Z 1313 - Comparison of Point-of-care Molecular Tests and Visual Inspection With Acetic Acid for Cervical Cancer Screening in HIV-infected Women in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
研究概览
简要总结
This study will compare the test performance characteristics of visual inspection with acetic acid (VIA), Xpert HPV, and OncoE6 in HIV-infected women, to inform the possible inclusion of these molecular tests in future cervical cancer screening
详细描述
This is a cross-sectional study taking place at cervical cancer prevention clinics in Lusaka, Zambia to determine the test performance characteristics (sensitivity, specificity, positive predictive value, and negative predictive value) of (1) visual inspection with acetic acid, (2) Xpert HPV, and (3) OncoE6 for the detection of CIN2+ among HIV-infected women. All cervical screening tests will be evaluated against a gold standard of histopathology obtained from cervical biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years and older.
- •Women with documented HIV-infection in their medical record or by on-site testing through voluntary counseling and testing.
- •Women willing to undergo pelvic examination and cervical cancer screening.
- •Women willing to provide written, informed consent.
排除标准
- •Pregnancy
结局指标
主要结局
Proportion of VIA-, Xpert HPV-, and OncoE6-positive results that are correctly identified
时间窗: once, at the enrollment visit
True positive rate (i.e., sensitivity) for CIN2+
Proportion of VIA-, Xpert HPV-, and OncoE6-negative results that are correctly identified
时间窗: once, at the enrollment visit
True negative rate (i.e., specificity) for CIN2+
次要结局
未报告次要终点
研究者
Carla Chibwesha, MD
Assistant Professor
University of North Carolina, Chapel Hill