Skip to main content
OpenTrials
Completed

NCT Number: NCT02537756

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-8557, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project Voice

Behavioral

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

Primary outcomes

  1. Survey Items Measuring Parental Intentions to vaccinate

    Time frame: During the intervention visit (1 hr)

    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.

Secondary outcomes

  1. HPV vaccination behavior documented in the electronic medical record, initiation

    Time frame: 12 months

    Number of parents who initiated the series by vaccinating their child within 12 months of the study appointment as evidenced by documentation in the child's electronic medical record.

  2. Change in Decision Stage

    Time frame: During the intervention visit (1 hr)

    Change in decision stage response of parents from baseline survey to post-educational video to post-intervention tasks.

Other outcomes

  1. HPV vaccination behavior documented in the electronic medical record, completion

    Time frame: 15 months

    Number of doses received and the dates of those doses within 15 months of the study appointment as evidenced by documentation in the child's electronic medical record.

  2. Vaccination Concerns, qualitative

    Time frame: During the intervention visit (1 hr)

    Number of parents reporting concerns during the intervention and exit interview; Describe the theme/category of concern expressed by parents about HPV vaccination

  3. Manipulation checks

    Time frame: During the intervention visit (1 hr)

    Measure of the accuracy of parental argument recall during intervention (cognitive processing: verbalize own arguments); Change in autonomous motivation during intervention (argument topic choice).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • Parkland Health and Hospital System
  • Southern Methodist University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 2, 2015
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.