An observational study in HIV Seropositivity, sponsored by Centre Hospitalier de Saint-Denis. Status unknown at 1 site in France. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Centre Hospitalier de Saint-Denis · Observational
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.
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.
215 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.
This study's planned enrollment of 200 is close to the median of 220 across 62 observational studies indexed under HIV Seropositivity.
Browse HIV Seropositivity studies →Centre Hospitalier de Saint-Denis is the lead sponsor of 45 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of patients who have been living with HIV seen in maternity consultations
over 1 year at our institution.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Demographic characteristics
Time frame: Day 1
HIV history
Time frame: Day 1
medical history
Time frame: Day 1
comorbidities
Time frame: Day 1
clinical examination data
Time frame: Day 1
Results of HPV Cytology
Time frame: Day 1
Results of cell smear
Time frame: Day 1
Results of additional examinations prescribed
Results of any additional examinations prescribed
Time frame: Day 1
Started Jul 2023 (actual). Primary completion is estimated for Jul 2024, 12 months after the start.
Of 19 observational studies under HIV Seropositivity, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 112. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Saint-Denis