Brief Intervention to Reduce STDs in ER Drug Users
Condition: Sexually Transmitted Infection
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): brief motivation intervention
Intervention type(s): Behavioral
Intervention description(s): Brief motivation intervention consisting of brief psychosocial counseling (20 minutes at the time of an ER visit)
Other intervention name(s): Brief Negotiation Interview; Safe Sex: Brief Negotiation Interview (SS-BNI); motivational interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cocaine; heroin; STIs; HIV; brief motivational intervention; voluntary testing and counseling