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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

The STIRR Intervention for Dually Diagnosed Clients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00316303
Enrollment
236
Registered
2006-04-20
Start date
2006-02-28
Completion date
2012-08-31
Last updated
2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Substance Abuse

Keywords

Serious Mental Illness, Dual Diagnosis, Mental Disorders, Substance-Related Disorders

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.

Interventions

This vaccine will be given in three parts: at entry and after 3 and 6 months.

BEHAVIORALEnhanced treatment as usual

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Immunization StatusMeasured at 6 Months relative to BaselineOf 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 C6 MonthsParticipant self-report of being tested for hepatitis C
Tested for Hepatitis B6 MonthsParticipant self-report of being tested for hepatitis B
Tested for HIV6 MonthsParticipant self-report of being tested for HIV
Referral for Medical Care6 MonthsFor participants infected with hepatitis C, their self-report of being referred for medical care.

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
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.
118
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.
118
Total236

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1116

Baseline characteristics

CharacteristicSTIRR InterventionTotalControl Group
Age Continuous46.6 years
STANDARD_DEVIATION 8.5
46.5 years
STANDARD_DEVIATION 8.9
46.3 years
STANDARD_DEVIATION 9.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
85 Participants171 Participants86 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants2 Participants
Race (NIH/OMB)
White
29 Participants59 Participants30 Participants
Region of Enrollment
United States
118 participants236 participants118 participants
Sex: Female, Male
Female
48 Participants90 Participants42 Participants
Sex: Female, Male
Male
70 Participants146 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1180 / 118
serious
Total, serious adverse events
0 / 1180 / 118

Outcome results

Primary

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.

Time frame: Measured at 6 Months relative to Baseline

ArmMeasureValue (NUMBER)
STIRR InterventionChange in Immunization Status73 participants
Control GroupChange in Immunization Status4 participants
p-value: <0.001Wald Chi-squared
Primary

Referral for Medical Care

For participants infected with hepatitis C, their self-report of being referred for medical care.

Time frame: 6 Months

ArmMeasureValue (NUMBER)
STIRR InterventionReferral for Medical Care17 participants
Control GroupReferral for Medical Care12 participants
p-value: 0.6Chi-squared
Primary

Tested for Hepatitis B

Participant self-report of being tested for hepatitis B

Time frame: 6 Months

ArmMeasureValue (NUMBER)
STIRR InterventionTested for Hepatitis B69 participants
Control GroupTested for Hepatitis B14 participants
p-value: <0.001Wald Chi-squared
Primary

Tested for Hepatitis C

Participant self-report of being tested for hepatitis C

Time frame: 6 Months

ArmMeasureValue (NUMBER)
STIRR InterventionTested for Hepatitis C70 participants
Control GroupTested for Hepatitis C10 participants
p-value: <0.001Wald Chi-squared
Primary

Tested for HIV

Participant self-report of being tested for HIV

Time frame: 6 Months

ArmMeasureValue (NUMBER)
STIRR InterventionTested for HIV18 participants
Control GroupTested for HIV6 participants
p-value: 0.011Wald Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026