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

NCT05910580 | Recruiting DMC

• 2 other identifiers: STUDY00005766R01AA030529
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (13)

• Average Number of Drinks Per Drinking Day

  Participants are asked to self-report the number of drinks consumed on days when alcohol was consumed, during the past 30 days.

  Baseline, Day 30, Month 3

• Number of Days of Drug Use

  Participants are asked to self-report the number of days of drug use in the past 30 days.

  Baseline, Day 30, Month 3

• Incidence of sex under influence of alcohol/drugs

  Any incidence of sex under influence of alcohol/drugs in past 30 days.

  Baseline, Day 30, Month 3

• Number of events of sex under influence of alcohol/drugs

  The number of events of sex while under influence of alcohol/drugs in past 30 days.

  Baseline, Day 30, Month 3

• Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire (PHQ-9) is a 9-item instrument assessing symptoms of depression during the prior two weeks. Responses are given on a 4-point scale where 0 = not at all and 3 = nearly everyday. Total scores range from 0 to 27 where higher scores indicate greater feelings of depression. Scores of 0 to 4 indicate minimal depression, scores of 5 to 9 indicate mild depression, scores of 10 to 14 indicate moderate depression, scores of 15 to 19 indicate moderately severe depression, and scores of 20 or more indicate severe depression.

  Baseline, Day 30, Month 3

• Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase

  The number of patients in each clinic who screen positive receiving a brief intervention during the implementation phase of the study.

  During the 12-month implementation phase

• Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase

  The number of patients in each clinic who screen positive who receive a brief intervention during the sustainment phase of the study.

  During the 12-month sustainment phase

• Number of Providers Using SBIRT During Implementation Phase

  The number of providers in each clinic using SBIRT during the implementation phase.

  During the 12-month implementation phase

• Number of Clinics Using SBIRT During Sustainment Phase

  The number of clinics using SBIRT during the sustainment phase.

  During the 12-month sustainment phase

• Number of Providers Using SBIRT During Sustainment Phase

  The number of providers in each clinic using SBIRT during the sustainment phase.

  During the 12-month sustainment phase

• Number of Completed BIOS Tracking Sheets to Achieve Competency

  The number of completed Brief Intervention Observation Sheets (BIOS) needed to achieve competency will be examined.

  During the preparation phase

• Brief Intervention Observation Sheet (BIOS) Score

  Fidelity to the intervention is assessed as the mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Responses to items are recorded as a "yes" or "no" assessment of whether the steps of the brief intervention were completed. The total score is the number of "yes" items and can range from 0 to 10, with higher scores indicating more steps completed.

  During the 12-month implementation phase

• Brief Intervention Observation Sheet (BIOS) Score - Motivational Style

  Fidelity to the intervention is assessed as the mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Item 11 assesses the overall motivational interviewing style used by the provider. Scores are rated on a 7-point scale where 1 = not at all and 7 = very effectively. Higher scores indicate greater motivational interviewing style.

  During the 12-month implementation phase

Secondary Outcomes (22)

• Number of Days of Alcohol Use

  Baseline, Day 30, Month 3

• Number of Days of Binge Drinking

  Baseline, Day 30, Month 3

• Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Score

  Baseline, Day 30, Month 3

• Drug Abuse Screening Test (DAST-10) Score

  Baseline, Day 30, Month 3

• Incidence of condom nonuse

  Baseline, Day 30, Month 3

Other Outcomes (2)

• Number of Participants with STI Diagnosis

  Baseline, Day 30, Month 3

• Past or current receipt of substance use treatment or services

  Baseline, Day 30, Month 3

Study Arms (2)

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

EXPERIMENTAL

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.

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

Usual Care

NO INTERVENTION

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) BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Stanford University: collaborator
• Planned Parenthood League of Massachusetts: collaborator

Study Sites (4)

Greater Boston Health Center

Boston, Massachusetts, 02215, United States

RECRUITING

Metro West Health Center

Marlborough, Massachusetts, 01752, United States

RECRUITING

Western Massachusetts Health Center

Springfield, Massachusetts, 01107, United States

RECRUITING

Central Massachusetts Health Center

Worcester, Massachusetts, 01609, United States

RECRUITING

Related Publications (31)

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  BACKGROUND

MeSH Terms

Conditions

Alcohol-Related Disorders; Substance-Related Disorders; Psychological Well-Being; Sexually Transmitted Diseases

Interventions

Mass Screening; Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kelli S Hall, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Justine Welsh, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelli S Hall, PhD MS

CONTACT

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

Jessica LaHote, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 18, 2023
• Study Start: July 3, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available for sharing following publication of finding from this study and will be available indefinitely.
• Access Criteria: Anyone who wishes to access the data will be able to do so.

Locations

US (4)