- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055207
VA Video Connect in HIV Care
August 3, 2026 updated by: VA Office of Research and Development
VA Video Connect to Improve Access to Multi-disciplinary Specialty Care
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
306
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030-4211
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VVC
Option to receive VA Video Connect (VVC) delivery of HIV care.
|
Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Other Names:
|
|
No Intervention: Usual Care
All HIV care available at MEDVAMC will be delivered as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constancy Retention in Care Measure
Time Frame: From enrollment to the end of follow-up at 12 months
|
Completion of at least 1 visit with a primary care or Infectious Disease provider in each 6 months of the year at least 60 days apart.
|
From enrollment to the end of follow-up at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence Retention in Care Measure
Time Frame: 12 months
|
Percentage of scheduled HIV clinic appointments attended over 12 months
|
12 months
|
|
Completed Visits for Adherence Counseling
Time Frame: 12 months
|
Number of completed visits for counseling, mental health, and social services during the year.
|
12 months
|
|
HIV Suppression
Time Frame: 12 months
|
Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was <200c/mL
|
12 months
|
|
Percent ART Medication Dispensed (as a Proxy for Medication Adherence)
Time Frame: 12 months
|
The percentage of ART medication dispensed was calculated by dividing the total number of ART medication pills dispensed during each 365-day observation period (i.e., baseline and 12-month follow-up) by 365 and then multiplying by 100, yielding a percentage (0-100%).
This pharmacy dispensing measure serves as a proxy for medication adherence, with higher percentages indicating greater medication availability.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CD4 Cell Count Greater Than or Equal to 200
Time Frame: 12 months
|
Last recorded value in medical record during 12 month period
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jan Alexandra Lindsay, PhD, Michael E. DeBakey VA Medical Center, Houston, TX
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Sheinfil AZ, Amspoker AB, Guajardo E, Day G, Walder A, Chen L, Hogan J, Giordano TP, Lindsay J, Ecker A. Telemental Healthcare and HIV Care: A National Study of US Veterans with HIV during COVID-19. AIDS Behav. 2026 May;30(5):1554-1567. doi: 10.1007/s10461-025-04988-1. Epub 2025 Dec 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
October 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
August 9, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIR 18-077
- I01HX002645 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.