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Employing eSBI in HIV Testing for At-risk Youth

Primary Purpose

HIV, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Use BI
Nutrition Intervention
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Substance Use

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ann & Robert H. Lurie Children's Hospital
  • Howard Brown Health Center
  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol Use BI

Nutrition Intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PrEP and HIV-related Care Engagement
PrEP and HIV-related medical care engagement (completed clinical visits) will be abstracted from medical records.

Full Information

First Posted
March 2, 2016
Last Updated
November 12, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02703116
Brief Title
Employing eSBI in HIV Testing for At-risk Youth
Official Title
Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance Use
Keywords
HIV, Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
464 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Use BI
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Intervention
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Use BI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Frequency of Alcohol Use
Description
Self-reported frequency of alcohol use in the previous 1 and 12 months assessed via computer-assisted self-interviewing.
Time Frame
1, 3, 6 and 12 months post-intervention
Secondary Outcome Measure Information:
Title
PrEP and HIV-related Care Engagement
Description
PrEP and HIV-related medical care engagement (completed clinical visits) will be abstracted from medical records.
Time Frame
1, 3, 6 and 12 months post-intervention

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
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)
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Garofalo, MD, MPH
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niranjan Karnik, MD, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Howard Brown Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
31914971
Citation
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.
Results Reference
derived

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Employing eSBI in HIV Testing for At-risk Youth

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