Human Papilloma Virus
Conditions
Keywords
HPV vaccination, Adolescent well care, Adolescent HPV immunization, HPV
Brief summary
The purpose of the study is to evaluate the effectiveness of a managed care-based HPV vaccination reminder/recall system using a randomized controlled trial (RCT) across diverse practices and patient populations. The trial will measure the effectiveness of text messaging reminder/recall on (a) improving initiation and (b) completion rate of the HPV vaccine series; (c) decreasing the time between vaccine doses; and (d) improving rates of preventive visits for adolescents The hypotheses are that text-messaged reminders to parents of adolescents will result in improved rates of HPV vaccine series initiation, HPV vaccine series completion, will decrease the intervals between vaccine doses and will improve rates of preventive care among adolescents. Parents receiving specific text-messaged reminders about services (i.e. HPV vaccination, well child care visits) for which their adolescent is due will be compared to a control group of parents receiving general health tips through text messages.
Detailed description
The study setting is western New York State and the Southern Tier of New York State (15 counties total). Investigators will work with the Monroe Plan for Medical Care, an IPA-model managed care organization (MCO) that serves Medicaid managed care and SCHIP enrollees. The MCO will conduct regular reviews of insurance claims data and the New York State Immunization Information System of adolescents ages 11-\<16 years. Parents (all over 18 years of age) of adolescents will receive the texted messages on their phones. There are no enrollment restrictions based upon race or ethnic origin. The inclusion criteria are that the adolescents are a) enrolled in Medicaid or SCHIP through the Monroe Plan, b) have been enrolled greater than 6 months with the Monroe Plan (in order to have sufficient claims data to determine whether they are due for a well child care visit or recommended immunizations), c) the Monroe Plan has received their consent to send preventive care text messages, d) their child attend a primary care practice that has agreed to participate and d) they are between the ages of 11-\<16 years at the start of the study. The key independent measure is group allocation (intervention vs. control); an intention-to-treat strategy will be used to assess the effectiveness of text messaging reminders. Key outcome measures will be: 1) receipt of 0, 1, 2 or 3 doses of HPV vaccine 2) interval (in days) between doses and 3) having a preventive visit in the 6 month period.
Interventions
Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Patients due for a well visit or HPV vaccine received a text reminder
Sponsors
Study design
Eligibility
Inclusion criteria
* 11-\<18 years * Member of MCO for \>6 months * Opted in to receive texted reminders from MCO
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving HPV Vaccination (Dose 1) | 9 months | Participants who received HPV vaccine dose 1 Kaplan-Meier failure function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving HPV Vaccination (Dose 2) | 9 months | Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function |
| Percentage of Participants Receiving HPV Vaccination (Dose 3) | 9 months | Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function |
Countries
United States
Participant flow
Recruitment details
4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers
Pre-assignment details
For this study, there was a waiver of consent; 4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers.
Participants by arm
| Arm | Count |
|---|---|
| Text-based Reminder for HPV Vaccine/WCC Parents of adolescents will receive text-based reminders if their adolescent is due for HPV vaccine (dose 1, 2 or 3) or well child care visit
Text-based reminder for recommended HPV vaccine or well care visit | 1,893 |
| Control Arm Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
Non-specific text-based reminder (general health tip): Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due) | 1,919 |
| Total | 3,812 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No functioning phone number | 200 | 170 |
Baseline characteristics
| Characteristic | Text-based Reminder for HPV Vaccine/WCC | Control Arm | Total |
|---|---|---|---|
| Age, Customized 11 year olds | 428 participants | 407 participants | 835 participants |
| Age, Customized 12 year olds | 341 participants | 380 participants | 721 participants |
| Age, Customized 13 year olds | 307 participants | 324 participants | 631 participants |
| Age, Customized 14 year olds | 281 participants | 288 participants | 569 participants |
| Age, Customized 15 year olds | 271 participants | 270 participants | 541 participants |
| Age, Customized 16 year olds | 265 participants | 250 participants | 515 participants |
| Sex: Female, Male Female | 863 Participants | 868 Participants | 1731 Participants |
| Sex: Female, Male Male | 1030 Participants | 1051 Participants | 2081 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,893 | 0 / 1,919 |
| serious Total, serious adverse events | 0 / 1,893 | 0 / 1,919 |
Outcome results
Percentage of Participants Receiving HPV Vaccination (Dose 1)
Participants who received HPV vaccine dose 1 Kaplan-Meier failure function
Time frame: 9 months
Population: Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text-based Reminder for HPV Vaccine/WCC | Percentage of Participants Receiving HPV Vaccination (Dose 1) | 16 percentage of eligible participants |
| Control Arm | Percentage of Participants Receiving HPV Vaccination (Dose 1) | 13 percentage of eligible participants |
Percentage of Participants Receiving HPV Vaccination (Dose 2)
Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function
Time frame: 9 months
Population: Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text-based Reminder for HPV Vaccine/WCC | Percentage of Participants Receiving HPV Vaccination (Dose 2) | 6 percentage of eligible participants |
| Control Arm | Percentage of Participants Receiving HPV Vaccination (Dose 2) | 7 percentage of eligible participants |
Percentage of Participants Receiving HPV Vaccination (Dose 3)
Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function
Time frame: 9 months
Population: Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Text-based Reminder for HPV Vaccine/WCC | Percentage of Participants Receiving HPV Vaccination (Dose 3) | 2 percentage of eligible participants |
| Control Arm | Percentage of Participants Receiving HPV Vaccination (Dose 3) | 2 percentage of eligible participants |