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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00316303 |
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 |
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HIV Infections Schizophrenia Schizoaffective Disorder Bipolar Disorder Depression Substance Abuse |
Drug: Twinrix Behavioral: Enhanced treatment as usual |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The STIRR Intervention for Dually Diagnosed Clients |
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 |
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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.
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Drug: Twinrix
This vaccine will be given in three parts: at entry and after 3 and 6 months.
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2: Placebo Comparator
Participants will receive enhanced treatment as usual.
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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.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
University of Maryland, Department of Psychaitry | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Stanley D. Rosenberg, PhD | Dartmouth-Hitchcock Medical Center |
Principal Investigator: | Lisa Dixon, MD | University of Maryland |
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 |
Serious Mental Illness Dual Diagnosis Mental Disorders Substance-Related Disorders |
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 |
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 |