An interventional study of anal swabbing in HPV Infection, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 2 sites in Reunion. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Diagnostic
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 398 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A self-swabbing then swabbing by a healthcare professional
Diagnostic Test: anal swabbing
swabbing by a healthcare professional and then self-swabbing
Diagnostic Test: anal swabbing
anal swabbing
Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
HPV-16 genotype results for the sample
Time frame: 7 days
Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.
HPV oncogenic genotype results for the sample
Time frame: 7 days
To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.
visual scale from 0 (strongly disagree) to 10 (strongly agree)
Time frame: 7 days
Compare the overall satisfaction of the 2 anal samplings.
visual scale from 0 (poor) to 10 (very good).
Time frame: 7 days
Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.
discomfort, pain, bleeding, inconvenience after each swabbing
Time frame: 7 days
Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional.
composite score, constructed from the satisfaction scores, from which we subtract the average of the adverse event and shame scores, asked after each swab.
Time frame: 7 days
Evaluate the prevalence of anal HPV (including oncogenic HPV).
The proportion and prevalence of the various HPVs in the study population will be described.
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
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