Trial record 11 of 14322 for:    mental illness

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).

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007709
First received: December 29, 2000
Last updated: February 2, 2011
Last verified: February 2011
  Purpose

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.


Condition
Hepatitis C
HIV Infections
Mental Disorders

Study Type: Observational
Official Title: CSP #706D - HIV Seroprevalence and Risks in Veterans With Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Study Start Date: January 1998

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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SMI veterans

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007709

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Study Chair: Marian I. Butterfield, MD MPH Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Butterfield, Marian - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00007709     History of Changes
Other Study ID Numbers: 706D
Study First Received: December 29, 2000
Last Updated: February 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hepatitis C
HIV
severe mental illness (SMI)

Additional relevant MeSH terms:
Mental Disorders
HIV Infections
Acquired Immunodeficiency Syndrome
Psychotic Disorders
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Schizophrenia and Disorders with Psychotic Features
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014