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To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). Clinical research trials and To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).. To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). clinical trial. Test subjects typically receive the most expert healthcare available for their To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).  To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).
To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).
For Condition: HIV Infections,Hepatitis C,Mental Disorders
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: It is suspected, but not well documented, that persons with severe mental illness (SMI) represent a significant transmission source of serious infectious diseases. SMI diagnoses are defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related infections among these individuals, the National Institute of Mental Health (NIMH) Office on AIDS funded the HIV/SMI five site collaborative study "Assessing HIV/AIDS and Associated Health Risks in People with Severe Mental Illness". This Durham ERIC study supplements the NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to measure utilization of health services over time. The Durham VA is the only VA site represented in the study and is collaborating with four non-VA sites including Dartmouth, University of New Hampshire, University of Connecticut and Duke University. As such, we have the additional goals of investigating health and health-care-service issues relevant to veterans with SMI and of establishing a database for the longitudinal study of veterans with SMI.
Details: Primary Objectives: To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI). Secondary Objectives: To identify the implications for mental health and medical services and to obtain a better understanding of the contextual factors that affect the health problems associated with HIV risk behavior. Primary Outcomes: The primary outcome variables are HIV seroprevalence, prevalence of HIV risk behaviors including injection drug use and sexual promiscuity, personal and social-contextual factors, comorbid mental disorders, and health service use among SMI persons in each group, veterans versus non-veterans. Intervention: N/A Study Abstract: It is suspected, but not well documented, that persons with severe mental illness represent a significant transmission source of serious infectious diseases. SMI diagnoses are defined as schizophrenia, schizoaffective disorder, bipolar disorder, or posttraumatic stress disorder (PTSD). Severely mentally ill persons are at high risk for Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS). To assess the risk of HIV and related infections among these individuals, the National Institute of Mental Health (NIMH) Office on AIDS funded the HIV/SMI five site collaborative study "Assessing HIV/AIDS and Associated Health Risks in People with Severe Mental Illness". This Durham ERIC study supplements the NIMH HIV/SMI study with a four-year longitudinal cohort study of 300-plus SMI veterans in order to estimate the prevalence of HIV risk behaviors and HIV infection, as well as to measure utilization of health services over time. The Durham VA is the only VA site represented in the study and is collaborating with four non-VA sites including Dartmouth, University of New Hampshire, University of Connecticut and Duke University. As such, we have the additional goals of investigating health and health-care-service issues relevant to veterans with SMI and of establishing a database for the longitudinal study of veterans with SMI. Study participation consisted of a one-hour structured HIV-risk behavior interview and a blood and urine sample. These samples are being tested for HIV, syphilis, hepatitis B and C, cytomegalovirus, gonorrhea, and chlamydia at the Durham VA Microbiology Laboratory. Subject enrollment for this study concluded 6/30/2000 with 399 total subjects enrolled. Of these 399 enrolled, 111 subjects were re-tested and re-interviewed. The percentage of subjects enrolled at the Durham VAMC with infectious diseases is as follows: 2.6% with HIV infection; 21% with Hepatitis B core antibodies; and, 18% with Hepatitis C antibodies. Clinical management of subjects with positive serology continues to be administered according to the procedures developed by Richard Frothingham, M.D. Final Results: The initial manuscript for the study was published in American Journal of Public Health in January, 2001 and analyses for additional publications are underway. Final Report to be submitted to Durham ERIC within 90 days of study end date (3/31/02).
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: SMI veterans
Total Enrollment:
Location and Contact Information:
Vamc - Durham, Nc
Durham, North Carolina, 27705
United States
Additional Information:
Study ID Numbers: 706D;
Study Start Date: January 1998
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007709
Other Mental Disorders Studies:
1. Adding New Drugs for HIV Infected Patients Failing Current Therapy
2. A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
3. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
4. The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients with HIV
5. A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
Related Studies:
Other Mental Disorders Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
To determine the prevalence of HIV and other related infections such as Hepatitis C, along with associated risk behaviors, in patients with severe mental illness (SMI).
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