Alcohol Consumption, Unsafe Sex
Conditions
Keywords
Brief, Alcohol, Intervention, Sex, Risk
Brief 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.
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.
Interventions
BEHAVIORALBrief 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.
BEHAVIORALBrief 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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Memorial Hospital of Rhode Island
Kent Hospital, Rhode Island
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days Engaged in Condomless Sex in the Past Month | 6-months | Number of days engaged in compless sex during the past month |
| Number of Alcoholic Drinks Consumed Per Week | 3 month | Number of standard alcoholic drinks consumed in the past month |
| Number of Alcoholic Drinks Consumed Past Month | 6-months | Number of standard alcoholic drinks consumed in the past month |
| Number of Days Engaged in Risky Sex in the Past Month | 3-months | Number of days engaged in risky sex during the past month (condomless sex) |
Countries
United States
Participant flow
Recruitment details
Conducted in two hospital Emergency Rooms in Rhode Island. Conducted between May 2011 and November 2013
Pre-assignment details
400 patients consented, 23 were lost prior to randomization, 5 withdrew from study prior to randomization, 45 did not completed the interventions
Participants by arm
| Arm | Count |
|---|---|
| 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. | 184 |
| 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. | 188 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not complete intervention | 23 | 15 |
| Overall Study | Withdrawal by Subject | 7 | 0 |
Baseline characteristics
| Characteristic | Brief Motivational Intervention (BMI) | Total | Brief Advice |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 184 Participants | 372 Participants | 188 Participants |
| Age, Continuous | 28.4 years STANDARD_DEVIATION 9.1 | 29.19 years STANDARD_DEVIATION 9.3 | 30.0 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 184 Participants | 372 Participants | 188 Participants |
| Sex: Female, Male Female | 104 Participants | 199 Participants | 95 Participants |
| Sex: Female, Male Male | 80 Participants | 173 Participants | 93 Participants |
| Time-line Follow-back Alcohol and Sex (30 day) | 5.8 Days STANDARD_DEVIATION 7.3 | 5.9 Days STANDARD_DEVIATION 7 | 5.9 Days STANDARD_DEVIATION 6.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 184 | 0 / 188 |
| serious Total, serious adverse events | 0 / 184 | 0 / 188 |
Outcome results
Primary
Number of Alcoholic Drinks Consumed Past Month
Number of standard alcoholic drinks consumed in the past month
Time frame: 6-months
Population: 7 participants in each group did not complete the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Alcoholic Drinks Consumed Past Month | 9.2 Drinks per month | Standard Deviation 12.4 |
| Brief Advice | Number of Alcoholic Drinks Consumed Past Month | 12.6 Drinks per month | Standard Deviation 17.9 |
Primary
Number of Alcoholic Drinks Consumed Past Month
Number of standard alcoholic drinks consumed in the past month
Time frame: 9-months
Population: 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Alcoholic Drinks Consumed Past Month | 8.4 Drinks per month | Standard Deviation 11.6 |
| Brief Advice | Number of Alcoholic Drinks Consumed Past Month | 12.1 Drinks per month | Standard Deviation 17.6 |
Primary
Number of Alcoholic Drinks Consumed Per Week
Number of standard alcoholic drinks consumed in the past month
Time frame: 3 month
Population: 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Alcoholic Drinks Consumed Per Week | 9.1 Drinks per week | Standard Deviation 11.5 |
| Brief Advice | Number of Alcoholic Drinks Consumed Per Week | 16.5 Drinks per week | Standard Deviation 28.1 |
Primary
Number of Days Engaged in Condomless Sex in the Past Month
Number of days engaged in compless sex during the past month
Time frame: 6-months
Population: 7 participants in each group did not complete the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Days Engaged in Condomless Sex in the Past Month | 0.7 Days | Standard Deviation 2.6 |
| Brief Advice | Number of Days Engaged in Condomless Sex in the Past Month | 1.7 Days | Standard Deviation 4.9 |
Primary
Number of Days Engaged in Condomless Sex in the Past Month
Number of days engaged in condomless sex during the past month
Time frame: 9-months
Population: 5 and 9 participants did not complete the assessment in the BMI and BA groups respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Days Engaged in Condomless Sex in the Past Month | 0.7 Days | Standard Deviation 2.9 |
| Brief Advice | Number of Days Engaged in Condomless Sex in the Past Month | 0.9 Days | Standard Deviation 3.3 |
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)
Time frame: 3-months
Population: 13 and 12 participants did not complete the assessment in the BMI and BA groups respectively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Motivational Intervention (BMI) | Number of Days Engaged in Risky Sex in the Past Month | 0.8 Days | Standard Deviation 2.6 |
| Brief Advice | Number of Days Engaged in Risky Sex in the Past Month | 1.3 Days | Standard Deviation 4 |