Clinical trial NCT05011903: Integrative Alcohol and Risky Sex Feedback for College Students
Official title: Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking in College
Sexual Behavior
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of North Texas Health Science Center
name: Klein Buendel, Inc.
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-08-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Increased student alcohol use and heavy drinking are linked to increased sexual activity and related risky behaviors (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs - sexually transmitted infections) and is also a pathway to sexual victimization and escalated drinking. The first few weeks of college, known as the 'red zone,' provide an opportunity to intervene at time when these behaviors increase. However, most prevention programs for college students tend to focus on student alcohol use and have little to no integration of content on the relationship between alcohol use and risky sexual behaviors. This is an important gap in the literature and a priority area for NIAAA. The research team established the short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. In this study, we propose to extend our integrated PFI to include a cross-tailored dynamic feedback (CDF) component. The CDF component will use technology to incorporate daily assessments of student behavior and provide students with dynamic weekly feedback over 12 weeks. The goal is to increase the effectiveness of the integrated PFI and to create a program that is easily implemented on college campuses.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* status as first-year college student at University of Kentucky or UNT-Denton
* 18-20 years old

Exclusion Criteria:

* the inability or unwillingness to give informed, voluntary consent to participate
* not meeting inclusion criteria
* currently in treatment to reduce alcohol or other substance use
* pregnant or planning to become pregnant

Primary outcomes:
measure: Change in self-reported alcohol-related sexual behavior frequency
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported alcohol-related sexual behavior quantity
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported alcohol-related hook-ups
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported alcohol-related sexual behavior consequences
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Secondary outcomes:
measure: Change in self-reported alcohol use quantity
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported heavy episodic drinking
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported quantity of sex partners
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
measure: Change in self-reported condom use
timeFrame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center at Fort Worth
state: Texas
Study officials:
affiliation: University of Kentucky
name: Anne E Ray, PhD
role: PRINCIPAL_INVESTIGATOR
References: