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NCT Number: NCT06507917

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

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de la Réunion Recherche Clinique, Saint-Denis, Reunion

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anal swabbing

Diagnostic Test

anal swabbing

Primary outcomes

  1. Evaluate the concordance of HPV-16 genotype results between self-sampling and professional sampling.

    Time frame: 7 days

    HPV-16 genotype results for the sample

Secondary outcomes

  1. Evaluate the concordance of results for other oncogenic HPV genotypes between self-sampling and professional sampling.

    Time frame: 7 days

    HPV oncogenic genotype results for the sample

  2. To assess the preference of anal self-swabbing over anal swabbing performed by a healthcare professional.

    Time frame: 7 days

    visual scale from 0 (strongly disagree) to 10 (strongly agree)

  3. Compare the overall satisfaction of the 2 anal samplings.

    Time frame: 7 days

    visual scale from 0 (poor) to 10 (very good).

  4. Compare the proportion of adverse events (discomfort, pain, bleeding, itching) in the 2 groups.

    Time frame: 7 days

    discomfort, pain, bleeding, inconvenience after each swabbing

  5. Compare the acceptability of anal self-swabbing versus anal swabbing performed by a healthcare professional.

    Time frame: 7 days

    composite score, constructed from the satisfaction scores, from which we subtract the average of the adverse event and shame scores, asked after each swab.

  6. Evaluate the prevalence of anal HPV (including oncogenic HPV).

    Time frame: 7 days

    The proportion and prevalence of the various HPVs in the study population will be described.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie AUZANNEAU

CONTACT

[email protected]

0262394999 ext. +262

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: a-HPVVIH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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