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

Alcohol Consumption Clinical Trial

— SAFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351389
• Other study ID #: 2R01AA009892-16A1
• Secondary ID: 2R01AA009892-16A
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: September 12, 2014
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Unsafe Sex

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island
United States	Brown University Center for Alcohol and Addiction Studies	Providence	Rhode Island
United States	Kent Hospital	Warwick	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Kent Hospital, Rhode Island, Memorial Hospital of Rhode Island, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of alcoholic drinks consumed	Number of standard alcoholic drinks consumed in the past month	3 month	No
Primary	Number of alcoholic drinks consumed	Number of standard alcoholic drinks consumed in the past month	6-months	No
Primary	Number of alcoholic drinks consumed	Number of standard alcoholic drinks consumed in the past month	9-months	No
Primary	Number of times engaged in risky sex	Number of times engaged in risky sex during the past month	3-months	No
Primary	Number of times engaged in risky sex	Number of times engaged in risky sex during the past month	6-months	No
Primary	Number of times engaged in risky sex	Number of times engaged in risky sex during the past month	9-months	No