About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Crossover
Treatments tested in this trial
anal swabbing
Diagnostic testanal swabbing
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
HPV-16 genotype results for the sample
Secondary outcomes
Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.
HPV oncogenic genotype results for the sample
To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.
visual scale from 0 (strongly disagree) to 10 (strongly agree)
Compare the overall satisfaction of the 2 anal samplings.
visual scale from 0 (poor) to 10 (very good).
Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.
discomfort, pain, bleeding, inconvenience after each swabbing
Sponsors and contacts
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