Promoting HPV Vaccination Among Young Adults in Texas

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Human Papillomavirus Infection

Treatments: Other: Interview; Other: Enhancing Accessibility to Health Care; Other: Questionnaire Administration; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05057312

R01CA248216 (U.S. NIH Grant/Contract)

NCI-2021-09416 (Other Identifier)

2020-1142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,200 participants in 6 patient groups

Group I (standard CDC information)

Active Comparator group

Description:

Participants receive standard CDC information about HPV vaccination.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Informational Intervention

Other: Interview

Group II (video narratives)

Experimental group

Description:

Participants receive video narratives about HPV vaccination.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Informational Intervention

Other: Interview

Group III (written narratives)

Experimental group

Description:

Participants receive written narratives about HPV vaccination.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Informational Intervention

Other: Interview

Group IV (enhanced access to vaccine, CDC information)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Enhancing Accessibility to Health Care

Other: Informational Intervention

Other: Interview

Group V (enhanced access to vaccine, video narratives)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Enhancing Accessibility to Health Care

Other: Informational Intervention

Other: Interview

Group VI (enhanced access to vaccine, written narratives)

Experimental group

Description:

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

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Other: Informational Intervention

Other: Enhancing Accessibility to Health Care

Other: Informational Intervention

Other: Interview