Employing eSBI in HIV Testing for At-risk Youth

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703116
• Other study ID #: R01DA041071
• Secondary ID: R01DA041071
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: October 2020

Study information

• Verified date: November 2021
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: October 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Howard Brown Health Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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