Clinical trial NCT05968183: The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV (PAPILLO-VIH)
Official title: The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Seropositivity
Keywords: HPV test
cervical cancer
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic characteristics
timeFrame: Day 1
measure: HIV history
timeFrame: Day 1
measure: medical history
timeFrame: Day 1
measure: comorbidities
timeFrame: Day 1
measure: clinical examination data
timeFrame: Day 1
Secondary outcomes:
measure: Results of HPV Cytology
timeFrame: Day 1
measure: Results of cell smear
timeFrame: Day 1
measure: Results of additional examinations prescribed
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
Study officials:
References:
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