Promoting HPV Vaccination Among Young Adults in Texas

Not Applicable

Recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Informational Intervention; Other: Enhancing Accessibility to Health Care; Other: Interview; Other: Questionnaire Administration

• Registration Number: NCT05057312
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the impact of addressing individual and system levels of influence on HPV vaccination initiation and completion rates.

II. To gain insight into mechanisms of the intervention's efficacy, individual differences, and implementation of the intervention using mixed methods.

OUTLINE: Participants are randomized to 1 of 6 groups.

GROUP I: Participants receive standard Centers for Disease Control and Prevention (CDC) information about HPV vaccination.

GROUP II: Participants receive video narratives about HPV vaccination.

GROUP III: Participants receive written narratives about HPV vaccination.

GROUP IV: Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.

GROUP V: Participants receive enhanced access to vaccination and video narratives about HPV vaccination.

GROUP VI: Participants receive enhanced access to vaccination and written narratives about HPV vaccination.

After completion of study, participants are followed up at 3 and 9 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-07-26
• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Age 18-26 years. This criterion is based on the CDC recommendation of vaccination up to 26 years of age 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

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Exclusion Criteria

• Being pregnant
• Having a life-threatening allergy to any component of the HPV vaccine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group III (written narratives)	Informational Intervention	Participants receive written narratives about HPV vaccination.
Group IV (enhanced access to vaccine, CDC information)	Informational Intervention	Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
Group IV (enhanced access to vaccine, CDC information)	Interview	Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
Group V (enhanced access to vaccine, video narratives)	Interview	Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
Group I (standard CDC information)	Interview	Participants receive standard CDC information about HPV vaccination.
Group II (video narratives)	Informational Intervention	Participants receive video narratives about HPV vaccination.
Group III (written narratives)	Interview	Participants receive written narratives about HPV vaccination.
Group III (written narratives)	Questionnaire Administration	Participants receive written narratives about HPV vaccination.
Group IV (enhanced access to vaccine, CDC information)	Enhancing Accessibility to Health Care	Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
Group VI (enhanced access to vaccine, written narratives)	Interview	Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
Group I (standard CDC information)	Informational Intervention	Participants receive standard CDC information about HPV vaccination.
Group I (standard CDC information)	Questionnaire Administration	Participants receive standard CDC information about HPV vaccination.
Group II (video narratives)	Interview	Participants receive video narratives about HPV vaccination.
Group V (enhanced access to vaccine, video narratives)	Enhancing Accessibility to Health Care	Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
Group V (enhanced access to vaccine, video narratives)	Questionnaire Administration	Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
Group II (video narratives)	Questionnaire Administration	Participants receive video narratives about HPV vaccination.
Group IV (enhanced access to vaccine, CDC information)	Questionnaire Administration	Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.
Group V (enhanced access to vaccine, video narratives)	Informational Intervention	Participants receive enhanced access to vaccination and video narratives about HPV vaccination.
Group VI (enhanced access to vaccine, written narratives)	Informational Intervention	Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
Group VI (enhanced access to vaccine, written narratives)	Enhancing Accessibility to Health Care	Participants receive enhanced access to vaccination and written narratives about HPV vaccination.
Group VI (enhanced access to vaccine, written narratives)	Questionnaire Administration	Participants receive enhanced access to vaccination and written narratives about HPV vaccination.

Primary Outcome Measures

Name	Time	Method
Rate of human papillomavirus (HPV) vaccination initiation	At 3 months
Rate of HPV vaccination completion	At 9 months

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States