Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination
2 other identifiers
interventional
737
1 country
1
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 second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedStudy Start
First participant enrolled
April 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2019
CompletedMay 18, 2020
May 1, 2020
2.3 years
August 26, 2015
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Survey Items Measuring Parental Intentions to vaccinate
Change in intentions of the parent to vaccinate from baseline survey to exit survey using measures adapted from Gerend \& Shepherd (2012). Intentions Likert Scale responses range from 1-very likely to 5-very unlikely.
During the intervention visit (1 hr)
Secondary Outcomes (2)
HPV vaccination behavior documented in the electronic medical record, initiation
12 months
Change in Decision Stage
During the intervention visit (1 hr)
Other Outcomes (3)
HPV vaccination behavior documented in the electronic medical record, completion
15 months
Vaccination Concerns, qualitative
During the intervention visit (1 hr)
Manipulation checks
During the intervention visit (1 hr)
Study Arms (4)
1- Verbalize, Choice
EXPERIMENTALParents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose
2- Listen, Choice
EXPERIMENTALParents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose
3- Verbalize, Assigned
EXPERIMENTALParents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them
4- Listen, Assigned
EXPERIMENTALParents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them
Interventions
A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition
Eligibility Criteria
You may qualify if:
- Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.
You may not qualify if:
- Parents whose child is a pregnant adolescent
- Lack telephone access
- Having impairing hearing or speech
- Participants will be excluded from participation in future stages
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- National Cancer Institute (NCI)collaborator
- Southern Methodist Universitycollaborator
- Parkland Health and Hospital Systemcollaborator
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390-8557, United States
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
Study Officials
- PRINCIPAL INVESTIGATOR
Jasmin A Tiro, PhD
University of Texas Southwestern Medical Center
- PRINCIPAL INVESTIGATOR
Austin S Baldwin, PhD
Southern Methodist University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 2, 2015
Study Start
April 5, 2016
Primary Completion
July 26, 2018
Study Completion
October 26, 2019
Last Updated
May 18, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- January 2020, for 10 years
- Access Criteria
- Researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Dr. Jasmin Tiro (jasmin.tiro@utsouthwestern.edu).
Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal and sign a data use agreement. Proposals should be submitted to Dr. Jasmin Tiro (jasmin.tiro@utsouthwestern.edu).