Trial Outcomes & Findings for Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial (NCT NCT02535845)

NCT ID: NCT02535845

Last Updated: 2024-01-30

Results Overview

Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-01-30

Participant Flow

Parent-adolescent dyads were randomized to intervention arms. Parents were exposed to the intervention arm. Primary outcome measure (HPV vaccination) was assessed on the adolescent child via the electronic health record. The number started/completed represents the number of parent-adolescent dyads.

Participant milestones

Measure	Self-persuasion Group - Parent HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video	Self-persuasion Group - Adolescent Adolescent's parent was exposed to HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video	Information Only Group - Parent HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only	Information Group Only - Adolescent HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only
Overall Study STARTED	7	7	4	4
Overall Study COMPLETED	7	7	4	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination: Feasibility Trial

Baseline characteristics by cohort

Measure	Self-persuasion Group-Parent n=7 Participants HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video	Self-persuasion Group- Adolescent n=7 Participants Parent exposed to HPV information plus self-persuasion intervention in a tablet-based application (Project Voice) Project Voice: Project Voice tablet-based intervention plus informational video	Information Only Group - Parent n=4 Participants HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only	Information Only Group - Adolescent n=4 Participants Parent exposed to HPV information only in a tablet-based application (HPV Informational Video) HPV Informational Video: Informational video only	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	11 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Data were not collected due to early termination of the study

Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 months

Population: Data were not collected due to early termination of the study

Number of doses received and the dates of those doses within 15 months of the study appointment as evidenced by documentation in the child's electronic medical record.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day

Population: Data were not collected due to early termination of the study

Investigators will explore the factors associated with parent degree of participation in the discussion with the healthcare provider during the clinical encounter using Street coding scheme of 3 types of active communication.

Outcome measures

Outcome data not reported

Adverse Events

Self-persuasion Group - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-persuasion Group - Adolescents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Information Only Group-Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Information Only Group - Adolescents

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. Jasmin Tiro

The University of Chicago

Phone: 773-834-4384

Email: jtiro@bsd.uchicago.edu

Results disclosure agreements

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