Acceptability of Human Papillomavirus Self-sampling in Women Living With HIV

NCT05026047 | Unknown

• 1 other identifier: APHP200078
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Papillomavirus Infection

Keywords

Smear test; Early detection of cancer; Papillomavirus infection; Vaginal self-sampling

Outcome Measures

Primary Outcomes (1)

• 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.

  Percentage of refusals to perform both tests.

  one day

Secondary Outcomes (5)

• 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.

  one day

• Evaluation of the quality of vaginal self-test

  one day

• Prevalence of HR-HPV in both samples (vaginal self-test and/or urinary self-sampling)

  one day

• Factors associated with the acceptability of self-sampling (vaginal self-test and/or urinary self-sampling)

  one day

• Feasibility in carrying out self-sampling

  one day

Study Arms (1)

patients consulting in an infectious disease department

EXPERIMENTAL

no comparator

Other: HPV self-sampling

Interventions

HPV self-sampling OTHER

HPV self-sampling in HIV-positive women

patients consulting in an infectious disease department

Eligibility Criteria

• Age: 30 Years+
• Gender Eligibility Details: HIV-positive women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat, SMIT

Paris, Île-de-France Region, 75877, France

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Morgane MAILHE, MD

  AP-HP SMIT, Bichat hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgane MAILHE, MD

CONTACT

+33 1 40 25 78 84; morgane.mailhe@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: August 30, 2021
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

FR (1)