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.
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.
France1 site
Hôpital Bichat, SMIT
Paris, Île-de-France Region, 75877
Morgane MAILHE, MD, +33 1 40 25 78 84, morgane.mailhe@aphp.fr
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.
- Conditions
- Papillomavirus Infection
- 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 group | Role | What they receive |
|---|---|---|
| patients consulting in an infectious disease department | Experimental | no comparator Receives: Other: HPV self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Evaluation of the quality of vaginal self-test
Quantification of cellularity in vaginal self-tests
Measured: one day
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
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
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.
- First posted30 Aug 2021
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgane MAILHE, MD, Principal investigator, AP-HP SMIT, Bichat hospital, Paris, France
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
- ClinicalTrials.gov ID
- NCT05026047
- Acronym / sponsor ID
- AUTOCol / APHP200078
- Conditions
- Papillomavirus Infection
- Keywords
- Smear test, Early detection of cancer, Papillomavirus infection, Vaginal self-sampling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients consulting in an infectious disease department | Experimental | Other: HPV self-samplingno comparator |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV self-samplingHPV self-sampling in HIV-positive women | Other | patients consulting in an infectious disease department |
Primary outcome
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
Percentage of refusals to perform both tests.
5 secondary outcomes
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.
Time frame: one day
Evaluation of the quality of vaginal self-test
Time frame: one day
Prevalence of HR-HPV in both samples (vaginal self-test and/or urinary self-sampling)
Time frame: one day
Factors associated with the acceptability of self-sampling (vaginal self-test and/or urinary self-sampling)
Time frame: one day
Feasibility in carrying out self-sampling
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgane MAILHE, MD principal investigator
AP-HP SMIT, Bichat hospital, Paris, France
1 site in 1 country: see every site and its status.
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.