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 (a-HPVVIH)

December 4, 2025 updated by: Centre Hospitalier Universitaire de la Réunion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Reunion
      • Saint-Denis, Reunion, 97400
        • Not yet recruiting
        • CHU de la Réunion Recherche Clinique
        • Contact:
        • Principal Investigator:
          • Kevin DIALLO
      • Saint-Pierre, Reunion, 97448
        • Recruiting
        • CHU de la Réunion Recherche Clinique
        • Contact:
        • Principal Investigator:
          • Kevin DIALLO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: self-swabbing first
Group A self-swabbing then swabbing by a healthcare professional
Diagnostic test: anal swabbing
anal swabbing
Active Comparator: swabbing by a healthcare professional first
swabbing by a healthcare professional and then self-swabbing
Diagnostic test: anal swabbing
anal swabbing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
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)
7 days
Compare the overall satisfaction of the 2 anal samplings.
Time Frame: 7 days
visual scale from 0 (poor) to 10 (very good).
7 days
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
7 days
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.
7 days
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

January 2, 2027

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/CHU/42
  • 2024-A01508-39 (Other Identifier: idRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV Infection

Clinical Trials on anal swabbing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe