Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER

This project will develop a technology-augmented HIV and substance use risk reduction intervention for delivery in the Emergency Department, a medical setting where at-risk emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.

Study Overview

• Status: Completed
• Conditions: Drug Use; Sex Behavior
• Intervention / Treatment: Behavioral: Brief Intervention

Detailed Description

Research regarding substance use (including illicit drugs and non-medical use of prescription drugs) and HIV-related sexual risk behaviors (HIV SRBs; e.g., inconsistent condom use, multiple partners, sex while intoxicated; and prevention of injection drug use) among emerging adults (EAs; ages 18-25) has generally focused on alcohol use among college students from campus settings; however, substance use and HIV (and other associated Sexually Transmitted Infections) disproportionately occur among young people living in urban, low-resource communities, particularly individuals of racial minorities. The Emergency Department (ED) is a critical venue for accessing at-risk EAs engaging in substance use and HIV risk behaviors. Research shows high rates of substance use and HIV SRBs among EA patients in the ED, yet no intervention exists for EAs in this setting. The ED may be the only opportunity to intervene with these young people because EAs in urban, low-resource settings often lack a primary care provider during the transition from pediatric to adult medicine, may be un-insured or under-insured, and may not be involved in a traditional college campus setting. Further the use of technology (e.g., mobile phones) is relatively ubiquitous among this age group, and most prefer technology-based communication (e.g., text messaging or instant messaging via apps), therefore interventions for EAs may be enhanced by this type of technology. In this phase we will test a tailored intervention for EA patients in the ED focusing on reducing substance use and HIV SRBs, which will be enhanced through the use of mobile app notifications.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically stable
• Mentally and physically able to consent
• English-speaking
• Between ages 18-25
• Past-month substance use (including illicit drugs and/or non-medical prescription drug use) and inconsistent condom use in the past month
• Ownership of a smartphone

Exclusion Criteria:

• ED presentation suicidality and/or acute psychosis, being in police custody, or present with psychological distress requiring intensive social work (e.g. sexual assault)
• Patients with a significant other that they live with who is currently participating in study
• Actively participating in another study
• Participated in prospective and intervention development phases of the study
• Married
• Do not wish to consent to audio-taping the in-person portion of the ED-based intervention session

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Intervention; ED-based computer-guided intervention for substance use and HIV risk reduction utilizing Motivational Interviewing	Behavioral: Brief Intervention; Intervention for emerging adults (EAs) seeking care in the ED. The intervention will be rooted in motivational interviewing (MI) and will be guided by social cognitive, self-determination, and the trans-theoretical theories. The ED visit presents a "teachable moment" for intervening to promote health behavior, therefore eligible EAs will receive a ~30 minute MI-based session in the ED. In order to capitalize on and potentially extend this moment, participants will receive daily booster notifications delivered through a secure mobile app that they will download to their phone at enrollment.
No Intervention: Enhanced Usual Care; Substance use and sexual health services information within a brochure provided to participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in days substance use	60-day Timeline Follow-Back (TLFB) will be used to assess total days of any substance use.	2-months post baseline
Change in quantity of marijuana use	60-day Timeline Follow-Back (TLFB) will be used to assess quantity of marijuana consumed.	2-months post baseline
Change in total alcohol consumption	60-day Timeline Follow-Back (TLFB) will be used to assess quantity of alcohol consumed	2-months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HIV risk behaviors	60-day Timeline Follow-Back (TLFB) will be used to assess frequency of unprotected sex.	2-months post baseline
Change in substance use consequences	Modified Rutgers Alcohol Problems Index adapted for alcohol and drugs will assess total substance related consequences experienced.	2-months post baseline

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Erin E Bonar, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: HIV; Emerging adults; Drugs; Risky Sex Behaviors
• Other Study ID Numbers: NIDA036008; 4K23DA036008-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No