Self-collected Vaginal and Urine Samples in HIV-positive Women

CompletedOBSERVATIONAL
Enrollment

502

Participants

Timeline

Start Date

May 29, 2023

Primary Completion Date

November 23, 2023

Study Completion Date

February 28, 2024

Conditions
HIV InfectionsHPV-Related Cervical CarcinomaCervical CancerCoinfection, HIV
Interventions
DIAGNOSTIC_TEST

Self-sampling for HPV infection

After informed consent has been provided, the woman will be asked to collect firstly a first-void urine sample using the Collipee device and secondly to collect a vaginal self-sample using the dry Evalyn® Brush device. Socioeconomic, demographic and clinical data will be collected in the Bissau HIV Cohort database and through study questionnaires to collect background information on risk factors for HPV persistence and development of cervical cancer (HIV genotype, immune status, parity). Questionnaires will collect additional information on the acceptance of cervical screening measures to better evaluate the feasibility of implementing self-collected screening among HIV infected women in Guinea-Bissau.

Trial Locations (1)

Unknown

Centro Tratamento Ambúlatorios na Guinea-Bissau, Bissau

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Universiteit Antwerpen

OTHER

collaborator

Randers Regional Hospital

OTHER

collaborator

Bandim Health Project

OTHER

lead

University of Aarhus

OTHER

NCT05783167 - Self-collected Vaginal and Urine Samples in HIV-positive Women | Biotech Hunter | Biotech Hunter