Design of the ANal Cancer/HSIL Outcomes Research study (ANCHOR study): A randomized study to prevent anal cancer among persons living with HIV
Lee, J. Y.; Lensing, S. Y.; Berry-Lawhorn, J. M.; Jay, N.; Darragh, T. M.; Goldstone, S. E.; Wilkin, T. J.; Stier, E. A.; Einstein, M.; Pugliese, J. C.; Palefsky, J. M.; Anchor Investigators
Contemp Clin Trials
*Anus Neoplasms/epidemiology/pathology/prevention & control *HIV Infections/complications/epidemiology Humans Outcome Assessment, Health Care *Papillomavirus Infections/epidemiology Risk Factors Surveys and Questionnaires Anal cancer prevention Clinical trial design Persons living with HIV
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.