Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 398
- 试验地点
- 2
- 主要终点
- Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
研究概览
简要总结
Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests.
The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population.
According to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. However, the proposal of a proctological examination in this population is not systematic.
In France, there is no HPV screening for people living with HIV, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (MSM) or for women with vaginal cervical lesions.
Several oncogenic HPV serotypes have been identified in the genesis of anal cancer. The serotype identified as the most carcinogenic is HPV-16 (89%).
This study will look at anal HPV screening in people over 30 living with HIV, thus including a population for which no screening is currently offered (heterosexual men living with HIV and women living with HIV without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living with HIV
- •aged 30 or over
- •resident on Reunion island and followed at the University Hospital of Reunion Island (the only follow-up center on the island)
- •Able to perform anal self-sampling
- •Able to answer a questionnaire
- •Affiliated with or benefiting from a social security scheme
- •Have given free, informed and signed consent
排除标准
- •People with a previous anal swab less than 7 days old
- •Persons with a known current diagnosis of anal cancer
- •Persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators
研究组 & 干预措施
self-swabbing first
Group A self-swabbing then swabbing by a healthcare professional
干预措施: anal swabbing (Diagnostic Test)
swabbing by a healthcare professional first
swabbing by a healthcare professional and then self-swabbing
干预措施: anal swabbing (Diagnostic Test)
结局指标
主要结局
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
时间窗: 7 days
HPV-16 genotype results for the sample
次要结局
- Compare the overall satisfaction of the 2 anal samplings.(7 days)
- Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.(7 days)
- Evaluate the prevalence of anal HPV (including oncogenic HPV).(7 days)
- Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.(7 days)
- To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.(7 days)
- Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional.(7 days)