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

NCT01351389 | Completed Results DMC

• 1 other identifier: 2R01AA009892-16A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Alcohol Consumption; Unsafe Sex

Keywords

Brief; Alcohol; Intervention; Sex; Risk

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Brief Motivational Intervention (BMI)

ACTIVE COMPARATOR

Behavioral: Brief Motivational Intervention (BMI)

Brief Advice

ACTIVE COMPARATOR

Behavioral: Brief Advice

Interventions

Brief Motivational Intervention (BMI) BEHAVIORAL

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.

Also known as: BMI

Brief Motivational Intervention (BMI)

Brief Advice BEHAVIORAL

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.

Also known as: BA

Brief Advice

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Memorial Hospital of Rhode Island: collaborator
• Kent Hospital, Rhode Island: collaborator

Study Sites (3)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

Kent Hospital

Warwick, Rhode Island, 02886, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Unsafe Sex; Coitus

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Peter Monti
• Organization: Brown University, Center for Alcohol and Addiction Studies

peter_monti@brown.edu

(401) 863-6661

Study Officials

• Peter M Monti, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Nadine R Mastroleo, PhD

  Brown University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: August 1, 2014
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Locations

US (3)