NCT06507917

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Nov 2025Jan 2027

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 28, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2027

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

July 12, 2024

Last Update Submit

December 4, 2025

Conditions

HPV Infection

Keywords

HPVHIVanal screening

Outcome Measures

Primary Outcomes (1)

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

    HPV-16 genotype results for the sample

    7 days

Secondary Outcomes (6)

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

    7 days

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

    7 days

  • Compare the overall satisfaction of the 2 anal samplings.

    7 days

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

    7 days

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

    7 days

  • +1 more secondary outcomes

Study Arms (2)

self-swabbing first

EXPERIMENTAL

Group A self-swabbing then swabbing by a healthcare professional

Diagnostic Test: anal swabbing

swabbing by a healthcare professional first

ACTIVE COMPARATOR

swabbing by a healthcare professional and then self-swabbing

Diagnostic Test: anal swabbing

Interventions

anal swabbingDIAGNOSTIC_TEST

anal swabbing

self-swabbing firstswabbing by a healthcare professional first

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de la Réunion Recherche Clinique

Saint-Denis, 97400, Reunion

NOT YET RECRUITING

CHU de la Réunion Recherche Clinique

Saint-Pierre, 97448, Reunion

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lucie AUZANNEAU

CONTACT

0262394999lucie.auzanneau@chu-reunion.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 18, 2024

Study Start

November 28, 2025

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

January 2, 2027

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

RE(2)