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Recruiting NCT06507917

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

No phase Interventional HPV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anal swabbing.
Who it may be relevant to
Registry conditions: HPV Infection. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Reunion
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test anal swabbing
    anal swabbing

Primary outcome measures

  • Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling. [Time frame: 7 days]
Secondary outcome measures (6)
  • Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling. [Time frame: 7 days]
  • To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional. [Time frame: 7 days]
  • Compare the overall satisfaction of the 2 anal samplings. [Time frame: 7 days]
  • Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups. [Time frame: 7 days]
  • Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional. [Time frame: 7 days]
  • Evaluate the prevalence of anal HPV (including oncogenic HPV). [Time frame: 7 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

Reunion · 2 centers
  • CHU de la Réunion Recherche Clinique — Saint-Denis
  • CHU de la Réunion Recherche Clinique — Saint-Pierre

Identifiers

NCT: NCT06507917 · 2024/CHU/42 · 2024-A01508-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗