Clinical trial NCT05057312: Promoting HPV Vaccination Among Young Adults in Texas
Official title: Promoting HPV Vaccination Among Young Adults in Texas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Papillomavirus Infection
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of human papillomavirus (HPV) vaccination initiation
timeFrame: At 3 months
measure: Rate of HPV vaccination completion
timeFrame: At 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Qian Lu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: