Employing eSBI in HIV Testing for At-risk Youth

NCT02703116 | Completed DMC

• 1 other identifier: R01DA041071
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV; Substance Use

Keywords

HIV; Substance Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PrEP and HIV-related Care Engagement

  1, 3, 6 and 12 months post-intervention

Study Arms (2)

Alcohol Use BI

EXPERIMENTAL

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

Nutrition Intervention

ACTIVE COMPARATOR

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

Interventions

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.

Alcohol Use BI

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).

Nutrition Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Gender Eligibility Details: 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)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• volunteer seems distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)
• volunteer seems intoxicated or under the influence of psychoactive agents

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

• Karnik NS, Kuhns LM, Hotton AL, Del Vecchio N, McNulty M, Schneider J, Donenberg G, Keglovitz Baker K, Diskin R, Muldoon A, Rivera J, Summersett Williams F, Garofalo R. Findings From the Step Up, Test Up Study of an Electronic Screening and Brief Intervention for Alcohol Misuse in Adolescents and Young Adults Presenting for HIV Testing: Randomized Controlled Efficacy Trial. JMIR Ment Health. 2023 Mar 29;10:e43653. doi: 10.2196/43653.

  PMID: 36989027 DERIVED

• 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.

  PMID: 31914971 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ethanol; Diet Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Nutrition Therapy; Therapeutics

Study Officials

• Robert Garofalo, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Niranjan Karnik, MD, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief - Adolescent Medicine; Director - Center for Gender, Sexuality and HIV Prevention

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 9, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• 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).

Locations

US (3)