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Completed

NCT Number: NCT01379599

Brief Intervention to Reduce STDs in ER Drug Users

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.

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Key information

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brief motivation intervention

Behavioral

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

Primary outcomes

  1. unprotected sexual acts

    Time frame: 1 year

Secondary outcomes

  1. sex acts while high on drugs

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Acronym: SAFE

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2011
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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