Actively Recruiting

Phase Not Applicable
Age: 30Years +
All Genders
ID06507917

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

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Loading map...

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

Similar Trials

A Multicenter Randomized, Double-Blind, Placebo-Controlled P...

HPV InfectioN

Actively Recruiting

8 locations

A Randomized Clinical Trial to Compare Thermal Ablation Vers...

HIV Infections

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here