Alcohol ConsumptionSAFERNCT01351389
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
A study testing Brief Motivational Intervention (BMI) and Brief Advice in people with Alcohol Consumption and Unsafe Sex, run by Brown University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Consumption, Unsafe Sex
- What is being tested?
- Brief Motivational Intervention (BMI) and Brief Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
Kent Hospital
Warwick, Rhode Island, 02886
About this study
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.
Read the 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.
- Conditions
- Alcohol Consumption, Unsafe Sex
- Being tested
- Brief Motivational Intervention (BMI), Brief Advice
- Keywords
- Brief, Alcohol, Intervention, Sex, Risk
- Medical subject headings
- Alcohol Drinking, Unsafe Sex, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Intervention (BMI)Behavioural
Also called 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 AdviceBehavioural
Also called BA
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Intervention (BMI) | Active comparator | Not described Receives: Behavioral: Brief Motivational Intervention (BMI) |
| Brief Advice | Active comparator | Not described Receives: Behavioral: Brief Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Alcoholic Drinks Consumed Per Week
Number of standard alcoholic drinks consumed in the past month
Measured: 3 month
Number of Alcoholic Drinks Consumed Past Month
Number of standard alcoholic drinks consumed in the past month
Measured: 6-months
Number of Alcoholic Drinks Consumed Past Month
Number of standard alcoholic drinks consumed in the past month
Measured: 9-months
Number of Days Engaged in Risky Sex in the Past Month
Number of days engaged in risky sex during the past month (condomless sex)
Measured: 3-months
Number of Days Engaged in Condomless Sex in the Past Month
Number of days engaged in compless sex during the past month
Measured: 6-months
Number of Days Engaged in Condomless Sex in the Past Month
Number of days engaged in condomless sex during the past month
Measured: 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Memorial Hospital of Rhode Island, Kent Hospital, Rhode Island
- Responsible party
- Principal investigator, Peter Monti, Brown University
- Investigators
- Peter M Monti, PhD, Principal investigator, Brown UniversityNadine R Mastroleo, PhD, Study director, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351389
- Sponsor's protocol ID
- 2R01AA009892-16A1
- Other IDs
- 2R01AA009892-16A1
- Acronym
- SAFER
- Status last verified
- Jun 2025
- First submitted
- 9 May 2011
- Last updated
- 19 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
- ClinicalTrials.gov ID
- NCT01351389
- Acronym / sponsor ID
- SAFER / 2R01AA009892-16A1
- Conditions
- Alcohol Consumption, Unsafe Sex
- Keywords
- Brief, Alcohol, Intervention, Sex, Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Memorial Hospital of Rhode Island, Kent Hospital, Rhode Island
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 19 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Intervention (BMI) | Active comparator | Behavioral: Brief Motivational Intervention (BMI) |
| Brief Advice | Active comparator | Behavioral: Brief Advice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational Intervention (BMI)Also: BMIThe 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. | Behavioural | Brief Motivational Intervention (BMI) |
| Brief AdviceAlso: BAPatients 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. | Behavioural | Brief Advice |
Primary outcome
Number of Alcoholic Drinks Consumed Per Week
Time frame: 3 month
Number of standard alcoholic drinks consumed in the past month
Number of Alcoholic Drinks Consumed Past Month
Time frame: 6-months
Number of standard alcoholic drinks consumed in the past month
Number of Alcoholic Drinks Consumed Past Month
Time frame: 9-months
Number of standard alcoholic drinks consumed in the past month
Number of Days Engaged in Risky Sex in the Past Month
Time frame: 3-months
Number of days engaged in risky sex during the past month (condomless sex)
Number of Days Engaged in Condomless Sex in the Past Month
Time frame: 6-months
Number of days engaged in compless sex during the past month
Number of Days Engaged in Condomless Sex in the Past Month
Time frame: 9-months
Number of days engaged in condomless sex during the past month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Monti, PhD principal investigator
Brown University
Nadine R Mastroleo, PhD study director
Brown University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention (BMI) and Brief Advice in people with Alcohol Consumption and Unsafe Sex, run by Brown University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Alcoholic Drinks Consumed Per Week (time frame: 3 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.