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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

Study acronym: a-HPVVIH
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Sep 1, 2026 to Dec 28, 2026
    • Study completion date: Nov 2, 2026 to Jan 2, 2027
    • Start date changed from estimate of Oct 1, 2025 to Nov 28, 2025
    • Site details revised at 2 of 2 sites
  2. Notable Start date: Sep 1, 2024 to Oct 1, 2025v4
  3. Minor Study title revisedv3
  4. Minor Study title shortened, about 5 wordsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06507917
Lead Sponsor Centre Hospitalier Universitaire de la Réunion
Conditions
(from sponsor)
HPV Infection
Related terms Papillomavirus Infections
Enrollment 398 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov