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CompletedNCT00007709Updated Feb 3, 2011

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).

An observational study in Hepatitis C, HIV Infections and Mental Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-03.

Sponsored by US Department of Veterans Affairs · Observational

Study type
Observational
Ages
18 Years and older
Sex
All
01

Study 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 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.

Read the 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).

02

Conditions studied

  • Hepatitis C
  • HIV Infections
  • Mental Disorders

Keywords

  • Hepatitis C
  • HIV
  • severe mental illness (SMI)
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

SMI veterans

Exclusion criteria

Exclusion Criteria:

05

Study design

Groups and cohorts

  • 1
06

Study locations

1 site
  • VA Medical Center
    Durham, North Carolina 27705, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00007709
Lead sponsor
US Department of Veterans Affairs
First posted
Jan 1, 2001
Start date
Jan 1998
Last update
Feb 3, 2011

Study contacts

Marian I. Butterfield, MD MPH
study chair · VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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