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Papillomavirus InfectionAUTOColNCT05026047

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

A study testing HPV self-sampling in people with Papillomavirus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older, women only
Conditions the study is for
Papillomavirus Infection
What is being tested?
HPV self-sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFrance
Study dates
May 2023to Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Morgane MAILHE, MD contact

+33 1 40 25 78 84

morgane.mailhe@aphp.fr

France1 site
  • Hôpital Bichat, SMIT

    Paris, Île-de-France Region, 75877

    Morgane MAILHE, MD, +33 1 40 25 78 84, morgane.mailhe@aphp.fr

Other trials in France

About this study

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.

Read the 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.

Being tested
HPV self-sampling
Keywords
Smear test, Early detection of cancer, Papillomavirus infection, Vaginal self-sampling
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPV self-samplingOther

    HPV self-sampling in HIV-positive women

Study groups in NCT05026047
Study groupRoleWhat they receive
patients consulting in an infectious disease departmentExperimentalno comparator
Receives: Other: HPV self-sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Percentage of refusals to perform both tests.

    Measured: one day

Secondary outcomes (5)
  1. 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.

    Percentage of refusal to perform vaginal or urinary self-sampling

    Measured: one day

  2. Evaluation of the quality of vaginal self-test

    Quantification of cellularity in vaginal self-tests

    Measured: one day

  3. Prevalence of HR-HPV in both samples (vaginal self-test and/or urinary self-sampling)

    Number of tests positive to at least one HPV-HR compared to the number of tests performed and interpretable

    Measured: one day

  4. Factors associated with the acceptability of self-sampling (vaginal self-test and/or urinary self-sampling)

    The acceptability of the self-sampling will be evaluated by the participants' answers to a standardized questionnaire (anxiety about finding abnormal results, preference for sample collection by a physician, fear of injury). The individual factors suspected of being associated with acceptability will be compared between the two groups.

    Measured: one day

  5. Feasibility in carrying out self-sampling

    The feasibility of self-sampling will be evaluated by the participants' answers to a standardized questionnaire on their feelings during the self-sampling: sensation at the time of the test, comfort and pain.

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study startMay 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026047
Sponsor's protocol ID
APHP200078
Acronym
AUTOCol
Status last verified
Apr 2023
First submitted
29 Apr 2021
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing HPV self-sampling in people with Papillomavirus Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Morgane MAILHE, MD (+33 1 40 25 78 84, morgane.mailhe@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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