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Clinical Trials/NCT01892358
NCT01892358
Completed
Not Applicable

Preventing Bacterial and Viral Infections Among Injection Drug Users

Butler Hospital2 sites in 1 country252 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacterial Infection
Sponsor
Butler Hospital
Enrollment
252
Locations
2
Primary Endpoint
high-risk behavior
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
January 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Stein, MD

Principal Investigator

Butler Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
  • have injected heroin, cocaine, or meth for at least three months
  • positive urine screen for heroin, cocaine, or meth

Exclusion Criteria

  • currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
  • cannot provide informed consent
  • not able to complete interviews in English (expected to exclude \<5% of IDUs)
  • in police custody, expecting incarceration
  • unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
  • plan to move out of the Boston area in the next 12 months.

Outcomes

Primary Outcomes

high-risk behavior

Time Frame: one year

health service use

Time Frame: one year

bacterial infections

Time Frame: one year

Study Sites (2)

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