Preventing Bacterial and Viral Infections Among Injection Drug Users

B

Butler Hospital

Status

Completed

Conditions

HIV
Bacterial Infection

Treatments

Other: Treatment as Usual
Behavioral: SKIN Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01892358
1210-003 (Other Identifier)
DA034957

Details and patient eligibility

About

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.

Enrollment

252 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

252 participants in 2 patient groups, including a placebo group

SKIN Intervention
Active Comparator group
Description:
Participants will receive the SKIN intervention at Baseline and 1-mo interviews.
Treatment:
Behavioral: SKIN Intervention
Assessment-Only
Placebo Comparator group
Description:
Participants in this arm will receive treatment-as-usual
Treatment:
Other: Treatment as Usual

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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