Brief Intervention to Reduce STDs in ER Drug Users - 1
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance-Related Disorders Sexual Risk Behaviors |
Behavioral: Motivational interviewing |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Brief Intervention to Reduce STDs in ER Drug Users |
- High risk sexual behaviors
| Estimated Enrollment: | 3340 |
| Study Start Date: | December 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 44 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- active use of heroin and/or crack/cocaine; orientation to person, place and time; plans to remain in area; ability to provide at least one contact person for follow-up
Exclusion Criteria:
- currently in active treatment or controlled setting
Contacts and Locations| Contact: Anne Valentine, M.P.H. | (617)414-4556 | anne.valentine@bmc.org |
| United States, Massachusetts | |
| Boston University Medical Campus | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Ellen Jamieson, M.B.A. 617-414-5646 ellen.jamieson@bmc.org | |
| Principal Investigator: | Edward Bernstein, M.D. | Boston Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00218400 History of Changes |
| Other Study ID Numbers: | NIDA-17061-1, R01DA017061, R01-17061-1 |
| Study First Received: | September 16, 2005 |
| Last Updated: | October 20, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013