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, and 124 of them (99%) agreed to participate in the study. Of the recruited participants, the mean age was 55±10 years, 60% were men, 56% had ≤12 years of education, and 96% had an annual family income ≤ $35,000. Close to half (44%) of the participants reported never having heard about CT, while most (84%) could not correctly identify the definition of a CT. Although 98% of participants thought that participating in an anal cancer CT could be beneficial for their health, 91% had never heard of a high-resolution anoscopy (HRA) and 26% were not interested in participating in a CT that used HRA. Among those not interested in participating in a CT that used HRA, the most common reasons reported were: lack of information provided about the study (87%), and fear to the procedure (6%). Conclusions: Preliminary data at the baseline interview showed a high willingness of PLWHA to participate in anal cancer CT; however, there is a lack of knowledge about anal cancer CT and CT in general. The methodology developed as well as the information obtained will be necessary to develop specific strategies to increase knowledge and awareness about anal cancer and anal cancer CT among PLWHA and promote the advance of RCT for cancer prevention among PLWHA.
Citation Format: Vivian Colon-Lopez, Omar Valentin-Rivera, Marievelisse Soto-Salgado, Darilyn Rivera, Julie H. Dang, DA Letran, Moon Jr Chen, Ana Patricia Ortiz. Randomized controlled trial to increase anal cancer clinical trial recruitment among persons living with HIV/AIDS in Puerto Rico: Methodology and baseline assessment. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr C03.