Promoting HPV Vaccination Among Young Adults in Texas

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05057312
Collaborator
National Cancer Institute (NCI) (NIH)
1,200
1
6
56.1
21.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Experimental arm 1
  • Behavioral: Experimental arm 2
  • Other: Experimental arm 3
  • Other: Experimental arm 4
  • Other: Experimental arm 5
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Partially masked for Care Provider to certain groups.
Primary Purpose:
Prevention
Official Title:
Promoting HPV Vaccination Among Young Adults in Texas
Actual Study Start Date :
Jul 26, 2021
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Qian Lu, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05057312
Other Study ID Numbers:
  • 2020-1142
  • NCI-2021-09416
  • 5R01CA248216-02
First Posted:
Sep 27, 2021
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022