NCT01892358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

5.9 years

First QC Date

July 1, 2013

Last Update Submit

June 4, 2020

Conditions

Bacterial InfectionHIV

Keywords

injection drug use

Outcome Measures

Primary Outcomes (3)

  • bacterial infections

    one year

  • high-risk behavior

    one year

  • health service use

    one year

Study Arms (2)

SKIN Intervention

ACTIVE COMPARATOR

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

Behavioral: SKIN Intervention

Assessment-Only

PLACEBO COMPARATOR

Participants in this arm will receive treatment-as-usual

Other: Treatment as Usual

Interventions

SKIN InterventionBEHAVIORAL
SKIN Intervention
Treatment as UsualOTHER
Assessment-Only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

  • Freibott CE, Phillips KT, Anderson BJ, Stewart C, Liebschutz JM, Stein MD. Under the Skin: The Relationship Between Subcutaneous Injection and Skin Infections Among People Who Inject Drugs. J Addict Med. 2022 Mar-Apr 01;16(2):164-168. doi: 10.1097/ADM.0000000000000844.

    PMID: 33813580DERIVED

  • Stein MD, Phillips KT, Herman DS, Keosaian J, Stewart C, Anderson BJ, Weinstein Z, Liebschutz J. Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial. Addiction. 2021 May;116(5):1122-1130. doi: 10.1111/add.15236. Epub 2020 Sep 21.

    PMID: 32830383DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 4, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

US(2)