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Integrative Alcohol and Risky Sex Feedback for College Students

Primary Purpose

Alcohol Drinking in College, Sexual Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cross-tailored Dynamic Feedback
Personalized Feedback Intervention
Dynamic Feedback on General Health Behaviors
Sponsored by
Anne E Ray
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking in College

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • status as first-year college student at University of Kentucky or UNT-Denton
  • 18-20 years old
  • one binge drinking episode within the past 30 days (4+/5+ drinks for women/men in one sitting) OR 3+ drinking occasions within the past month
  • sexually active, defined as having oral, anal, or vaginal sex within the past 12 months
  • not in a monogamous relationship (defined as less than 3 months, single, not dating, dating, not serious, or open to cheating)

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

Sites / Locations

  • University of Kentucky
  • University of North Texas Health Science Center at Fort Worth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

PFI+CDF with diary surveys

PFI+GHI with diary surveys

PFI-only with no diary surveys

Control

Arm Description

Participants 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.

Participants 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.

Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys.

Participants in this condition get no intervention and do not complete weekend diary surveys.

Outcomes

Primary Outcome Measures

Change in self-reported alcohol-related sexual behavior frequency
Number of times alcohol was consumed during or before sex in the last month
Change in self-reported alcohol-related sexual behavior quantity
Number of alcoholic beverages consumed before sex in the last month
Change in self-reported alcohol-related hook-ups
Number of alcohol-related hook-ups experienced in the last month
Change in self-reported alcohol-related sexual behavior consequences
Number of alcohol-related sexual consequences experienced in the last month

Secondary Outcome Measures

Change in self-reported alcohol use quantity
Typical number of drinks consumed on each day of week in the last month
Change in self-reported heavy episodic drinking
Number of heavy drinking episodes (4+ drinks female, 5+ drinks male) in the last month
Change in self-reported quantity of sex partners
Number of casual sex partners in the last month
Change in self-reported condom use
Number of times condom was used during sex in the last month

Full Information

First Posted
August 10, 2021
Last Updated
October 2, 2023
Sponsor
Anne E Ray
Collaborators
University of North Texas Health Science Center, Klein Buendel, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05011903
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anne E Ray
Collaborators
University of North Texas Health Science Center, Klein Buendel, Inc., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 at-risk 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 who report recent heavy episodic drinking and are sexually active. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking in College, Sexual Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PFI+CDF with diary surveys
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
PFI+GHI with diary surveys
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
PFI-only with no diary surveys
Arm Type
Experimental
Arm Description
Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this condition get no intervention and do not complete weekend diary surveys.
Intervention Type
Behavioral
Intervention Name(s)
Cross-tailored Dynamic Feedback
Intervention Description
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback Intervention
Intervention Description
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Dynamic Feedback on General Health Behaviors
Intervention Description
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.
Primary Outcome Measure Information:
Title
Change in self-reported alcohol-related sexual behavior frequency
Description
Number of times alcohol was consumed during or before sex in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported alcohol-related sexual behavior quantity
Description
Number of alcoholic beverages consumed before sex in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported alcohol-related hook-ups
Description
Number of alcohol-related hook-ups experienced in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported alcohol-related sexual behavior consequences
Description
Number of alcohol-related sexual consequences experienced in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Secondary Outcome Measure Information:
Title
Change in self-reported alcohol use quantity
Description
Typical number of drinks consumed on each day of week in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported heavy episodic drinking
Description
Number of heavy drinking episodes (4+ drinks female, 5+ drinks male) in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported quantity of sex partners
Description
Number of casual sex partners in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Title
Change in self-reported condom use
Description
Number of times condom was used during sex in the last month
Time Frame
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: status as first-year college student at University of Kentucky or UNT-Denton 18-20 years old one binge drinking episode within the past 30 days (4+/5+ drinks for women/men in one sitting) OR 3+ drinking occasions within the past month sexually active, defined as having oral, anal, or vaginal sex within the past 12 months not in a monogamous relationship (defined as less than 3 months, single, not dating, dating, not serious, or open to cheating) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne E Ray, PhD
Phone
8592184944
Email
anne.ray@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne E Ray, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne E Ray, PhD
Phone
859-218-4944
Email
anne.ray@uky.edu
First Name & Middle Initial & Last Name & Degree
Anne E Ray, PhD
First Name & Middle Initial & Last Name & Degree
Jerod L Stapleton, PhD
First Name & Middle Initial & Last Name & Degree
Seth Himelhoch, PhD
First Name & Middle Initial & Last Name & Degree
Heather Bush, PhD
Facility Name
University of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Young Mun, PhD
Phone
817-735-5158
Email
eun-young.mun@unthsc.edu
First Name & Middle Initial & Last Name & Degree
Eun-Young Mun, PhD
First Name & Middle Initial & Last Name & Degree
Melissa A Lewis, PhD
First Name & Middle Initial & Last Name & Degree
Zhengyang Zhou, PhD
First Name & Middle Initial & Last Name & Degree
Dana M. Litt, PhD
First Name & Middle Initial & Last Name & Degree
Lin Tan, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
To be determined.
IPD Sharing Access Criteria
To be determined.

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Integrative Alcohol and Risky Sex Feedback for College Students

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