Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder

NCT00316303 | Completed Phase 2 Results

• 2 other identifiers: R01MH072556DAHBR 9A-ASNM
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effectiveness of the STIRR (Screen, Test, Immunize, Reduce risk, and Refer) intervention in increasing rates of testing, immunization, referral, and treatment for blood-borne diseases, such as hepatitis and HIV, in people with both a mental disorder and a substance abuse disorder.

Conditions

HIV Infections; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression; Substance Abuse

Keywords

Serious Mental Illness; Dual Diagnosis; Mental Disorders; Substance-Related Disorders

Outcome Measures

Primary Outcomes (5)

• Change in Immunization Status

  Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.

  Measured at 6 Months relative to Baseline

• Tested for Hepatitis C

  Participant self-report of being tested for hepatitis C

  6 Months

• Tested for Hepatitis B

  Participant self-report of being tested for hepatitis B

  6 Months

• Tested for HIV

  Participant self-report of being tested for HIV

  6 Months

• Referral for Medical Care

  For participants infected with hepatitis C, their self-report of being referred for medical care.

  6 Months

Study Arms (2)

1

EXPERIMENTAL

Participants will receive screening, testing, immunization, and risk reduction. Screening and testing will take place at study entry, immunization will occur at entry and after 3 and 6 months, and risk reduction will take place at study entry and after 3 and 6 months.

Drug: Twinrix

2

PLACEBO COMPARATOR

Participants will receive enhanced treatment as usual.

Behavioral: Enhanced treatment as usual

Interventions

Twinrix DRUG

This vaccine will be given in three parts: at entry and after 3 and 6 months.

1

Enhanced treatment as usual BEHAVIORAL

Participants will receive comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression
• Diagnosis of a substance use disorder
• Enrolled in clinical care at Creative Alternatives or People Encouraging People for at least 3 months

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Maryland, Department of Psychaitry

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

• Rosenberg S, Brunette M, Oxman T, Marsh B, Dietrich A, Mueser K, Drake R, Torrey W, Vidaver R. The STIRR model of best practices for blood-borne diseases among clients with serious mental illness. Psychiatr Serv. 2004 Jun;55(6):660-4. doi: 10.1176/appi.ps.55.6.660.

  PMID: 15175463 BACKGROUND

• Rosenberg SD, Drake RE, Brunette MF, Wolford GL, Marsh BJ. Hepatitis C virus and HIV co-infection in people with severe mental illness and substance use disorders. AIDS. 2005 Oct;19 Suppl 3:S26-33. doi: 10.1097/01.aids.0000192067.94033.aa.

  PMID: 16251824 BACKGROUND

• Rosenberg SD, Goldberg RW, Dixon LB, Wolford GL, Slade EP, Himelhoch S, Gallucci G, Potts W, Tapscott S, Welsh CJ. Assessing the STIRR model of best practices for blood-borne infections of clients with severe mental illness. Psychiatr Serv. 2010 Sep;61(9):885-91. doi: 10.1176/ps.2010.61.9.885.

  PMID: 20810586 DERIVED

MeSH Terms

Conditions

HIV Infections; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depression; Substance-Related Disorders; Mental Disorders

Interventions

twinrix

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders

Results Point of Contact

• Title: Stanley Rosenberg, Ph.D.
• Organization: Dartmouth-Hitchcock

Stanley.d.rosenberg@dartmouth.edu

603-653-0740

Study Officials

• Stanley D. Rosenberg, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Lisa Dixon, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 20, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2012
• Last Updated: May 22, 2013
• Results First Posted: May 22, 2013

Record last verified: 2013-04

Locations

US (1)