Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk (SAFER)
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| First Received Date ICMJE | May 9, 2011 | ||||||||
| Last Updated Date | November 6, 2011 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01351389 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual Risk | ||||||||
| Official Title ICMJE | Brief Interventions in the Emergency Department for Alcohol and HIV/Sexual 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 302 | ||||||||
| Estimated Completion Date | July 2015 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
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| NCT Number ICMJE | NCT01351389 | ||||||||
| Other Study ID Numbers ICMJE | 2R01AA009892-16A1, 2R01AA009892-16A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Peter Monti, Brown University | ||||||||
| Study Sponsor ICMJE | Brown University | ||||||||
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| Investigators ICMJE |
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| Information Provided By | Brown University | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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