Trial Outcomes & Findings for Text Reminders to Immunize in a Managed Care Organization (NCT NCT01806714)

NCT ID: NCT01806714

Last Updated: 2017-06-26

Results Overview

Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3812 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2017-06-26

Participant Flow

4182 subjects met eligibility but only a subset were enrolled to receive the intervention because they has functional phone numbers

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.

Participant milestones

Measure	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	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)
Overall Study STARTED	2093	2089
Overall Study COMPLETED	1893	1919
Overall Study NOT COMPLETED	200	170

Reasons for withdrawal

Measure	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	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)
Overall Study No functioning phone number	200	170

Baseline Characteristics

Text Reminders to Immunize in a Managed Care Organization

Baseline characteristics by cohort

Measure	Text-based Reminder for HPV Vaccine/WCC n=1893 Participants 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	Control Arm n=1919 Participants 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)	Total n=3812 Participants Total of all reporting groups
Age, Customized 11 year olds	428 participants n=5 Participants	407 participants n=7 Participants	835 participants n=5 Participants
Age, Customized 12 year olds	341 participants n=5 Participants	380 participants n=7 Participants	721 participants n=5 Participants
Age, Customized 13 year olds	307 participants n=5 Participants	324 participants n=7 Participants	631 participants n=5 Participants
Age, Customized 14 year olds	281 participants n=5 Participants	288 participants n=7 Participants	569 participants n=5 Participants
Age, Customized 15 year olds	271 participants n=5 Participants	270 participants n=7 Participants	541 participants n=5 Participants
Age, Customized 16 year olds	265 participants n=5 Participants	250 participants n=7 Participants	515 participants n=5 Participants
Sex: Female, Male Female	863 Participants n=5 Participants	868 Participants n=7 Participants	1731 Participants n=5 Participants
Sex: Female, Male Male	1030 Participants n=5 Participants	1051 Participants n=7 Participants	2081 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.

Participants who received HPV vaccine dose 1 Kaplan-Meier failure function

Outcome measures

Measure	Text-based Reminder for HPV Vaccine/WCC n=964 Participants 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	Control Arm n=961 Participants 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)
Percentage of Participants Receiving HPV Vaccination (Dose 1)	16 percentage of eligible participants	13 percentage of eligible participants

SECONDARY outcome

Timeframe: 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.

Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function

Outcome measures

Measure	Text-based Reminder for HPV Vaccine/WCC n=1007 Participants 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	Control Arm n=1014 Participants 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)
Percentage of Participants Receiving HPV Vaccination (Dose 2)	6 percentage of eligible participants	7 percentage of eligible participants

SECONDARY outcome

Timeframe: 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.

Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function

Outcome measures

Measure	Text-based Reminder for HPV Vaccine/WCC n=958 Participants 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	Control Arm n=966 Participants 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)
Percentage of Participants Receiving HPV Vaccination (Dose 3)	2 percentage of eligible participants	2 percentage of eligible participants

Adverse Events

Text-based Reminder for HPV Vaccine/WCC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cynthia Rand

University of Rochester

Phone: 585 275-9316

Email: cynthia_rand@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place