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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Emory University
Study ID
NCT05910580
Status
Recruiting
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Conditions

  • Alcohol-Related Disorders
  • Contraception
  • Maternal Health
  • Mental Health
  • Pregnancy
  • Reproductive Health
  • Sexual Health
  • Sexually Transmitted Diseases
  • Substance-Related Disorders
  • Women's Health

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Average Number of Drinks Per Drinking Day [ Time Frame: Baseline, Day 30, Month 3 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Greater Boston Health CenterBostonMassachusetts02215-
Metro West Health CenterMarlboroughMassachusetts01752-
Western Massachusetts Health CenterSpringfieldMassachusetts01107-
Central Massachusetts Health CenterWorcesterMassachusetts01609-

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By research site
Greater Boston Health Center· Boston, MAMetro West Health Center· Marlborough, MAWestern Massachusetts Health Center· Springfield, MACentral Massachusetts Health Center· Worcester, MA

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