Viewing Study NCT00316303



Ignite Creation Date: 2024-05-05 @ 4:46 PM
Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00316303
Status: COMPLETED
Last Update Posted: 2013-05-22
First Post: 2006-04-18

Brief Title: Effectiveness of the Screen Test Immunize Reduce Risk and Refer STIRR Intervention for People With Both a Mental and Substance Abuse Disorder
Sponsor: Dartmouth-Hitchcock Medical Center
Organization: Dartmouth-Hitchcock Medical Center

Study Overview

Official Title: The STIRR Intervention for Dually Diagnosed Clients
Status: COMPLETED
Status Verified Date: 2013-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DAHBR 9A-ASNM US NIH GrantContract None httpsreporternihgovquickSearchR01MH072556
R01MH072556 NIH None None