Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anal swabbing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- self-swabbing first
- description
- Group A self-swabbing then swabbing by a healthcare professional
- interventionNames
- Diagnostic Test: anal swabbing
- type
- ACTIVE_COMPARATOR
- label
- swabbing by a healthcare professional first
- description
- swabbing by a healthcare professional and then self-swabbing
- interventionNames
- Diagnostic Test: anal swabbing
Primary outcomes (1)
- measure
- Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available