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

NCT ID: NCT04611022

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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The investigator will use a one-group post-test design to assess the effects of the intervention on the primary outcomes. The educational intervention will be delivered to 400 participants by a trained CHE who will deliver the educational materials to eligible DHHA patients. The CHE will administer the post-education survey at baseline to participants. Additionally, we will use a one-group post-test design to assess the impact of the intervention on the secondary outcomes. At the patient-level, we will track participants that receive (a) 1st dose, 2nd dose, or 3rd dose of the HPV vaccine; and the number of referrals to care by recording the number of patients received (b) referrals to health insurance, discount, or no-cost HPV vaccine programs; or (c) to other services to facilitate HPV vaccine dose completion. To assess clinic-level impact, we will track each clinic's HPV vaccine rates for adolescents (9-17 years old) and young adults (18-26) and compare rates from before we start the intervention and then quarterly there after we have introduced the intervention to each respective Denver Health clinic.

Conditions

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Human Papilloma Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients Eligible for HPV Vaccine

Group Type EXPERIMENTAL

HPV Educational Intervention

Intervention Type 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.

Interventions

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HPV Educational Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 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).
2. 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)
3. English and/or Spanish Speaking
4. 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

Exclusion Criteria

1. Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \[at the discretion of the CHE or PN upon recruitment\]
2. 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 \[at the discretion of the CHE or PN upon recruitment\]
3. Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment \[at the discretion of the CHE or PN upon recruitment\]
4. Individuals under the age of 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evelinn Borrayo

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sindy Gonzalez

Role: CONTACT

303-724-5445

Facility Contacts

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Sindy Gonzalez

Role: primary

303-724-5445

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-2236.cc

Identifier Type: -

Identifier Source: org_study_id

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