A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to help people who have missed their regular cervical cancer screening. The investigators are evaluating whether mailing an HPV self-sampling kit to participant home makes it easier and more convenient for people to get screened for cervical cancer. This study will also help to understand if people find this process acceptable and whether it is an effective way to improve screening rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, transgender men, and nonbinary individuals aged 30 to 75 who have a cervix.
- •No history of hysterectomy or cervical cancer.
- •No documented cervical cancer screening within guideline-recommended intervals: specifically, no Pap test in the past 3.5 years, no Pap/HPV co-test in the past 5.5 years, and no standalone HPV test results in the past 5.5 years. (A 6-month grace period is included to allow time for response to usual care outreach.)
- •At least two visits to University Hospital ambulatory care over the past five years, ensuring opportunity for follow-up and continuity of care.
排除标准
- •History of cervical dysplasia within the past 3.5 years, reflecting those likely under active surveillance or treatment protocols.
- •Currently pregnant, due to differing screening recommendations and clinical considerations.
- •Prior or current diagnosis of cervical cancer or ongoing treatment for cervical neoplasia.
- •Physical, cognitive, or functional limitations that would preclude use of the mailed self-sampling kit without assistance. Examples include severe arthritis or significant impairment affecting self-collection capability.
- •Lack of a telephone number or reliable mailing address on file.
- •Inability to communicate in English or Spanish, given study materials and staffing capabilities. Use of additional language services is not available.
- •Current enrollment in other cervical cancer screening or intervention studies that may interfere with participation or outcomes.
- •Inability to provide informed consent or comprehend study procedures based on cognitive capacity, as assessed by the Research Coordinator during initial contact.
研究组 & 干预措施
Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
干预措施: Standard Pap Smear (Diagnostic Test)
HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
干预措施: BD Onclarity HPV test (Diagnostic Test)
研究者
Ana Isabel Tergas, MD, MPH
Director, Division of Gynecologic Oncology
Rutgers, The State University of New Jersey