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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01351389

First Posted: May 10, 2011

Last Update Posted: September 15, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Memorial Hospital of Rhode Island

Kent Hospital, Rhode Island

Information provided by (Responsible Party):

Peter Monti, Brown University

Purpose

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.

Condition	Intervention
Alcohol Consumption Unsafe Sex	Behavioral: Brief Motivational Intervention (BMI) Behavioral: Brief Advice


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk

Resource links provided by NLM:

MedlinePlus related topics: Alcohol HIV/AIDS

U.S. FDA Resources

Further study details as provided by Peter Monti, Brown University:

Primary Outcome Measures:

Number of alcoholic drinks consumed [ Time Frame: 3 month ]
Number of standard alcoholic drinks consumed in the past month
Number of alcoholic drinks consumed [ Time Frame: 6-months ]
Number of standard alcoholic drinks consumed in the past month
Number of alcoholic drinks consumed [ Time Frame: 9-months ]
Number of standard alcoholic drinks consumed in the past month
Number of times engaged in risky sex [ Time Frame: 3-months ]
Number of times engaged in risky sex during the past month
Number of times engaged in risky sex [ Time Frame: 6-months ]
Number of times engaged in risky sex during the past month
Number of times engaged in risky sex [ Time Frame: 9-months ]
Number of times engaged in risky sex during the past month


Enrollment:	400
Study Start Date:	May 2011
Study Completion Date:	August 2014
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: BA

Arms

Assigned Interventions

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 Name: 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 Name: BA

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351389

Locations


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

Sponsors and Collaborators

Brown University

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

More Information


Responsible Party:	Peter Monti, Professor, Brown University
ClinicalTrials.gov Identifier:	NCT01351389 History of Changes
Other Study ID Numbers:	2R01AA009892-16A1 ( U.S. NIH Grant/Contract )
First Submitted:	May 9, 2011
First Posted:	May 10, 2011
Last Update Posted:	September 15, 2014
Last Verified:	September 2014

Keywords provided by Peter Monti, Brown University:


Brief Alcohol Intervention Sex Risk

Additional relevant MeSH terms:


Emergencies Alcohol Drinking Disease Attributes Pathologic Processes Drinking Behavior	Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs

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