Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

Human Papillomavirus Vaccines Clinical Trial

Official title:

Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537756
• Other study ID #: STU 022013-016
• Secondary ID: 1R01CA178414-01
• Status: Completed
• Phase: N/A
• Start date: April 5, 2016
• Est. completion date: October 26, 2019

Study information

• Verified date: May 2020
• 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 second phase of the study. The results of the second phase will inform the third phase of the trial (also registered in clinical trials).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: October 26, 2019
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

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

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 & Hospital System, Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HPV vaccination behavior documented in the 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
Other	Vaccination Concerns, qualitative	Number of parents reporting concerns during the intervention and exit interview; Describe the theme/category of concern expressed by parents about HPV vaccination	During the intervention visit (1 hr)
Other	Manipulation checks	Measure of the accuracy of parental argument recall during intervention (cognitive processing: verbalize own arguments); Change in autonomous motivation during intervention (argument topic choice).	During the intervention visit (1 hr)
Primary	Survey Items Measuring Parental Intentions to vaccinate	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.	During the intervention visit (1 hr)
Secondary	HPV vaccination behavior documented in the electronic medical record, initiation	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.	12 months
Secondary	Change in Decision Stage	Change in decision stage response of parents from baseline survey to post-educational video to post-intervention tasks.	During the intervention visit (1 hr)