Human Papillomavirus in Young People Epidemiological Research 4

NCT05587738 | Unknown

• 1 other identifier: 15/22
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program. Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

Conditions

Human Papillomavirus Infection; HPV; HPV Infection; Anal Cancer; Cancer; Men; HPV 16 Infection

Keywords

Vaccination; Vaccine; Public health; Prevention; Men who have sex with men; Gay and bisexual men; Immunisation

Outcome Measures

Primary Outcomes (2)

• Prevalence of quadrivalent vaccine HPV types

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

  Baseline

• Prevalence of type-specific HPV types

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

  Baseline

Eligibility Criteria

• Age: 21 Years - 25 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.

You may qualify if:

• Men aged 21 to 25 years old in 2023-2024
• Same-sex attracted
• Residing in Australia since 2013

You may not qualify if:

• Unable to complete all study requirements in English

Sponsors & Collaborators

• Monash University: lead
• The Alfred: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Papillomavirus Infections; Anus Neoplasms; Neoplasms; Multiple Endocrine Neoplasia Type 1; Homosexuality

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Sexuality; Sexual Behavior; Behavior

Central Study Contacts

Eric Chow, PhD

CONTACT

+61393416233; eric.chow@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

AU (1)