Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Employing eSBI in a community-based HIV testing environment for at-risk youth
Previous Study | Return to List | Next Study

Employing eSBI in HIV Testing for At-risk Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 2, 2016
First Posted Date  ICMJE March 9, 2016
Last Update Posted Date February 1, 2018
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02703116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Employing eSBI in HIV Testing for At-risk Youth
Official Title  ICMJE Employing eSBI in a Community-based HIV Testing Environment for At-risk Youth
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Substance Use
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Alcohol Use BI
  • 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).
    Intervention: Behavioral: Nutrition Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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)
Ages  ICMJE 16 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Abigail L Muldoon, MA 773-649-1916 amuldoon@luriechildrens.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02703116
Other Study ID Numbers  ICMJE R01DA041071( U.S. NIH Grant/Contract )
R01DA041071 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Robert Garofalo, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
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
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP