A Cluster Randomized Controlled Trial Testing Communication Strategies to Increase HPV Vaccination in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9,002
- 试验地点
- 1
- 主要终点
- Aim 1 - Intention to Vaccinate
研究概览
简要总结
This research aims to identify communication strategies to improve the uptake of vaccines using an experimental design, focusing on the Human Papillomavirus (HPV) vaccine, which is highly effective in preventing HPV-related cancers. However, low HPV vaccination rates among adults remain a significant public health challenge. Although randomized controlled trials (RCTs) have demonstrated that interventions can increase vaccine uptake in children, few RCTs have been conducted among adults.
To address this gap, a multidisciplinary investigative team with expertise in communication, medicine, nursing, and behavior-change intervention research will conduct a survey experiment and a cluster randomized controlled trial. First, a national sample of adults ages 18 to 45 who have not received the HPV vaccine or are unsure of their vaccination status will participate in a survey experiment to identify the most promising theory-based messages to strengthen HPV vaccine intentions. The two messages associated with the largest increases in vaccination intentions will then be selected for further testing.
Next, 16 Penn Medicine primary care clinics will participate in a factorial cluster randomized controlled trial to test patient-level and clinic-level interventions designed to increase HPV vaccine uptake. Patient-level interventions will include theory-based text messages and a reminder-only message condition. The clinic-level intervention will provide healthcare providers with feedback on missed opportunities for HPV vaccination and a toolkit to support strong HPV vaccine recommendations.
The study will evaluate whether these interventions increase receipt of the first HPV vaccine among eligible adult patients and whether combining patient-directed messages with the clinic-level intervention further increases HPV vaccination. HPV vaccination will be assessed using Penn Medicine electronic health records and, when needed, patient self-report.
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 (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years old
排除标准
- •Under 18 and over 45 years old
- •Received HPV vaccine or unsure about receipt
研究组 & 干预措施
HPV Message 1 + Clinic Intervention
干预措施: HPV Message 1 (Behavioral)
HPV Message 1 + Clinic Intervention
干预措施: Provider Strong-Recommendation Toolkit (Behavioral)
HPV Message 1 + No Clinic Intervention
干预措施: HPV Message 1 (Behavioral)
HPV Message 2 + Clinic Intervention
干预措施: HPV Message 2 (Behavioral)
HPV Message 2 + Clinic Intervention
干预措施: Provider Strong-Recommendation Toolkit (Behavioral)
HPV Message 2 + No Clinic Intervention
干预措施: HPV Message 2 (Behavioral)
Control Message + Clinic Intervention
干预措施: Control Message (Behavioral)
Control Message + Clinic Intervention
干预措施: Provider Strong-Recommendation Toolkit (Behavioral)
Control Message + No Clinic Intervention
干预措施: Control Message (Behavioral)
HPV Message 3 + Clinic Intervention
干预措施: HPV Message 3 (Behavioral)
HPV Message 3 + Clinic Intervention
干预措施: Provider Strong-Recommendation Toolkit (Behavioral)
HPV Message 3 + No Clinic Intervention
干预措施: HPV Message 3 (Behavioral)
结局指标
主要结局
Aim 1 - Intention to Vaccinate
时间窗: Immediately after exposure to the assigned message
Assessed using a three-item validated HPV Vaccination Intention Scale. The three items evaluate the participant's intent, plan, and likelihood to receive the HPV vaccine within the next 6 months. Responses for each item were recorded on a 5-point Likert scale. A composite intention score was calculated as the mean of the three items, with total scores ranging from 1 to 5. Higher scores indicate a better outcome (a greater intention to receive the HPV vaccine).
Aim 2 - Receipt of HPV Vaccine
时间窗: From intervention initiation through 9 months of follow-up
Receipt of HPV vaccine during the follow-up period, determined from HPV vaccination documentation in the electronic health record or patient self-report.
次要结局
未报告次要终点
研究者
Florence Momplaisir
Associate Professor
University of Pennsylvania