Clinical trial NCT01351389: Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Official title: Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Unsafe Sex
Keywords: Brief
Alcohol
Intervention
Sex
Risk
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Memorial Hospital of Rhode Island
name: Kent Hospital, Rhode Island
First posted: 2011-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of alcoholic drinks consumed
timeFrame: 3 month
measure: Number of alcoholic drinks consumed
timeFrame: 6-months
measure: Number of alcoholic drinks consumed
timeFrame: 9-months
measure: Number of times engaged in risky sex
timeFrame: 3-months
measure: Number of times engaged in risky sex
timeFrame: 6-months
measure: Number of times engaged in risky sex
timeFrame: 9-months
Secondary outcomes:
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Providence
country: United States
facility: Brown University Center for Alcohol and Addiction Studies
state: Rhode Island
city: Warwick
country: United States
facility: Kent Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Peter M Monti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Nadine R Mastroleo, PhD
role: STUDY_DIRECTOR
References: