Brief Intervention to Reduce STDs in ER Drug Users

NCT01379599 | Completed Phase 3 DMC

• 1 other identifier: NCT00218400
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexually Transmitted Infection

Keywords

cocaine; heroin; STIs; HIV; brief motivational intervention; voluntary testing and counseling

Outcome Measures

Primary Outcomes (1)

• unprotected sexual acts

  1 year

Secondary Outcomes (1)

• sex acts while high on drugs

  1 year

Study Arms (2)

Brief motivation intervention

EXPERIMENTAL

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

control group

NO INTERVENTION

Care as usual.

Interventions

brief motivation intervention BEHAVIORAL

Brief motivation intervention consisting of brief psychosocial counseling (20 minutes at the time of an ER visit)

Also known as: Brief Negotiation Interview, Safe Sex: Brief Negotiation Interview (SS-BNI), motivational interviewing

Brief motivation intervention

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• severity of medical illness
• suicidality
• police custody
• residential substance abuse treatment
• ability to provide contact information

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

• 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.

  PMID: 22506942 BACKGROUND

• 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.

  PMID: 23618318 BACKGROUND

• 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.

  PMID: 24330568 BACKGROUND

• 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.

  PMID: 22261830 BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Edward Bernstein, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine BU SOM; Professor of Community Health Sciences BUSPH

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 23, 2011
• Study Start: November 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)