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Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccin

Primary Purpose

Human Papilloma Virus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HPV Educational Intervention
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Eligible for HPV Vaccine

Arm Description

Outcomes

Primary Outcome Measures

The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine
As measured by pre and post intervention surveys
Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake
Collected by the study team

Secondary Outcome Measures

Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).
As determined by follow up phone calls

Full Information

First Posted
September 30, 2020
Last Updated
June 12, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04611022
Brief Title
Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccin
Official Title
Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
May 21, 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The educational intervention to be delivered by the CHE(Community Health Educator) 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
The investigator will use a one-group pre- and post-test design to assess the effects of the intervention on the primary outcomes. The educational intervention will be delivered to 200 participants by a trained CHE who will conduct educational workshops to deliver the educational materials at DHHA outpatient clinics. The CHE will administer the pre- and post-intervention survey to workshop participants. The follow-up survey will occur over the phone at 3 months post baseline only for parent participants that indicate having unvaccinated children or are a young adult participant and indicated not being vaccinated at baseline. The last follow up survey will occur over the phone at 6 months only for those parent participants that indicated having unvaccinated children at the 3 month follow up call, or are a young adult participant and indicated not being vaccinated at the 3 month follow up call. Additionally, the investigator will use a one-group post-test design to assess the impact of the intervention on the secondary outcomes. At the patient-level, the investigator 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, the investigator will track each clinic's HPV vaccine rates for adolescents (9-17 years old) and young adults (18-26), and compare rates from before the investigator started the intervention and then quarterly there after the investigator had introduced the intervention to each respective Denver Health clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Eligible for HPV Vaccine
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
HPV Educational Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine
Description
As measured by pre and post intervention surveys
Time Frame
Day 0/Baseline
Title
Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake
Description
Collected by the study team
Time Frame
Day 0/Baseline
Secondary Outcome Measure Information:
Title
Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).
Description
As determined by follow up phone calls
Time Frame
3 and 6 months post intervention
Other Pre-specified Outcome Measures:
Title
Intervention's delivery and patient-level & system-level impact.
Description
As determined by rates of HPV vaccine dose completion reported by clinics
Time Frame
3, 6, 9 and 12 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Barron
Phone
303-724-5439
Email
jose.barron@CUAnschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelinn Borrayo
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Barron
Phone
303-724-5439
Email
jose.barron@CUAnschutz.edu
First Name & Middle Initial & Last Name & Degree
Evelinn Borrayo

12. IPD Sharing Statement

Plan to Share IPD
No

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Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccin

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