Boston, Massachusetts 02118


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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00218400


Primary Contact:

Principal Investigator
Edward Bernstein, M.D.
Boston Medical Center

Anne Valentine, M.P.H.
Phone: (617)414-4556
Email: anne.valentine@bmc.org


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02118
United States

Ellen Jamieson, M.B.A.
Phone: 617-414-5646
Email: ellen.jamieson@bmc.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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