Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Communicable Diseases

Papillomavirus Infections

Anus Neoplasms

Disease Attributes

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Oculocerebral Syndrome With Hypopigmentation

Anal Cancer

All Drugs and Chemicals

Vaccines

Eric Chow, PhD

Eric PF Chow, PhD

Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program.

The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination.

Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

1. Self-collected oral rinse sample for HPV testing
2. Self-collected penile swab for HPV testing
3. Clinician-collected anal swab for HPV testing

Human Papillomavirus in Young People Epidemiological Research 3

A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia

The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)

The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)

The oral, penile and anal prevalence of type-specific HPV types

The Alfred

University of Melbourne

Monash University

Associate Professor

Uterine Cervical Neoplasms

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

Patient serves as own comparator/control in this method comparison study where the investigational intervention is use of the self-collect device and the comparator is the standard of care clinician collection.

Participants will use the Instructions for Use to perform self-collection of vaginal cells and material using the Teal Wand Self-Collection Device, and will fill out a usability survey and a satisfaction and needs survey. A healthcare provider collected sample will be performed by a clinician after self-collection. The patient will serve as their own comparator/control.

Teal Wand Self-Collection Device Group

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.

Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).

To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).

Primary Effectiveness Objective

• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:

* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
* Calculating the invalid rate of tested samples.

SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening

PPA/NPA (Positive Percent Agreement)/(Negative Percent Agreement) of hrHPV detection of self-collected and clinician collected samples

SAE rate is equivalent for both self-collect and clinician collect interventions

Teal Health, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Human Papillomavirus in Young People Epidemiological Research 3	NCT05587725	Human Papilloma... HPV HPV Infection Anal Cancer Cancer Men HPV 16 Infectio...		16 Years - 20 Years	Monash University
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening	NCT06120205	Hpv HPV 16 Infectio... HPV Infection High Risk HPV	Teal Wand Self-...	25 Years - 65 Years	Teal Health, Inc.

Spots Global Cancer Trial Database for hpv 16 infection