Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk (SAFER)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Kent Hospital, Rhode Island
Information provided by (Responsible Party):
Peter Monti, Brown University
ClinicalTrials.gov Identifier:
NCT01351389
First received: May 9, 2011
Last updated: February 17, 2014
Last verified: February 2014

May 9, 2011
February 17, 2014
May 2011
November 2013   (final data collection date for primary outcome measure)
  • Number of alcoholic drinks consumed [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
  • Number of alcoholic drinks consumed [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
  • Number of alcoholic drinks consumed [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Number of standard alcoholic drinks consumed in the past month
  • Number of times engaged in risky sex [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    Number of times engaged in risky sex during the past month
  • Number of times engaged in risky sex [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    Number of times engaged in risky sex during the past month
  • Number of times engaged in risky sex [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Number of times engaged in risky sex during the past month
30 day Timeline Followback for Alcohol and Sexual Behaviors [ Time Frame: baseline, 3-, 6-, and 9-month followup ] [ Designated as safety issue: No ]
Timeline FollowBack: Sexual Behavior and Substance Use (TLFB-SS). The TLFB-SS (Carey, et al., 2001) assesses drinking and sexual behavior. It is a structured, calendar-aided interview that yields an assessment of sex, drinking and their co-occurrence on each day. Length of time spent drinking will be collected for calculating estimated BAC. For every sexual experience, the following will be collected: main or casual partner, gender of the partner, condom use, vaginal or analsex, and sex with alcohol, drugs, neither, or both.
Complete list of historical versions of study NCT01351389 on ClinicalTrials.gov Archive Site
Not Provided
Readiness to Change [ Time Frame: Baseline, post-intervention ] [ Designated as safety issue: No ]
Readiness Ladder (Alcohol and Sex Behavior). This item assesses motivation to change drinking behavior and engage in condom use. The states, "Each rung of this ladder represents where a person might be in thinking about changing their drinking. Select the number that best represents where you are now." Item options range from (0) no thought of changing to (10) taking action to change. An identical ladder exploring motivation to change sexual behaviors will also be used and will be explored as mediators of intervention effects.
Not Provided
Not Provided
 
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk
Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol Consumption
  • Unsafe Sex
  • 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
  • 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
  • Active Comparator: Brief Motivational Intervention
    Intervention: Behavioral: Brief Motivational Intervention (BMI)
  • Active Comparator: Brief Advice
    Intervention: Behavioral: Brief Advice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
302
August 2014
November 2013   (final data collection date for primary outcome measure)

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 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01351389
2R01AA009892-16A1, 2R01AA009892-16A1
Yes
Peter Monti, Brown University
Brown University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Memorial Hospital of Rhode Island
  • Kent Hospital, Rhode Island
Principal Investigator: Peter M Monti, PhD Brown University
Study Director: Nadine R Mastroleo, PhD Brown University
Brown University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP