NCT02537756|CompletedDMC
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Sponsor study identifier
Secondary identifiers
interventional
737
1 country
1
Study Start
April 5, 2016
Actual (reported)Primary Completion
July 26, 2018
Actual (reported)Study Completion
October 26, 2019
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 26, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2015
Actual (reported)September 2, 2015
Actual (reported)April 5, 2016
Actual (reported)July 26, 2018
Actual (reported)October 26, 2019
Actual (reported)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)
HPV vaccination behavior documented in the electronic medical record, initiation
12 months
Change in Decision Stage
During the intervention visit (1 hr)
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)
Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose
Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose
Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them
A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UT Southwestern Medical Center
Dallas, Texas, 75390-8557, United States
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.
Jasmin A Tiro, PhD
University of Texas Southwestern Medical Center
Austin S Baldwin, PhD
Southern Methodist University
737 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2015
First Posted
September 2, 2015
Study Start
April 5, 2016
Actual (reported)The STOP-HPV Scale Up Study
Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them
Contact the study team to confirm eligibility.
Primary Completion
July 26, 2018
Actual (reported)Study Completion
October 26, 2019
Actual (reported)Last Updated
May 18, 2020
Record last verified: 2020-05
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).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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