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NCT05783167Completed

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

Self-collected Cervical Cancer Screening Samples for Detection of Human Papillomavirus in HIV-positive Women - a Pilot Study of Self-collected Vaginal and Urine Samples

Source: ClinicalTrials.gov · Last updated 28 Aug 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
502 (actual)
First submitted
13 Mar 2023
Start date
29 May 2023
Primary completion date
23 Nov 2023
Lead sponsor
University of Aarhus
NCT number
NCT05783167

What you commit to

  • Study type: Observational
  • Participants enrolled: 502
  • From 29 May 2023 to the primary completion date, 23 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior hysterectomy

Other illness

  • Bleeding due to ongoing period

Other

  • Current pregnancy
  • Pregnancy within the last 3 months
  • Women using other vaginal products than contraceptives and water based lubricants
  • Women who don't understand the extent of the study

Who the study is looking for

  • HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible)
  • Age between 18 and 65 years

Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centro Tratamento Ambúlatorios na Guinea-Bissau
Coordinator of this site? Confirm its status
BissauGuinea-BissauUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.