NCT02535845

Brief Summary

HPV vaccine coverage among adolescents in the US is suboptimal. This is particularly true among traditionally underserved adolescents. Few parent-targeted interventions have focused on the parental decision-making process. Self-persuasion, generating one's own arguments for engaging in a behavior, may be an effective means to influence parents' motivation to vaccinate their children. In a three-phase study, investigators are using quantitative and qualitative research methods to develop and refine a tablet-based self-persuasion intervention for parents who are undecided about the HPV vaccine. This clinical trial submission focuses on the third phase of the study (the second stage is also registered in clinical trials).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
5 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

August 26, 2015

Results QC Date

October 25, 2023

Last Update Submit

January 22, 2024

Conditions

Human Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

  • HPV Vaccination Behavior Documented in Electronic Health Record, Initiation

    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.

    30 days

Secondary Outcomes (2)

  • HPV Vaccination Behavior Documented in Electronic Medical Record, Completion

    15 months

  • Active Parent Participation During Clinical Encounter

    1 day

Study Arms (2)

Self-persuasion group

EXPERIMENTAL

HPV information plus self-persuasion intervention in a tablet-based application (Project Voice)

Behavioral: Project Voice

Information only group

ACTIVE COMPARATOR

HPV information only in a tablet-based application (HPV Informational Video)

Behavioral: HPV Informational Video

Interventions

Project VoiceBEHAVIORAL

Project Voice tablet-based intervention plus informational video

Self-persuasion group
HPV Informational VideoBEHAVIORAL

Informational video only

Information only group

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents: Undecided about the HPV vaccine
  • Adolescent child: 11-17 years old and has not begun the HPV vaccine series.

You may not qualify if:

  • Parents: Having impairing hearing or speech
  • Adolescents: pregnant at the time of the clinic visit
  • Dyad: participated in Phase 1 and 2 of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8557, United States

Location

Related Publications (1)

  • Tiro JA, Lee SC, Marks EG, Persaud D, Skinner CS, Street RL, Wiebe DJ, Farrell D, Bishop WP, Fuller S, Baldwin AS. Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study. JMIR Res Protoc. 2016 Jan 29;5(1):e19. doi: 10.2196/resprot.5092.

    PMID: 26825137DERIVED

Results Point of Contact

Title
Dr. Jasmin Tiro
Organization
The University of Chicago
jtiro@bsd.uchicago.edu
773-834-4384

Study Officials

  • Jasmin A Tiro, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • Austin S Baldwin, PhD

    Southern Methodist University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 31, 2015

Study Start

December 21, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Locations

US(1)