Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 665
- 试验地点
- 2
- 主要终点
- Percent of participants that complete cervical cancer screening
研究概览
简要总结
This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.
详细描述
Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.
This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).
Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.
Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.
Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 25 to 64 years old
- •Living at ≤250% of the federal poverty line
- •Eligible to receive cervical cancer screening from a study-associated clinic
- •Resides within the same or bordering county of a study-associated clinic
排除标准
- •Completion of cervical Pap screening in preceding 4 years
- •Completion of HPV testing in preceding 6 years
- •History of hysterectomy
- •Private insurance
- •Unable to provide informed consent
结局指标
主要结局
Percent of participants that complete cervical cancer screening
时间窗: Six months after enrollment
Completion of cervical cancer screening is defined as (a) testing HPV negative by self-collection, or (b) completing in-clinic screening by i. HPV/Pap co-testing or ii. Pap smear alone.
次要结局
- Level of self-efficacy to complete cervical cancer screening(1-5 weeks after completion of self-collection or screening invitation)
- Costs to payers(Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation))
- Level of intention to complete cervical cancer screening(1-5 weeks after completion of self-collection or screening invitation)
- Levels of risk appraisal with regards to cervical cancer and screening(1-5 weeks after completion of self-collection or screening invitation)
- Percentage of participants who schedule a clinic appointment to get cervical cancer screening(1-5 weeks after completion of self-collection or screening invitation)