Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

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
• Sexually Transmitted Diseases
• Contraception
• Maternal Health
• Pregnancy
• Women's Health

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Stanford University

  collaborator OTHER

• Planned Parenthood League of Massachusetts

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Kelli S Hall, MD · Columbia University

• Justine Welsh, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-03

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• United States

Study Locations