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Completed

NCT Number: NCT02703116

Employing eSBI in HIV Testing 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.

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Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol Use BI

Behavioral

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.

Nutrition Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 9, 2016
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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