The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV (PAPILLO-VIH) (PAPILLO-VIH)

July 20, 2023 updated by: Centre Hospitalier de Saint-Denis

The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV

The main objective of this study is to evaluate the interest of a screening strategy based on the HPV test in patients living with HIV, compared to the cell smear alone in the same population.

The Secondary objective of this study is to verify if the use of HPV testing could allow for a longer follow-up of these patients in case of negativity, and thus allow for a standardization of clinicians' practices.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Since 2019, a new screening strategy has been implemented and is based on high-risk, HPV tests, which, when negative, allow for spaced monitoring in the general population after age 30 (every 5 years instead of every 3 years.)

These tests therefore allow for earlier detection of patients at risk but also for longer follow-up when they are negative.

To our knowledge, there is currently no evaluation of HPV testing as part of routine screening in patients living with HIV.

The recommendations for this population are based on the use of the cervico-vaginal smear with cytological analysis. The smear should be taken every year and surveillance may be repeated every 3 years. If there are 3 consecutive smears without abnormalities and a controlled viral load with CD4 counts > 500 mm3. In practice, many patients do not meet these criteria and must, therefore, undergo annual screening; the increase in the number of smears also leads to an increase in the number of second-line examinations such as colposcopy.

Since there is no recommendation for HPV testing in this population, the use of dual detection (cytology and HPV testing) is left to the discretion of the clinician.

By mutual agreement with the clinicians of the maternity department of the Saint-Denis Hospital (CHSD), this double detection was introduced in 2021, using the same sample (single swab for both analyses: cytology and HPV test).

Therefore, it seems interesting to verify the possibility of a screening strategy based on HPV testing in patients living with HIV, by correlating the results of HPV testing and cell smears in the population of patients living with HIV.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Locations

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Cohort of patients who have been living with HIV seen in maternity consultations

over 1 year at our institution.

Description

Inclusion Criteria:

  • Women living with HIV
  • Age 25-65 years
  • Managed in the CHSD maternity ward: consultation or hospitalization
  • Having signed a consent form

Exclusion Criteria:

  • Age ≤ 24 years, or ≥ 66 years
  • Women who are not HIV positive
  • Patients under legal protection (guardianship, curatorship)
  • Patients deprived of liberty
  • Patients not affiliated to a social security system
  • Refusal to participate in the research

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Demographic characteristics
Time Frame: Day 1
Day 1
HIV history
Time Frame: Day 1
Day 1
medical history
Time Frame: Day 1
Day 1
comorbidities
Time Frame: Day 1
Day 1
clinical examination data
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of HPV Cytology
Time Frame: Day 1
Day 1
Results of cell smear
Time Frame: Day 1
Day 1
Results of additional examinations prescribed
Time Frame: Day 1
Results of any additional examinations prescribed
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier de Saint-Denis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHSD_0026_MATER
  • 2022-A01844-39 (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.

Clinical Trials on HIV Seropositivity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe