Brief Intervention to Reduce STDs in ER Drug Users (SAFE)

This study has been completed.
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01379599
First received: June 22, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

The goal of the proposed project is to determine the effectiveness of a brief motivational intervention among Emergency Department (ED) patients who use cocaine and/or heroin to prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by comparing cumulative incidence and frequency of safe sex behavior between intervention and standard voluntary counseling, testing and referral to substance abuse treatment (control) groups over a one year follow-up period.


Condition Intervention Phase
Sexually Transmitted Infections.
Behavioral: brief motivation intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • unprotected sexual acts [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sex acts while high on drugs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1030
Study Start Date: November 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: brief motivational intervention Behavioral: brief motivation intervention
brief psychosocial counseling (20 minutes at the time of an ER visit)
Other Names:
  • Brief Negotiation Interview
  • Safe Sex: Brief Negotiation Interview (SS-BNI)
  • motivational interviewing

Detailed Description:

Barriers to health care utilization limit drug users' interaction with the primary health care system, resulting in episodic health care received through Emergency Departments (ED) and Urgent Care Centers (UCC). Since 1994, the Boston Medical Center ED and UCC have provided substance abuse screening as standard of care. This program employs the Brief Negotiated Interview (BNI) to assess patient's reasons for drug use, readiness to change and offer intervention alternatives and referrals to substance treatment and other resources. Drug users' high rates of STIs, HIV, and Hepatitis C (HCV) and utilization of EDs and UCCs as usual sources of health care support the introduction of sexual behavior intervention in the ED and UCC setting. The proposed study will apply existing BNI theory and research to a new behavioral context. The proposed project is a collaborative effort to adapt the BNI to encourage safe sex behaviors to prevent gonorrhea, chlamydia, and HIV among male and female ED and UCC patients age 18-54 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 1,030 patients to intervention (safe sex BNI) or control (voluntary counseling and testing and referral to substance abuse treatment) over a 2.5-year period, with 6-month and 12-month follow-up. STIs and HIV will be diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up. Sexual and drug using behavior will be determined by participant self-report at baseline, 6-month, and 12-month follow-up on a 30 day time-line follow-up calender, with biochemical testing of hair samples for opiates and cocaine at enrollment 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 safe sex behavior between intervention and control groups will be evaluated using GEE modeling. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, injection use, HIV status and sexual and drug using behavior. 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 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • registered ER patient
  • English and Spanish speakers
  • 30 day use of heroin and or cocaine
  • DAST score=>3

Exclusion Criteria:

  • severity of medical illness
  • suicidality
  • police custody
  • residential substance abuse treatment
  • ability to provide contact information
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01379599

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Edward Bernstein, MD Boston Medical Center
  More Information

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jamieson, Ellen MS, MBA/Associate Director Grants Administration, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01379599     History of Changes
Other Study ID Numbers: NCT00218400
Study First Received: June 22, 2011
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Boston Medical Center:
cocaine
heroin
STIs
HIV
brief motivational intervention
voluntary testing and counseling

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014