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临床试验/NCT00813319
NCT00813319已完成3 期

Overcoming Barriers to Vaccination With GARDASIL in Underserved Girls and Adolescents

Emory University4 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
216
试验地点
4
主要终点
GARDASIL Vaccination Uptake and Compliance With Second and Third Doses

研究概览

简要总结

African American adolescent females seeking treatment for STIs are an underserved population at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine, vaccination rates are low. Given the risk for HPV infection among this subgroup and the negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The goal of this project is to promote GARDASIL vaccination through the development of a new multi-component, culturally-appropriate, interactive DVD.

We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age, from participating clinic sites in Atlanta, Georgia. While seeking clinical services, adolescents will be contacted and invited to participate in the proposed study. Eligible adolescents will be required to provide written assent/consent prior to participation. Adolescents who are eligible and willing to participate in the project will complete a short survey on a laptop computer. The survey is designed to assess adolescents' risk taking and preventive behaviors. After they complete the survey, adolescents will be assigned at random to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses. In the second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating study clinics as part of their routine standard of care.

With the help of clinic staff, participant medical records will be reviewed over a 7 month period to assess vaccination rates. Vaccination rates from adolescents who received the interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who received the healthy lifestyles DVD. It is hypothesized that study participants receiving the interactive DVD intervention that promotes HPV awareness will have higher vaccination rates over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • African American
  • Age 13-18 years
  • Seeking reproductive/STI services at participating clinic
  • Ability to give written informed consent or assent

排除标准

  • Already received the HPV vaccine

结局指标

主要结局

GARDASIL Vaccination Uptake and Compliance With Second and Third Doses

时间窗: measured at 7 months post-randomization

Number of participants who received at least 1 dose, 2 doses, 3 doses

Total Doses Received of HPV Vaccine

时间窗: measured at 7-months post randomization

As an additional primary outcome, we assessed the total number of vaccine doses received

次要结局

  • STD Incidence(7 months post randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ralph J. DiClemente

Professor

Emory University

研究点 (4)

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