Clinical trial · Interventional
Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Women living with HIV are unsufficiently screened for cervix cancer although they have a higher risk of developping it, resulting in many obstacles. Offering a new screening technique, more accessible and which doesn't require gynecologic examination, could help improving this coverage rate. Human Papillomavirus (HPV) screening have a higher-performance for cervix cancer than smear test. Self-collected vaginal swabs are as efficient as vaginal swabs performed by clinicians. They are also shown as acceptable among general population but only one study in South Africa has been performed on women living with HIV. In addition, recent studies on urine self-sampling for high risk HPV (HR-HPV) screening report satisfactory performance. The main hypothesis is that self-collected vaginal swabs and urine self-sampling are also acceptable among women living with HIV in the CoreVIH Ile de France Nord (CoreVIH) cohort.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV self-sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients consulting in an infectious disease department
- description
- no comparator
- interventionNames
- Other: HPV self-sampling
Primary outcomes (1)
- measure
- Acceptability of vaginal self-test coupled to urinary self-sampling in HIV-positive women in the population of the CoreVIH Ile de France Nord area.
- timeFrame
- one day
- description
- Percentage of refusals to perform both tests.
Secondary outcomes (5)
- measure
- Acceptability of the vaginal self-test alone and the urinary self-sampling alone in HIV-positive women in the population of the CoreVIH Ile de France Nord area.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion criteria : * HIV-positive women over or equal to 30 years old * HIV-positive patient who has already consulted at least once at the CoreVIH Ile de France Nord Exclusion criteria : * Refusal to sign a consent form * Personal history of cervical cancer, conization, suspicious smears undergoing exploration or known high oncogen risk HPV * Ongoing menstruation * Physical impossibility to carry out self-sampling (e.g. motor disability, significant visual disturbances) * Ongoing gynecological infection * Patient not affiliated to a social security scheme or without AME * Protected adult patient (under guardianship, curatorship) * Pregnant or breastfeeding woman
References
Publications (0)
Data not yet available