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

Обзор

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.

Вмешательства

• Диагностический тест anal swabbing
  anal swabbing

Первичные конечные точки

• Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling. [Срок оценки: 7 days]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Reunion · 2 центра

• CHU de la Réunion Recherche Clinique — Saint-Denis
• CHU de la Réunion Recherche Clinique — Saint-Pierre

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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