28. Investigating motivations for participation in an anal cancer screening trial (IMPACT)

Abstract

Background: The efficacy of preventing anal cancer by treating the anal cancer precursor, anal high-grade squamous intraepithelial lesions (HSIL), has not yet been demonstrated. The AIDS Malignancy Consortium’s (AMC) 076 protocol is a 2-year randomised controlled trial (RCT) of infrared coagulation to treat HSIL compared with observation only. The goal of the present study was to understand motivations for participation in AMC 076 in preparation for a larger 5-year study of the efficacy of HSIL treatment in prevention of anal cancer. Methods: AMC 076 participants (n = 17) from three clinical sites were recruited for telephone interviews at 3 months and 12 months after enrolment. Topics covered included motivations for participating in the clinical trial, randomisation, preferences for treatment versus monitoring, understanding of HSIL diagnosis, tolerability of the clinical procedures and treatment sequelae. Results: Participants reported a desire to contribute to research to help the HIV community as motivation for joining the study. Regardless of their assigned study arm, participants valued frequent monitoring of their HSIL. Those in the monitoring arm expressed trust that the provider would treat them upon early signs of cancer. Concerns expressed about participating in a 5-year trial were more often related to transportation issues than randomisation or tolerability of clinical procedures. Conclusions: Trust in providers’ clinical assessment is vital for willingness to be observed without treatment for pre-cancerous anal lesions. The experience of living with HIV appears to condition participants to trust providers’ treatment advice, value frequent screening, and to live with the ambiguity of test results.