Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Kent Hospital, Rhode Island
Information provided by (Responsible Party):
Peter Monti, Brown University
ClinicalTrials.gov Identifier:
NCT01351389
First received: May 9, 2011
Last updated: September 12, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Number of alcoholic drinks consumed [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month

  • Number of alcoholic drinks consumed [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month

  • Number of alcoholic drinks consumed [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month

  • Number of times engaged in risky sex [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Number of times engaged in risky sex during the past month

  • Number of times engaged in risky sex [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Number of times engaged in risky sex during the past month

  • Number of times engaged in risky sex [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Peter Monti, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01351389     History of Changes
Other Study ID Numbers: 2R01AA009892-16A1, 2R01AA009892-16A1
Study First Received: May 9, 2011
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Brief
Alcohol
Intervention
Sex
Risk

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014