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Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
This study is ongoing, but not recruiting participants.
First Received: April 18, 2006   Last Updated: April 13, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00316303
  Purpose

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.


Condition Intervention Phase
HIV Infections
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Substance Abuse
Drug: Twinrix
Behavioral: Enhanced treatment as usual
Phase II

MedlinePlus related topics: AIDS Bipolar Disorder Depression Mental Health Schizophrenia
Drug Information available for: Twinrix
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: The STIRR Intervention for Dually Diagnosed Clients

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Use of physical health and mental health services or barriers to care [ Time Frame: Measured at baseline and after 6 months of treatment; also measured 12 months after treatment for a subgroup ] [ Designated as safety issue: No ]
  • AIDS Risk Inventory [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • HIV laboratory tests [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • HBV laboratory tests [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • HCV laboratory tests [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • Confirmatory testing (RIBA or a nucleic acid test (NAT HCV Viral Load Assay: HCV-PCR)) [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 236
Study Start Date: February 2006
Estimated Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
This vaccine will be given in three parts: at entry and after 3 and 6 months.
2: Placebo Comparator
Participants will receive enhanced treatment as usual.
Behavioral: Enhanced treatment as usual
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.

Detailed Description:

People who have been dually diagnosed with a severe mental illness and a substance abuse disorder are at an elevated risk for contracting blood-borne infections, such as HIV, hepatitis B, and hepatitis C virus (HCV). Prevention, early detection, and treatment for these diseases are essential for this particular population. Research has shown that rates of HCV infection are 11 times higher in people with mental illnesses than in the general population.

People with mental health illnesses and those with dual diagnoses should receive basic CDC-recommended services for risk screening and testing of HIV infection, AIDS, and hepatitis. They should also receive hepatitis A and B immunizations, risk reduction counseling, and referrals for medical care.

However, most people with severe mental illnesses and substance abuse disorders do not receive the care they need. The STIRR (screen, test, immunize, reduce risk, and refer) intervention will provide necessary prevention and treatment services to an at-risk, under-treated population. This study will determine the effectiveness of the STIRR 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.

Participants in this open-label study will be recruited from two publicly funded community mental health agencies in Baltimore, MD. Participants will be randomly assigned to receive either enhanced treatment as usual or the STIRR intervention. Individuals assigned to STIRR will attend three sessions over the course of 6 months. The first session will involve education, personalized risk assessment, risk reduction counseling, pre-test counseling, blood testing, and an initial immunization with Twinrix for hepatitis A and B viruses (HAV and HBV). At the second session, participants will receive their test results, as well as post-test and risk reduction counseling, medical referral and linkage, if necessary, and a second Twinrix immunization. The third session will include an assessment of risk level and reinforcement of risk reduction, a final immunization, an assessment of progress on treatment and linkage, and behavior reinforcement or modification. Enhanced treatment as usual will entail 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. All participants will be assessed for treatment outcomes at Month 6. A 12-month post-intervention follow-up will be carried out with the infected participants in the STIRR group to evaluate quality of care.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316303

Locations
United States, Maryland
University of Maryland, Department of Psychaitry
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Investigators
Principal Investigator: Stanley D. Rosenberg, PhD Dartmouth-Hitchcock Medical Center
Principal Investigator: Lisa Dixon, MD University of Maryland
  More Information

Publications:
Responsible Party: Dartmouth Medical School ( Stanley D. Rosenberg, PhD )
Study ID Numbers: R01 MH072556, DAHBR 9A-ASNM
Study First Received: April 18, 2006
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00316303     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Serious Mental Illness
Dual Diagnosis
Mental Disorders
Substance-Related Disorders

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Depression
Bipolar Disorder
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Depressive Disorder
Immunologic Deficiency Syndromes
Behavioral Symptoms
Schizophrenia
Virus Diseases
Affective Disorders, Psychotic
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Mood Disorders
Substance-Related Disorders
Psychotic Disorders
Retroviridae Infections
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Disorders of Environmental Origin
Infection
Schizophrenia
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Substance-Related Disorders
Psychotic Disorders
Retroviridae Infections
Schizophrenia and Disorders with Psychotic Features
RNA Virus Infections
Disease
Depression
Immune System Diseases
Bipolar Disorder
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Behavioral Symptoms
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mood Disorders

ClinicalTrials.gov processed this record on May 07, 2009