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临床试验/NCT05026047
NCT05026047尚未招募不适用

Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Acceptability of vaginal self-test coupled to urinary self-sampling in HIV-positive women in the population of the CoreVIH Ile de France Nord area.

研究概览

简要总结

Women living with HIV are unsufficiently screened for cervix cancer although they have a higher risk of developping it, resulting in many obstacles. Offering a new screening technique, more accessible and which doesn't require gynecologic examination, could help improving this coverage rate. Human Papillomavirus (HPV) screening have a higher-performance for cervix cancer than smear test. Self-collected vaginal swabs are as efficient as vaginal swabs performed by clinicians. They are also shown as acceptable among general population but only one study in South Africa has been performed on women living with HIV. In addition, recent studies on urine self-sampling for high risk HPV (HR-HPV) screening report satisfactory performance. The main hypothesis is that self-collected vaginal swabs and urine self-sampling are also acceptable among women living with HIV in the CoreVIH Ile de France Nord (CoreVIH) cohort.

详细描述

Worldwide, cervical cancer is the second most common cancer (10% of all cancers), in 2012: 528,000 cases and 266,000 deaths. In France, in 2012, the incidence is estimated at 6.7 per 100,000 women, with 3,028 new cases per year and 1,102 deaths. Screening for cervical cancer is a public health issue because cancer affects young, healthy women and early detection is available. Persistent infection with oncogenic HPV (Human Papillomavirus) is responsible for the development of pre-cancerous lesions and cervical cancer. There are more than a hundred genotypes of HPV identified. Among them, HPV 16 and 18 are the genotypes most often associated with cancer. The natural history of cervical cancer has led to the definition of several ways to prevent the development of cancer, such as vaccination to prevent infection, screening for infection using HPV virological tests that detect DNA, and cervical smears to detect precancerous or cancerous lesions. In France, in the general population, screening is done by smear test performed by a clinician or in a biological laboratory for cytological analysis. The recommendations of the French Health Authority (HAS) are to perform a smear test every three years, after two normal smears one year apart from 25 to 65 years of age, except in women who have never had sexual intercourse and those who have had a hysterectomy with removal of the cervix. Since July 2019, the HAS has introduced in its recommendations for cervical cancer screening the use of HPV testing, which must now replace the cytological examination from the age of 30 years and must be performed 3 years after the last cytological examination with a normal result and then every 5 years in case of negativity.

This test can be offered as a vaginal self-sampling for women who are not or insufficiently screened. Women living with HIV are part of this population and are included in these recommendations. Other countries such as the Netherlands have included virological analysis in their strategy: in 2011 the health authorities have decided to use HPV self-tests in primary care instead of cervical smear tests (FCU). In 2016, the recommendation in the Netherlands is to perform an HPV test every 5 years from 30 to 60 years of age. In case of a positive HPV test, an FCU is performed.

Virological tests can be carried out on vaginal swabs by hetero or self-sampling or on urine samples. In HIV patients, earlier screening is recommended because of the increased risk of developing cancerous lesions as a result of immunosuppression. The Morlat report (2013) recommends an annual smear test as soon as seropositivity is discovered, with no upper age limit. France has individual and unorganized screening (such as breast or colon cancer) with incomplete coverage. According to HAS data in 2010, only 8% of women eligible for smear screening have an adequate follow-up rate. 52% of women aged 25-65 are not screened at all or have smears too far apart (more than 3 years). A majority of cases of cervical cancer are diagnosed in France in women participating irregularly or not participating in individual screening. The tests are based on the detection of HPV on a sample of the cervix. The virological technique is already recommended in the triage of smear test with atypical squamous cells of undetermined significance (ASC-US). Several types of self-samples are currently available. Studies show a good level of agreement for all vaginal swabs using HPV testing by polymerase chain reaction (PCR) technique (dry swab, swab with liquid transport medium). The different studies that have tested the acceptability of HPV self-sampling in the general population show good acceptability; between 66 and 94% acceptability depending on the studies.

The use could be interesting in the first instance to catch up with women who have not been screened due to the hindrance of gynaecological examination or the constraint of a medical consultation. In a French study, the APACHE project, the proposal of self-sampling in unscreened women had increased participation in cervical cancer screening. The use of self-sampling improves participation in screening by sending the kits to women who are not up-to-date in their smear test. In a study conducted among HIV-infected women in South Africa in 2015, there was 90% acceptability.

The APACHE project is a series of studies carried out in France between 2009 and 2014 on the subject whose two objectives were to evaluate the performance of self-sampling for the detection of cervical HPV infection and to assess the effectiveness on participation of sending a self-sampling kit to the homes of undetected women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •HIV-positive women over or equal to 30 years old
  • •HIV-positive patient who has already consulted at least once at the CoreVIH Ile de France Nord

排除标准

  • •Refusal to sign a consent form
  • •Personal history of cervical cancer, conization, suspicious smears undergoing exploration or known high oncogen risk HPV
  • •Ongoing menstruation
  • •Physical impossibility to carry out self-sampling (e.g. motor disability, significant visual disturbances)
  • •Ongoing gynecological infection
  • •Patient not affiliated to a social security scheme or without AME
  • •Protected adult patient (under guardianship, curatorship)
  • •Pregnant or breastfeeding woman

研究组 & 干预措施

patients consulting in an infectious disease department

Experimental

no comparator

干预措施: HPV self-sampling (Other)

结局指标

主要结局

Acceptability of vaginal self-test coupled to urinary self-sampling in HIV-positive women in the population of the CoreVIH Ile de France Nord area.

时间窗: one day

Percentage of refusals to perform both tests.

次要结局

  • Factors associated with the acceptability of self-sampling (vaginal self-test and/or urinary self-sampling)(one day)
  • Acceptability of the vaginal self-test alone and the urinary self-sampling alone in HIV-positive women in the population of the CoreVIH Ile de France Nord area.(one day)
  • Evaluation of the quality of vaginal self-test(one day)
  • Prevalence of HR-HPV in both samples (vaginal self-test and/or urinary self-sampling)(one day)
  • Feasibility in carrying out self-sampling(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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