Brief Intervention to Reduce STDs in ER Drug Users - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Boston Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00218400
First received: September 16, 2005
Last updated: October 20, 2011
Last verified: October 2011

September 16, 2005
October 20, 2011
December 2004
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High risk sexual behaviors
Same as current
Complete list of historical versions of study NCT00218400 on ClinicalTrials.gov Archive Site
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Brief Intervention to Reduce STDs in ER Drug Users - 1
Brief Intervention to Reduce STDs in ER Drug Users

The purpose of this study is to test whether a brief motivational interview focused on sexual practices will facilitate behavior change, risk reduction and reduced rate of sexually transmitted infections among emergency department patients who use heroin and cocaine and are out-of-treatment for their substance abuse.

Project SAFE is a multidisciplinary effort to test whether brief motivational interviewing in an emergency department setting may encourage change in sex behaviors and thus prevent gonorrhea, chlamydia, and HIV among male and female patients aged 18-44 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 3,340 patients to intervention (safe sex BNI) or control (standard counseling) over a 2.5-year period, with 6-month and 12-month follow-up. Outcome measures include: 1) comparing cumulative STD incidence and frequency of safe sex behavior between intervention and standard counseling (control) groups over a one year follow-up period; 2) STD and HIV as diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up; participant self-report of sexual and drug using behavior at baseline and 6 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 cumulative incidence between intervention and control groups will be evaluated using Poisson regression with random effects modeling if needed. Differences in safe sex behavior between intervention and control groups will be evaluated using logistic regression. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, and baseline readiness to change and sexual and drug using behavior. We will conduct exploratory analyses for the potential interaction and mediating effects between intervention status and abstinence from drug use on incidence of STDs and self-reported behaviors. 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Substance-Related Disorders
  • Sexual Risk Behaviors
Behavioral: Motivational interviewing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3340
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Inclusion Criteria:

  • active use of heroin and/or crack/cocaine; orientation to person, place and time; plans to remain in area; ability to provide at least one contact person for follow-up

Exclusion Criteria:

  • currently in active treatment or controlled setting
Both
18 Years to 44 Years
No
Contact: Anne Valentine, M.P.H. (617)414-4556 anne.valentine@bmc.org
United States
 
NCT00218400
NIDA-17061-1, R01DA017061, R01-17061-1
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Not Provided
Boston Medical Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: Edward Bernstein, M.D. Boston Medical Center
Boston Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP