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

Study Overview
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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).

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). Investigators will also examine the impact of the intervention on parent-provider discussions about HPV vaccination.

Official Title
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Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

Conditions
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Human Papillomavirus Vaccines

Intervention / Treatment
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* Behavioral: Project Voice
* Behavioral: HPV Informational Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undecided parents of 11-17 year old patients who have not begun the HPV vaccine series. Exclusion Criteria: Pregnant adolescents Having impairing hearing or speech Phase 1 and 2 participants will be excluded from participation this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV vaccination behavior documented in electronic medical record, initiation | Number of parents who initiated the three dose series and vaccinated their child 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 |