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

Recruiting

• Conditions: HIV Seropositivity

• Registration Number: NCT05968183
• Lead Sponsor: Centre Hospitalier de Saint-Denis

Brief Summary

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.

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 Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic characteristics	Day 1
comorbidities	Day 1
clinical examination data	Day 1
HIV history	Day 1
medical history	Day 1

Secondary Outcome Measures

Name	Time	Method
Results of cell smear	Day 1
Results of HPV Cytology	Day 1
Results of additional examinations prescribed	Day 1	Results of any additional examinations prescribed

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Denis; 🇫🇷 Saint-Denis, France