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.

Autor:	Nyitray AG; Clinical Cancer Center, Medical College of Wisconsin, Milwaukee, Wisconsin, USA anyitray@mcw.edu.; Center for AIDS Intervention Research, Department of Psychiatry and Behavioural Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Schick V; Department of Management, Policy, and Community Health, The University of Texas Health Science Center at Houston School of Public Health, Houston, Texas, USA., Swartz MD; Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston School of Public Health, Houston, Texas, USA., Giuliano AR; Center for Immunization and Infection Research in Cancer, H Lee Moffitt Cancer Center and Research Insitute, Tampa, Florida, USA., Fernandez ME; Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston School of Public Health, Houston, Texas, USA., Deshmukh AA; Department of Management, Policy, and Community Health, The University of Texas Health Science Center at Houston School of Public Health, Houston, Texas, USA., Ridolfi TJ; Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Ajala C; Center for AIDS Intervention Research, Department of Psychiatry and Behavioural Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Brzezinski B; Center for AIDS Intervention Research, Department of Psychiatry and Behavioural Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Sandoval M; Department of Epidemiology, Human Genetics, and Environmental Sciences, The University of Texas Health Science Center at Houston School of Public Health, Houston, Texas, USA., Nedjai B; Wolfson Institute of Preventive Medicine, Centre for Cancer Prevention, Queen Mary University of London, London, UK., Smith JS; University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, USA., Chiao EY; Department Epidemiology, Division of Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Jun 29; Vol. 11 (6), pp. e051118. Date of Electronic Publication: 2021 Jun 29.
DOI:	10.1136/bmjopen-2021-051118
Abstrakt:	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. Competing Interests: 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.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu