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Preventing Bacterial and Viral Infections Among Injection Drug Users

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ClinicalTrials.gov Identifier: NCT01892358
Recruitment Status : Recruiting
First Posted : July 4, 2013
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Bacterial Infection HIV Behavioral: SKIN Intervention Other: Treatment as Usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Bacterial and Viral Infections Among Injection Drug Users
Study Start Date : September 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: SKIN Intervention
Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Behavioral: SKIN Intervention
Placebo Comparator: Assessment-Only
Participants in this arm will receive treatment-as-usual
Other: Treatment as Usual



Primary Outcome Measures :
  1. bacterial infections [ Time Frame: one year ]
  2. high-risk behavior [ Time Frame: one year ]
  3. health service use [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892358


Contacts
Contact: Michael Stein, MD 401-455-6646 mstein@butler.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States
Contact: Jane Liebschutz, MD         
Principal Investigator: Jane Liebschutz, MD         
United States, Rhode Island
Butler Hospital Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Michael Stein, MD    401-455-6646    mstein@butler.org   
Principal Investigator: Michael Stein, MD         
Sponsors and Collaborators
Butler Hospital

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01892358     History of Changes
Other Study ID Numbers: DA034957
1210-003 ( Other Identifier: Butler Hospital )
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: July 2017

Keywords provided by Michael Stein, MD, Butler Hospital:
injection drug use

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Virus Diseases