NCT05057312

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2021Jul 2026

Study Start

First participant enrolled

July 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

August 25, 2021

Last Update Submit

January 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of human papillomavirus (HPV) vaccination initiation

    At 3 months

  • Rate of HPV vaccination completion

    At 9 months

Study Arms (6)

Group I (standard CDC information)

ACTIVE COMPARATOR

Participants receive standard CDC information about HPV vaccination.

Other: Informational InterventionOther: InterviewOther: Questionnaire Administration

Group II (video narratives)

EXPERIMENTAL

Participants receive video narratives about HPV vaccination.

Other: Informational InterventionOther: InterviewOther: Questionnaire Administration

Group III (written narratives)

EXPERIMENTAL

Participants receive written narratives about HPV vaccination.

Other: Informational InterventionOther: InterviewOther: Questionnaire Administration

Group IV (enhanced access to vaccine, CDC information)

EXPERIMENTAL

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

Other: Enhancing Accessibility to Health CareOther: Informational InterventionOther: InterviewOther: Questionnaire Administration

Group V (enhanced access to vaccine, video narratives)

EXPERIMENTAL

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

Other: Enhancing Accessibility to Health CareOther: Informational InterventionOther: InterviewOther: Questionnaire Administration

Group VI (enhanced access to vaccine, written narratives)

EXPERIMENTAL

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

Other: Enhancing Accessibility to Health CareOther: Informational InterventionOther: InterviewOther: Questionnaire Administration

Interventions

Receive enhanced access to vaccination

Group IV (enhanced access to vaccine, CDC information)Group V (enhanced access to vaccine, video narratives)Group VI (enhanced access to vaccine, written narratives)

Receive standard CDC information

Group I (standard CDC information)Group IV (enhanced access to vaccine, CDC information)

Ancillary studies

Group I (standard CDC information)Group II (video narratives)Group III (written narratives)Group IV (enhanced access to vaccine, CDC information)Group V (enhanced access to vaccine, video narratives)Group VI (enhanced access to vaccine, written narratives)

Ancillary studies

Group I (standard CDC information)Group II (video narratives)Group III (written narratives)Group IV (enhanced access to vaccine, CDC information)Group V (enhanced access to vaccine, video narratives)Group VI (enhanced access to vaccine, written narratives)

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Lu Q, Dawkins-Moultin L, Cho D, Tan NQP, Hopfer S, Li Y, Ramondetta L, Xu Y, Lun D, Chen M. A multilevel intervention to promote HPV vaccination among young adults in Texas: protocol for a randomized controlled trial. BMC Public Health. 2024 Jun 5;24(1):1506. doi: 10.1186/s12889-024-18828-9.

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Qian Lu, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 27, 2021

Study Start

July 26, 2021

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations