4.1 Article

Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV

Journal

CONTEMPORARY CLINICAL TRIALS
Volume 113, Issue -, Pages -

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2022.106679

Keywords

Anal cancer prevention; Persons living with HIV; Clinical trial design

Funding

  1. National Cancer Institute of the National Institutes of Health [UM1CA121947]

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It is known that people living with HIV have a higher risk of anal HSIL and anal cancer compared to those without HIV. A randomized trial conducted by the AIDS Malignancy Consortium aimed to compare preventive strategies for anal cancer among PLWH with anal HSIL. The study design of the ANCHOR trial, which estimates the anal cancer event rate in this high-risk population, is described in this paper.
It is well established that persons living with HIV (PLWH) have highly elevated rates of anal HSIL and anal cancer compared with those who are not living with HIV. The 5-year risk of anal cancer following anal HSIL has been reported to be as high as 14.1% among PLWH compared with 3.2% among those who are not living with HIV. To address these concerns, the AIDS Malignancy Consortium completed a large-scale, randomized trial to compare strategies for the prevention of anal cancer among PLWH with anal HSIL. The objective of the study was to determine whether treating anal HSIL was effective in reducing the incidence of anal cancer in PLWH compared with active monitoring. This paper describes the design of the ANal Cancer/HSIL Outcomes Research Study (ANCHOR) with respect to estimating the anal cancer event rate in this high risk population.

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