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
Results First Received: April 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Substance Abuse
Interventions: Drug: Twinrix
Behavioral: Enhanced treatment as usual

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with co-occuring mental illness and substance use disorders who were receiving services from 2 publicly funded community mental health programs in Baltimore, MD.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
STIRR Intervention The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
Control Group Participants will receive enhanced treatment as usual. This entails 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, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.

Participant Flow:   Overall Study
    STIRR Intervention     Control Group  
STARTED     118     118  
COMPLETED     107     102  
NOT COMPLETED     11     16  
Lost to Follow-up                 11                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
STIRR Intervention The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
Control Group Participants will receive enhanced treatment as usual. This entails 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, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
Total Total of all reporting groups

Baseline Measures
    STIRR Intervention     Control Group     Total  
Number of Participants  
[units: participants]
  118     118     236  
Age  
[units: years]
Mean ± Standard Deviation
  46.6  ± 8.5     46.3  ± 9.3     46.5  ± 8.9  
Gender  
[units: participants]
     
Female     48     42     90  
Male     70     76     146  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     85     86     171  
White     29     30     59  
More than one race     0     0     0  
Unknown or Not Reported     4     2     6  
Region of Enrollment  
[units: participants]
     
United States     118     118     236  



  Outcome Measures
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1.  Primary:   Change in Immunization Status   [ Time Frame: Measured at 6 Months relative to Baseline ]

2.  Primary:   Tested for Hepatitis C   [ Time Frame: 6 Months ]

3.  Primary:   Tested for Hepatitis B   [ Time Frame: 6 Months ]

4.  Primary:   Tested for HIV   [ Time Frame: 6 Months ]

5.  Primary:   Referral for Medical Care   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stanley Rosenberg, Ph.D.
Organization: Dartmouth-Hitchcock
phone: 603-653-0740
e-mail: Stanley.d.rosenberg@dartmouth.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00316303     History of Changes
Other Study ID Numbers: R01 MH072556, R01MH072556, DAHBR 9A-ASNM
Study First Received: April 18, 2006
Results First Received: April 4, 2013
Last Updated: April 4, 2013
Health Authority: United States: Federal Government