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Trial 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
NCT ID:
NCT06507917
Condition:
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Anus Neoplasms
Conditions: Keywords:
HPV
HIV
anal screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
anal swabbing
Description:
anal swabbing
Arm group label:
self-swabbing first
Arm group label:
swabbing by a healthcare professional first
Summary:
Anal canal cancers are on the increase in France, with around 2,000 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patient :
- living with HIV
- aged 30 or over
- resident on Reunion island and followed at the University Hospital of Reunion Island
(the only follow-up center on the island)
- Able to perform anal self-sampling
- Able to answer a questionnaire
- Affiliated with or benefiting from a social security scheme
- Have given free, informed and signed consent
Exclusion Criteria:
- People with a previous anal swab less than 7 days old
- Persons with a known current diagnosis of anal cancer
- Persons deprived of liberty by judicial or administrative decision, minors, and
persons under legal protection: guardianship or curators
Gender:
All
Minimum age:
30 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de la Réunion Recherche Clinique
Address:
City:
Saint-Denis
Zip:
97400
Country:
Réunion
Contact:
Last name:
Kevin DIALLO
Email:
kevin.diallo@chu-reunion.fr
Investigator:
Last name:
Kevin DIALLO
Email:
Principal Investigator
Facility:
Name:
CHU de la Réunion Recherche Clinique
Address:
City:
Saint-Pierre
Zip:
97448
Country:
Réunion
Contact:
Last name:
Kevin DIALLO
Email:
kevin.diallo@chu-reunion.fr
Investigator:
Last name:
Kevin DIALLO
Email:
Principal Investigator
Start date:
September 1, 2024
Completion date:
November 2, 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de la Réunion
Agency class:
Other
Source:
Centre Hospitalier Universitaire de la Réunion
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06507917
