Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk (SAFER)

This brief alcohol and sexual risk taking intervention has the potential to influence the public health by reducing alcohol use and sexual risk taking behavior in individuals who are seeking treatment in an Emergency Department.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption; Unsafe Sex
• Intervention / Treatment: Behavioral: Brief Motivational Intervention (BMI); Behavioral: Brief Advice

Detailed Description

Linkages between alcohol use and HIV/sexual risk behaviors have been observed in multiple groups and each behavior has been successfully treated individually. Indeed, some studies suggest these behaviors can be successfully treated together. The Emergency Department (ED) provides a venue through which many patients with multiple risks are treated. Yet, to date no study has addressed these behaviors together in an ED, where admission may represent an opportunistic moment when patients are particularly willing to discuss these risky behaviors. Motivational Interviewing (MI) has demonstrated promise with alcohol risk in the ED in several of our previous studies, and has shown promise with sexual risk populations as well. Accordingly, this study (N=302) will address whether a one session multiple risk MI can more effectively decrease and maintain reduction in alcohol use, alcohol related problems, and sexual risk taking following discharge from the ED than Brief Advice (BA). Baseline, MI Session 1 and BA will be administered in the ED. Follow-ups will be conducted at 3, 6 and 9 months. This project will allow us to address the next phase of our program of research that has been designed to develop easily disseminable treatments for high-risk populations in medical settings. This study will also address potential mediators (motivation to change risk taking, self-efficacy) of MI effects. We will also examine whether reductions in sexual risk associated with MI compared to BA are accounted for by reduced drinking. A tertiary aim will examine the moderating effect of co-occurring substance use on outcomes. The cost-effectiveness of the interventions will also be addressed. Thus, this study will address two significant Public Health problems and provide significant information about MI mechanisms that may be relevant to the treatment community.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University Center for Alcohol and Addiction Studies
    • Warwick, Rhode Island, United States, 02886
      • Kent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female patients older than 18 who receive medical care in the ED *score positive (> 8 for males; > 6 for females) for harmful alcohol use on the AUDIT screening questionnaire and report past 3-month binge drinking

  • be sexually active (past 6 months)

  • endorse any past-year sex-risk behavior criterion, including:

    • having more than one sexual partner
    • having sexual intercourse without a condom
    • consuming alcohol prior to or during sex
    • sing illicit drugs (or using licit drugs to get high) prior to or during sex.

Exclusion Criteria:

• Patients under the age of 18; Patients in a mutually monogamous relationship for longer than 1 year will be excluded unless either the patient or his/her partner are HIV+ or has unknown HIV status. Other exclusion criteria include:

  • scoring below 18 on a mini-mental status exam
  • no verifiable address
  • plans to move outside a 45-mile radius within the follow-up period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brief Motivational Intervention (BMI)	Behavioral: Brief Motivational Intervention (BMI); The BMI incorporates open-ended exploration, personalized feedback, and discussion about patients' alcohol use and sexual behaviors and the consequences of these behaviors. Using the central principles described by Miller and Rollnick (2002), the goal of the session, conducted in the hospital as soon as possible, is to explore the patient's alcohol use and sexual behaviors and to help patients consider what they might want to change. Also included is a presentation of personalized feedback, and for patients who are interested in change, a focus on establishing goals for reduced drinking and sexual risk abstinence. Collaboratively the counselor and patient develop a plan for the future, identify goals for behavior change, explore barriers to changes, and provide strategic advice.; Other Names: BMI
Active Comparator: Brief Advice	Behavioral: Brief Advice; Patients in the Brief Advice (BA) condition will receive intervention consistent with standard medical practice when alcohol problems or sex-risk behaviors are indicated. Project staff will offer BA about level of alcohol/drug and sexual behaviors and drug problems risk, and will provide a list of treatment resources (including options for HIV testing) in the local area. Patients will be told they show signs of risk associated with alcohol use in that they scored above a cut-score for our alcohol screen, and that they reported recently engaging in sexually risky behaviors. The staff person will advise patients that reducing their alcohol use, and illicit drug use when relevant, and using condoms is advised. BA will take approximately 5 minutes.; Other Names: BA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Alcoholic Drinks Consumed Per Week	Number of standard alcoholic drinks consumed in the past month	3 month
Number of Alcoholic Drinks Consumed Past Month	Number of standard alcoholic drinks consumed in the past month	6-months
Number of Alcoholic Drinks Consumed Past Month	Number of standard alcoholic drinks consumed in the past month	9-months
Number of Days Engaged in Risky Sex in the Past Month	Number of days engaged in risky sex during the past month (condomless sex)	3-months
Number of Days Engaged in Condomless Sex in the Past Month	Number of days engaged in compless sex during the past month	6-months
Number of Days Engaged in Condomless Sex in the Past Month	Number of days engaged in condomless sex during the past month	9-months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Memorial Hospital of Rhode Island; Kent Hospital, Rhode Island
• Investigators: Principal Investigator: Peter M Monti, PhD, Brown University; Study Director: Nadine R Mastroleo, PhD, Brown University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimated): May 10, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Alcohol; Intervention; Risk; Sex; Brief
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2R01AA009892-16A1 (U.S. NIH Grant/Contract)