhanced text messages notifying when due for next dose coupled with educational information | 0 | 475 | 0 | 475 | 0 | 475 |
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