Clinical trial NCT04611022: Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine
Official title: Intervention to Educate and Improve Underserved Populations' Uptake and Completion of the HPV Vaccine Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine
timeFrame: Day 0/Baseline
measure: Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake
timeFrame: Day 0/Baseline
Secondary outcomes:
measure: Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old).
timeFrame: 3 and 6 months post intervention
Other outcomes:
measure: Intervention's delivery and patient-level & system-level impact.
timeFrame: 3, 6, 9 and 12 months post intervention
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Evelinn Borrayo
role: PRINCIPAL_INVESTIGATOR
References: