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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03079856
Other study ID # NIDA036008
Secondary ID 4K23DA036008-04
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2017
Est. completion date August 13, 2018

Study information

Verified date August 2018
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date August 13, 2018
Est. primary completion date August 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Hurley Medical Center Flint Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in HIV risk behaviors 60-day Timeline Follow-Back (TLFB) will be used to assess frequency of unprotected sex. 2-months post baseline
Secondary 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
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