Trial Outcomes & Findings for Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk (NCT NCT01351389)
NCT ID: NCT01351389
Last Updated: 2025-06-19
Results Overview
Number of standard alcoholic drinks consumed in the past month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
3 month
Results posted on
2025-06-19
Participant Flow
Conducted in two hospital Emergency Rooms in Rhode Island. Conducted between May 2011 and November 2013
400 patients consented, 23 were lost prior to randomization, 5 withdrew from study prior to randomization, 45 did not completed the interventions
Participant milestones
| Measure |
Brief Motivational Intervention (BMI)
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
188
|
|
Overall Study
COMPLETED
|
154
|
173
|
|
Overall Study
NOT COMPLETED
|
30
|
15
|
Reasons for withdrawal
| Measure |
Brief Motivational Intervention (BMI)
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
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
|
Overall Study
did not complete intervention
|
23
|
15
|
Baseline Characteristics
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Baseline characteristics by cohort
| Measure |
Brief Motivational Intervention (BMI)
n=184 Participants
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
n=188 Participants
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.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
184 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
372 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
28.4 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
30.0 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
29.19 years
STANDARD_DEVIATION 9.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
173 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
184 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
372 Participants
n=27 Participants
|
|
Time-line Follow-back Alcohol and Sex (30 day)
|
5.8 Days
STANDARD_DEVIATION 7.3 • n=93 Participants
|
5.9 Days
STANDARD_DEVIATION 6.8 • n=4 Participants
|
5.9 Days
STANDARD_DEVIATION 7.0 • n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthPopulation: 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively
Number of standard alcoholic drinks consumed in the past month
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=141 Participants
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
n=161 Participants
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.
|
|---|---|---|
|
Number of Alcoholic Drinks Consumed Per Week
|
9.1 Drinks per week
Standard Deviation 11.5
|
16.5 Drinks per week
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: 7 participants in each group did not complete the assessment.
Number of standard alcoholic drinks consumed in the past month
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=147 Participants
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
n=166 Participants
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.
|
|---|---|---|
|
Number of Alcoholic Drinks Consumed Past Month
|
9.2 Drinks per month
Standard Deviation 12.4
|
12.6 Drinks per month
Standard Deviation 17.9
|
PRIMARY outcome
Timeframe: 9-monthsPopulation: 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively
Number of standard alcoholic drinks consumed in the past month
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=149 Participants
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
n=164 Participants
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.
|
|---|---|---|
|
Number of Alcoholic Drinks Consumed Past Month
|
8.4 Drinks per month
Standard Deviation 11.6
|
12.1 Drinks per month
Standard Deviation 17.6
|
PRIMARY outcome
Timeframe: 3-monthsPopulation: 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively
Number of days engaged in risky sex during the past month (condomless sex)
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=141 Participants
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
n=161 Participants
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.
|
|---|---|---|
|
Number of Days Engaged in Risky Sex in the Past Month
|
0.8 Days
Standard Deviation 2.6
|
1.3 Days
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: 6-monthsPopulation: 7 participants in each group did not complete the assessment.
Number of days engaged in compless sex during the past month
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=147 Participants
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
n=166 Participants
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.
|
|---|---|---|
|
Number of Days Engaged in Condomless Sex in the Past Month
|
0.7 Days
Standard Deviation 2.6
|
1.7 Days
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: 9-monthsPopulation: 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively
Number of days engaged in condomless sex during the past month
Outcome measures
| Measure |
Brief Motivational Intervention (BMI)
n=149 Participants
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
n=164 Participants
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.
|
|---|---|---|
|
Number of Days Engaged in Condomless Sex in the Past Month
|
0.7 Days
Standard Deviation 2.9
|
0.9 Days
Standard Deviation 3.3
|
Adverse Events
Brief Motivational Intervention (BMI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Peter Monti
Brown University, Center for Alcohol and Addiction Studies
Phone: (401) 863-6661
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place