The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Demographic characteristics
研究概览
简要总结
The main objective of this study is to evaluate the interest of a screening strategy based on the HPV test in patients living with HIV, compared to the cell smear alone in the same population.
The Secondary objective of this study is to verify if the use of HPV testing could allow for a longer follow-up of these patients in case of negativity, and thus allow for a standardization of clinicians' practices.
详细描述
Since 2019, a new screening strategy has been implemented and is based on high-risk, HPV tests, which, when negative, allow for spaced monitoring in the general population after age 30 (every 5 years instead of every 3 years.)
These tests therefore allow for earlier detection of patients at risk but also for longer follow-up when they are negative.
To our knowledge, there is currently no evaluation of HPV testing as part of routine screening in patients living with HIV.
The recommendations for this population are based on the use of the cervico-vaginal smear with cytological analysis. The smear should be taken every year and surveillance may be repeated every 3 years. If there are 3 consecutive smears without abnormalities and a controlled viral load with CD4 counts > 500 mm3. In practice, many patients do not meet these criteria and must, therefore, undergo annual screening; the increase in the number of smears also leads to an increase in the number of second-line examinations such as colposcopy.
Since there is no recommendation for HPV testing in this population, the use of dual detection (cytology and HPV testing) is left to the discretion of the clinician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Women living with HIV
- •Age 25-65 years
- •Managed in the CHSD maternity ward: consultation or hospitalization
- •Having signed a consent form
排除标准
- •Age ≤ 24 years, or ≥ 66 years
- •Women who are not HIV positive
- •Patients under legal protection (guardianship, curatorship)
- •Patients deprived of liberty
- •Patients not affiliated to a social security system
- •Refusal to participate in the research
结局指标
主要结局
Demographic characteristics
时间窗: Day 1
comorbidities
时间窗: Day 1
clinical examination data
时间窗: Day 1
HIV history
时间窗: Day 1
medical history
时间窗: Day 1
次要结局
- Results of cell smear(Day 1)
- Results of HPV Cytology(Day 1)
- Results of additional examinations prescribed(Day 1)