Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

NCT ID: NCT02537756

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

737 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-05

Study Completion Date

2019-10-26

Brief Summary

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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).

Detailed Description

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Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine 3 dose coverage among adolescents is poor (38% for girls, 14% for boys). HPV-related cancers are a significant burden on the US healthcare system and could be prevented through adolescent vaccination. Rates of vaccination are suboptimal among underserved populations (uninsured, low-income, racial and ethnic minorities) often seen in safety-net clinics. Few interventions have been designed that target decision-making among parents of unvaccinated adolescents. Self-persuasion, generating of one's own arguments for a health behavior, may be an effective means of influencing HPV vaccination behaviors among undecided or ambivalent parents. Through three stages, investigators will identify and develop a self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. The current trial, Stage 2, is a four-arm randomized controlled trial (RCT), using a 2x2 factorial design, in which investigators will assign participants to one of four self-persuasion intervention conditions that vary by cognitive processing level (verbalize vs. listen to arguments) and choice of argument topics (parents choose vs. are assigned topics) to identify which intervention condition is optimal. Conducted in a laboratory setting, investigators will identify and select the optimal intervention condition through quantitative analysis of the effects on parents' vaccination intentions and qualitatively by exploring parental experiences with the self-persuasion tasks.

Conditions

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Human Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1- Verbalize, Choice

Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose

Group Type EXPERIMENTAL

Project Voice

Intervention Type BEHAVIORAL

A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition

2- Listen, Choice

Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose

Group Type EXPERIMENTAL

Project Voice

Intervention Type BEHAVIORAL

A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition

3- Verbalize, Assigned

Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them

Group Type EXPERIMENTAL

Project Voice

Intervention Type BEHAVIORAL

A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition

4- Listen, Assigned

Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them

Group Type EXPERIMENTAL

Project Voice

Intervention Type BEHAVIORAL

A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition

Interventions

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Project Voice

A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Undecided parents (18 years and older) whose children are 11-17 year old patients who have not begun the HPV vaccine series.

Exclusion Criteria

* Parents whose child is a pregnant adolescent
* Lack telephone access
* Having impairing hearing or speech
* Participants will be excluded from participation in future stages
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Southern Methodist University

OTHER

Sponsor Role collaborator

Parkland Health and Hospital System

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jasmin A Tiro, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Austin S Baldwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Methodist University

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26825137 (View on PubMed)

Other Identifiers

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1R01CA178414-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 022013-016

Identifier Type: -

Identifier Source: org_study_id

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