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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379599
First Posted: June 23, 2011
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Edward Bernstein, Boston Medical Center
  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 Infection Behavioral: brief motivation intervention Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brief Intervention to Reduce STDs in ER Drug Users

Resource links provided by NLM:


Further study details as provided by Edward Bernstein, Boston Medical Center:

Primary Outcome Measures:
  • unprotected sexual acts [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • sex acts while high on drugs [ Time Frame: 1 year ]

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 motivation intervention
Brief motivation intervention was implemented with enrollees identified with heroin and cocaine use who were allocated to the experimental group. The aim was to test the ability of a peer-delivered intervention to reduce risk of HIV and STIs related to sexual behaviors (condom use and sex while high on drugs.
Behavioral: brief motivation intervention
Brief motivation intervention consisting of 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
No Intervention: control group
Care as usual.

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 Brief Negotiation Interview (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 General Estimating Equation (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

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Edward Bernstein, Professor of Emergency Medicine BU SOM; Professor of Community Health Sciences BUSPH, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01379599     History of Changes
Obsolete Identifiers: NCT00218400
First Submitted: June 22, 2011
First Posted: June 23, 2011
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified may be shared on request

Keywords provided by Edward Bernstein, 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


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