Trial Outcomes & Findings for Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series (NCT NCT01343485)

NCT ID: NCT01343485

Last Updated: 2018-06-26

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

365 participants

Primary outcome timeframe

32 weeks after receipt of initial vaccine

Results posted on

2018-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Control, Standard Care for HPV Vaccine Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol	Intervention, Computer Reminder System Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
Overall Study STARTED	185	180
Overall Study COMPLETED	36	46
Overall Study NOT COMPLETED	149	134

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Innovative Tool to Increase Completion of Human Papillomavirus (HPV) Vaccine Series

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control, Standard Care for HPV Vaccine n=185 Participants Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol	Intervention, Computer Reminder System n=180 Participants Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series	Total n=365 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	185 Participants n=93 Participants	180 Participants n=4 Participants	365 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	23.64 years STANDARD_DEVIATION 2.15 • n=93 Participants	23.17 years STANDARD_DEVIATION 2.18 • n=4 Participants	23.41 years STANDARD_DEVIATION 2.18 • n=27 Participants
Sex: Female, Male Female	185 Participants n=93 Participants	180 Participants n=4 Participants	365 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	185 participants n=93 Participants	180 participants n=4 Participants	365 participants n=27 Participants

PRIMARY outcome

Timeframe: 32 weeks after receipt of initial vaccine

Outcome measures

Outcome measures
Measure	Control, Standard Care for HPV Vaccine n=185 Participants Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol	Intervention, Computer Reminder System n=180 Participants Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine. Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
On-time Completion of the Human Papillomavirus Vaccine Series	36 participants	31 participants

Adverse Events

Control, Standard Care for HPV Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention, Computer Reminder System

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

Zoe Unger, Research Program Coordinator

Planned Parenthood Federation of America

Phone: 212-261-4702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place