Back to resultsPreventing Bacterial and Viral Infections Among Injection Drug Users
Primary Purpose
Bacterial Infection, HIV
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SKIN Intervention
Treatment as Usual
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Infection focused on measuring injection drug use
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.
Sites / Locations
- Boston Medical Center
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
SKIN Intervention
Assessment-Only
Arm Description
Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Participants in this arm will receive treatment-as-usual
Outcomes
Primary Outcome Measures
bacterial infections
high-risk behavior
health service use
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01892358
Brief Title
Preventing Bacterial and Viral Infections Among Injection Drug Users
Official Title
Preventing Bacterial and Viral Infections Among Injection Drug Users
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection, HIV
Keywords
injection drug use
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SKIN Intervention
Arm Type
Active Comparator
Arm Description
Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Arm Title
Assessment-Only
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive treatment-as-usual
Intervention Type
Behavioral
Intervention Name(s)
SKIN Intervention
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
bacterial infections
Time Frame
one year
Title
high-risk behavior
Time Frame
one year
Title
health service use
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33813580
Citation
Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.
Results Reference
derived
PubMed Identifier
32830383
Citation
Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.
Results Reference
derived
Learn more about this trial
Preventing Bacterial and Viral Infections Among Injection Drug Users
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