- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748968
Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
December 11, 2015 updated by: VA Eastern Colorado Health Care System
The purpose of this project is to gather pilot data related to risk factors associated with suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide that can be utilized by local and national providers to increase understanding regarding suicide risk assessment.
There are no hypotheses associated with this qualitative pilot study.
Study Overview
Status
Completed
Detailed Description
To achieve these goals, a semi-structured interview will be conducted to gather this qualitative information.
Specifically, this study aims to gather the following information from Veterans with HIV/AIDS: a) information regarding disease acquisition; b) psychosocial stressors; c) social supports; d) protective factors; and e) previous suicidal ideation and behaviors.
Further, additional exploratory questions will be asked regarding proposed modifications to the Suicide Risk Assessment Guide Pocket Card, an existing VA tool, so that it can be modified for use by local and national HIV/AIDS providers.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- Denver VA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Veterans with HIV/AIDS
Description
Inclusion Criteria:
- Between ages 18 to 90
- Have a diagnosis of HIV/AIDS
- Currently receiving HIV/AIDS treatment
- Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System
Exclusion Criteria:
- Psychosis at time of interview as determined by observation and/or interview.
- Intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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Veterans with HIV/AIDS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Semi-Structured Interview
Time Frame: Interview conducted one time per participant (completion time: approximately 1 hour)
|
Semi-structured interview will be utilized to gather the following information from Veterans with HIV/AIDS: a) information regarding disease acquisition; b) psychosocial stressors; c) social supports; d) protective factors; and e) previous suicidal ideation and behaviors.
Further, additional exploratory questions will be asked regarding proposed modifications to the Suicide Risk Assessment Guide Pocket Card, an existing VA tool, so that it can be modified for use by local and national HIV/AIDS providers.
|
Interview conducted one time per participant (completion time: approximately 1 hour)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gina Signoracci, Ph.D., VISN 19 Denver VA MIRECC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
December 11, 2012
First Submitted That Met QC Criteria
December 11, 2012
First Posted (Estimate)
December 13, 2012
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 11, 2015
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Virus Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 12-0755
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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