@Article{info:doi/10.2196/44593,
author="Hedges, Joanne
and Sethi, Sneha
and Garvey, Gail
and Whop, Lisa J
and Canfell, Karen
and Dodd, Zell
and Larkins, Priscilla
and Antonsson, Annika
and Smith, Megan A
and Mittinty, Murthy
and Leane, Catherine
and Reid, Nicolas
and Ooi, Eng H
and Ju, Xiangqun
and Logan, Richard
and Jamieson, Lisa",
title="The Indigenous Australian Human Papillomavirus (HPV) Cohort Study 2, Continuation for 5 to 10 Years: Protocol for a Longitudinal Study",
journal="JMIR Res Protoc",
year="2023",
month="May",
day="17",
volume="12",
pages="e44593",
keywords="Aboriginal South Australian; human papillomavirus; oral HPV infection; oral pharyngeal squamous cell carcinoma; OPSCC",
abstract="Background: Human papillomavirus (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 type of cancer involving the head and neck area that is rapidly increasing across the globe. There are higher rates of OPSCC among Indigenous populations relative to non--Indigenous Australian populations, 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 collect 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 the 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 in January 2023. The first results are expected to be submitted for publication 1 year after 48-month follow-up begins. Conclusions: Our findings have potential to change the way in which OPSCC among Australian Indigenous adults is managed, with desired impacts including cost-savings on expensive cancer treatments; improved nutritional, social, and emotional outcomes; and improved quality of life for both Indigenous adults and the Indigenous community more broadly. Continuing a large, representative Indigenous adult cohort to track oral HPV infection and monitor early OPSCC is essential to yield critical information to include in the management armamentarium of health and well-being recommendations for Australia's First Nations. International Registered Report Identifier (IRRID): PRR1-10.2196/44593 ",
issn="1929-0748",
doi="10.2196/44593",
url="https://www.researchprotocols.org/2023/1/e44593",
url="https://doi.org/10.2196/44593",
url="http://www.ncbi.nlm.nih.gov/pubmed/37195752"
}