Preventing Bacterial and Viral Infections Among Injection Drug Users
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Butler Hospital
- Enrollment
- 252
- Locations
- 2
- Primary Endpoint
- health service use
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SKIN Intervention
Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Intervention: SKIN Intervention (Behavioral)
Assessment-Only
Participants in this arm will receive treatment-as-usual
Intervention: Treatment as Usual (Other)
Outcomes
Primary Outcomes
health service use
Time Frame: one year
high-risk behavior
Time Frame: one year
bacterial infections
Time Frame: one year
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Stein, MD
Principal Investigator
Butler Hospital