An Intervention Promoting HPV Vaccination in Safety-net Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 831
- 试验地点
- 4
- 主要终点
- 1 Dose Coverage of the HPV vaccine series at End of Study Period
研究概览
简要总结
This randomized controlled trial is designed to evaluate whether a behavioral intervention that includes three components: 1) reminder letters and education materials delivered before the clinic visit, 2) telephone recalls after the visit for those who originally decline the vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1 and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls attending four Parkland primary care clinics in Dallas county.
Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the Intervention group than those in the General Adolescent Vaccine Brochure group.
Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among patients in the Intervention group who initially declined the vaccine than those in the General Adolescent Vaccine Brochure group who initially declined.
Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the Intervention group than those in the General Adolescent Vaccine Brochure group.
详细描述
The primary research goal is to implement and evaluate evidence-based intervention strategies targeted to adolescent girls and their parents that stimulate patient demand for the human papillomavirus (HPV) vaccine and compliment provider-directed strategies already employed by Parkland clinics.
The project has three specific aims:
- Aim 1. Determine if a mailed packet with an invitation letter and educational material (HPV-specific or general brochure about all recommended adolescent vaccines) delivered prior to clinic visit, increases 1 dose coverage of the HPV vaccine series.
- Aim 2. Determine if a telephone recall delivered 2 weeks after the clinic visit, increases 1 dose coverage among parent-patient dyads who decline the vaccine during the clinic visit.
- Aim 3. Determine if telephone reminders to those overdue for Dose 2 or 3 of the HPV vaccine series, increase 3 dose coverage of the series.
Phase 1 - Cognitive interviews: To ensure the usability and cultural appropriateness of all project materials, investigators will conduct 40 in-person, cognitive interviews with parents of female patients ages 11-18 attending Parkland clinics.
Phase 2 - Randomized controlled trial. Investigators will select and invite 1200 families whose daughter has an upcoming appointment at one of four Parkland clinic sites. Eligible patients will be randomized to either the Intervention group or the General Adolescent Vaccine Brochure group. The Intervention group participants will be mailed a packet containing an invitation letter to join the study and HPV vaccine-specific educational materials; General Adolescent Vaccine Brochure group participants will be mailed a packet with educational materials on all four of the recommended adolescent vaccines (HPV, meningococcal, TDAP, and influenza). A few days after the packet has been sent, a research assistant will call participants to verify that the letter was received and assess interest in completing a pre-clinic visit survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •11-18 year old female patients and their parent
- •Patient has an upcoming appointment at one of four Parkland clinics
- •Patient has not initiated the HPV vaccine series
排除标准
- •Adolescent patient was currently pregnant
- •Parent Participated in Phase 1 Cognitive Interviews
- •Sibling already enrolled in study
- •Parent opted out or was not interested in the study
- •Parent did not have a working address
结局指标
主要结局
1 Dose Coverage of the HPV vaccine series at End of Study Period
时间窗: 12 months
Receipt of 1 or more doses of the HPV vaccine during 12-month study period
3 Dose Coverage of the HPV vaccine series at End of Study Period
时间窗: 12 months
Receipt of 3 doses of the HPV vaccine during the 12 month study period
次要结局
未报告次要终点