Preventing Bacterial and Viral Infections Among Injection Drug Users

This study is not yet open for participant recruitment.
Verified July 2013 by Butler Hospital
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01892358
First received: July 1, 2013
Last updated: July 3, 2013
Last verified: July 2013

July 1, 2013
July 3, 2013
September 2013
January 2018   (final data collection date for primary outcome measure)
  • bacterial infections [ Time Frame: one year ] [ Designated as safety issue: No ]
  • high-risk behavior [ Time Frame: one year ] [ Designated as safety issue: No ]
  • health service use [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01892358 on ClinicalTrials.gov Archive Site
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Preventing Bacterial and Viral Infections Among Injection Drug Users
Preventing Bacterial and Viral Infections Among Injection Drug Users

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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
  • Bacterial Infection
  • HIV
Behavioral: SKIN Intervention
  • Active Comparator: SKIN Intervention
    Intervention: Behavioral: SKIN Intervention
  • Placebo Comparator: Assessment-Only
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
350
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January 2018   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Michael Stein, MD 401-455-6646 mstein@butler.org
United States
 
NCT01892358
DA034957, 1210-003
Yes
Michael Stein, MD, Butler Hospital
Butler Hospital
Not Provided
Not Provided
Butler Hospital
July 2013

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