Abstract
<title>Abstract</title> <p> Background Latinas in the U.S. experience higher cervical cancer incidence and mortality compared with non-Hispanic White women. In the U.S.-Mexico border community of El Paso, Texas, cervical cancer screening rates remain below the national average, attributable to many structural and cultural barriers. At-home HPV self-sampling is a promising, evidence-based strategy for improving cervical cancer screening rates. <italic>Unidos Contra el VPH</italic> is a randomized controlled trial (RCT) that evaluates whether at-home urine-based or vaginal swab self-collection increases cervical cancer screening completion compared with clinician collected co-testing (usual care) among patients receiving care at a Federally Qualified Health Center in a U.S.-Mexico border community. Methods Unidos is an individual-level, three-arm, single blinded RCT. The primary outcome is screening completion. Secondary outcomes include changes in knowledge, attitudes, beliefs, and preferences for HPV sampling strategies. Eligible participants are individuals with a cervix 30–65 years old who are due for screening. The study has a target enrollment of 735 participants. The intervention is facilitated by a bilingual Community Health Worker (CHW), who recruits and consents patients, administers a pre-intervention survey, randomizes the participant to one of three study arms, and provides health education along with instructions on the appropriate collection method. The CHW provides reminders, facilitates specimen return, and administers a post-intervention survey. Discussion This study evaluates the effectiveness and acceptability of two at-home HPV self-collection methods among an underserved border population. Findings will inform evidence-based, culturally responsive approaches to increase cervical cancer screening completion and advance cervical cancer elimination goals. Trial Registration: This trial was registered as University of Texas at Austin Protocol Record CPRIT-RP240208, Unidos Contra el VPH, at clinicaltrials.gov on February 25, 2025, and assigned identifier NCT06825689. </p>