Clinical trial NCT00316303: Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
Official title: The STIRR Intervention for Dually Diagnosed Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Substance Abuse
Keywords: Serious Mental Illness
Dual Diagnosis
Mental Disorders
Substance-Related Disorders
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-04-20
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in Immunization Status
timeFrame: Measured at 6 Months relative to Baseline
measure: Tested for Hepatitis C
timeFrame: 6 Months
measure: Tested for Hepatitis B
timeFrame: 6 Months
measure: Tested for HIV
timeFrame: 6 Months
measure: Referral for Medical Care
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Department of Psychaitry
state: Maryland
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Stanley D. Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Lisa Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenberg S, Brunette M, Oxman T, Marsh B, Dietrich A, Mueser K, Drake R, Torrey W, Vidaver R. The STIRR model of best practices for blood-borne diseases among clients with serious mental illness. Psychiatr Serv. 2004 Jun;55(6):660-4. doi: 10.1176/appi.ps.55.6.660.
citation: Rosenberg SD, Drake RE, Brunette MF, Wolford GL, Marsh BJ. Hepatitis C virus and HIV co-infection in people with severe mental illness and substance use disorders. AIDS. 2005 Oct;19 Suppl 3:S26-33. doi: 10.1097/01.aids.0000192067.94033.aa.
citation: Rosenberg SD, Goldberg RW, Dixon LB, Wolford GL, Slade EP, Himelhoch S, Gallucci G, Potts W, Tapscott S, Welsh CJ. Assessing the STIRR model of best practices for blood-borne infections of clients with severe mental illness. Psychiatr Serv. 2010 Sep;61(9):885-91. doi: 10.1176/ps.2010.61.9.885.