Brief Intervention to Reduce STDs in ER Drug Users - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00218400
First received: September 16, 2005
Last updated: October 20, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • High risk sexual behaviors

Estimated Enrollment: 3340
Study Start Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218400

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

Locations
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   
Sponsors and Collaborators
Boston Medical Center
Investigators
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014