Clinical trial NCT04055207: VA Video Connect in HIV Care
Official title: VA Video Connect to Improve Access to Multi-disciplinary Specialty Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-08-13
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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)

Primary outcomes:
measure: Constancy retention in care measure
timeFrame: 12 months
Secondary outcomes:
measure: Adherence retention in care measure
timeFrame: 12 months
measure: Completed visits for adherence counseling
timeFrame: 12 months
measure: HIV suppression
timeFrame: 12 months
measure: Adherence to ART medications
timeFrame: 12 months
Other outcomes:
measure: AUDIT
timeFrame: 12 months
measure: Patient Health Questionnaire depression scale (PHQ-9)
timeFrame: 12 months
measure: Posttraumatic Disorder Checklist (PCL-5) total
timeFrame: 12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 12 months
measure: CD4 cell count
timeFrame: 12 months
measure: HIV viral load
timeFrame: 12 months
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Jan Alexandra Lindsay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson JL, Matchanova A, Beltran-Najera I, Ridgely NC, Mustafa A, Babicz MA, Hasbun R, Giordano TP, Woods SP. Preliminary Validity of a Telephone-Based Neuropsychological Battery in a Consecutive Series of Persons with HIV Disease Referred for Clinical Evaluation. Arch Clin Neuropsychol. 2023 May 22;38(4):570-585. doi: 10.1093/arclin/acac104.
citation: Sheinfil AZ, Day G, Walder A, Hogan J, Giordano TP, Lindsay J, Ecker A. Rural Veterans with HIV and Alcohol Use Disorder receive less video telehealth than urban Veterans. J Rural Health. 2024 Jun;40(3):419-429. doi: 10.1111/jrh.12799. Epub 2023 Sep 27.
citation: Gloston GF, Day GA, Touchett HN, Marchant-Miros KE, Hogan JB, Chen PV, Amspoker AB, Fletcher TL, Giordano TP, Lindsay JA. Pivoting to Video Telehealth for Delivery of HIV Care During COVID-19: A Brief Report. Telemed Rep. 2021 Aug 6;2(1):205-210. doi: 10.1089/tmr.2021.0010. eCollection 2021.