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Employing eSBI in HIV Testing for At-risk Youth

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ClinicalTrials.gov Identifier: NCT02703116
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Garofalo, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease Intervention/treatment Phase
HIV Substance Use Behavioral: Alcohol Use BI Behavioral: Nutrition Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth
Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

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).




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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   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)
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703116


Contacts
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Contact: Abigail L Muldoon, MA 773-649-1916 amuldoon@luriechildrens.org

Locations
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United States, Illinois
University of Illinois at Chicago Withdrawn
Chicago, Illinois, United States, 60607
Ann & Robert H. Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Robert Garofalo, MD, MPH         
Sub-Investigator: Lisa M Kuhns, PhD, MPH         
Howard Brown Health Center Recruiting
Chicago, Illinois, United States, 60613
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Robert Garofalo, MD, MPH Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Niranjan Karnik, MD, PhD Rush University Medical Center

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Responsible Party: Robert Garofalo, MD, Division Chief - Adolescent Medicine; Director - Center for Gender, Sexuality and HIV Prevention, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02703116     History of Changes
Other Study ID Numbers: R01DA041071 ( U.S. NIH Grant/Contract )
R01DA041071 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).
Time Frame: Post publication. Exact time frame undecided.
Access Criteria: Share de-identified study data upon request to study contacts and with approval from the principal investigator(s).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Garofalo, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
HIV
Substance Use
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs