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

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: brief motivation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 1030
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: motivational interviewing; Brief Negotiation Interview; Safe Sex: Brief Negotiation Interview (SS-BNI)
No Intervention: control group; Care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
unprotected sexual acts	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
sex acts while high on drugs	1 year

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Edward Bernstein, MD, Boston Medical Center

Publications and helpful links

General Publications

• Bernstein E, Heeren T, Winter M, Ashong D, Bliss C, Madico G, Ayalew B, Bernstein J. Long-term follow-up after voluntary human immunodeficiency virus/sexually transmitted infection counseling, point-of-service testing, and referral to substance abuse treatment from the emergency department. Acad Emerg Med. 2012 Apr;19(4):386-95. doi: 10.1111/j.1553-2712.2012.01314.x.
• Bernstein E, Ng V, McCloskey L, Vazquez K, Ashong D, Stapleton S, Cromwell J, Bernstein J. Qualitative analysis of cocaine and heroin users' main partner sex-risk behavior: is safety in love safety in health? Addict Sci Clin Pract. 2013 Apr 23;8(1):10. doi: 10.1186/1940-0640-8-10.
• Tassiopoulos K, Bernstein J, Bernstein E. Age and sharing of needle injection equipment in a cohort of Massachusetts injection drug users: an observational study. Addict Sci Clin Pract. 2013 Dec 13;8(1):20. doi: 10.1186/1940-0640-8-20.
• Bernstein E, Ashong D, Heeren T, Winter M, Bliss C, Madico G, Bernstein J. The impact of a brief motivational intervention on unprotected sex and sex while high among drug-positive emergency department patients who receive STI/HIV VC/T and drug treatment referral as standard of care. AIDS Behav. 2012 Jul;16(5):1203-16. doi: 10.1007/s10461-012-0134-0.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 17, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: HIV; STIs; cocaine; heroin; brief motivational intervention; voluntary testing and counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: NCT00218400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified may be shared on request