Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial

简要总结

详细描述

The project utilizes a multisite, hybrid type 1 effectiveness-implementation study design to (1) evaluate the impact of CDF for first-year college students and (2) identify implementation factors critical to its success to facilitate future scale-up in campus settings. The first aim is to conduct a multi-level stakeholder-engaged adaptation of the integrated alcohol and risky sex PFI through the development and inclusion of CDF. The second aim is to conduct a randomized controlled trial (RCT) of the enhanced intervention (PFI+CDF) in a sample of 600 first-year college students. The primary hypothesis is that participants who receive the PFI+CDF intervention will report less alcohol use, fewer risky sexual behaviors, and fewer consequences relative to those who receive a PFI supplemented with generic health information at follow-up (1, 2, 3, 6, and 13 months). Participants (N=600 total, 300 per site) will be randomized to 1 of 4 groups: (1) PFI+CDF with weekend diary surveys, (2) PFI+GHI with weekend diary surveys, (3) PFI-only, no weekend diary surveys, and (4) assessment-only control, no weekend diary surveys. All participants will complete a baseline survey during the first week of the semester, be randomly assigned to condition, and complete follow-up surveys at 1, 2, 3, 6, and 13 months. This staggered design allows for comparison of the enhanced PFI+CDF relative to the PFI+GHI condition, which may be consistent with a "treatment-as-usual" comparison group (e.g., of the universities that have adopted an evidence-guided alcohol intervention program for their campus, many currently deliver commercialized alcohol-focused PFIs to incoming first-year students). Providing weekly GHI in the comparison condition allows for an equal number of "exposures" between the more intensive conditions (PFI+CDF vs. PFI+GHI), analogous to an attention control group, offering a clearer understanding of the overall impact of the PFI+CDF adaptation. The inclusion of two PFI conditions, one with weekend diary assessments and one without allows us to control for potential assessment reactivity that might result from the diary-style assessment approach. Overall, this design is intended to allow a separation of the "true" intervention effect of the CDF above and beyond the effect of assessment reactivity. The PFI-only vs. assessment-only control group comparison will provide a test of basic efficacy of the integrated PFI that has been adapted based on stakeholder feedback. The third aim seeks to identify factors critical to PFI+CDF implementation in campus settings through conducting focus groups with a subset of students from the RCT and with local and national systems-level stakeholders. The intervention has strong potential for widespread dissemination and targets a group at high risk for alcohol misuse and RSB.

主要结局

次要结局

• Change in self-reported condom use(Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months)
• Change in self-reported quantity of sex partners(Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months)
• Change in self-reported alcohol use quantity(Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months)
• Change in self-reported heavy episodic drinking(Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months)