Preventing Bacterial and Viral Infections Among Injection Drug Users

HIV Clinical Trial

Official title:

Preventing Bacterial and Viral Infections Among Injection Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892358
• Other study ID #: DA034957
• Secondary ID: 1210-003
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: January 2020

Study information

• Verified date: June 2020
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: January 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• HIV
• Infection
• Virus Diseases

Intervention

Behavioral:
• SKIN Intervention

Other:
• Treatment as Usual

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bacterial infections		one year
Primary	high-risk behavior		one year
Primary	health service use		one year