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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Centre Hospitalier Universitaire de la Réunion · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HPV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	anal swabbing	anal swabbing

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-12-28
• Completion: 2027-01-02
• First posted: 2024-07-18
• Last updated: 2025-12-11

Locations

2 sites across 1 country: Reunion