search
Back to results

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

Primary Purpose

Alcohol Consumption, Unsafe Sex

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention (BMI)
Brief Advice
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption focused on measuring Brief, Alcohol, Intervention, Sex, Risk

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Hospital of Rhode Island
  • Brown University Center for Alcohol and Addiction Studies
  • Kent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Brief Motivational Intervention (BMI)

Brief Advice

Arm Description

Outcomes

Primary Outcome Measures

Number of alcoholic drinks consumed
Number of standard alcoholic drinks consumed in the past month
Number of alcoholic drinks consumed
Number of standard alcoholic drinks consumed in the past month
Number of alcoholic drinks consumed
Number of standard alcoholic drinks consumed in the past month
Number of times engaged in risky sex
Number of times engaged in risky sex during the past month
Number of times engaged in risky sex
Number of times engaged in risky sex during the past month
Number of times engaged in risky sex
Number of times engaged in risky sex during the past month

Secondary Outcome Measures

Full Information

First Posted
May 9, 2011
Last Updated
September 12, 2014
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Memorial Hospital of Rhode Island, Kent Hospital, Rhode Island
search

1. Study Identification

Unique Protocol Identification Number
NCT01351389
Brief Title
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Acronym
SAFER
Official Title
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Memorial Hospital of Rhode Island, Kent Hospital, Rhode Island

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Unsafe Sex
Keywords
Brief, Alcohol, Intervention, Sex, Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Motivational Intervention (BMI)
Arm Type
Active Comparator
Arm Title
Brief Advice
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention (BMI)
Other Intervention Name(s)
BMI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Other Intervention Name(s)
BA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of alcoholic drinks consumed
Description
Number of standard alcoholic drinks consumed in the past month
Time Frame
3 month
Title
Number of alcoholic drinks consumed
Description
Number of standard alcoholic drinks consumed in the past month
Time Frame
6-months
Title
Number of alcoholic drinks consumed
Description
Number of standard alcoholic drinks consumed in the past month
Time Frame
9-months
Title
Number of times engaged in risky sex
Description
Number of times engaged in risky sex during the past month
Time Frame
3-months
Title
Number of times engaged in risky sex
Description
Number of times engaged in risky sex during the past month
Time Frame
6-months
Title
Number of times engaged in risky sex
Description
Number of times engaged in risky sex during the past month
Time Frame
9-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Monti, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadine R Mastroleo, PhD
Organizational Affiliation
Brown University
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Brown University Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
Kent Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs