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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00316303
First received: April 18, 2006
Last updated: April 4, 2013
Last verified: April 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The STIRR Intervention for Dually Diagnosed Clients

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Change in Immunization Status [ Time Frame: Measured at 6 Months relative to Baseline ] [ Designated as safety issue: No ]
    Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.

  • Tested for Hepatitis C [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Participant self-report of being tested for hepatitis C

  • Tested for Hepatitis B [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Participant self-report of being tested for hepatitis B

  • Tested for HIV [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Participant self-report of being tested for HIV

  • Referral for Medical Care [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    For participants infected with hepatitis C, their self-report of being referred for medical care.


Enrollment: 236
Study Start Date: February 2006
Study Completion Date: August 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Stanley D. Rosenberg, PhD Dartmouth-Hitchcock Medical Center
Principal Investigator: Lisa Dixon, MD University of Maryland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00316303     History of Changes
Other Study ID Numbers: R01 MH072556, R01MH072556, DAHBR 9A-ASNM
Study First Received: April 18, 2006
Results First Received: April 4, 2013
Last Updated: April 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
Serious Mental Illness
Dual Diagnosis
Mental Disorders
Substance-Related Disorders

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

ClinicalTrials.gov processed this record on October 02, 2014