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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine [Срок оценки: Day 0/Baseline]
• Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake [Срок оценки: Day 0/Baseline]

Вторичные конечные точки (1)

• Uptake of one, two, or three HPV vaccine doses among adolescents (9 to 17 years old) and young adults (18-26 years old). [Срок оценки: 3 and 6 months post intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Colorado Hospital — Denver

Идентификаторы

NCT: NCT04611022 · 19-2236.cc · P30CA046934

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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