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

Sponsor

University of Aarhus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783167

Collaborator

Aarhus University Hospital (Other), Universiteit Antwerpen (Other), Randers Regional Hospital (Other), Bandim Health Project (Other)

500

Enrollment

10.1

Anticipated Duration (Months)

Study Details

Study Description

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 we 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections HPV-Related Cervical Carcinoma Cervical Cancer Coinfection, HIV	Diagnostic Test: Self-sampling for HPV infection

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, we 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
HIV-positive females in Guinea-Bissau 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.	Diagnostic Test: Self-sampling for HPV infection After informed consent has been provided, the woman will be asked to collect firstly a first-void urine sample using the Collipee device and secondly to collect a vaginal self-sample using the dry Evalyn® Brush device. Socioeconomic, demographic and clinical data will be collected in the Bissau HIV Cohort database and through study questionnaires to collect background information on risk factors for HPV persistence and development of cervical cancer (HIV genotype, immune status, parity). Questionnaires will collect additional information on the acceptance of cervical screening measures to better evaluate the feasibility of implementing self-collected screening among HIV infected women in Guinea-Bissau. Other Names: Collipee Evalyn Brush

Arm

Intervention/Treatment

HIV-positive females in Guinea-Bissau

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.

Diagnostic Test: Self-sampling for HPV infection

After informed consent has been provided, the woman will be asked to collect firstly a first-void urine sample using the Collipee device and secondly to collect a vaginal self-sample using the dry Evalyn® Brush device. Socioeconomic, demographic and clinical data will be collected in the Bissau HIV Cohort database and through study questionnaires to collect background information on risk factors for HPV persistence and development of cervical cancer (HIV genotype, immune status, parity). Questionnaires will collect additional information on the acceptance of cervical screening measures to better evaluate the feasibility of implementing self-collected screening among HIV infected women in Guinea-Bissau.

Other Names:

Collipee

Evalyn Brush

Outcome Measures

Primary Outcome Measures

Feasibility of implementing HPV self sampling for cervical cancer screening [April 2023 - February 2024]
Among women meeting the inclusion criteria, we 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]
We 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

Experiences with self-collected vaginal and urine samples [April 2023 - February 2024]
Among the women accepting the invitation to enroll in the study, we 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 we want to describe the genotype agreement among the two sample types

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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