NCT03190317

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

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

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6.3 years

First QC Date

June 14, 2017

Last Update Submit

April 24, 2025

Conditions

Keywords

electronic medical recordpersonal health recordVeteranself-management

Outcome Measures

Primary Outcomes (3)

  • Medical Record Review

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

    1 year

  • Interviews

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

    1 year

  • Intervention

    Develop and test an intervention that will encourage use of MHV

    1 year

Study Arms (3)

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

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

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

Interventions

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 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.

HIV-infected Veterans who do not use MHV

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.

Providers and staff of HIV-infected veteran

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, 32803, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, 89106, United States

Location

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

New York, New York, 10010, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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 Diseases

Study Officials

  • Amanda M. Midboe, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

June 24, 2019

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations