Most anal cancer is caused by high-risk types of human papillomavirus (HRHPV) infection. Anal cancer incidence is highly concentrated in a few high-risk populations. The highest risk occurs in HIV positive gay, bisexual and other men who have sex with men (GBM) where the risk of anal cancer is over 100 times that of men in the general population. Risk is also very high in other people living with HIV (PLHIV). There is no consensus on how to screen for anal HPV and the precursor lesions, high grade squamous intraepithelial lesions.
The REACH study is a pilot study, investigating an anal cancer screening program comprising of anal HPV testing and p16/Ki67 testing, in people living with HIV, recruited from community clinics.
We aimed to recruit 200 participants aged 35 years and older, living with HIV. Participants underwent a digital anorectal examination (DARE) and an anal swab for HPV and p16/Ki67 testing. Participants positive at baseline or at the 12 month visit for HPV16 were referred for high resolution anoscopy (HRA) and biopsy of an abnormal lesion, regardless of the p16/Ki67 results. Participants who were HPV16 negative but non-16 HRHPV positive and/or p16/Ki67 stain positive at baseline underwent a repeat anal swab 12 months after study entry. Participants who have evidence of persistent HRHPV infection or positive baseline and/or 12 month p16/Ki67 stain were referred for HRA.
The study is ongoing. Recruitment is complete, with 138 participants enrolled. Follow-up is expected to be completed by December 2022.
This research study aims to address this health disparity by investigating novel screening methodologies, alone and in combination, to provide evidence for prevention strategies for people living with HIV. We aim to help answer whether anal HRHPV testing and dual staining testing will identify people living with HIV at high risk of anal cancer.
Sydney Sexual Health Centre, NSW; Holdsworth House General Practice, Darlinghurst, NSW; The Albion Centre, Surry Hills, NSW; St Vincent's Hospital, Darlinghurst, NSW; Douglass Hanly Moir Pathology, Macquarie Park, NSW.
The Glendonbrook Foundation; NHMRC.