Clinical trial NCT05783167: Self-collected Vaginal and Urine Samples in HIV-positive Women
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
HPV-Related Cervical Carcinoma
Cervical Cancer
Coinfection, HIV
Keywords: Cervical cancer screening
Self-sampling
Urine sample
Vaginal sample
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Universiteit Antwerpen
name: Randers Regional Hospital
name: Bandim Health Project
First posted: 2023-03-24
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is part of an international collaboration between the Department of Infectious Medicine at Aarhus University Hospital, the Bandim Health Project in Guinea-Bissau and Belgian researchers. Bandim Health project is a health and demographic surveillance system site that follows a population of more than 200.000 individuals in Guinea-Bissau. That population has created the base for the Guinea-Bissau Nationwide HIV-cohort with more than 35.000 patients.

The patients are provided free HIV-treatment and follow-up in the country. There is currently 9 large HIV-clinics in the country, and women presenting at these clinics will be invited to enroll if they meet the inclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementing HPV self sampling for cervical cancer screening
timeFrame: April 2023 - February 2024
measure: HPV-prevalence among HIV-infected women in Guinea-Bissau
timeFrame: April 2023 - February 2024
Secondary outcomes:
measure: Experiences with self-collected vaginal and urine samples
timeFrame: April 2023 - February 2024
measure: HPV-genotype agreement between vaginal- and urine samples
timeFrame: April 2023 - February 2024
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Centro Tratamento Ambúlatorios na Guinea-Bissau
Study officials:
affiliation: Department of infectious diseases, Aarhus University Hospital, Denmark
name: Sanne Jespersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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