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

April 18, 2006
April 4, 2013
February 2006
April 2009   (final data collection date for primary outcome measure)
  • 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.
  • Confirmatory testing (RIBA or a nucleic acid test (NAT HCV Viral Load Assay: HCV-PCR))
  • AIDS Risk Inventory
  • HBV laboratory tests
  • HIV laboratory tests
  • HCV laboratory tests
  • Measured at Month 6: Use of physical health and mental health services/barriers to hare
Complete list of historical versions of study NCT00316303 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
The STIRR Intervention for Dually Diagnosed Clients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Depression
  • Substance Abuse
  • Drug: Twinrix
    This vaccine will be given in three parts: at entry and after 3 and 6 months.
  • 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.
  • 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.
    Intervention: Drug: Twinrix
  • Placebo Comparator: 2
    Participants will receive enhanced treatment as usual.
    Intervention: Behavioral: Enhanced treatment as usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
August 2012
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00316303
R01 MH072556, R01MH072556, DAHBR 9A-ASNM
Not Provided
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Stanley D. Rosenberg, PhD Dartmouth-Hitchcock Medical Center
Principal Investigator: Lisa Dixon, MD University of Maryland
Dartmouth-Hitchcock Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP