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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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ClinicalTrials.gov Identifier: NCT00316303
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Substance Abuse
Interventions Drug: Twinrix
Behavioral: Enhanced treatment as usual
Enrollment 236
Recruitment Details 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  
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 118 118
Completed 107 102
Not Completed 11 16
Reason Not Completed
Lost to Follow-up             11             16
Arm/Group Title STIRR Intervention Control Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 118 118 236
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 118 participants 118 participants 236 participants
46.6  (8.5) 46.3  (9.3) 46.5  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 118 participants 236 participants
Female
48
  40.7%
42
  35.6%
90
  38.1%
Male
70
  59.3%
76
  64.4%
146
  61.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 118 participants 236 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
85
  72.0%
86
  72.9%
171
  72.5%
White
29
  24.6%
30
  25.4%
59
  25.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.4%
2
   1.7%
6
   2.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 118 participants 118 participants 236 participants
118 118 236
1.Primary Outcome
Title Change in Immunization Status
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 86
Measure Type: Number
Unit of Measure: participants
73 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STIRR Intervention, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wald Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Tested for Hepatitis C
Hide Description Participant self-report of being tested for hepatitis C
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description:
The STIRR Intervention involved 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.
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 and hepatitis B immunizations, and any necessary treatments.
Overall Number of Participants Analyzed 81 69
Measure Type: Number
Unit of Measure: participants
70 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STIRR Intervention, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wald Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Tested for Hepatitis B
Hide Description Participant self-report of being tested for hepatitis B
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description:
The STIRR Intervention involved 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.
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, HAV and HBV immunizations, and any necessary treatments.
Overall Number of Participants Analyzed 80 73
Measure Type: Number
Unit of Measure: participants
69 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STIRR Intervention, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wald Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Tested for HIV
Hide Description Participant self-report of being tested for HIV
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description:
The STIRR Intervention involved 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.
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, HAV and HBV immunizations, and any necessary treatments.
Overall Number of Participants Analyzed 21 13
Measure Type: Number
Unit of Measure: participants
18 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STIRR Intervention, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Wald Chi-squared
Comments [Not Specified]
5.Primary Outcome
Title Referral for Medical Care
Hide Description For participants infected with hepatitis C, their self-report of being referred for medical care.
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description:
The STIRR Intervention involved 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.
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, HAV and HBV immunizations, and any necessary treatments.
Overall Number of Participants Analyzed 21 16
Measure Type: Number
Unit of Measure: participants
17 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection STIRR Intervention, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title STIRR Intervention Control Group
Hide Arm/Group Description The STIRR Intervention involved 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. 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, HAV and HBV immunizations, and any necessary treatments.
All-Cause Mortality
STIRR Intervention Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
STIRR Intervention Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)   0/118 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
STIRR Intervention Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)   0/118 (0.00%) 
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
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00316303     History of Changes
Other Study ID Numbers: R01MH072556 ( U.S. NIH Grant/Contract )
R01MH072556 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASNM
First Submitted: April 18, 2006
First Posted: April 20, 2006
Results First Submitted: April 4, 2013
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013