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

NCT05783167 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 502

Last updated 2024-08-28

No results posted yet for this study

Summary

This study assesses topics as Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV), and cancer screening methods. The focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in Guinea-Bissau and further to estimate the prevalence of the precancerous virus HPV amongst women living with HIV. In the study the investigators will collect urinary and vaginal self-samples for HPV testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.

Conditions

  • HIV Infections
  • HPV-Related Cervical Carcinoma
  • Cervical Cancer
  • Coinfection, 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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • Bandim Health Project

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Sanne Jespersen, MD, PhD · Department of infectious diseases, Aarhus University Hospital, Denmark

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2023-11-23
Completion
2024-02-28

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783167 on ClinicalTrials.gov