The Indigenous Australian HPV Cohort Study 2; continuation 5 to 10 years: Study Protocol (Preprint)

Author:

Hedges JoanneORCID,Sethi Sneha,Garvey GailORCID,Whop Lisa,Canfell Karen,Dodd Zell,Larkins Priscilla,Antonsson AnnikaORCID,Smith Megan,Mittinty Murthy,Leane Cathy,Reid NicORCID,Ooi Eng HORCID,Ju XiangqunORCID,Logan Richard,Jamieson LisaORCID

Abstract

BACKGROUND

Human papilloma virus (HPV) infection, a common sexually transmitted disease, is associated with cancers of the cervix, vulva, vagina, penis, anus, and head and neck. Oropharyngeal squamous cell carcinoma (OPSCC; throat cancer) is a globally rapidly increasingly type of cancer involving the head and neck area. There are higher rates of OPSCC among Aboriginal & Torres Strait Islander relative to non-Aboriginal & Torres Strait Islander Australians, although the HPV-attributable fraction remains unknown. For the first time at a global level, we plan to extend an Indigenous Australian adult cohort to monitor, screen and ultimately prevent HPV-associated OPSCC and to undertake extensive cost-effectiveness modelling around HPV vaccination.

OBJECTIVE

This study aims to: (1) extend follow-up to a minimum of 7-years post recruitment to describe the prevalence, incidence, clearance and persistence of oral HPV infection and; (2) conduct clinical examinations of the head and neck, oral cavity and oropharynx, and saliva samples for early stage OPSCC testing.

METHODS

We will continue to implement a longitudinal design for the next study phase, where we will ascertain prevalence, incidence, clearance and persistence of oral HPV infection at 48, 60 and 72 months, undertake clinical examinations/saliva assessments to detect early stage OPSCC and refer for treatment. The primary outcome measures are changes in oral HPV infection status, biomarker measures of early HPV-related cancer and clinical evidence of early-stage OPSCC.

RESULTS

Participant 48-month follow-up will commence Jan 2023. The first results are expected to be submitted for publication one year after 48-month follow-up begins.

CONCLUSIONS

Our findings have potential to change the way in which OPSCC among Australian Aboriginal & Torres Strait Islander adults is managed, with desired impacts including cost-savings on expensive cancer treatments; improved nutrition, social and emotional outcomes; and improved quality of life for both Aboriginal & Torres Strait Islander adults and the Indigenous community more broadly. Continuing a large, representative Indigenous adult cohort through which to track oral HPV infection and monitor early OPSCC is essential to yield critical information to include in the management armamentarium of health and wellbeing recommendations for Australia’s First Peoples.

Publisher

JMIR Publications Inc.

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