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Health Information for Infected Veterans (HI-FIV)

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ClinicalTrials.gov Identifier: NCT03190317
Recruitment Status : Not yet recruiting
First Posted : June 16, 2017
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
VA Palo Alto Health Care System
Edith Nourse Rogers Memorial Veterans Hospital
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This is a study of study of My HealtheVet (MHV) use by Veterans diagnosed with Human Immunodeficiency Virus (HIV) and VA providers/staff who care for them. The investigators hope to learn and understand how MHV can improve the self-management of chronic conditions like HIV. First, the investigators will review Veteran medical records to look at the relationship between use of MHV and whether it has a positive or negative impact on the Veteran's management of HIV. Next, the investigators will interview participants to find out how MHV for self-management is used by Veterans and to find out why Veterans and providers choose to use (or not use) specific MHV tools. Lastly, the investigators will use the information found from the first two steps and create an intervention that will encourage non-MHV users to use the MHV tools that can help achieve health-related goals. Once the intervention has been developed,Veterans and providers will participate in a "cognitive walkthrough" to help the researchers test the intervention to see if it is usable, possible, and acceptable.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Other: HIV-infected Veterans who use MHV Other: HIV-infected Veterans who do not use MHV Other: Providers and staff of HIV-infected veteran

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2592 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Health Information for Infected Veterans
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-infected Veterans who use MHV
This group represents the population of HIV-infected Veterans active in care at a VA health system, who have been diagnosed with HIV and use MHV.
Other: HIV-infected Veterans who use MHV
The investigators will use information from Veteran medical records to assess the relationship between Veteran HIV health care outcomes and the use of MHV. Next, the investigators will interview Veterans to understand why MHV is used. Finally, the investigators will create an intervention based on the information learned that will encourage use of MHV and ask Veterans to test it out.

HIV-infected Veterans who do not use MHV
This group represents the population of HIV-infected Veterans active in care at a VA health system, who have been diagnosed with HIV and do not use MHV.
Other: HIV-infected Veterans who do not use MHV
The investigators will use information from Veteran medical records to assess the relationship between Veteran HIV health care outcomes and the use of MHV. Next, the investigators will interview Veterans to understand why MHV is not used. Finally, the investigators will create an intervention based on the information learned that will encourage use of MHV and ask Veterans to test it out.

Providers and staff of HIV-infected veteran
This groups represents the population of providers and staff who utilize the MHV portal to deliver care for HIV-infected veterans.
Other: Providers and staff of HIV-infected veteran
The investigators will interview providers and staff to understand why they think Veterans at their health system use or do not use the MHV portal for self management. The investigators will create and test an intervention based on information learned that will encourage use of MHV among Veterans and providers/staff.




Primary Outcome Measures :
  1. Medical Record Review [ Time Frame: 1 year ]
    Determine the relationship between MHV tools and quality of care and outcomes for Veterans who are HIV positive.

  2. Interviews [ Time Frame: 1 year ]
    Understand how Veterans with HIV use or choose not to use MHV for self-management

  3. Intervention [ Time Frame: 1 year ]
    Develop and test an intervention that will encourage use of MHV



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consists of entire patient population of HIV-infected Veterans active in care at a VA Health Care System who are non-users of MHV or have used MHV.
Criteria

Inclusion Criteria:

  • HIV diagnosis (determined by the presence of two outpatient HIV diagnoses or one inpatient HIV diagnosis from 10/2007 to 10/2018)

Exclusion Criteria:

  • Children under the age of 18
  • Non-English speakers
  • Those considered incompetent (as determined by the presence of an ICD-9/10 code for dementia or Alzheimer's)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190317


Contacts
Contact: Amanda M Midboe, PhD (650) 493-5000 ext 27829 Amanda.Midboe@va.gov
Contact: Hannah H Cheng, BS BS (650) 614-9997 HoYee.Cheng@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Amanda M Midboe, PhD    650-493-5000 ext 27829    Amanda.Midboe@va.gov   
Principal Investigator: Amanda M. Midboe, PhD         
VA San Diego Healthcare System, San Diego, CA Not yet recruiting
San Diego, California, United States, 92161
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
United States, Florida
Orlando VA Medical Center, Orlando, FL Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN Not yet recruiting
Indianapolis, Indiana, United States, 46202-2884
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Not yet recruiting
Bedford, Massachusetts, United States, 01730
Contact: Donald K McInnes, ScD MS BA    781-687-3507    Keith.McInnes@va.gov   
Sub-Investigator: Donald K McInnes, ScD MS BA         
Sub-Investigator: Gemmae M Fix, PhD MA BS         
United States, Nevada
VA Southern Nevada Healthcare System, North Las Vegas, NV Not yet recruiting
Las Vegas, Nevada, United States, 89106
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
United States, New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Not yet recruiting
New York, New York, United States, 10010
Contact: Amanda M Midboe, PhD    650-614-9997 ext 27829    Amanda.Midboe@va.gov   
Contact: Hannah H Cheng    6506149997 ext 27556    HoYee.Cheng@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
VA Palo Alto Health Care System
Edith Nourse Rogers Memorial Veterans Hospital
Investigators
Principal Investigator: Amanda M. Midboe, PhD VA Palo Alto Health Care System, Palo Alto, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03190317     History of Changes
Other Study ID Numbers: IIR 15-327
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
electronic medical record
personal health record
Veteran
self-management

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases