Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007709
Status:
COMPLETED
Last Update Posted:
2011-02-03
First Post:
2000-12-29
Brief Title:
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
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 706D - HIV Seroprevalence and Risks in Veterans With Severe Mental Illness
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 VirusAcquired Immunodeficiency Syndrome HIVAIDS To assess the risk of HIV and related infections among these individuals the National Institute of Mental Health NIMH Office on AIDS funded the HIVSMI five site collaborative study Assessing HIVAIDS and Associated Health Risks in People with Severe Mental Illness This Durham ERIC study supplements the NIMH HIVSMI 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
Detailed Description:
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 NA
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 VirusAcquired Immunodeficiency Syndrome HIVAIDS To assess the risk of HIV and related infections among these individuals the National Institute of Mental Health NIMH Office on AIDS funded the HIVSMI five site collaborative study Assessing HIVAIDS and Associated Health Risks in People with Severe Mental Illness This Durham ERIC study supplements the NIMH HIVSMI 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 6302000 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 26 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 MD
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 33102
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 NA
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 VirusAcquired Immunodeficiency Syndrome HIVAIDS To assess the risk of HIV and related infections among these individuals the National Institute of Mental Health NIMH Office on AIDS funded the HIVSMI five site collaborative study Assessing HIVAIDS and Associated Health Risks in People with Severe Mental Illness This Durham ERIC study supplements the NIMH HIVSMI 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 6302000 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 26 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 MD
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 33102
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None