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

NCT ID: NCT01351389

Last Updated: 2025-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Alcohol Consumption Unsafe Sex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brief Motivational Intervention (BMI)

Group Type ACTIVE_COMPARATOR

Brief Motivational Intervention (BMI)

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Brief Advice

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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BMI BA

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role collaborator

Kent Hospital, Rhode Island

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Peter Monti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter M Monti, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Nadine R Mastroleo, PhD

Role: STUDY_DIRECTOR

Brown University

Locations

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Site Status

Kent Hospital

Warwick, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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2R01AA009892-16A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01AA009892-16A1

Identifier Type: NIH

Identifier Source: org_study_id

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