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VA Video Connect in HIV Care

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ClinicalTrials.gov Identifier: NCT04055207
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
The purpose of this research study is to see how effective the addition of video to home telehealth services is in helping patients with HIV to remain in care, which is vital to management of their illness. The investigators also want to understand how to best put the video to home services into practice.

Condition or disease Intervention/treatment Phase
HIV Other: VVC Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Veterans in the Infections Disease clinic at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) will be randomly assigned to either an offer of VA Video Connect (VVC) delivered HIV care or to usual care for HIV. All treatment as usual options for HIV care will be available to all patients in both treatment arms, however only the Veterans in the VVC arm will be actively offered this VA-approved technology.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: VA Video Connect to Improve Access to Multi-disciplinary Specialty Care
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: VVC
Option to receive VA Video Connect (VVC) delivery of HIV care.
 Other: VVC
Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Other Name: VA Video Connect
No Intervention: Usual Care
All HIV care available at MEDVAMC will be delivered as usual.


Outcome Measures
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Primary Outcome Measures :
  1. Constancy retention in care measure [ Time Frame: 12 months ]
    Percentage of patients who completed at least 1 visit with a primary care or Infectious Diseases provider in each 6 months of the year at least 60 days apart.


Secondary Outcome Measures :
  1. Adherence retention in care measure [ Time Frame: 12 months ]
    Percentage of scheduled HIV clinic appointments attended over the year

  2. Completed visits for adherence counseling [ Time Frame: 12 months ]
    Number of completed visits for counseling, mental health, and social services during the year.

  3. HIV suppression [ Time Frame: 12 months ]
    Percentage of Veterans with HIV on ART whose most recent viral load during the 12-month period was <200c/mL

  4. Adherence to ART medications [ Time Frame: 12 months ]
    Number of ART medication pills dispensed from pharmacy over the year divided by days in year.


Other Outcome Measures:
  1. AUDIT [ Time Frame: 12 months ]
    10-item screening tool to assess alcohol consumption, drinking behaviors and alcohol-related problems. Item responses range from 0-4. Scores range from 0-40. Higher scores indicate more harmful alcohol use.

  2. Patient Health Questionnaire depression scale (PHQ-9) [ Time Frame: 12 months ]
    Brief measure of depression symptoms consisting of 9 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 27. Higher scores indicate greater depression severity.

  3. Posttraumatic Disorder Checklist (PCL-5) total [ Time Frame: 12 months ]
    Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 months ]
    Brief screening tool that assesses cognitive functioning across 8 domains; attention and concentration, executive functions, memory, language, conceptual thinking, calculations and orientation. Scores range from 0-30. Higher scores indicate greater cognitive function.

  5. CD4 cell count [ Time Frame: 12 months ]
    Last recorded value in medical record during 12 month period

  6. HIV viral load [ Time Frame: 12 months ]
    Last recorded value in 12 months period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in the Infectious Diseases clinic at Michael E. DeBakey VA Medical Center (MEDVAMC), Houston, TX, with HIV infection
  • At least 18 years of age
  • Able to speak English
  • Able to consent to the use of VVC

Exclusion Criteria:

  • Unable to use or consent to use VVC, due to either significant physical or mental disability
  • Incarcerated (though MEDVAMC does not generally provide care for prisoners)
Contacts and Locations
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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): NCT04055207


Contacts
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Contact: Thomas P Giordano, MD MPH (713) 794-8682 Thomas.Giordano@va.gov
Contact: Jan A Lindsay, PhD (713) 440-4482 Jan.Lindsay2@va.gov

Locations
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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Contact: Thomas P Giordano, MD MPH    713-794-8682    Thomas.Giordano@va.gov   
Principal Investigator: Thomas P. Giordano, MD MPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Thomas P. Giordano, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04055207    
Other Study ID Numbers: IIR 18-077
I01HX002645 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
HIV
Telemedicine