Preventing Bacterial and Viral Infections Among Injection Drug Users

Not Applicable

Completed

• Conditions: Bacterial Infection; HIV
• Interventions: Behavioral: SKIN Intervention; Other: Treatment as Usual

• Registration Number: NCT01892358
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Study Start: 2013-09
• Primary Completion: 2019-08
• Study Completion: 2020-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SKIN Intervention	SKIN Intervention	Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Assessment-Only	Treatment as Usual	Participants in this arm will receive treatment-as-usual

Primary Outcome Measures

Name	Time	Method
high-risk behavior	one year
health service use	one year
bacterial infections	one year

Trial Locations

Locations (2)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States