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
NCT Number: NCT06507917
Acronym: a-HPVVIH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HPV Infection
Interventions: DIAGNOSTIC_TEST: anal swabbing
Sponsor: Centre Hospitalier Universitaire de la Réunion
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 398
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-11-02
Locations: CHU de la Réunion Recherche Clinique, Saint-Denis, 97400, Réunion|CHU de la Réunion Recherche Clinique, Saint-Pierre, 97448, Réunion

Summary:
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.

Primary Outcome Measures: Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling., HPV-16 genotype results for the sample, 7 days
Secondary Outcome Measures: Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling., HPV oncogenic genotype results for the sample, 7 days|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), 7 days|Compare the overall satisfaction of the 2 anal samplings., visual scale from 0 (poor) to 10 (very good)., 7 days|Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups., discomfort, pain, bleeding, inconvenience after each swabbing, 7 days|Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional., composite score, constructed from the satisfaction scores, from which we subtract the average of the adverse event and shame scores, asked after each swab., 7 days|Evaluate the prevalence of anal HPV (including oncogenic HPV)., The proportion and prevalence of the various HPVs in the study population will be described., 7 days