Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk (SAFER)
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ClinicalTrials.gov Identifier: NCT01351389 |
Recruitment Status
:
Completed
First Posted
: May 10, 2011
Last Update Posted
: September 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcohol Consumption Unsafe Sex | Behavioral: Brief Motivational Intervention (BMI) Behavioral: Brief Advice | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | August 2014 |
Arm | Intervention/treatment |
---|---|
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
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- Number of alcoholic drinks consumed [ Time Frame: 3 month ]Number of standard alcoholic drinks consumed in the past month
- Number of alcoholic drinks consumed [ Time Frame: 6-months ]Number of standard alcoholic drinks consumed in the past month
- Number of alcoholic drinks consumed [ Time Frame: 9-months ]Number of standard alcoholic drinks consumed in the past month
- Number of times engaged in risky sex [ Time Frame: 3-months ]Number of times engaged in risky sex during the past month
- Number of times engaged in risky sex [ Time Frame: 6-months ]Number of times engaged in risky sex during the past month
- Number of times engaged in risky sex [ Time Frame: 9-months ]Number of times engaged in risky sex during the past month

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351389
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 |
Principal Investigator: | Peter M Monti, PhD | Brown University | |
Study Director: | Nadine R Mastroleo, PhD | Brown University |
Responsible Party: | Peter Monti, Professor, Brown University |
ClinicalTrials.gov Identifier: | NCT01351389 History of Changes |
Other Study ID Numbers: |
2R01AA009892-16A1 ( U.S. NIH Grant/Contract ) |
First Posted: | May 10, 2011 Key Record Dates |
Last Update Posted: | September 15, 2014 |
Last Verified: | September 2014 |
Keywords provided by Peter Monti, Brown University:
Brief Alcohol Intervention Sex Risk |
Additional relevant MeSH terms:
Emergencies Alcohol Drinking Disease Attributes Pathologic Processes Drinking Behavior |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |