Preventing Bacterial and Viral Infections Among Injection Drug Users

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01892358

Enrollment

252

Registered

2013-07-04

Start date

2013-09-30

Completion date

2020-01-31

Last updated

2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection, HIV

Keywords

injection drug use

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.

Interventions

BEHAVIORALSKIN Intervention

OTHERTreatment as Usual

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
bacterial infections	one year
high-risk behavior	one year
health service use	one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026