Recruiting

SBIRT

Sponsor:

Emory University

Code:

NCT05910580

Conditions

Alcohol-Related Disorders

Substance-Related Disorders

Mental Health

Reproductive Health

Sexual Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Screening, Brief Intervention, and Referral to Treatment (SBIRT)

Study Details

Brief summary:

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic.

The main questions it aims to answer are:

  • Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing?
  • Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity?
  • Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)?

Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months.

Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Conditions

Alcohol-Related Disorders

Substance-Related Disorders

Mental Health

Reproductive Health

Sexual Health

Study ID

NCT05910580

Start date

Jul 3, 2025

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Over the age of 18 years
  • U.S. residing
  • Have internet access (own a computer or smart phone)
  • Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments

Exclusion Criteria:

  • Not capable of communicating (reading, speaking, writing) in English or Spanish

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Screening, Brief Intervention, and Referral to Treatment (SBIRT)

Patients at study clinics who are randomized to receive the Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention, which is delivered in-person and through telemedicine.

no intervention: Usual Care

Patients at study clinics who are randomized to receive usual care. None of the clinic sites have implemented standardized screening, brief intervention, or referral to treatment components. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Interventions

Screening, Brief Intervention, and Referral to Treatment (SBIRT)

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach supported by national healthcare organizations, including the Preventative Services Task Force and the American College of Obstetrics and Gynecologists. Validated tools will efficiently screen an individual's substance use risk. Patients who screen in the risky/harmful range then receive a brief motivational interviewing-based intervention adapted from the evidence-based Brief Negotiated Interview, lasting 5-10 minutes, which provides feedback, helps explore health risks, and motivates change. Individuals who screen in the severe category, indicating a likely AUD/SUD, also receive a brief intervention, aimed at increasing motivation to accept a referral to treatment, and requiring a more intensive approach will also receive a warm-hand off referral to specialty addiction treatment. Procedures for SBIRT delivery will be adapted to the flow of telemedicine visits.

Primary outcome measure

  • Average Number of Drinks Per Drinking Day [ Time Frame: Baseline, Day 30, Month 3 ]
  • Number of Days of Drug Use [ Time Frame: Baseline, Day 30, Month 3 ]
  • Incidence of sex under influence of alcohol/drugs [ Time Frame: Baseline, Day 30, Month 3 ]
  • Number of events of sex under influence of alcohol/drugs [ Time Frame: Baseline, Day 30, Month 3 ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, Day 30, Month 3 ]
  • Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase [ Time Frame: During the 12-month implementation phase ]
  • Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase [ Time Frame: During the 12-month sustainment phase ]
  • Number of Providers Using SBIRT During Implementation Phase [ Time Frame: During the 12-month implementation phase ]
  • Number of Clinics Using SBIRT During Sustainment Phase [ Time Frame: During the 12-month sustainment phase ]
  • Number of Providers Using SBIRT During Sustainment Phase [ Time Frame: During the 12-month sustainment phase ]
  • Number of Completed BIOS Tracking Sheets to Achieve Competency [ Time Frame: During the preparation phase ]
  • Brief Intervention Observation Sheet (BIOS) Score [ Time Frame: During the 12-month implementation phase ]
  • Brief Intervention Observation Sheet (BIOS) Score - Motivational Style [ Time Frame: During the 12-month implementation phase ]

Central Contacts and Locations

Central contacts

Kelli S Hall, PhD MS

212-305-4805ksh2110@cumc.columbia.edu

Jessica LaHote, MPH

212-305-4805jl5348@cumc.columbia.edu

Locations

Greater Boston Health Center

Recruiting

Boston, Massachusetts, United States, 02215

Metro West Health Center

Recruiting

Marlborough, Massachusetts, United States, 01752

Western Massachusetts Health Center

Recruiting

Springfield, Massachusetts, United States, 01107

Central Massachusetts Health Center

Recruiting

Worcester, Massachusetts, United States, 01609

More Information

Sponsor

Emory University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Implementation Science
  • Mass Screening
  • Motivational Interviewing
  • Referral and Consultation
  • Quality of Health Care
  • Early Medical Intervention
  • Family Planning Services
  • Primary Health Care
  • Reproductive Health Services
  • Telemedicine
  • Preconception Care
  • Young Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-15.