Promoting HPV Vaccination Among Young Adults in Texas

HPV 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-2021-094165R
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Qian Lu
• Phone: (713) 745-8324
• Email: qlu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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 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.

Related Conditions & MeSH terms

• HPV
• Neoplasms

Intervention

Behavioral:
• Experimental arm 1
Video narrative persuasion
• Experimental arm 2
Written narrative Persuasion

Other:
• Experimental arm 3
Enhanced Access to HPV vaccines
• Experimental arm 4
Video narrative persuasion; Enhanced Access to HPV vaccines
• Experimental arm 5
Written narrative Persuasion; Enhanced access to HPV vaccines

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	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

External Links

•   M D Anderson Cancer Center