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临床试验/NCT04611022
NCT04611022招募中不适用

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

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine

时间窗: Day 0/Baseline

Behavioral factors precede uptake of preventive vaccines. Measured by survey post watching HPV video.

Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake

时间窗: Day 0/Baseline

Collected by the study team. Variables known as associated with vaccine uptake

The change in parents & young adults' knowledge & intentions to obtain the HPV vaccine

时间窗: Day 0/Baseline

Behavioral factors precede uptake of preventive vaccines. Measured by survey post watching HPV video.

Sociodemographic data (e.g., age, gender, ethnicity, insurance, income, zip code) as it relates to vaccine uptake

时间窗: Day 0/Baseline

Collected by the study team. Variables known as associated with vaccine uptake

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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