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 (a-HPVVIH)

Centre Hospitalier Universitaire de la Réunion

Status: Enrolling

Conditions: HPV Infection

Treatments: Diagnostic Test: anal swabbing

Study type: Interventional

Funder types: Other

Identifiers

NCT06507917

2024/CHU/42

2024-A01508-39 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 398 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

self-swabbing first

Experimental group

Description:

Group A self-swabbing then swabbing by a healthcare professional

Treatment:

Diagnostic Test: anal swabbing

swabbing by a healthcare professional first

Active Comparator group

Description:

swabbing by a healthcare professional and then self-swabbing

Treatment:

Diagnostic Test: anal swabbing