Verified March 2017 by University of Michigan
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Erin Bonar, University of Michigan
ClinicalTrials.gov Identifier:
NCT03079856
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 |
- 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
- 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
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 Drugs HIV Risky Sex Behaviors |
ClinicalTrials.gov processed this record on March 15, 2017