Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Percent of Exams With Lesions Identified
研究概览
简要总结
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope
详细描述
Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.
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
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 25 years old and < 65 years old
- •Sex: Female
- •Positive HPV test within past 6 months
排除标准
- •Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
- •Women with a negative HPV test
- •Patients incapable of giving informed consent
- •Women with a history of cervical cancer
- •Pelvic exam concerning for cervical cancer or cervical infection
结局指标
主要结局
Percent of Exams With Lesions Identified
时间窗: Baseline
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Sensitivity
时间窗: Baseline
Sensitivity of Pocket vs VIA
Specificity
时间窗: Baseline
Specificity of Pocket vs VIA
Negative Predictive Value (NPV)
时间窗: Baseline
Negative predictive value (NPV) of Pocket vs VIA
Positive Predictive Value (PPV)
时间窗: Baseline
Positive predictive value (PPV) of Pocket vs VIA
次要结局
- Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire(baseline)
- Percent of Providers Who Reported Experiencing no Challenges During the Exam(baseline)
- Percent of Participants Who Reported Experiencing Pain During Their Exam(Baseline)
- Percent of Participants Who Expressed Confidence in Their Provider's Assessment(Baseline)
- Percent of Participants Who Would Recommend the Exam to a Friend(Baseline)