Brief Intervention to Reduce STDs in ER Drug Users - 1
| Tracking Information | |||||
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| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | October 20, 2011 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
High risk sexual behaviors | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00218400 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brief Intervention to Reduce STDs in ER Drug Users - 1 | ||||
| Official Title ICMJE | Brief Intervention to Reduce STDs in ER Drug Users | ||||
| Brief Summary | The purpose of this study is to test whether a brief motivational interview focused on sexual practices will facilitate behavior change, risk reduction and reduced rate of sexually transmitted infections among emergency department patients who use heroin and cocaine and are out-of-treatment for their substance abuse. |
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| Detailed Description | Project SAFE is a multidisciplinary effort to test whether brief motivational interviewing in an emergency department setting may encourage change in sex behaviors and thus prevent gonorrhea, chlamydia, and HIV among male and female patients aged 18-44 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 3,340 patients to intervention (safe sex BNI) or control (standard counseling) over a 2.5-year period, with 6-month and 12-month follow-up. Outcome measures include: 1) comparing cumulative STD incidence and frequency of safe sex behavior between intervention and standard counseling (control) groups over a one year follow-up period; 2) STD and HIV as diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up; participant self-report of sexual and drug using behavior at baseline and 6 and 12 month follow-up. Sexual behavior risk will be measured in terms of proportion of vaginal and anal sex acts protected by condom use and condom use at last sexual act, by sexual partner type. Differences in cumulative incidence between intervention and control groups will be evaluated using Poisson regression with random effects modeling if needed. Differences in safe sex behavior between intervention and control groups will be evaluated using logistic regression. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, and baseline readiness to change and sexual and drug using behavior. We will conduct exploratory analyses for the potential interaction and mediating effects between intervention status and abstinence from drug use on incidence of STDs and self-reported behaviors. An effective, brief intervention for safe sex behaviors to reduce STDs and HIV among drug users in ED and UCC settings may provide a sustainable intervention opportunity for drug users who are otherwise difficult to access. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Motivational interviewing | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | 3340 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 44 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00218400 | ||||
| Other Study ID Numbers ICMJE | NIDA-17061-1, R01DA017061, R01-17061-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Boston Medical Center | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Boston Medical Center | ||||
| Verification Date | October 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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