Trial Outcomes & Findings for Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder (NCT NCT00316303)
NCT ID: NCT00316303
Last Updated: 2013-05-22
Results Overview
Of the participants that were not immunized at baseline, the number of participants who were immunized for Hepatitis A and B at 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
236 participants
Primary outcome timeframe
Measured at 6 Months relative to Baseline
Results posted on
2013-05-22
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
118
|
|
Overall Study
COMPLETED
|
107
|
102
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
16
|
Baseline Characteristics
Effectiveness of the Screen, Test, Immunize, Reduce Risk, and Refer (STIRR) Intervention for People With Both a Mental and Substance Abuse Disorder
Baseline characteristics by cohort
| Measure |
STIRR Intervention
n=118 Participants
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
n=118 Participants
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
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.6 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=5 Participants
|
118 participants
n=7 Participants
|
236 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured 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.
Outcome measures
| Measure |
STIRR Intervention
n=96 Participants
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
n=86 Participants
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.
|
|---|---|---|
|
Change in Immunization Status
|
73 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 6 MonthsParticipant self-report of being tested for hepatitis C
Outcome measures
| Measure |
STIRR Intervention
n=81 Participants
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
n=69 Participants
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.
|
|---|---|---|
|
Tested for Hepatitis C
|
70 participants
|
10 participants
|
PRIMARY outcome
Timeframe: 6 MonthsParticipant self-report of being tested for hepatitis B
Outcome measures
| Measure |
STIRR Intervention
n=80 Participants
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
n=73 Participants
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.
|
|---|---|---|
|
Tested for Hepatitis B
|
69 participants
|
14 participants
|
PRIMARY outcome
Timeframe: 6 MonthsParticipant self-report of being tested for HIV
Outcome measures
| Measure |
STIRR Intervention
n=21 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Tested for HIV
|
18 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 6 MonthsFor participants infected with hepatitis C, their self-report of being referred for medical care.
Outcome measures
| Measure |
STIRR Intervention
n=21 Participants
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
n=16 Participants
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.
|
|---|---|---|
|
Referral for Medical Care
|
17 participants
|
12 participants
|
Adverse Events
STIRR Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place