NCT00007709

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 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2001

Completed
Last Updated

February 3, 2011

Status Verified

February 1, 2011

First QC Date

December 29, 2000

Last Update Submit

February 2, 2011

Conditions

Keywords

Hepatitis CHIVsevere mental illness (SMI)

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SMI veterans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hepatitis CHIV InfectionsMental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marian I. Butterfield, MD MPH

    VA Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
FED

Study Record Dates

First Submitted

December 29, 2000

First Posted

January 1, 2001

Study Start

January 1, 1998

Last Updated

February 3, 2011

Record last verified: 2011-02

Locations