HIV Infections, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depression, Substance Abuse
Conditions
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Immunization Status | Measured at 6 Months relative to Baseline | 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 | 6 Months | Participant self-report of being tested for hepatitis C |
| Tested for Hepatitis B | 6 Months | Participant self-report of being tested for hepatitis B |
| Tested for HIV | 6 Months | Participant self-report of being tested for HIV |
| Referral for Medical Care | 6 Months | For 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
| Arm | Count |
|---|---|
| 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 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 16 |
Baseline characteristics
| Characteristic | STIRR Intervention | Total | Control Group |
|---|---|---|---|
| Age Continuous | 46.6 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 85 Participants | 171 Participants | 86 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 59 Participants | 30 Participants |
| Region of Enrollment United States | 118 participants | 236 participants | 118 participants |
| Sex: Female, Male Female | 48 Participants | 90 Participants | 42 Participants |
| Sex: Female, Male Male | 70 Participants | 146 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 118 | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 | 0 / 118 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STIRR Intervention | Change in Immunization Status | 73 participants |
| Control Group | Change in Immunization Status | 4 participants |
Referral for Medical Care
For participants infected with hepatitis C, their self-report of being referred for medical care.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STIRR Intervention | Referral for Medical Care | 17 participants |
| Control Group | Referral for Medical Care | 12 participants |
Tested for Hepatitis B
Participant self-report of being tested for hepatitis B
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STIRR Intervention | Tested for Hepatitis B | 69 participants |
| Control Group | Tested for Hepatitis B | 14 participants |
Tested for Hepatitis C
Participant self-report of being tested for hepatitis C
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STIRR Intervention | Tested for Hepatitis C | 70 participants |
| Control Group | Tested for Hepatitis C | 10 participants |
Tested for HIV
Participant self-report of being tested for HIV
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STIRR Intervention | Tested for HIV | 18 participants |
| Control Group | Tested for HIV | 6 participants |