NCT03079856

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

February 27, 2017

Last Update Submit

August 28, 2018

Conditions

Drug UseSex Behavior

Keywords

Emerging adultsDrugsHIVRisky Sex Behaviors

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in HIV risk behaviors

    2-months post baseline

  • Change in substance use consequences

    2-months post baseline

Study Arms (2)

Brief Intervention

EXPERIMENTAL

ED-based computer-guided intervention for substance use and HIV risk reduction utilizing Motivational Interviewing

Behavioral: Brief Intervention

Enhanced Usual Care

NO INTERVENTION

Substance use and sexual health services information within a brochure provided to participants

Interventions

Brief InterventionBEHAVIORAL

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.

Brief Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Erin E Bonar, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 15, 2017

Study Start

October 9, 2017

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)