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Trial Title:
The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV (PAPILLO-VIH)
NCT ID:
NCT05968183
Condition:
HIV Seropositivity
Conditions: Official terms:
HIV Seropositivity
Uterine Cervical Neoplasms
Conditions: Keywords:
HPV test
cervical cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Cohort of patients who have been living with HIV seen in maternity consultations
over 1 year at our institution.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Minimum age:
25 Years
Maximum age:
65 Years
Locations:
Facility:
Name:
Centre Hospitalier de Saint-Denis
Address:
City:
Saint-Denis
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire FIEVRE
Phone:
01 42 35 68 97
Email:
claire.fievre@ch-stdenis.fr
Start date:
July 1, 2023
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Centre Hospitalier de Saint-Denis
Agency class:
Other
Source:
Centre Hospitalier de Saint-Denis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968183
