Logistical issues in implementing a clinical trial on oral cancer prevention through HPV vaccination: Implementation of Ulacnet201 in Mexico.

Abstract This poster describes logistical issues related to implementing a randomized, double- blinded, placebo-controlled Phase III interventional trial on the nine-valent HPV vaccine (9vHPV) among cisgender men and transgender women living with HIV, at the Mexico site. The trial seeks to demonstrate that 9vHPV reduces the incidence of persistent oral HPV infection (a surrogate for HPV-associated oropharyngeal cancer) with the 9 vaccine types. Five-hundred participants will be randomized in a 1:1 allocation to receive 9vHPV or placebo, stratified based on clinical site (Brazil, Mexico, Puerto Rico) and age. The team invites potential participants through local community organizations and public HIV clinics. People may be invited when waiting in line in the morning to get laboratory testing done, when they have an appointment for HIV care or through their treating physician or a community organizer. Initially, we worked at a single HIV clinic, although we did distribute study flyers to treating physicians at other clinics. As of mid-2022 we began enrolling at two additional clinics. Participants are prescreened when initially invited or by phone to prevent unnecessary trips for those ineligible. Once prescreened, participants are given an appointment for their first study visit; reminders about their first or other study visits are sent by text message 2-3 times before the appointment. Participants are provided with financial compensation in cash at each visit. We have implemented both study-wide mechanisms and additional locally-designed strategies and forms to guarantee quality control. For example, registering participant issues, study agent trail and persons invited, pre-screened and enrolled (including reasons for exclusion). Data is registered on paper forms and in a bespoke data base program (DatStat, designed at Moffitt Cancer Center). DatStat carries out the randomization (only the Mexico site pharmacist is unblinded) and requires a wireless internet connection, which can sometimes fail even though a router is installed by the study at each clinic. Vaccine and syringe importation can be time consuming and cause enrollment delays, given the need to acquire permissions for importation or problems getting the shipment out of Customs. Making sure shipments go through an airport with better functioning Customs offices is also important. Citation Format: Betania Allen-Leigh, Alejandra Portillo-Romero, Manuel Quiterio, Maribel Acosta, Abraham Rivera- Ramirez, Guillermina Sanchez, Aurelio Cruz, Tonatiuh Barrientos, Carlos Magis, Kimberly Isaacs-Soriano, Martha E. Abrahamsen, Margaret House, Emma Brofsky, Vikrant Sahasrabuddhe, Timothy Wilkin, Anna Giuliano, Luisa Villa, Eduardo Lazcano-Ponce. Logistical issues in implementing a clinical trial on oral cancer prevention through HPV vaccination: Implementation of Ulacnet201 in Mexico [abstract]. In: Proceedings of the Second Biennial NCI Meeting: Translational Advances in Cancer Prevention Agent Development (TACPAD); 2022 Sep 7-9. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_2): Abstract nr A002.