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NCT Number: NCT05783167

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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Cervical Cancer Coinfection, HIV Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV-Related Cervical Carcinoma Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro Tratamento Ambúlatorios na Guinea-Bissau

Bissau, Guinea-Bissau

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-sampling for HPV infection

Diagnostic Test

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

Primary outcomes

  1. Feasibility of implementing HPV self sampling for cervical cancer screening

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Experiences with self-collected vaginal and urine samples

    Time frame: 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.

  2. HPV-genotype agreement between vaginal- and urine samples

    Time frame: April 2023 - February 2024

    Among HPV-positive women the investigators want to describe the genotype agreement among the two sample types

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Bandim Health Project
  • Randers Regional Hospital
  • Universiteit Antwerpen

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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