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Verified March 2017 by University of Michigan



National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Erin Bonar, University of Michigan

ClinicalTrials.gov Identifier:


First received: February 27, 2017

Last updated: March 8, 2017

Last verified: March 2017

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.

Drug Use
Sex Behavior
Behavioral: Brief Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Health Services Research
Official Title: Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER

Primary Outcome Measures:

  • Change in days substance use [ Time Frame: 2-months post baseline ]

    60-day Timeline Follow-Back (TLFB) will be used to assess total days of any substance use.

  • Change in quantity of marijuana use [ Time Frame: 2-months post baseline ]

    60-day Timeline Follow-Back (TLFB) will be used to assess quantity of marijuana consumed.

  • Change in total alcohol consumption [ Time Frame: 2-months post baseline ]

    60-day Timeline Follow-Back (TLFB) will be used to assess quantity of alcohol consumed

Secondary Outcome Measures:

  • Change in HIV risk behaviors [ Time Frame: 2-months post baseline ]

    60-day Timeline Follow-Back (TLFB) will be used to assess frequency of unprotected sex.

  • Change in substance use consequences [ Time Frame: 2-months post baseline ]

    Modified Rutgers Alcohol Problems Index adapted for alcohol and drugs will assess total substance related consequences experienced.

Estimated Enrollment: 80
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
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

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.

Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03079856

University of Michigan

National Institute on Drug Abuse (NIDA)

Principal Investigator: Erin E Bonar, Ph.D. University of Michigan

Responsible Party: Erin Bonar, Assistant Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03079856     History of Changes
Other Study ID Numbers: NIDA036008  4K23DA036008-04 
Study First Received: February 27, 2017
Last Updated: March 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Michigan:

Emerging adults
Risky Sex Behaviors

ClinicalTrials.gov processed this record on March 15, 2017