Preventing Bacterial and Viral Infections Among Injection Drug Users

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Bacterial Infection
HIV
Behavioral: SKIN Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Preventing Bacterial and Viral Infections Among Injection Drug Users

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: September 2013
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SKIN Intervention Behavioral: SKIN Intervention
Placebo Comparator: Assessment-Only

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01892358     History of Changes
Other Study ID Numbers: DA034957, 1210-003
Study First Received: July 1, 2013
Last Updated: July 16, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by Butler Hospital:
injection drug use

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

ClinicalTrials.gov processed this record on October 01, 2014