Clinical trial NCT05026047: Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
Official title: Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillomavirus Infection
Keywords: Smear test
Early detection of cancer
Papillomavirus infection
Vaginal self-sampling
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

A previous medical thesis showed that 54% of patients followed up at the CoreVIH Ile de France Nord had a smear that was less than two years old (9). The idea is therefore to explore alternative options for these women who are being followed at CoreVIH Ile de France Nord but who are not being screened at the recommended rate.

Eligibility criteria: Inclusion criteria :

* 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

Exclusion criteria :

* 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

Primary outcomes:
measure: 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.
timeFrame: one day
Secondary outcomes:
measure: 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.
timeFrame: one day
measure: Evaluation of the quality of vaginal self-test
timeFrame: one day
measure: Prevalence of HR-HPV in both samples (vaginal self-test and/or urinary self-sampling)
timeFrame: one day
measure: Factors associated with the acceptability of self-sampling (vaginal self-test and/or urinary self-sampling)
timeFrame: one day
measure: Feasibility in carrying out self-sampling
timeFrame: one day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat, SMIT
state: Ile De France
Study officials:
affiliation: AP-HP SMIT, Bichat hospital, Paris, France
name: Morgane MAILHE, MD
role: PRINCIPAL_INVESTIGATOR
References: