Self-collected versus clinician-collected anal swabs for HPV screening in people living with HIV in Réunion
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
NA · Centre Hospitalier Universitaire de la Réunion · NCT06507917
This study tries to see if people living with HIV aged 30 and older can collect their own anal swab as accurately and comfortably as a healthcare professional for HPV screening.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 398 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de la Réunion (other) |
| Locations | 2 sites (Saint-Denis and 1 other locations) |
| Trial ID | NCT06507917 on ClinicalTrials.gov |
What this trial studies
The trial enrolls people living with HIV aged 30 and over who are followed at the University Hospital of Réunion and asks participants to provide an anal self-swab as well as a clinician-collected swab. Samples will be tested for oncogenic HPV types (notably HPV-16) and the results from self-collection and clinician collection will be compared for concordance. Participants will also complete a questionnaire about the acceptability and ease of self-sampling. The goal is to determine whether self-sampling could be a reliable, acceptable option to expand anal HPV screening in this high-risk population on Réunion Island.
Who should consider this trial
Good fit: Ideal candidates are people living with HIV aged 30 or older who live on Réunion Island, are followed at the CHU de la Réunion, can perform self-sampling, can complete a questionnaire, and can give informed consent.
Not a fit: People with a known current diagnosis of anal cancer, a recent anal swab within 7 days, minors, those under legal protection, or individuals unable to perform self-sampling are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, self-sampling could increase access to anal HPV screening, leading to earlier detection and treatment of precancerous lesions in people living with HIV.
How similar studies have performed: Previous studies of self-collected genital and anal HPV samples, including work in people living with HIV and MSM, have shown promising concordance and acceptability, but results vary by population and setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient : * living with HIV * aged 30 or over * resident on Reunion island and followed at the University Hospital of Reunion Island (the only follow-up center on the 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 Exclusion Criteria: * People with a previous anal swab less than 7 days old * Persons with a known current diagnosis of anal cancer * Persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators
Where this trial is running
Saint-Denis and 1 other locations
- CHU de la Réunion Recherche Clinique — Saint-Denis, Reunion (NOT_YET_RECRUITING)
- CHU de la Réunion Recherche Clinique — Saint-Pierre, Reunion (RECRUITING)
Study contacts
- Study coordinator: Lucie AUZANNEAU
- Email: lucie.auzanneau@chu-reunion.fr
- Phone: 0262394999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HPV Infection, HPV, HIV, anal screening