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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2019-01-31

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 third phase of the study (the second stage is also registered in clinical trials).

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Detailed Description

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Despite the fact that HPV vaccination is recommended for male and female adolescents, HPV vaccine coverage among adolescents age 13-17 is poor (60% for girls, 41.7% 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. In Stage 3, reported here, investigators will conduct a two-arm pilot randomized control trial in the safety-net clinics to assess feasibility of testing the self-persuasion intervention condition against standard of care (control group). Parent-adolescent child dyads will be enrolled. Parents will be exposed to the intervention and the primary outcome (HPV vaccination) will be assessed on the adolescent child via the electronic health record. Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.

Conditions

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Human Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Self-persuasion group

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

Group Type EXPERIMENTAL

Project Voice

Intervention Type BEHAVIORAL

Project Voice tablet-based intervention plus informational video

Information only group

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

Group Type ACTIVE_COMPARATOR

HPV Informational Video

Intervention Type BEHAVIORAL

Informational video only

Interventions

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Project Voice

Project Voice tablet-based intervention plus informational video

Intervention Type BEHAVIORAL

HPV Informational Video

Informational video only

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes