Actively Recruiting
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
Led by Centre Hospitalier Universitaire de la Réunion · Updated on 2025-12-11
398
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Anal canal cancers are becoming more common in France, especially among people living with HIV, who face a risk 30 times higher than the general population. This study focuses on people living with HIV aged 30 or older, including heterosexual men and women without vaginal cervical lesions, to evaluate anal HPV screening methods. The goal is to assess the agreement and acceptance of self-screening compared to screening performed by healthcare professionals as part of a strategy to detect anal cancer risk. Participants will be randomly assigned to one of two groups: one group will perform anal self-swabbing first followed by a healthcare professional swabbing, and the other group will have the professional swabbing first followed by self-swabbing. Both methods involve collecting anal swabs to test for HPV, particularly the HPV-16 genotype known for its cancer risk. The study compares the results from the two sampling methods and gathers information on participant preference, satisfaction, and any side effects like discomfort or bleeding. During the study, participants will provide samples and answer questionnaires about their experience. Researchers will evaluate how well the self-sampling matches professional sampling and measure the prevalence of anal HPV infections. The study will also monitor any adverse events and assess overall acceptability of both methods. Participation includes follow-up within 7 days after sampling to gather results and feedback, with the entire process designed to improve anal cancer screening in this high-risk group.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living with HIV
- Aged 30 or older
- Resident on Reunion Island and followed at the University Hospital of Reunion 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
You will not qualify if you...
- Previous anal swab less than 7 days old
- Known current diagnosis of anal cancer
- Persons deprived of liberty by judicial or administrative decision, minors, or persons under legal protection such as guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants perform anal swabbing by themselves and by a healthcare professional to collect samples for HPV testing.
2 visits (in-person) for swabbing, one for self-swabbing and one by a healthcare professional
Trial Site Locations
Total: 2 locations
1
CHU de la Réunion Recherche Clinique
Saint-Denis, Reunion, 97400
Not Yet Recruiting
2
CHU de la Réunion Recherche Clinique
Saint-Pierre, Reunion, 97448
Actively Recruiting
Research Team
L
Lucie AUZANNEAU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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