Brief Intervention to Reduce STDs in ER Drug Users (SAFE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexually Transmitted Infections. |
Behavioral: brief motivation intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Brief Intervention to Reduce STDs in ER Drug Users |
- unprotected sexual acts [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- sex acts while high on drugs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 1030 |
| Study Start Date: | November 2004 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: brief motivational intervention |
Behavioral: brief motivation intervention
brief psychosocial counseling (20 minutes at the time of an ER visit)
Other Names:
|
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 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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 54 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Edward Bernstein, MD | Boston Medical Center |
More Information
No publications provided
| Responsible Party: | Jamieson, Ellen MS, MBA/Associate Director Grants Administration, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01379599 History of Changes |
| Other Study ID Numbers: | NCT00218400 |
| Study First Received: | June 22, 2011 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Boston Medical Center:
|
cocaine heroin STIs |
HIV brief motivational intervention voluntary testing and counseling |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013