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

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

Study Overview

• Status: Terminated
• Conditions: Human Papillomavirus Vaccines
• Intervention / Treatment: Behavioral: Project Voice; Behavioral: HPV Informational Video

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8557
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for the Parent-Adolescent Dyad:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-persuasion group; HPV information plus self-persuasion intervention in a tablet-based application (Project Voice)	Behavioral: Project Voice; Project Voice tablet-based intervention plus informational video
Active Comparator: Information only group; HPV information only in a tablet-based application (HPV Informational Video)	Behavioral: HPV Informational Video; Informational video only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccination Behavior Documented in Electronic Health Record, Initiation	Number of parents who decided to start the HPV vaccine three dose series and got their child vaccinated within 30 days of the study appointment as evidenced by documentation in the child's electronic medical record.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV Vaccination Behavior Documented in Electronic Medical Record, Completion	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.	15 months
Active Parent Participation During Clinical Encounter	Investigators will explore the factors associated with parent degree of participation in the discussion with the healthcare provider during the clinical encounter using Street coding scheme of 3 types of active communication.	1 day

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Cancer Institute (NCI); Southern Methodist University; Parkland Health and Hospital System
• Investigators: Principal Investigator: Jasmin A Tiro, PhD, UT Southwestern Medical Center; Principal Investigator: Austin S Baldwin, PhD, Southern Methodist University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimated): August 31, 2015

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1R01CA178414-04;STU 022013-016; 1R01CA178414 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No