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临床试验/NCT00316303
NCT00316303已完成2 期

The STIRR Intervention for Dually Diagnosed Clients

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
236
试验地点
1
主要终点
Change in Immunization Status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

Participants will receive screening, testing, immunization, and risk reduction. Screening and testing will take place at study entry, immunization will occur at entry and after 3 and 6 months, and risk reduction will take place at study entry and after 3 and 6 months.

干预措施: Twinrix (Drug)

2

Placebo Comparator

Participants will receive enhanced treatment as usual.

干预措施: Enhanced treatment as usual (Behavioral)

结局指标

主要结局

Change in Immunization Status

时间窗: 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

时间窗: 6 Months

Participant self-report of being tested for hepatitis C

Tested for HIV

时间窗: 6 Months

Participant self-report of being tested for HIV

Tested for Hepatitis B

时间窗: 6 Months

Participant self-report of being tested for hepatitis B

Referral for Medical Care

时间窗: 6 Months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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