Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)NCT01748968
Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
An observational study of Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS) and Self-Directed Violence, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS), Self-Directed Violence
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans with HIV/AIDS
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS), Self-Directed Violence
- Keywords
- Veterans, Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS), Self-Directed Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with HIV/AIDS | Veterans with HIV/AIDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-Structured Interview
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.
Measured: Interview conducted one time per participant (completion time: approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Public Health Grant Program, Veterans Health Administration Office of Public Health
- Responsible party
- Sponsor
- Investigators
- Gina Signoracci, Ph.D., Principal investigator, VISN 19 Denver VA MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748968
- Sponsor's protocol ID
- 12-0755
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
- ClinicalTrials.gov ID
- NCT01748968
- Acronym / sponsor ID
- 12-0755
- Conditions
- Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS), Self-Directed Violence
- Keywords
- Veterans, Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS), Self-Directed Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Public Health Grant Program, Veterans Health Administration Office of Public Health
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veterans with HIV/AIDS | – | –Veterans with HIV/AIDS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with HIV/AIDS
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Signoracci, Ph.D. principal investigator
VISN 19 Denver VA MIRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS) and Self-Directed Violence, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-Structured Interview (time frame: Interview conducted one time per participant (completion time: approximately 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.