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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AA009892-16A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Memorial Hospital of Rhode Island | OTHER |
| Kent Hospital, Rhode Island | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Active Comparator |
| |
| Brief Advice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Motivational Intervention (BMI) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alcoholic Drinks Consumed Per Week | Number of standard alcoholic drinks consumed in the past month | 3 month |
| Number of Alcoholic Drinks Consumed Past Month | Number of standard alcoholic drinks consumed in the past month | 6-months |
| Number of Alcoholic Drinks Consumed Past Month | Number of standard alcoholic drinks consumed in the past month | 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) | 3-months |
| Number of Days Engaged in Condomless Sex in the Past Month | Number of days engaged in compless sex during the past month | 6-months |
| Number of Days Engaged in Condomless Sex in the Past Month | Number of days engaged in condomless sex during the past month | 9-months |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Monti, PhD | Brown University | Principal Investigator |
| Nadine R Mastroleo, PhD | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hospital of Rhode Island | Pawtucket | Rhode Island | 02860 | United States | ||
| Brown University Center for Alcohol and Addiction Studies |
400 patients consented, 23 were lost prior to randomization, 5 withdrew from study prior to randomization, 45 did not completed the interventions
Conducted in two hospital Emergency Rooms in Rhode Island. Conducted between May 2011 and November 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Alcoholic Drinks Consumed Per Week | Number of standard alcoholic drinks consumed in the past month | 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively | Posted | Mean | Standard Deviation | Drinks per week | 3 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Monti | Brown University, Center for Alcohol and Addiction Studies | (401) 863-6661 | peter_monti@brown.edu |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D047568 | Unsafe Sex |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
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| Brief Advice | 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. |
|
|
| Providence |
| Rhode Island |
| 02912 |
| United States |
| Kent Hospital | Warwick | Rhode Island | 02886 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Time-line Follow-back Alcohol and Sex (30 day) | Tool used to retrospectively assess drinking and sexual behavior over the previous 30 days. | Mean | Standard Deviation | Days |
|
| OG001 | 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. |
|
|
| Primary | Number of Alcoholic Drinks Consumed Past Month | Number of standard alcoholic drinks consumed in the past month | 7 participants in each group did not complete the assessment. | Posted | Mean | Standard Deviation | Drinks per month | 6-months |
|
|
|
| Primary | Number of Alcoholic Drinks Consumed Past Month | Number of standard alcoholic drinks consumed in the past month | 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively | Posted | Mean | Standard Deviation | Drinks per month | 9-months |
|
|
|
| Primary | Number of Days Engaged in Risky Sex in the Past Month | Number of days engaged in risky sex during the past month (condomless sex) | 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively | Posted | Mean | Standard Deviation | Days | 3-months |
|
|
|
| Primary | Number of Days Engaged in Condomless Sex in the Past Month | Number of days engaged in compless sex during the past month | 7 participants in each group did not complete the assessment. | Posted | Mean | Standard Deviation | Days | 6-months |
|
|
|
| Primary | Number of Days Engaged in Condomless Sex in the Past Month | Number of days engaged in condomless sex during the past month | 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively | Posted | Mean | Standard Deviation | Days | 9-months |
|
|
|
| 0 |
| 184 |
| 0 |
| 184 |
| EG001 | 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. | 0 | 188 | 0 | 188 |
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