Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial.

Abstract

Underage drinking and related risky sexual behavior (RSB) are major public health concerns on United States college campuses. Although technology-delivered personalized feedback interventions are considered a best practice for individual-level campus alcohol prevention, there is room for improving the effectiveness of this approach with regard to alcohol-related RSB. The aims of the present study are to (1) evaluate the impact of a brief, personalized feedback intervention (PFI) that integrates content on alcohol use and RSB and is adapted to include a novel cross-tailored, dynamic feedback (CDF) component for at-risk first-year college students and (2) identify implementation factors critical to the CDF's success to facilitate future scale-up in campus settings. This study utilizes a hybrid type 1 effectiveness-implementation design and will be conducted in three phases. Phase 1 is a stakeholder-engaged PFI+CDF adaptation guided by focus groups and usability testing. In Phase 2, 600 first-year college students who drink and are sexually active will be recruited from two sites (n=300 per site) to participate in a 4-group randomized controlled trial to examine the effectiveness of PFI+CDF in reducing alcohol-related RSB. Eligible participants will complete a baseline survey during the first week of the semester and follow-up surveys at 1, 2, 3, 6, and 13 months postbaseline. Phase 3 is a qualitative evaluation with stakeholders to better understand relevant implementation factors. Recruitment and enrollment for Phase 1 began in January of 2022. Recruitment for Phases 2 and 3 is planned for the summer of 2023 and 2024, respectively. Upon collection of data, the effectiveness of PFI+CDF will be examined, and factors critical to implementation will be evaluated. This hybrid type 1 trial is designed to impact the field by testing an innovative adaptation that extends evidence-based alcohol programs to reduce alcohol-related RSB and providing insights related to implementation to bridge the gap between research and practice at the university level. ClinicalTrials.gov NCT05011903; https://clinicaltrials.gov/ct2/show/NCT05011903.