Brief Intervention to Reduce STDs in ER Drug Users

Sexually Transmitted Infection Clinical Trial

— SAFE  

Official title:

Brief Intervention to Reduce STDs in ER Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379599
• Other study ID #: NCT00218400
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2011
• Last updated: December 17, 2016
• Start date: November 2004
• Est. completion date: May 2009

Study information

• Verified date: December 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00218400

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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;8:10. doi: 10.1186/1940-0640-8-10. — View Citation

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;8:20. doi: 10.1186/1940-0640-8-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unprotected sexual acts		1 year	No
Secondary	sex acts while high on drugs		1 year	No