Promoting HPV Vaccination Among Young Adults in Texas

Study Overview
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Brief Summary
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The study uses a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. The two primary outcomes will be the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-up.

Detailed Description
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Primary Objective To use a randomized controlled trial (RCT) to test an innovative multilevel intervention to increase HPV vaccination rates among young adults. Secondary Objective(s) To gain insight into mechanisms of the intervention's efficacy, individual differences, and implementation of the intervention using mixed methods.

Official Title
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Promoting HPV Vaccination Among Young Adults in Texas

Conditions
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HPV, Related Malignancy, Related Carcinoma

Intervention / Treatment
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* Behavioral: Experimental arm 1
* Behavioral: Experimental arm 2
* Other: Experimental arm 3
* Other: Experimental arm 4
* Other: Experimental arm 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-26 years. This criterion is based on the CDC recommendation of vaccination up to 26 years of age5 and the fact that individuals 18 years and older can consent by themselves for on-site vaccination. Ability to read and understand English. Self-identification as not yet having received any HPV vaccine injections. Self-identification is justified because it is safe to be vaccinated again, which could happen if a previously vaccinated person forgets their vaccination. Furthermore, in a person previously vaccinated with an older version of the vaccine, which targeted fewer HPV types, receiving the newer version would be advantageous and not cause any harm. Alternatives to self-identification, such as obtaining medical records from doctors' offices, would be very challenging for young adults, especially for those who do not remember when and where they might have received vaccination. Access to a smart phone, tablet or computer that is connected to the internet Current enrollment in one of the participating schools with an anticipated continuous enrollment of at least 9 months. Exclusion criteria Being pregnant Having a life-threatening allergy to any component of the HPV vaccine. Additional screening for pregnancy and allergy will be performed by the clinics and pharmacy when students present for vaccination as part of routine care. We will also query participants' pregnancy status at baseline and the 3-month follow-up. Participants who report a pregnancy will be dropped from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm 1<br>Video narrative persuasion | Behavioral: Experimental arm 1<br>* Video narrative persuasion<br>|
| Experimental: Experimental arm 2<br>Written narrative Persuasion | Behavioral: Experimental arm 2<br>* Written narrative Persuasion<br>|
| Experimental: Experimental arm 3<br>Enhanced Access to HPV vaccines | Other: Experimental arm 3<br>* Enhanced Access to HPV vaccines<br>|
| Experimental: Experimental arm 4<br>Video narrative persuasion; Enhanced Access to HPV vaccines | Other: Experimental arm 4<br>* Video narrative persuasion; Enhanced Access to HPV vaccines<br>|
| Experimental: Experimental arm 5<br>Written narrative Persuasion | Other: Experimental arm 5<br>* Written narrative Persuasion; Enhanced access to HPV vaccines<br>|
| No Intervention: Control/ active comparator Arm 6<br>CDC information | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The two primary outcomes will be the rate of HPV vaccination initiation by 3-month follow-up and rate of HPV vaccination completion by 9-month follow-up |  | through study completion, an average of 1 year |