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Completed

NCT Number: NCT03079856

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.

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Key information

Conditions

Drug Use Behavior Sex Behavior Sexual Behavior

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hurley Medical Center

Flint, Michigan, 48503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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