AzTrials
AzTrials

Human Immunodeficiency VirusHI-FIVNCT03190317

Health Information for Infected Veterans

An observational study of Human Immunodeficiency Virus, run by VA Office of Research and Development at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
HIV-infected Veterans who use MHV, HIV-infected Veterans who do not use MHV and Providers and staff of HIV-infected veteran
How many people
123 participants
Where
8 sitesUnited States
Study dates
24 Jun 2019to 30 Sep 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201

  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

  • VA Southern Nevada Healthcare System, North Las Vegas, NV

    Las Vegas, Nevada, 89106

  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

    New York, New York, 10010

  • Orlando VA Medical Center, Orlando, FL

    Orlando, Florida, 32803

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161

Other trials in United States

About this study

This is a 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.

Read the detailed description

Over the last twenty years, HIV has transformed from a terminal disease to a condition with near normal life expectancy for patients who follow ideal treatment regimens. HIV-infected individuals still face many challenges and need to be active in self-management of HIV and other conditions in order to live a healthy life. In order to ensure that this population of HIV-infected individuals actively self-manages the condition, personal health records (PHRs) should be used more often. PHRs may simplify disease self-management, improve health outcomes, and reduce unnecessary health care use.

The VA has one of the nation's largest PHR systems - My HealtheVet (MHV). MHV includes features that can help patient's self-manage the disease (e.g., prescription refill, viewing lab results view, secure messaging). While there has been recognition that MHV holds promise as a self-management tool, there has not yet been an examination of use of MHV features and the relationship to health outcomes in any chronic disease group, let alone in HIV-infected Veterans.

The objective of this project is to evaluate MHV use by HIV-infected Veterans and providers, by completing three aims/steps.

Aim/Step 1: Describe the relationship between use of MHV tools for self-management across HIV-infected Veterans and determine the relationship to health outcomes and care processes in these Veterans through review of medical records.

The investigators will use the VA medical record data, which allows for the study of the diverse VA patient population with patients from a range of personal backgrounds, geographic locations, and VA health care networks. HIV infection will be determined by the presence of two outpatient HIV diagnoses or one inpatient HIV diagnosis. This study will use a retrospective group of HIV-infected Veterans who used MHV between October 2007- October 2018 to evaluate the relationship between patient HIV care outcomes and MHV tool use. The investigators will look at data to carefully consider HIV-infected patient health status, health care received, and activity. The investigators will also look at Quality of Care (QC) outcomes which include medication adherence, CD4 count, viral load testing and detectable viral load, appointments, patient cancellations, patient no-shows, emergency department visits, flu vaccination, and syphilis and lipid testing. This aim/step will allow the investigators to examine differences in VA patients who have opted to use MHV versus those who have not opted to use MHV.

Aim/Step 2: Describe how Veterans with HIV use MHV for self-management, and why Veterans choose to use (or not to use) specific MHV tools; and similarly how and why providers use (or do not use) MHV.

The investigators will interview Veterans and providers to learn what motivates certain patients and providers/staff to use MHV in a certain way, or to understand MHV system issues, as well as attitudes and perceptions that prevent others from using MHV. The investigators will select patients and providers from six VA medical centers and interview those with high-, low, or no- MHV use. The investigators will discuss how participants use MHV to manage HIV and other conditions. The investigators will discuss with Veterans how providers use MHV as a tool for communication and coordination. With Veterans not using MHV (or minimal use), the investigators will ask about reasons. The interviews will be audio-recorded.

Aim/Step 3: Incorporate findings from Aims/Steps 1 and 2 to design an intervention that will be tested by Veterans and providers.

The investigators will compare the data from aims/steps 1 and 2 to develop an intervention that may improve self-management in Veterans with HIV. The investigators will identify Veterans and providers from two VA medical centers that will help the investigators test the intervention through "cognitive walkthroughs." Cognitive walkthroughs are used to test an intervention that is in the early stages of development. Veterans and providers will be the first to test if the intervention is acceptable and feasible. Participants will also offer feedback to the researchers as it relates to problems with using the intervention. The cognitive walkthroughs will be audio- and video-recorded.

Additional Aim a: Analyze qualitative data across the racial/ethnic and gender groups to evaluate MHV use, utilizing these findings to tailor interventions to racial/ethnic minority groups use an modified intervention mapping approach.

The investigators will develop an MHV intervention that meets the diversity of MHV user's needs, including Black and women Veterans. These findings could help MHV better understand how to target new interventions to potentially increase access to MHV and increase use of MHV for managing chronic conditions, among Black Veterans.

Additional Aim b: Develop a protocol for conducting virtual modified intervention mapping.

The investigators will develop the capability to conduct modified intervention mapping virtually. As no standard protocol has been developed for conducting intervention mapping virtually, the development of such protocol can contribute to lower cost, timely, and effective intervention design.

COVID-19 Expansion Aim 1: Explore historical trends of HIV clinical outcomes and indicators of care and trends observed during the COVID-19 pandemic, among Veterans living with HIV.

The investigators will use VA medical record data to examine these differences across racial/ethnic subgroups.

COVID-19 Expansion Aim 2: Use interrupted time series models to statistically compare pre-COVID-19 and COVID-19 pandemic HIV clinical outcomes and indicators of care.

The investigators will evaluate changes in disparities by expanding interrupted time series models to stratify by race/ethnicity.

Being tested
HIV-infected Veterans who use MHV, HIV-infected Veterans who do not use MHV, Providers and staff of HIV-infected veteran
Keywords
electronic medical record, personal health record, Veteran, self-management
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV-infected Veterans who use MHVOther

    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 MHVOther

    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 veteranOther

    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.

Study groups in NCT03190317
Study groupRoleWhat they receive
HIV-infected Veterans who use MHVThis 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.
Receives: Other: HIV-infected Veterans who use MHV
HIV-infected Veterans who do not use MHVThis 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.
Receives: Other: HIV-infected Veterans who do not use MHV
Providers and staff of HIV-infected veteranThis groups represents the population of providers and staff who utilize the MHV portal to deliver care for HIV-infected veterans.
Receives: Other: Providers and staff of HIV-infected veteran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical Record Review

    Determine the relationship between MHV tools and quality of care and outcomes for Veterans who are HIV positive.

    Measured: 1 year

  2. Interviews

    Understand how Veterans with HIV use or choose not to use MHV for self-management

    Measured: 1 year

  3. Intervention

    Develop and test an intervention that will encourage use of MHV

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2017
  2. Study start24 Jun 2019
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
Other
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03190317
Sponsor's protocol ID
IIR 15-327
Acronym
HI-FIV
Status last verified
May 2026
First submitted
14 Jun 2017
Last updated
20 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Javier SJ, Troszak LK, Shimada SL, McInnes DK, Ohl ME, Avoundjian T, Erhardt TA, Midboe AM. Racial and ethnic disparities in use of a personal health record by veterans living with HIV. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):696-702. doi: 10.1093/jamia/ocz024.

    PubMed 30924875
  • Giannitrapani KF, Fereydooni S, Silveira MJ, Azarfar A, Glassman PA, Midboe A, Zenoni M, Becker WC, Lorenz KA. How Patients and Providers Weigh the Risks and Benefits of Long-Term Opioid Therapy for Cancer Pain. JCO Oncol Pract. 2021 Jul;17(7):e1038-e1047. doi: 10.1200/OP.20.00679. Epub 2021 Feb 3.

    PubMed 33534632
  • Avoundjian T, Troszak L, Cave S, Shimada S, McInnes K, Midboe AM. Correlates of personal health record registration and utilization among veterans with HIV. JAMIA Open. 2021 Jun 16;4(2):ooab029. doi: 10.1093/jamiaopen/ooab029. eCollection 2021 Apr.

    PubMed 34278241
  • Conti J, Fix GM, Javier SJ, Cheng H, Perez T, Dunlap S, McInnes DK, Midboe AM. Patient and provider perspectives of personal health record use: a multisite qualitative study in HIV care settings. Transl Behav Med. 2023 Jul 1;13(7):475-485. doi: 10.1093/tbm/ibac118.

    PubMed 37084300
  • Midboe AM, Cave S, Shimada SL, Griffin AC, Avoundjian T, Asch SM, Gifford AL, McInnes DK, Troszak LK. Relationship Between Patient Portal Tool Use and Medication Adherence and Viral Load Among Patients Living with HIV. J Gen Intern Med. 2024 Feb;39(Suppl 1):127-135. doi: 10.1007/s11606-023-08474-z. Epub 2024 Jan 22.

    PubMed 38252241

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus, run by VA Office of Research and Development at 8 sites 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 1 inclusion and 3 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Medical Record Review (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03190317, which also lists 5 linked publications.

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 20 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in