Neoplasms

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Immune System Diseases

Carcinoma

Uterine Cervical Neoplasms

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

HIV Seropositivity

Coinfection

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Syndrome

Immunologic Deficiency Syndromes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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.

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.

Self-sampling for HPV infection

Kia Lærke Madsen

Sanne Jespersen, MD, PhD

Candida Medina, MD

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.

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.

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

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

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.

The investigators want to estimate the prevalence of high risk HPV infection among HIV-infected women in the Nationwide HIV-cohort in Guinea-Bissau.

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.

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

Aarhus University Hospital

Universiteit Antwerpen

Randers Regional Hospital

Bandim Health Project

University of Aarhus

Rare Diseases

Papilloma

Uterine Cervical Dysplasia

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Cervical Intraepithelial Neoplasia

This control group will receive no intervention. Cervical cancer screening (having a Pap smear taken by a clinician for cytology-based screening) is completely opportunistic, i.e. based on the initiative of the participant or their clinician.

No reminder letter will be sent.

This control group will receive the standard (recall) invitation letter send out by the Centre for Cancer Detection (CvKO). In this invitation letter, participants are encouraged to make an appointment with their clinician to have a Pap smear taken (for cytology-based screening).

A reminder letter will be sent after 5-6 months.

Women will receive a first-void urine self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a vaginal self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

A reminder letter will be sent after 5-6 months.

Women will self-collect a first-void urine sample at home upon receipt of the study package using the Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube is prefilled with a preservative (UCM, Novosanis, Belgium). Women will send the collector vial containing first-void urine along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.

Colli-Pee Small Volumes

Women will self-collect a vaginal sample at home upon receipt of the study package using the Evalyn Brush device (Rovers Medical Devices, The Netherlands). Women will send the used brush along with the informed consent form to the laboratory at University of Antwerp using the prestamped envelope.

Evalyn Brush

Severien Van Keer, MSc, PhD

Alex Vorsters, Ir, PhD

Pierre Van Damme, MD, PhD

The goal of the ScreenUrSelf trial is to increase cervical cancer screening attendance and compliance to follow-up by offering a first-void urine self-sampling alternative to women who are currently not participating in the organized cervical cancer screening program (defined in this project as un(der)-screened women), either on the woman or her physician's personal initiative, or by responding on the invitation letter.

Patient: In this population-based study we target real un(der)-screened women, i.e., women (31-64y) eligible for the Flemish population-based cervical cancer screening program without any cytology/histology/pathological result retrieved from the Belgian Cancer Registry (BCR) for at least the last six years (i.e., two screening rounds). Women who opted out of the screening program, who are pregnant (self-reported), underwent total hysterectomy, have (had) cervical or uterine cancer, or are included in other Centre for Cancer Detection (CvKO) pilot projects are not eligible.

Intervention: The proposed randomized controlled trial (RCT) will be embedded in the Flemish organized cervical cancer screening program, which is coordinated by CvKO under governance of the Flemish government. The goal is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test).

Comparison: The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practise within the organized cervical cancer screening program in Flanders).

Primary outcome: The primary outcome is the actual response rate, i.e., proportions of women that participate in each intervention and in the control arms at 12 months after initiation of the intervention (the intervention being one of six study arms). Response in this project is defined as having a preventive cervical screen exam, either by a self-sample or by a physician-taken Pap smear, at 12 months after initiation of the intervention.

Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial

Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

1. Compliance to a hrHPV positive result on a self-sample measured by standard of care follow-up, i.e., a Pap smear taken by a clinician.
2. Compliance to an abnormal Pap smear measured by standard of care follow-up.

Preference and attitudes of women between intervention arms (measured via a questionnaire)

Age-related differences in response rates within and between different study arms

Response rates: Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

Socio-economic status-related differences in response rates within and between different study arms

Response rates: Proportions of women that participate in each intervention (measured by PP\* and ITT\*) and in the control arms (measured by Pap smears taken) within 10 months after the intervention.

\*PP: participation in intervention arm measured by self-sample analyses only

\*\*ITT: participation in intervention arm measured by self-sample analyses or Pap smears taken

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ of a hrHPV positive result on a self-sample in un(der)-screened women; absolute measures in each arm and ratios of measures between arms.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate CIN2+ of a methylation-based reflex test (index test) to triage hrHPV positive self-sample in un(der)screened women, compared to reflex cytology on a Pap smear (comparator test); absolute measures in each arm and ratios of measures between arms.

Test-positivity, positive predictive value, referral rate to colposcopy, and detection rate of CIN2+ will be combined to report clinical accuracy.

1. Differences in time needed per women to obtain a test result between study arms
2. Differences in costs per women between the different study arms
3. Differences in total cost between the different study arms

The above differences in time and costs will be combined to report cost-effectiveness.

Antwerp University Hospital (UZA)

Centre for Cancer Detection (CvKO)

Sciensano

Principal Investigator

Women will receive a first-void urine self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a first-void urine self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, first-void urine self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a vaginal self-sampling study package at home.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

Women will receive a letter at home with instructions how to order (via phone, e-mail, or webform) a vaginal self-sampling study package.

The study package will include an invitation letter/informed consent form, information brochure, vaginal self-sampling device, safety bag with absorbent paper, pre-stamped return envelope, and instructions explaining how to collect the sample and send it to the lab.

The proposed study is the Dry Run preceding the ScreenUrSelf trial.

The ScreenUrSelf trial will be embedded in the Flemish organized cervical cancer screening program. The goal of ScreenUrSelf is to reach women who are eligible but do not participate in cervical cancer screening, by offering two self-sampling methods (first-void urine and vaginal) in an opt-in and -out strategy (total of four interventions) to collect samples for primary high-risk (hr) Human Papillomavirus (HPV) testing, and if positive, reflex 1) cytology on a Pap smear (standard of care) and 2) methylation marker triage (index test). The two control arms include 1) no intervention; and 2) sending (recall) invitation letters to women, inviting them to make an appointment for a Pap smear (i.e., current practice within the organized cervical cancer screening program in Flanders).

The Dry Run which is the subject of this clinical trial will test the study materials and data flows developed for the interventional study arms (C, D, E and F) of the ScreenUrSelf trial. The primary outcome of the Dry Run is to check if the flow for data- and sample collection is ready for start of the ScreenUrSelf trial, and if optimizations are deemed necessary before start of the trial.

Dry Run of the ScreenUrSelf Trial

Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: Dry Run of the ScreenUrSelf Trial

HPV DNA concentration \[copies/µl DNA\] in self-samples from all study participants.

Human DNA concentration \[copies/µl DNA\] in self-samples from all study participants

Preferences and attitudes of women regarding self-sampling (measured using a questionnaire)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-collected Vaginal and Urine Samples in HIV-positive Women	NCT05783167	HIV Infections HPV-Related Cer... Cervical Cancer Coinfection, HI...	Self-sampling f...	18 Years - 65 Years	University of Aarhus
Self-collected Vaginal and Urine Samples in HIV-positive Women	NCT05783167	HIV Infections HPV-Related Cer... Cervical Cancer Coinfection, HI...	Self-sampling f...	18 Years - 65 Years	University of Aarhus
Cervical Cancer Screening Based on First-void Urine Self-sampling to Reach un(Der)-Screened Women: ScreenUrSelf Trial	NCT05996783	Cervix Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	31 Years - 64 Years	Universiteit Antwerpen
Dry Run of the ScreenUrSelf Trial	NCT05996796	Cervical Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	30 Years - 64 Years	Universiteit Antwerpen
Self-collected Vaginal and Urine Samples in HIV-positive Women	NCT05783167	HIV Infections HPV-Related Cer... Cervical Cancer Coinfection, HI...	Self-sampling f...	18 Years - 65 Years	University of Aarhus
Dry Run of the ScreenUrSelf Trial	NCT05996796	Cervical Cancer Cervical Intrae... Human Papilloma... HPV-Related Cer...	Colli-Pee Small... Evalyn Brush	30 Years - 64 Years	Universiteit Antwerpen

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