CompletedNot Applicable

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

Guinea-Bissau502 participantsStarted 2023-05-29

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion Criteria: * HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible) * Age between 18 and 65 years Exclusion Criteria: * Current pregnancy * Pregnancy within the last 3 months * Prior hysterectomy * Women using other vaginal products than contraceptives and water based lubricants * Women who don't understand the extent of the study * Bleeding due to ongoing period

What they're measuring

Feasibility of implementing HPV self sampling for cervical cancer screening

Timeframe: April 2023 - February 2024

HPV-prevalence among HIV-infected women in Guinea-Bissau

Timeframe: April 2023 - February 2024

Trial details

NCT IDNCT05783167

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-23

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