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

ConditionHPV Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorCentre Hospitalier Universitaire de la Réunion

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • anal swabbing

    Diagnostic test

    anal swabbing

Treatment groups

398 Participants
are divided into 2 treatment groups
Group A: self-swabbing firstExperimental treatment 1 intervention
Group B: swabbing by a healthcare professional firstActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.

HPV-16 genotype results for the sample

Time frame
7 days

Secondary outcomes

1

Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.

HPV oncogenic genotype results for the sample

Time frame
7 days
2

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)

Time frame
7 days
3

Compare the overall satisfaction of the 2 anal samplings.

visual scale from 0 (poor) to 10 (very good).

Time frame
7 days
4

Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.

discomfort, pain, bleeding, inconvenience after each swabbing

Time frame
7 days

Other outcomes

Sponsors and contacts

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