Preventing Bacterial and Viral Infections Among Injection Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01892358
Recruitment Status : Recruiting
First Posted : July 4, 2013
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

July 1, 2013
July 4, 2013
April 12, 2018
September 2013
January 2019   (Final data collection date for primary outcome measure)
  • bacterial infections [ Time Frame: one year ]
  • high-risk behavior [ Time Frame: one year ]
  • health service use [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT01892358 on 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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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Bacterial Infection
  • HIV
  • Behavioral: SKIN Intervention
  • Other: Treatment as Usual
  • Active Comparator: SKIN Intervention
    Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
    Intervention: Behavioral: SKIN Intervention
  • Placebo Comparator: Assessment-Only
    Participants in this arm will receive treatment-as-usual
    Intervention: Other: Treatment as Usual
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2019
January 2019   (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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact: Michael Stein, MD 401-455-6646
United States
1210-003 ( Other Identifier: Butler Hospital )
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Michael Stein, MD, Butler Hospital
Butler Hospital
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Butler Hospital
July 2017

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