Faculty Collaboration Database

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. BMJ Open 2021 Jun 29;11(6):e051118

Date

07/01/2021

Pubmed ID

34187833

Pubmed Central ID

PMC8245463

DOI

10.1136/bmjopen-2021-051118

Scopus ID

2-s2.0-85110179885 (requires institutional sign-in at Scopus site)   6 Citations

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.

Author List

Nyitray AG, Schick V, Swartz MD, Giuliano AR, Fernandez ME, Deshmukh AA, Ridolfi TJ, Ajala C, Brzezinski B, Sandoval M, Nedjai B, Smith JS, Chiao EY

Authors

Alan Nyitray PhD Associate Professor in the Psychiatry and Behavioral Medicine department at Medical College of Wisconsin
Timothy J. Ridolfi MD, MS, FACS Associate Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Anal Canal
Anus Neoplasms
Early Detection of Cancer
Homosexuality, Male
Humans
Male
Papillomavirus Infections
Pharmaceutical Preparations
Prospective Studies
Randomized Controlled Trials as Topic
Wisconsin