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

Human Papillomavirus Vaccines Clinical Trial

Official title:

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02535845
• Other study ID #: 1R01CA178414-04;STU 022013-016
• Secondary ID: 1R01CA178414
• Status: Terminated
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

Behavioral:
• Project Voice
Project Voice tablet-based intervention plus informational video
• HPV Informational Video
Informational video only

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (4)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Cancer Institute (NCI), Parkland Health and Hospital System, Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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