Developing a Self-persuasion Intervention Promoting Adolescent HPV Vaccination

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 second phase of the study. The results of the second phase will inform the third phase of the trial (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 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.

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


Participation Criteria
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Eligibility Criteria
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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

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- Verbalize, Choice<br>Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics they choose | Behavioral: Project Voice<br>* A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition<br>|
| Experimental: 2- Listen, Choice<br>Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics they choose | Behavioral: Project Voice<br>* A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition<br>|
| Experimental: 3- Verbalize, Assigned<br>Parents will use a tablet-based application (Project Voice) that directs them to verbalize their own arguments based on topics assigned to them | Behavioral: Project Voice<br>* A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition<br>|
| Experimental: 4- Listen, Assigned<br>Parents will use a tablet-based application (Project Voice) that directs them to listen to peer-generated arguments based on topics assigned to them | Behavioral: Project Voice<br>* A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) |