Promoting HPV Vaccination Among Young Adults in Texas

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.

Study Overview

• Status: Recruiting
• Conditions: HPV; Related Malignancy; Related Carcinoma
• Intervention / Treatment: Behavioral: Experimental arm 1; Behavioral: Experimental arm 2; Other: Experimental arm 3; Other: Experimental arm 4; Other: Experimental arm 5

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Lu; Phone Number: (713) 745-8324; Email: qlu@mdanderson.org
• Study Contact Backup: Name: Lenna Dawkins-Moultin; Phone Number: 713-792-0005; Email: ldawkins@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Qian Lu; Phone Number: 713-745-8324; Email: qlu@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Qian Lu, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020-1142; NCI-2021-09416 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Process); 5R01CA248216-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No