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

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04611022
• Other study ID #: 19-2236.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 372
• Est. completion date: February 2025
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papilloma Virus
• Papilloma

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention's delivery and patient-level & system-level impact.	As determined by rates of HPV vaccine dose completion reported by clinics	3, 6, 9 and 12 months post intervention
Primary	The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine	As measured by pre and post intervention surveys	Day 0/Baseline
Primary	Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake	Collected by the study team	Day 0/Baseline
Secondary	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	3 and 6 months post intervention