NCT01749007

Brief Summary

The purpose of this project is to gather pilot data related to exploring relationships between cognitive impairment and/or psychiatric distress and suicidal thoughts and/or behaviors in Veterans with Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS). To achieve this goal, a neuropsychological battery will be administered to Veterans with HIV/AIDS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

December 1, 2012

Enrollment Period

3.8 years

First QC Date

December 11, 2012

Last Update Submit

May 12, 2017

Conditions

HIV/AIDS

Keywords

VeteransHIVAIDSCognitive FunctioningSuicide

Outcome Measures

Primary Outcomes (8)

  • Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV)

    The WAIS-IV is a widely used and well established instrument used to assesses an individual's intellectual functioning within various cognitive domains and organizes performance into several indices including Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index. A composite, Full Scale IQ, is also generated to represent an estimation of overall intellectual functioning.

    1 Time Administration

  • Trail Making Test (TMT): Parts A & B

    The TMT is a timed, pencil-paper, measure of attention, speed, and cognitive flexibility and requires participants to draw a line to accurately sequence 25 circles containing numbers (Part A) and alternating letters and numbers (Part B).

    1 Time Administration

  • California Verbal Learning Test, Second Edition (CVLT-II)

    The CVLT-II examines several aspects of verbal learning, organization, and memory.

    1 Time Adminstration

  • Delis-Kaplan Executive Function System (D-KEFS)

    Measure of executive functioning.

    1 Time Administration

  • Brief VisuoSpatial Memory Test-Revised (BVMT-R)

    The BVMT-R measures immediate and delayed visual memory.

    1 Time Administration

  • Wisconsin Card Sorting Test (WCST)

    Measure of executive functioning.

    1 Time Administration

  • Outcome Questionnaire (OQ-45)

    The OQ-45 is a 45-item questionnaire that was designed to measure key areas of mental health functioning (symptom distress, interpersonal functioning, and social role).

    1 Time Administration

  • Beck Scale for Suicide Ideation (BSS)

    The BSS is a 19-item scale that assesses severity of suicide ideation.

    1 Time Administration

Secondary Outcomes (11)

  • Health Status Questionnaire (HSQ)

    1 Time Administration

  • University of Washington Risk Assessment Protocol-Revised (UWRAP)

    1 Time Administration

  • Test of Memory Malingering (TOMM)

    1 Time Administration

  • The Structured Clinical Interview for DSM-IV-Research Version (SCID-I)

    1 Time Administration

  • Lifetime Suicide Attempt Self Injury Interview (L-SASI)

    1 Time Administration

  • +6 more secondary outcomes

Study Arms (1)

Veterans with HIV/AIDS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans with HIV/AIDS

You may qualify if:

  • Veterans between ages 18 to 65
  • Have a diagnosis of HIV/AIDS confirmed via medical record
  • Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

You may not qualify if:

  • Acute intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.
  • Psychosis at time of interview as determined by observation and/or interview.
  • Poor Test of Memory Malingering (TOMM) performance (scores below 25 on Trial 1 or scores lower than 45 on Trial 2)
  • Current status as a prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSuicide

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gina Signoracci, Ph.D.

    VISN 19 Denver VA MIRECC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2016

Study Completion

January 1, 2017

Last Updated

May 15, 2017

Record last verified: 2012-12

Locations

US(1)