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

This study is looking at how well a program called Screening, Brief Intervention, and Referral to Treatment (SBIRT) works for adults who show signs of risky alcohol or substance use. SBIRT is a proven method to help people with these issues. The study wants to see if SBIRT can improve your alcohol and substance use, sexual and reproductive health, mental health, physical health, quality of life, and overall well-being. Researchers also want to know if SBIRT works differently for people of various backgrounds, ages, genders, or depending on whether it's delivered in-person or through telemedicine. You could receive SBIRT in-person, through telemedicine, or receive usual care. The study is enrolling about 400 participants who are over 18, live in the U.S., have internet access, and screen positive for risky alcohol or substance use.

Study design
This is an interventional study, meaning participants will receive a specific treatment or intervention. It plans to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your alcohol and drug use will be measured at the start of the study, after 30 days, and after 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05910580

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

Recruiting
NAAges 18+InterventionalTreatment
Emory University
~400 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Screening, Brief Intervention, and Referral to Treatment (SBIRT)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Average Number of Drinks Per Drinking Day
Measured over Baseline, Day 30, Month 3
+12 more outcomes measured
Alcohol-Related Disorders
Substance-Related Disorders
Mental Health
Reproductive Health
Sexual Health
Sexually Transmitted Diseases
Contraception
Maternal Health
Pregnancy
Women's Health
4 sites across 1 states
Massachusetts4
  • Kelli S Hall, MD · PRINCIPAL_INVESTIGATOR · Columbia University
  • Justine Welsh, MD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

Not capable of communicating (reading, speaking, writing) in English or Spanish
  • Average Number of Drinks Per Drinking DayBaseline, Day 30, Month 3

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

  • Number of Days of Drug UseBaseline, Day 30, Month 3

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

  • Incidence of sex under influence of alcohol/drugsBaseline, Day 30, Month 3

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

  • Number of events of sex under influence of alcohol/drugsBaseline, Day 30, Month 3

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

  • Patient Health Questionnaire (PHQ-9)Baseline, Day 30, Month 3

    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.

  • Number of Clinic Patients Receiving a Brief Intervention During Implementation PhaseDuring the 12-month implementation phase

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

  • Number of Clinic Patients Receiving a Brief Intervention During Sustainment PhaseDuring the 12-month sustainment phase

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

  • Number of Providers Using SBIRT During Implementation PhaseDuring the 12-month implementation phase

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

  • Number of Clinics Using SBIRT During Sustainment PhaseDuring the 12-month sustainment phase

    The number of clinics using SBIRT during the sustainment phase.

  • Number of Providers Using SBIRT During Sustainment PhaseDuring the 12-month sustainment phase

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

  • Number of Completed BIOS Tracking Sheets to Achieve CompetencyDuring the preparation phase

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

  • Brief Intervention Observation Sheet (BIOS) ScoreDuring the 12-month implementation phase

    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.

  • Brief Intervention Observation Sheet (BIOS) Score - Motivational StyleDuring the 12-month implementation phase

    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.