Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
Condition: HIV Infections; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Depression; Substance Abuse
MeSH terms: Substance-Related Disorders; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Twinrix; Enhanced treatment as usual
Intervention type(s): Drug; Behavioral
Intervention description(s): This vaccine will be given in three parts: at entry and after 3 and 6 months.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Serious Mental Illness; Dual Diagnosis; Mental Disorders; Substance-Related Disorders