Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05026047
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-12
First Post:
2021-04-29
Brief Title:
Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUTOCol
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 doesnt 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 528000 cases and 266000 deaths In France in 2012 the incidence is estimated at 67 per 100000 women with 3028 new cases per year and 1102 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None