Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening

Alan G Nyitray, Vanessa Schick, Michael D Swartz, Anna R Giuliano, Maria E Fernandez, Ashish A Deshmukh, Timothy J Ridolfi, Christopher Ajala, Bridgett Brzezinski, Micaela Sandoval, Belinda Nedjai, Jennifer S Smith, Elizabeth Y Chiao, Alan G Nyitray, Vanessa Schick, Michael D Swartz, Anna R Giuliano, Maria E Fernandez, Ashish A Deshmukh, Timothy J Ridolfi, Christopher Ajala, Bridgett Brzezinski, Micaela Sandoval, Belinda Nedjai, Jennifer S Smith, Elizabeth Y Chiao

Abstract

Introduction: Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA.

Methods and analysis: This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm.

Ethics and dissemination: The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences.

Trial registration number: NCT03489707.

Keywords: HIV & AIDS; epidemiology; gastrointestinal tumours; preventive medicine; public health.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study activity: home and clinical flow activities. DARE, Digital Anal Rectal Examinations; HPV, human papillomavirus; HRA, high-resolution anoscopy; PAC, Prevent Anal Cancer.
Figure 2
Figure 2
Confounding by perceived susceptibility to COVID-19.

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