Concordance and Acceptability of Self-screening Compared to Screening Carried Out by a Health Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV. A Randomized Controlled Crossover Study (ALONDEPISTHPV)

February 26, 2026 updated by: Centre Hospitalier Universitaire de la Réunion

Comunity health actions are set up in populations of women aged 30 to 65 in vulnerable situations living in the outlying areas of Reunion Island.

The idea is to evaluate those action on health

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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

  • Name: Emmanuelle THORE, dr
  • Phone Number: +262 262 74 23 80
  • Email: direction@chor.re

Study Locations

  • France
      • Saint-Paul, France
        • Recruiting
        • Cegidd Saint Paul
        • Contact:
        • Principal Investigator:
          • Dr Emmanuelle THORE
      • Saint-Pierre, France

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:

  • Aged 30 to 65,
  • In a vulnerable situation (beneficiary of a state or departmental social service, or referred by a charity),
  • Resident in one of the two municipalities targeted by the study,
  • Supported by the social services of one of the two municipalities targeted by the study,
  • Having agreed to participate in sexual health awareness meetings organized on site

Exclusion Criteria:

  • Refusing to participate in the study
  • Having had a hysterectomy

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participant
  1. Awareness workshops on uterine cancer screening - small group workshops conducted in the form of discussion groups
  2. Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants whose CC screening is not up to date
Other: Public health workshop in community

1) Cervical cancer screening awareness workshops, conducted in small groups through focus groups.

-2) Proposal for an HPV self-test (vaginal self-swab to detect high-risk HPV) as part of an individual consultation for participants who are not up-to-date with their cervical cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of women who complete cervical cancer screening after the community health intervention,
Time Frame: 3 months
Rate of women aged 30 to 65 years living in vulnerable areas of Reunion Island who complete cervical cancer screening (HPV test or Pap smear) within 3months after the community health intervention, as documented in medical records or screening databases.
3 months

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)

April 9, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 7, 2025

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/CHU/37
  • 2023-A02588-37 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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