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

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Dartmouth Health

Status and phase

Completed
Phase 2

Conditions

Schizophrenia
Bipolar Disorder
Schizoaffective Disorder
Depression
Substance Abuse
HIV Infections

Treatments

Drug: Twinrix
Behavioral: Enhanced treatment as usual

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00316303
DAHBR 9A-ASNM
R01MH072556 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

236 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

236 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
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.
Treatment:
Drug: Twinrix
2
Placebo Comparator group
Description:
Participants will receive enhanced treatment as usual.
Treatment:
Behavioral: Enhanced treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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