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NCT05057312 Clinical Trial

Promoting HPV Vaccination Among Young Adults in Texas

Human Papillomavirus Infection Clinical Trial

Official title:
Promoting HPV Vaccination Among Young Adults in Texas

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05057312
Other study ID # 2020-1142
Secondary ID NCI-2021-0941620
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date July 31, 2026

Study information
Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date July 31, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 26 Years
Eligibility 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 Exclusion Criteria: - Being pregnant - Having a life-threatening allergy to any component of the HPV vaccine

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Enhancing Accessibility to Health Care
Receive enhanced access to vaccination
• Informational Intervention
Receive standard CDC information
• Informational Intervention
Receive video narratives
• Informational Intervention
Receive written narratives
• Interview
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of human papillomavirus (HPV) vaccination initiation At 3 months
Primary Rate of HPV vaccination completion At 9 months
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