Health Information for Infected Veterans

Human Immunodeficiency Virus Clinical Trial

— HI-FIV  

Official title:

Health Information for Infected Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03190317
• Other study ID #: IIR 15-327
• Status: Active, not recruiting
• Start date: June 24, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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
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
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.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana
United States	VA Southern Nevada Healthcare System, North Las Vegas, NV	Las Vegas	Nevada
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York
United States	Orlando VA Medical Center, Orlando, FL	Orlando	Florida
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Edith Nourse Rogers Memorial Veterans Hospital, VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Erratu — View Citation

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/tb — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Record Review	Determine the relationship between MHV tools and quality of care and outcomes for Veterans who are HIV positive.	1 year
Primary	Interviews	Understand how Veterans with HIV use or choose not to use MHV for self-management	1 year
Primary	Intervention	Develop and test an intervention that will encourage use of MHV	1 year