Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507917
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV a Risk Factor for Anal Cancer by Swab in People Living With HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV a Risk Factor for Anal Cancer by Swab in People Living With HIV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
a-HPVVIH
Brief Summary:
Anal canal cancers are on the increase in France with around 2000 new cases per year These lesions can be detected by directed biopsies or smear tests
The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population
According to a recent study the risk of anal cancer is highest in this population but is also high in heterosexual men over 30 and women over 30 However the proposal of a proctological examination in this population is not systematic
In France there is no HPV screening for people living with HIV but there is a recommendation for proctology consultation in certain cases notably for men who have sex with men MSM or for women with vaginal cervical lesions
Several oncogenic HPV serotypes have been identified in the genesis of anal cancer The serotype identified as the most carcinogenic is HPV-16 89
This study will look at anal HPV screening in people over 30 living with HIV thus including a population for which no screening is currently offered heterosexual men living with HIV and women living with HIV without vaginal cervical lesions and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population
The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population
According to a recent study the risk of anal cancer is highest in this population but is also high in heterosexual men over 30 and women over 30 However the proposal of a proctological examination in this population is not systematic
In France there is no HPV screening for people living with HIV but there is a recommendation for proctology consultation in certain cases notably for men who have sex with men MSM or for women with vaginal cervical lesions
Several oncogenic HPV serotypes have been identified in the genesis of anal cancer The serotype identified as the most carcinogenic is HPV-16 89
This study will look at anal HPV screening in people over 30 living with HIV thus including a population for which no screening is currently offered heterosexual men living with HIV and women living with HIV without vaginal cervical lesions and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None