Despite declines over the past several decades, underage drinking and related harm continue to be major public health concerns on United States college campuses [1-3]. National data show two-thirds of college students are current drinkers, 1 in 3 reports past-month heavy-episodic drinking (more than 5 drinks in a row), and 1 in 10 reports high-intensity drinking (more than 10 drinks in a row) [1]. Greater college student alcohol consumption and heavy drinking on a given day are linked to increased sexual activity and risky sexual behavior (RSB; eg, unprotected sex and unplanned hookups) [4-9]. Alcohol-related RSB puts college students at risk for negative health outcomes (eg, sexually transmitted infections and unplanned pregnancies) and is a pathway to sexual victimization and escalated drinking [10-14]. Notably, alcohol use is implicated in approximately half of college student sexual assaults [14,15]. Given the high rates of alcohol misuse in college and the association between alcohol use and RSB, prevention efforts that reduce alcohol-related RSB have been identified as a priority area in the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Strategic Plan 2017-2021 [3].

The first weeks of college are referred to as the red zone with escalations in heavy drinking [16-18] and sexual assault [19-23]. Changes in the salience of social and achievement goals and stressors during the transition to college impact alcohol use during this period [24]. Students who drink heavily prior to college are likely to escalate drinking [25], and nondrinkers or light drinkers may consume heavy amounts on occasion, increasing their risk of experiencing serious consequences [26,27]. This coincides with changes in students’ sex-related cognitions and behaviors [8,28]. Thus, effective interventions for escalated alcohol use and RSB during this critical period of risk can result in high public health and clinical impacts [29].

NIAAA’s College Alcohol Intervention Matrix identifies technology-delivered personalized feedback interventions (PFIs) as a best practice for individual-level campus alcohol prevention [30]. PFIs typically involve a one-time, web-based assessment of an individual’s alcohol use behaviors, followed by the provision of a tailored profile based on the assessment of the individual’s drinking patterns and strategies to reduce harm [31-33]. The utilization of technology for assessment and feedback allows PFIs to retain key features of efficacious in-person brief motivational interventions without the high costs and need for trained personnel [34]. Many universities now opt for commercially developed PFIs for first-year students (eg, AlcoholEdu for College [35] and eCHECKUPTOGO [36]) [37-42].

Past work from the investigative team [32,43,44] highlights 2 important concerns with PFIs as widely implemented. First, a rather exclusive focus on the assessment and feedback of alcohol use means other health behaviors impacted by alcohol use, such as RSB, are rarely addressed [32]. To address this gap, a PFI with integrated alcohol and RSB content for sexually active, college-aged young adults who regularly drink was developed. The integrated PFI showed promise in reducing alcohol-related sexual outcomes [43]. Second, there is considerable heterogeneity in PFI effects across participants [45] and studies [44,46]. Further, PFIs tend to provide short-term intervention benefits but offer diminished protection to college students beyond 6 months [46,47]. The current intervention is designed to increase and extend the effects of the integrated alcohol and RSB PFI by incorporating repeated and dynamic assessment and feedback.

The prevailing approach to technology-delivered PFIs is to provide a single, point-in-time snapshot of one’s behaviors and beliefs relative to others, analogous to a “between-person” comparison, which can create initial discrepancy and enhance motivation to change [48]. However, this feedback is limited to a one-time snapshot of individual differences in risk, does not capitalize on the beneficial effects of continued monitoring, and cannot capture dynamic changes in an individual’s beliefs or behavior in response to feedback. The proposed PFI and cross-tailored dynamic feedback (CDF) adaptation (PFI+CDF) leverages semester-long diary assessments (once a day for 4 days a week over 12 weeks) to iteratively refine (ie, optimize) initial feedback. The addition of CDF has the potential to amplify the effects of PFIs through the provision of feedback linked to a user’s personal, day-to-day trajectory of a target behavior. The integration of adaptive (“just-in-time”) and dynamic feedback is designed to bolster and sustain the initial impact of the PFI by creating a unique form of self-monitoring of “within-person” trajectories. In this way, positive behavior change can be acknowledged, and the participant can be redirected when less desirable behaviors are reported. The CDF adaptation of a PFI is intended to develop discrepancy regarding alcohol-related RSB, alcohol use, and other RSB; enhance motivation to change; and boost self-efficacy in one’s ability to change. To our knowledge, dynamic optimization of intervention content with rapid deployment and evaluation has never been attempted with alcohol-related RSB interventions.

Over the past 3 decades, researchers have made strides to enhance brief alcohol intervention implementation through a number of key adaptations (eg, extending to different subpopulations [44], altering delivery modality [49], adding boosters [50-52], giving students a choice for intervention assignment [53], adding video content [54], and adding substance-free activities [55]). Despite these efforts, a significant proportion of college campuses do not implement evidence-based strategies [56-58]. Although PFIs are a popular choice among campuses that do implement such strategies, little is known regarding strategies they use to encourage stakeholder groups’ participation or how PFIs complement other student health efforts.

Accordingly, the current intervention study is guided by a hybrid type 1 effectiveness-implementation design to examine PFI+CDF effectiveness and related implementation factors to improve and accelerate translation. Effectiveness-implementation hybrid designs offer a dual focus on both outcomes and process, which can serve to speed up the translation of an intervention if it is effective [59,60]. Process-oriented formative evaluations will be used with stakeholders at multiple levels prior to, during, and after program implementation to better understand implementation context, and barriers and facilitators to implementation [61-64]. It is critical to identify college-specific PFI implementation gaps at both the student level and systems level for the purpose of improving PFI+CDF’s acceptance by students and achieving greater adoption on campuses. By engaging multilevel stakeholders at the outset, a “designing for dissemination” approach is followed, using feedback from members of the population of users and organizational adopters [65-68]. In this paper, we provide a description of the proposed hybrid type 1 effectiveness-implementation study protocol.

Figure 1 provides an overview of the 3-phase, multisite hybrid type 1 effectiveness-implementation design to evaluate the effectiveness and understand the implementation of a novel PFI+CDF to reduce first-year college students’ alcohol-related RSB. Phase 1 is a focus group-guided PFI+CDF adaptation and usability test. In phase 2, first-year college students who report past-month heavy-episodic drinking (more than 4 or 5 drinks for females or males within 2 hours) or drinking at least 3 times in the past month and who are sexually active without being in a monogamous relationship will be recruited from the University of Kentucky (UK) and the University of North Texas (UNT) to participate in a 4-group randomized controlled trial (RCT) to examine the effectiveness of PFI+CDF in reducing alcohol-related RSB. PFI+CDF will have 3 other comparison conditions: a PFI followed by the 12-week dynamic feedback on general health information (PFI+GHI), a PFI without any additional exposure to intervention (PFI), and assessment-only control (AOC). In phase 3, a qualitative evaluation will be conducted with multilevel stakeholders to better understand relevant implementation factors.

Phases 1 and 3 are guided by the Consolidated Framework for Implementation Research (CFIR), a comprehensive set of constructs describing factors influencing implementation across all stages of the implementation process [69,70]. CFIR is commonly used to guide formative investigations within the context of hybrid type 1 designs [61,64]. Constructs are grouped into 5 domains in the current intervention study: intervention characteristics (ie, characteristics of PFI+CDF), outer setting (ie, context surrounding student affairs), inner setting (ie, context within student affairs), individual characteristics (ie, students and student affairs staff), and process (ie, process for implementing PFI+CDF) [69].

A qualitative postintervention assessment of intervention implementation will be conducted with multilevel stakeholders, including students and both campus- and national-level student affairs staff. The goals are to better understand (1) participating students’ experiences with the intervention; (2) barriers and facilitators to implementation, guided by CFIR; (3) potential program sustainability; and (4) necessary modifications for other sites for scale-up.

Focus group participants will be a subset of students from the PFI+CDF arm of the RCT, as well as campus- and national-level stakeholders who also participated in preimplementation focus groups. Participants in the PFI+CDF condition will be asked if they are interested in participating in a follow-up study after the 13-month follow-up. We will randomly select up to 48 students who indicate interest in participating (n=24 per site) at varying levels of engagement with the intervention (as guided by program analytic measures) for a maximum of 3 focus groups per site (5-8 participants per group). Campus student affairs staff will be contacted via phone and email for staff focus groups (1 focus group per site for student affairs staff with 5-8 participants per group). At the national level, we will conduct 4 focus groups, with 5-8 participants per group, yielding a total of up to 32 participants. All focus groups will last 60-90 minutes with US $50 and US $100 gift card incentives for students and staff, respectively. The analytic plan for phase 3 qualitative data will mirror phase 1.

The study underwent review and approval by the UK Institutional Review Board (IRB #62769), which serves as the single IRB of record for this study. All participants will sign an approved consent form in accordance with the ethical standards of Helsinki.

This project aims to fill a gap highlighted in the NIAAA Strategic Plan 2017-2021 [3] by advancing an intervention that integrates alcohol misuse and RSB. It also directly addresses the 2 primary areas of foci underlying a recent NIAAA workshop to advance the science on evidence-based brief interventions for young adult populations: (1) optimizing intervention design and (2) implementation and scale-up [85]. To the best of our knowledge, the use of dynamic feedback based on individual behavior trajectories to optimize PFI content with rapid and sustained deliveries and ongoing evaluations has never been attempted with this population and area of study. Understanding the impact of a dual-risk behavior PFI that incorporates novel, cross-tailored between- and within-person feedback profiles can help inform best practices for the delivery of prevention interventions relevant to college students. If successful, our approach could influence how PFIs are developed and delivered in other populations and settings for maximum benefit. In addition, employment of a hybrid type 1 effectiveness-implementation design for this population, behavior, and campus setting is also the first of its kind and is expected to yield broadly informative outcomes through its rigorous randomized trial design testing intervention effectiveness and multilevel stakeholder engagement pre- and postimplementation.

There are several potential limitations that need to be acknowledged. First, the emphasis on first-year college students may be restrictive. We chose to focus on first-year students because they are at risk for alcohol use and RSB [16-26], but older students also experience alcohol-related harms. Many college campuses require students to complete a brief alcohol intervention at the start of college and often use existing commercialized PFIs, providing a built-in audience for the adapted PFI+CDF intervention [35,36]. We encourage future studies to explore PFI+CDF in other at-risk populations, such as older students and young adults not in college. Second, the PFI+CDF intervention approach is intensive and could lead to concerns about student engagement. However, our past work on integrated PFIs indicates that participants engaged with feedback content and viewed it multiple times [86]. We demonstrated that increased personalization leads to a stronger program effect, potentially mediated through increased attention to content [32]. By involving students in the design process in phase 1, we should enhance their interest [59,87,88]. Students also reported favorable reactions to the proposed study methods. Thus, we anticipate high levels of engagement, but will also examine program engagement in phase 2 analyses and phase 3 focus groups. Third, there are alternatives to a web-based app platform. Technology changes rapidly, with many other options for content delivery (eg, native mobile apps, smartwatches, social media). Our goal was to create a flexible system to deliver content in multiple ways (email and SMS text message), increasing the likelihood of engagement. Native mobile apps require more programming than web apps to operate across smartphone types and operating systems. Social media offers opportunities (eg, user-generated interaction and content) but also its own challenges (eg, spread of misinformation). Alternate delivery platforms will be explored during focus groups, and we anticipate the need for content to be portable to other platforms in future implementation.

This innovative, multisite hybrid effectiveness-implementation study will (1) evaluate the impact of a PFI that integrates content on alcohol use and RSB and is adapted to include an innovative CDF component for at-risk first-year college students and (2) identify implementation factors critical to its success to facilitate future scale-up in campus settings. The findings of this study will improve existing evidence-based alcohol programs and bridge the gap between research and practice at the university level.