Integrative Alcohol and Risky Sex Feedback for College Students
Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial
2 other identifiers
interventional
600
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
February 18, 2026
February 1, 2026
10 months
August 10, 2021
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Change in self-reported alcohol-related sexual behavior frequency
Number of times alcohol was consumed during or before sex in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior quantity
Number of alcoholic beverages consumed before sex in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related hook-ups
Number of alcohol-related hook-ups experienced in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior consequences
Number of alcohol-related sexual consequences experienced in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Secondary Outcomes (4)
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
Change in self-reported quantity of sex partners
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported condom use
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Study Arms (4)
PFI+CDF with diary surveys
EXPERIMENTALParticipants in this condition receive a Personalized Feedback Intervention (PFI) and Cross-tailored Dynamic Feedback (CDF) related to alcohol use and related sexual behavior. They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors.
PFI+GHI with diary surveys
EXPERIMENTALParticipants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior, and generic health information (GHI). They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors.
PFI-only with no diary surveys
EXPERIMENTALParticipants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys.
Control
NO INTERVENTIONParticipants in this condition get no intervention and do not complete weekend diary surveys.
Interventions
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.
Eligibility Criteria
You may qualify if:
- status as first-year college student at University of Kentucky or UNT-Denton
- years old
You may not qualify if:
- the inability or unwillingness to give informed, voluntary consent to participate
- currently in treatment to reduce alcohol or other substance use
- pregnant or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anne E Raylead
- University of North Texas Health Science Centercollaborator
- Klein Buendel, Inc.collaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (2)
University of Kentucky
Lexington, Kentucky, 40506, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107, United States
Related Publications (1)
Ray AE, Mun EY, Lewis MA, Litt DM, Stapleton JL, Tan L, Buller DB, Zhou Z, Bush HM, Himelhoch S. Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Mar 20;12:e43986. doi: 10.2196/43986.
PMID: 36716301DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne E Ray, PhD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 18, 2021
Study Start
April 1, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- To be determined.
- Access Criteria
- To be determined.
Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.