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

University of Aarhus

Status: Completed

Conditions: HPV-Related Cervical Carcinoma; HIV Infections; Coinfection, HIV; Cervical Cancer

Treatments: Diagnostic Test: Self-sampling for HPV infection

Study type: Observational

Funder types: Other

Identifiers

NCT05783167

R351-A20092

Details and patient eligibility

About

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.

Full description

This pilot study will partly take place at the outpatient HIV clinic, based in the Hospital National Simão Mendes (HNSM) in the capital city Bissau, Guinea-Bissau. HNSM is the main hospital in Bissau, and the HIV clinic is the biggest HIV treatment center in Guinea-Bissau in terms of patients on follow-up. The Bissau Nationwide HIV Cohort is a clinical HIV Cohort started in 2007. As of today, the investigators collect data from 9 outpatient HIV clinics in the country, and samples will be collected from all 9 clinics.

Study participants who present at the HIV clinic will be thoroughly instructed in correct usage of the vaginal and urine devices by trained healthcare workers. At the HIV clinics, facilities will be available for the women to conduct self-sampling in privacy, before handing in the samples. At the local laboratory, the dry brush head will be suspended in Thinprep medium and stored until shipment to Denmark. The urine samples will be stored at room temperature for up to 7 days before transferred to a -20º freezer until shipment to Denmark.

Analyses: vaginal and urine samples will be analyzed at Randers Regional Hospital using the Cobas 4800 HPV DNA test. The Department is specialized in self-collected samples from previous studies. This procedure is considered feasible based on data showing that the dry brush is analytically stable for HPV DNA detection for up to 32 weeks at temperatures ranging from 4 ºC to 30 ºC. After HPV analyses, residual material from the self-collected samples will be stored in a biobank in Denmark at Aarhus University hospital and saved for future research.

Enrollment: 502 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

502 participants in 1 patient group

HIV-positive females in Guinea-Bissau

Description:

The study is conducted on female HIV-infected patients in the Nationwide HIV-cohort at the 9 biggest HIV-clinics in Guinea-Bissau. Participants will be invited to enroll in the project when they present to the HIV-clinics for HIV-treatment and consultations.

Treatment:

Diagnostic Test: Self-sampling for HPV infection