Self-collected Vaginal and Urine Samples in HIV-positive Women
- Conditions
- HPV-Related Cervical CarcinomaHIV InfectionsCervical CancerCoinfection, HIV
- Interventions
- Diagnostic Test: Self-sampling for HPV infection
- Registration Number
- NCT05783167
- Lead Sponsor
- University of Aarhus
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 502
- HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible)
- Age between 18 and 65 years
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV-positive females in Guinea-Bissau Self-sampling for HPV infection 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.
- Primary Outcome Measures
Name Time Method Feasibility of implementing HPV self sampling for cervical cancer screening April 2023 - February 2024 Among women meeting the inclusion criteria, the investigators want to estimate the prevalence of how many accepts the offer to collect self-samples, thereby gaining knowledge on the feasibility of implementing self-sampling as a cervical cancer screening method in Guinea-Bissau.
HPV-prevalence among HIV-infected women in Guinea-Bissau April 2023 - February 2024 The investigators want to estimate the prevalence of high risk HPV infection among HIV-infected women in the Nationwide HIV-cohort in Guinea-Bissau.
- Secondary Outcome Measures
Name Time Method Experiences with self-collected vaginal and urine samples April 2023 - February 2024 Among the women accepting the invitation to enroll in the study, the investigators will through a questionnaire obtain data on the participants experiences with the two self-sampling devices.
HPV-genotype agreement between vaginal- and urine samples April 2023 - February 2024 Among HPV-positive women the investigators want to describe the genotype agreement among the two sample types
Trial Locations
- Locations (1)
Centro Tratamento Ambúlatorios na Guinea-Bissau
🇬🇼Bissau, Guinea-Bissau