Human Papillomavirus
Conditions
Keywords
Human papillomavirus, vaccination, text message, reminder
Brief summary
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.
Interventions
BEHAVIORALConventional text message reminder
Receipt of conventional text message notifying when due for next dose
BEHAVIORALEnhanced text message reminders
Receipt of enhanced text messages notifying when due for next dose coupled with educational information
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Parenting adult of adolescent age 11-17 years * Adolescent received 1st dose of HPV at a study site within the last 2 weeks. * Eligible parent's cell phone has text message capability
Exclusion criteria
* Language other than English or Spanish only * Parent already in the study * Intends to move away from the New York City area in \<12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed HPV Vaccine Series | 12 months | receipt of 3 doses of HPV vaccine by 12 months after initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Between 1st and 2nd Dose | 12 months | Time elapsed in days between first and second dose- for those in need of three doses |
| Time Between 1st and 3rd Dose | 12 months | Time elapsed (in days) between 1st and 3rd dose for those in need of three doses |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Text Message Conventional text message reminder
Conventional text message reminder: Receipt of conventional text message notifying when due for next dose | 481 |
| 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 | 475 |
| Total | 956 |
Baseline characteristics
| Characteristic | Conventional Text Message | Enhanced Reminders | Total |
|---|---|---|---|
| Age, Customized < 14 years | 443 Participants | 437 Participants | 880 Participants |
| Age, Customized 15- 17 years | 38 Participants | 38 Participants | 76 Participants |
| Language English | 171 Participants | 171 Participants | 342 Participants |
| Language Spanish | 310 Participants | 304 Participants | 614 Participants |
| Race/Ethnicity, Customized Black | 47 Participants | 66 Participants | 113 Participants |
| Race/Ethnicity, Customized Latinx | 270 Participants | 255 Participants | 525 Participants |
| Race/Ethnicity, Customized Other | 91 Participants | 73 Participants | 164 Participants |
| Race/Ethnicity, Customized White | 73 Participants | 81 Participants | 154 Participants |
| Sex: Female, Male Female | 236 Participants | 242 Participants | 478 Participants |
| Sex: Female, Male Male | 245 Participants | 233 Participants | 478 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 481 | 0 / 475 |
| other Total, other adverse events | 0 / 481 | 0 / 475 |
| serious Total, serious adverse events | 0 / 481 | 0 / 475 |
Outcome results
Primary
Number of Participants Who Completed HPV Vaccine Series
receipt of 3 doses of HPV vaccine by 12 months after initiation
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Text Message | Number of Participants Who Completed HPV Vaccine Series | 364 Participants |
| Enhanced Reminders | Number of Participants Who Completed HPV Vaccine Series | 344 Participants |
Secondary
Time Between 1st and 2nd Dose
Time elapsed in days between first and second dose- for those in need of three doses
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Text Message | Time Between 1st and 2nd Dose | 84.1 days | Standard Deviation 59 |
| Enhanced Reminders | Time Between 1st and 2nd Dose | 82.8 days | Standard Deviation 57 |
Secondary
Time Between 1st and 3rd Dose
Time elapsed (in days) between 1st and 3rd dose for those in need of three doses
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Text Message | Time Between 1st and 3rd Dose | 210 days | Standard Deviation 43 |
| Enhanced Reminders | Time Between 1st and 3rd Dose | 210 days | Standard Deviation 43 |