Mail-in HPV Screening Program in NJ
2026年8月3日 更新者：Ana Isabel Tergas, MD, MPH、Rutgers, The State University of New Jersey
A Mail-based HPV Sampling Program to Increase Cervical Cancer Screening in New Jersey
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.
研究概览
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
New Jersey
-
Newark、New Jersey、美国、07103
- Rutgers New Jersey Medical School
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Standard Pap Smear
Participants will have the option to choose a standard pap smear for cervical cancer screening
|
Healthcare provider collected (in a hospital or clinical setting) cervicovaginal sample
|
|
实验性的：HPV Self-Sampling Test
Participants are able to opt-in for an at-home self-sampling HPV test for cervical cancer screening
|
Self-collected cervicovaginal sample
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Completion of CC screening within 6 months of initial outreach.
大体时间：Outcome will be measured at 6 months post-initial outreach call.
|
Defined as either (a) return of a valid HPV self-sample kit to the processing laboratory, or (b) attendance for a clinic-based Pap test documented in the medical record.
|
Outcome will be measured at 6 months post-initial outreach call.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Screening Pathway Choices and Performance
大体时间：From enrollment to the end of participation at 9 months
|
Proportion of participants selecting self-sampling vs clinic-based Pap test (percentage of women choosing each modality after initial outreach)
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
大体时间：From enrollment to the end of participation at 9 months
|
Timeliness of screening completion (measured as days from outreach to Pap attendance or kit return).
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
大体时间：From enrollment to the end of participation at 9 months
|
Screening test result distribution (categorized as negative, positive, or inadequate, stratified by modality).
|
From enrollment to the end of participation at 9 months
|
|
Screening Pathway Choices and Performance
大体时间：From enrollment to the end of participation at 9 months
|
HPV genotype distribution among positive samples (individual and group reporting per lab protocol)
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
大体时间：From enrollment to the end of participation at 9 months
|
Clinical follow-up completion after abnormal results (attendance at colposcopy or initiation of treatment).
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
大体时间：From enrollment to the end of participation at 9 months
|
Detection of histologically confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2+) or invasive cervical cancer.
|
From enrollment to the end of participation at 9 months
|
|
Clinical Follow-Up and Downstream Outcomes
大体时间：From enrollment to the end of participation at 9 months
|
Treatment initiation and completion rates among those diagnosed with CIN2+ or cancer.
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
大体时间：From enrollment to the end of participation at 9 months
|
Associations between demographic/clinical factors and screening completion (e.g., race/ethnicity, insurance status, education, prior screening history).
|
From enrollment to the end of participation at 9 months
|
|
Exploratory and Patient-Reported Outcomes
大体时间：From enrollment to the end of participation at 9 months
|
Patient-reported experiences including satisfaction, ease of kit use, clarity of instructions, stress/anxiety during self-sampling, trust in results, and willingness to undergo self-sampling in future screening.
|
From enrollment to the end of participation at 9 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reach and Adoption
大体时间：From enrollment to the end of participation at 9 months
|
Proportion of eligible participants successfully contacted and offered the intervention.
|
From enrollment to the end of participation at 9 months
|
|
Reach and Adoption
大体时间：From enrollment to the end of participation at 9 months
|
Participant acceptance vs refusal rates, stratified by screening modality.
|
From enrollment to the end of participation at 9 months
|
|
Reach and Adoption
大体时间：From enrollment to the end of participation at 9 months
|
Equity assessment: Differences in screening uptake across demographic and socioeconomic subgroups.
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
大体时间：From enrollment to the end of participation at 9 months
|
Return rate of mailed self-sampling kits (valid, invalid, and late returns).
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
大体时间：From enrollment to the end of participation at 9 months
|
Proportion requiring replacement kits.
|
From enrollment to the end of participation at 9 months
|
|
Feasibility and Fidelity
大体时间：From enrollment to the end of participation at 9 months
|
Staff adherence to outreach protocol (number, spacing, and mode of call attempts and reminders per protocol).
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
大体时间：From enrollment to the end of participation at 9 months
|
Barriers and facilitators to participation identified via telephone structured surveys.
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
大体时间：From enrollment to the end of participation at 9 months
|
Acceptability of self-sampling as routine care (participant endorsement of future use of mail-based HPV kits).
|
From enrollment to the end of participation at 9 months
|
|
Acceptability and Sustainability
大体时间：From enrollment to the end of participation at 9 months
|
Institutional ability to sustain or scale implementation strategies (assessed through staff feedback and system-level considerations).
|
From enrollment to the end of participation at 9 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ana Tergas, MD, MPH、Rutgers, The State University of New Jersey
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月20日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年4月16日
研究注册日期
首次提交
2026年2月8日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro2025001687
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.