Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine

NCT04611022 | Recruiting DMC

• 2 other identifiers: 19-2236.ccP30CA046934
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The educational intervention to be delivered by the PN(Patient Navigator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (2)

• The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine

  Behavioral factors precede uptake of preventive vaccines. Measured by survey post watching HPV video.

  Day 0/Baseline

• Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake

  Collected by the study team. Variables known as associated with vaccine uptake

  Day 0/Baseline

Secondary Outcomes (1)

• Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).

  3 and 6 months post intervention

Other Outcomes (1)

• Intervention's delivery and patient-level & system-level impact.

  3, 6, 9 and 12 months post intervention

Study Arms (1)

Patients Eligible for HPV Vaccine

EXPERIMENTAL

Behavioral: HPV Educational Intervention

Interventions

HPV Educational Intervention BEHAVIORAL

The videos are 8-minute narrative films created using an entertainment-education (E-E) approach that embeds an educational narrative message into an entertainment format such as media. E-E narratives have demonstrated a significant effect (r = .12, p \< .001) on health behavior change. Evidence-based small media interventions that Dr. Borrayo has produced include videos that are highly verbal, visual, and entertaining (e.g., acted fictional stories). The aims of the video will be to model uptake of the HPV vaccine, but also to reinforce self-efficacy, subjective norms, and behavioral intentions, all significant precursors to behavior change.

Patients Eligible for HPV Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a Denver Health patient\* 18-26 years old, who has not started or completed the HPV vaccine series (Vaccine completion for this age group is 3 doses).
• Be a parent of a Denver Health adolescent patient\* aged 9-17 years old, who has not started or completed the HPV vaccine series. (Vaccine completion is 2 doses for 9-14-year-old, and 3 doses for 14-17-year old)
• English and/or Spanish Speaking
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Denver Health patients will be identified from one of the following clinics; Denver Health Clinics Eastside Adult Clinic, Eastside Women's Care Clinic, Westside Adult Clinic, Westside Women's Care Clinic, Pavilion C: Women's Care Clinic, La Casa-Quigg Newton Family Health Center, Lowry Family Health Center, Montbello Family Health Center, Westwood Family Health Center, Parkhill Family Health Center, Webb Center For Primary Care, Pena Southwest Clinic

You may not qualify if:

• Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \[at the discretion of the CHE or PN upon recruitment\]
• Decisionally-challenged adults with cognitive or personality impairment or due to intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study \[at the discretion of the CHE or PN upon recruitment\]
• Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment \[at the discretion of the CHE or PN upon recruitment\]
• Individuals under the age of 18 years.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80237, United States

RECRUITING

Study Officials

• Evelinn Borrayo

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindy Gonzalez

CONTACT

303-724-5445; Sindy.Gonzalez@CUAnschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: November 2, 2020
• Study Start: August 28, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)