Preventing Bacterial and Viral Infections Among Injection Drug Users

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.

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Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses HIV Infections

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SKIN Intervention

Behavioral

Treatment as Usual

Other

Primary outcomes

bacterial infections

Time frame: one year
high-risk behavior

Time frame: one year
health service use

Time frame: one year

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2020
First posted: Jul 4, 2013
Registry last updated: Jun 9, 2020

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed