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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2027-01-02

Brief Summary

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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.

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Detailed Description

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Conditions

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HPV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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self-swabbing first

Group A self-swabbing then swabbing by a healthcare professional

Group Type EXPERIMENTAL

anal swabbing

Intervention Type DIAGNOSTIC_TEST

anal swabbing

swabbing by a healthcare professional first

swabbing by a healthcare professional and then self-swabbing

Group Type ACTIVE_COMPARATOR

anal swabbing

Intervention Type DIAGNOSTIC_TEST

anal swabbing

Interventions

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anal swabbing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No