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

Author:

Ray Anne EORCID,Mun Eun-YoungORCID,Lewis Melissa AORCID,Litt Dana MORCID,Stapleton Jerod LORCID,Tan LinORCID,Buller David BORCID,Zhou ZhengyangORCID,Bush Heather MORCID,Himelhoch SethORCID

Abstract

BACKGROUND

Underage drinking and related risky sexual behavior (RSB) are major public health concerns on United States college campuses. Although technology-delivered personalized feedback interventions (PFIs) 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.

OBJECTIVE

The aims of this study are to (1) evaluate the impact of a brief 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.

METHODS

This study uses a hybrid type 1 effectiveness-implementation design and will be conducted in 3 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 2 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 post baseline. Phase 3 is a qualitative evaluation with stakeholders to better understand relevant implementation factors.

RESULTS

Recruitment and enrollment for phase 1 began in January 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.

CONCLUSIONS

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 provides insights related to implementation to bridge the gap between research and practice at the university level.

CLINICALTRIAL

ClinicalTrials.gov NCT05011903; https://clinicaltrials.gov/ct2/show/NCT05011903

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/43986

Publisher

JMIR Publications Inc.

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