Employing eSBI in HIV Testing for At-risk Youth

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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Substance Use
• Intervention / Treatment: Behavioral: Alcohol Use BI; Behavioral: Nutrition Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol Use BI; Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach.	Behavioral: Alcohol Use BI; Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach.
Active Comparator: Nutrition Intervention; Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition).	Behavioral: Nutrition Intervention; Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frequency of Alcohol Use	Self-reported frequency of alcohol use in the previous 1 and 12 months assessed via computer-assisted self-interviewing.	1, 3, 6 and 12 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP and HIV-related Care Engagement	PrEP and HIV-related medical care engagement (completed clinical visits) will be abstracted from medical records.	1, 3, 6 and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Niranjan Karnik, MD, PhD, Rush University Medical Center

Publications and helpful links

General Publications

• Kuhns LM, Karnik N, Hotton A, Muldoon A, Donenberg G, Keglovitz K, McNulty M, Schneider J, Summersett-Williams F, Garofalo R. A randomized controlled efficacy trial of an electronic screening and brief intervention for alcohol misuse in adolescents and young adults vulnerable to HIV infection: step up, test up study protocol. BMC Public Health. 2020 Jan 8;20(1):30. doi: 10.1186/s12889-020-8154-6.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Substance Use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R01DA041071 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).
• IPD Sharing Time Frame: Post publication. Exact time frame undecided.
• IPD Sharing Access Criteria: Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No