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Clinical Trials/NCT02703116
NCT02703116
Completed
Not Applicable

Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth

Ann & Robert H Lurie Children's Hospital of Chicago3 sites in 1 country464 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
464
Locations
3
Primary Endpoint
Change in Frequency of Alcohol Use
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis) care continuum.

Detailed Description

The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV and PrEP (pre-exposure prophylaxis) care continuum. We will do this with the following aims: Aim 1: Assess the feasibility, acceptability and initial efficacy of electronic Screening \& Brief Intervention + Seek, Test, Treat and Retain (eSBI+ STTR) compared to STTR-only to reduce alcohol and other substance use among 450 YMSM and YTW in Chicago, ages 16-25, at 1, 3, 6, and 12 months post-intervention. Aim 2: To explore the initial efficacy of eSBI+STTR in comparison to STTR-only on secondary exploratory outcomes within the HIV and PrEP care continuum among YMSM and YTW. Aim 3: Determine the degree to which sub-groups of youth are differentially impacted by eSBI+STTR based on socio-demographic characteristics and co-morbid mental health problems to inform future targeting and/or tailoring of the intervention.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
October 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Garofalo, MD

Division Chief - Adolescent Medicine; Director - Center for Gender, Sexuality and HIV Prevention

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Inclusion Criteria

  • aged 16 to 25 years
  • seeking testing for HIV infection
  • HIV-negative or HIV status unknown (per self-report)
  • Male who has had sex with men OR transgender woman who has had sex with men (i.e., born male, identify as female/transgender, and at any point in the gender transition process)
  • English-speaking.

Exclusion Criteria

  • volunteer seems distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)
  • volunteer seems intoxicated or under the influence of psychoactive agents

Outcomes

Primary Outcomes

Change in Frequency of Alcohol Use

Time Frame: 1, 3, 6 and 12 months post-intervention

Self-reported frequency of alcohol use in the previous 1 and 12 months assessed via computer-assisted self-interviewing.

Secondary Outcomes

  • PrEP and HIV-related Care Engagement(1, 3, 6 and 12 months post-intervention)

Study Sites (3)

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