Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
研究概览
简要总结
The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.
Cervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.
详细描述
Invasive cervical cancer is a significant health burden in low and middle income countries.
HIV-infected women in Africa are particularly affected and have an estimated invasive cervical cancer risk ~20-fold higher than women without HIV. Previous studies have been performed among only HIV-uninfected women or those whose HIV status was unknown. Additionally, HIV infected women are often diagnosed with invasive cervical cancer at younger ages.
Cervical cancer is preventable by regular screenings which includes doing a pap smear or HPV tests. There is also treatment of precancerous cervical lesions and vaccination against high risk types of HPV. World Health Organization currently recommends high risk HPV testing for cervical cancer screening in both high and low resources settings. National Guidelines in many low and middle income countries, including South Africa, have been updated to include plans to transition from cytology or visual screening to primary HPV screening. Urine HPV testing could provide a simpler approach for cervical screening that is more easily scaled in low and middle income countries.
The study hypothesizes that high-risk human papillomavirus (hrHPV) testing on urine specimens will be similar in sensitivity and specificity for the detection of cervical intra-epithelial neoplasia grade 2 or worse (CIN2+) compared to self- or clinician-collected sampling.
This study will investigate whether women can collect their own samples for HPV testing using either urine or a small brush in the vagina. The results of HPV tests on urine, self-collected vaginal samples, and provider-collected cervical samples will be compared to see which sample type works best.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Confirmed HIV-1 infection
- •Age 25 years and older.
- •Be willing and able to provide written informed consent.
排除标准
- •Pregnant or intend to become pregnant within 90 days of enrollment
- •Have been screened for cervical cancer within the preceding year (365 days)
- •Have an active sexually transmitted infection (STI; women may participate once treated)
- •Have a surgically absent cervix
- •Have a history of cervical cancer
- •have been vaccinated against HPV.
研究组 & 干预措施
Single Arm
This is a single arm study. All participants will receive same interventions.
干预措施: Self-collected cervicovaginal specimen (Other)
Single Arm
This is a single arm study. All participants will receive same interventions.
干预措施: Provider-collected cervical samples (Other)
Single Arm
This is a single arm study. All participants will receive same interventions.
干预措施: Urine HPV testing (Other)
结局指标
主要结局
Clinical performance of hrHPV testing in the three sample types for the detection of CIN2
时间窗: 4 weeks (Entry visit)
The clinical performance (sensitivity, specificity, positive predictive value, and negative predictive value) for CIN2+ detection of sample collection methods namely urine, self-collected samples, and provider-collected samples will be determined.
次要结局
- The proportion of participants positive for hrHPV(4 weeks)
- Clinical performance of hrHPV testing in in the three sample types for the detection of CIN3 or worse(4 weeks)