Abstract C03: Randomized controlled trial to increase anal cancer clinical trial recruitment among persons living with HIV/AIDS in Puerto Rico: Methodology and baseline assessment

• Published in: Cancer epidemiology, biomarkers & prevention biomarkers & prevention, 2017-02, Vol.26 (2_Supplement), p.C03-C03
• Main Authors: Colon-Lopez, Vivian, Valentin-Rivera, Omar, Soto-Salgado, Marievelisse, Rivera, Darilyn, Dang, Julie H., Letran, DA, Chen, Moon Jr, Ortiz, Ana Patricia
• Format: Article
• Language: English
• ISSN: 1055-9965; 1538-7755
• DOI: 10.1158/1538-7755.DISP16-C03

Introduction: Anal cancer is more frequent among people living with HIV/AIDS (PLWHA), with incidence rates increasing among PLWHA despite effective HIV treatments. This highlights the need for effective anal cancer screening guidelines. As part of the development of such guidelines for anal cancer prevention, participation and retention in clinical trials (CT) is pivotal. Previous studies showed lower participation of Hispanics in cancer-related CT among PLWHA. We are conducting a randomized controlled trial (RCT) aimed to test the effectiveness of an educational intervention in recruiting PLWHA in one of the anal cancer-related CT of the AIDS Malignancy Consortium (AMC) being conducted in Puerto Rico (PR), the Anal Cancer Prevention Study (ANCHOR). This work describes the methodology of this study and baseline characteristics of study participants. Methods: A collaboration in the development of an educational linear video for anal cancer was conducted in 2015 between UC Davis Comprehensive Cancer Center and the University of Puerto Rico (UPR) Comprehensive Cancer Center. As a result, a RCT is being conducted at the 9 immunology/STI clinics of the PR Department of Health, to test the effectiveness of this audiovisual intervention in increasing: (1) HIV/AIDS patients' knowledge of anal cancer and CT; (2) favorable attitudes towards CT; and (3) willingness to participate in ANCHOR, a CT aimed to developing anal cancer screening and treatment guidelines for PLWHA. Our RCT is expected to recruit 308 PLWHA aged ≤ 35 years, that receive HIV care at these clinics, and that have not participated in any cancer CT or have been diagnosed with any cancer type in their lifetime. The randomization of this study is at the clinic level, in which we randomly allocated each clinic to either: the intervention group (receiving the audiovisual educational intervention focused on CT and anal cancer screening) or the control group (receiving a standard CT recruitment education). Participants who agree to participate complete an informed consent, a baseline survey, and an initial contact survey through a face-to-face computer-based interview. Participants are followed-up at 2-weeks (by phone) and 3-months (at the clinic) in order to assess changes in willingness to participate in anal cancer CT and to determine if the participant has called, been screened, or been enrolled into an AMC CT. Results: As of Mid-June 2016, 134 patients had been screened, 125 (93%) PLWHA were eligible,