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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

Primary Purpose

HIV Infections, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Twinrix
Enhanced treatment as usual
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Serious Mental Illness, Dual Diagnosis, Mental Disorders, Substance-Related Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Maryland, Department of Psychaitry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm 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.

Participants will receive enhanced treatment as usual.

Outcomes

Primary Outcome Measures

Change in Immunization Status
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
Participant self-report of being tested for hepatitis C
Tested for Hepatitis B
Participant self-report of being tested for hepatitis B
Tested for HIV
Participant self-report of being tested for HIV
Referral for Medical Care
For participants infected with hepatitis C, their self-report of being referred for medical care.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2006
Last Updated
April 4, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00316303
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Substance Abuse
Keywords
Serious Mental Illness, Dual Diagnosis, Mental Disorders, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive enhanced treatment as usual.
Intervention Type
Drug
Intervention Name(s)
Twinrix
Intervention Description
This vaccine will be given in three parts: at entry and after 3 and 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Immunization Status
Description
Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.
Time Frame
Measured at 6 Months relative to Baseline
Title
Tested for Hepatitis C
Description
Participant self-report of being tested for hepatitis C
Time Frame
6 Months
Title
Tested for Hepatitis B
Description
Participant self-report of being tested for hepatitis B
Time Frame
6 Months
Title
Tested for HIV
Description
Participant self-report of being tested for HIV
Time Frame
6 Months
Title
Referral for Medical Care
Description
For participants infected with hepatitis C, their self-report of being referred for medical care.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley D. Rosenberg, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Dixon, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Department of Psychaitry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15175463
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.
Results Reference
background
PubMed Identifier
16251824
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.
Results Reference
background
PubMed Identifier
20810586
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.
Results Reference
derived

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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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