Preventing Bacterial and Viral Infections Among Injection Drug Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2020-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Bacterial Infection HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SKIN Intervention

Participants will receive the SKIN intervention at Baseline and 1-mo interviews.

Group Type ACTIVE_COMPARATOR

SKIN Intervention

Intervention Type BEHAVIORAL

Assessment-Only

Participants in this arm will receive treatment-as-usual

Group Type PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Interventions

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SKIN Intervention

Intervention Type BEHAVIORAL

Treatment as Usual

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No