Estudio Oportunidad: Optimizing Screening for Cervical Cancer Among Women Living With HIV in the Dominican Republic
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 619
- 试验地点
- 2
- 主要终点
- Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
研究概览
简要总结
This study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. The lesions are caused by an infection of human papillomavirus, also called HPV. Using new methods to detect HPV may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (HIV) in the Dominican Republic and in other countries.
详细描述
OUTLINE:
Participants participate in three annual interviews and clinical exams that last approximately 2 hours. Study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. Any positive results are followed up in the study clinic.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 25 - 49 years old will be eligible to participate in the study
- •Women living with HIV who have an intact cervix
- •Intent to reside in the Santo Domingo area
- •Ability to attend routine study visits at IDCP for at least 24 months during the study. If women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible
- •Ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria
排除标准
- •Women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (CIN2+) will be excluded
- •Women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study
- •Women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study
- •Women who have no history of vaginal sexual exposure will not be eligible for the study
结局指标
主要结局
Detection of cervical precancerous lesions (CIN2+) by cytology vs HPV restricted genotyping
时间窗: At baseline
Compare performance characteristics of two screening strategies. Comparison between dichotomous tests will be summarized by: (i) the true positive rate (TPR) and (ii) the false positive rate (FPR).
次要结局
未报告次要终点