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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Screening, Brief Intervention, and Referral to Treatment (SBIRT)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Day 30, Month 3
2

Number of Days of Drug Use

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

Time frame
Baseline, Day 30, Month 3
3

Incidence of sex under influence of alcohol/drugs

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

Time frame
Baseline, Day 30, Month 3
4

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.

Time frame
Baseline, Day 30, Month 3

Secondary outcomes

1

Number of Days of Alcohol Use

Participants are asked to self-report the number of days they consumed alcohol during the past 30 days.

Time frame
Baseline, Day 30, Month 3
2

Number of Days of Binge Drinking

Participants are asked to self-report the number of days they consumed 4 or more alcoholic drinks per day during the past 30 days.

Time frame
Baseline, Day 30, Month 3
3

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

The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a 3-item alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The questionnaire asks about drinking behavior in the past 30 days. Responses to items are given on a 5-point scale where 0 = never and 4 = the highest frequency of alcohol use or consumption per drinking day. Total scores range from 0 (non-drinkers) to 12. Higher scores indicate that a person's alcohol consumption is likely to affect his or her health and safety.

Time frame
Baseline, Day 30, Month 3
4

Drug Abuse Screening Test (DAST-10) Score

The Drug Abuse Screening Test (DAST-10) is a 10-item instrument assessing drug use (not including alcohol and tobacco use). Each item is responded to as "yes" or "no" and the total score is the sum of all "yes" responses. Total scores range from 0 to 10 with a score of 0 indicating that no problems are reported and the degree of problems related to drug abuse increase as the total score increases. Scores of 1 or 2 indicate a low level of problems, scores of 3 to 5 indicate a moderate level of problems, scores of 6 to8 indicate substantial levels of problems, and scores of 9 and 10 indicate severe levels of problems related to drug abuse.

Time frame
Baseline, Day 30, Month 3

Other outcomes

1

Number of Participants with STI Diagnosis

The number of participants receiving a diagnosis of one more sexually transmitted infections (STIs) in past 30 days.

Time frame
Baseline, Day 30, Month 3
2

Past or current receipt of substance use treatment or services

Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days

Time frame
Baseline, Day 30, Month 3

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Stanford University

Collaborator

Planned Parenthood League of Massachusetts

Collaborator