Health Information for Infected Veterans

Active, not recruiting

• Conditions: Human Immunodeficiency Virus
• Interventions: Other: HIV-infected Veterans who do not use MHV; Other: Providers and staff of HIV-infected veteran; Other: HIV-infected Veterans who use MHV

• Registration Number: NCT03190317
• Lead Sponsor: VA Office of Research and Development

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.

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.

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Study Start: 2019-06-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-infected Veterans who do not 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.
Providers and staff of HIV-infected veteran	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.
HIV-infected Veterans who use MHV	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.

Primary Outcome Measures

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

Trial Locations

Locations (8)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN; 🇺🇸 Indianapolis, Indiana, 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

Orlando VA Medical Center, Orlando, FL; 🇺🇸 Orlando, Florida, United States

VA Southern Nevada Healthcare System, North Las Vegas, NV; 🇺🇸 Las Vegas, Nevada, United States

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY; 🇺🇸 New York, New York, United States