CClinicalTrials.gg
Sign In
CompletedNCT04055207Updated Aug 26, 2026Results posted

VA Video Connect in HIV Care

An interventional study of VVC in HIV, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
306
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • HIV

Keywords

  • HIV
  • Telemedicine
03

In context

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
306 participants (actual)

Study arms

  • Experimental
    VVC

    Option to receive VA Video Connect (VVC) delivery of HIV care.

    Other: VVC

  • No intervention
    Usual Care

    All HIV care available at MEDVAMC will be delivered as usual.

Interventions

  • OtherVVC

    Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.

    Also known as: VA Video Connect

06

What researchers measure

Primary outcomes

  1. Constancy Retention in Care Measure

    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.

    Time frame: From enrollment to the end of follow-up at 12 months

Secondary outcomes

  1. Adherence Retention in Care Measure

    Percentage of scheduled HIV clinic appointments attended over 12 months

    Time frame: 12 months

  2. Completed Visits for Adherence Counseling

    Number of completed visits for counseling, mental health, and social services during the year.

    Time frame: 12 months

  3. HIV Suppression

    Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was \<200c/mL

    Time frame: 12 months

  4. Percent ART Medication Dispensed (as a Proxy for Medication Adherence)

    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.

    Time frame: 12 months

Other outcomes

  1. CD4 Cell Count Greater Than or Equal to 200

    Last recorded value in medical record during 12 month period

    Time frame: 12 months

07

Results

Posted Aug 26, 2026
Limitations and caveats
This project began in January 2020, just before the onset of the COVID-19 pandemic, which rapidly altered clinical operations across VA and likely contributed to variability in implementation. Social distancing required supporting providers in delivering VTH from their homes rather than from the clinic. Limitations in electronic health record infrastructure, including clinic stop codes and workload capture for video visits, created challenges in documenting and tracking intervention delivery.

Participant flow

Participants were enrolled at completion of a scheduled medical visit. The first participant was enrolled on July 1, 2021 and the last participant was enrolled on May 24, 2022.

Participant flow — Overall Study
MilestoneVVC OptionUsual Care
Started154152
Completed149148
Not completed54
Withdrew: Death34
Withdrew: Moved to a different clinic20

Outcome measures

PrimaryConstancy Retention in Care Measure

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.

Time frame:
From enrollment to the end of follow-up at 12 months
Reported as:
Count of participants · Participants
Constancy Retention in Care Measure
ParticipantsVVC OptionUsual Care
Constancy Retention in Care Measure9994
Statistical analysis
  • VVC Option vs Usual Care · Regression, Logistic · p = 0.71 · Odds ratio (or): 1.09 · 95% CI 0.68 to 1.75
SecondaryAdherence Retention in Care Measure

Percentage of scheduled HIV clinic appointments attended over 12 months

Time frame:
12 months
Reported as:
Mean · percentage of HIV clinic visits attended
Adherence Retention in Care Measure
percentage of HIV clinic visits attendedVVC OptionUsual Care
Adherence Retention in Care Measure61.74 ± 31.3566.49 ± 27.88
Statistical analysis
  • VVC Option vs Usual Care · Regression, Linear · p = 0.14 · Regression coefficient: -5.01
  • VVC Option vs Usual Care · Regression, Linear · p = 0.14 · Regression coefficient: -5.03
SecondaryCompleted Visits for Adherence Counseling

Number of completed visits for counseling, mental health, and social services during the year.

Time frame:
12 months
Reported as:
Mean · number of visits
Completed Visits for Adherence Counseling
number of visitsVVC OptionUsual Care
Completed Visits for Adherence Counseling2.55 ± 1.882.73 ± 1.64
Statistical analysis
  • VVC Option vs Usual Care · Regression, Linear · p = 0.35 · Regression coefficient: -0.17
SecondaryHIV Suppression

Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was \<200c/mL

Time frame:
12 months
Reported as:
Count of participants · Participants
HIV Suppression
ParticipantsVVC OptionUsual Care
HIV Suppression121128
Statistical analysis
  • VVC Option vs Usual Care · Regression, Logistic · p = 0.59 · Odds ratio (or): 1.37 · 95% CI 0.43 to 4.38
  • VVC Option vs Usual Care · Regression, Logistic · p = 0.67 · Odds ratio (or): 1.30 · 95% CI 0.39 to 4.35
SecondaryPercent ART Medication Dispensed (as a Proxy for Medication Adherence)

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.

Time frame:
12 months
Reported as:
Mean · mean percentage ART medication dispensed
Percent ART Medication Dispensed (as a Proxy for Medication Adherence)
mean percentage ART medication dispensedVVC OptionUsual Care
Percent ART Medication Dispensed (as a Proxy for Medication Adherence)90.30 ± 14.9191.32 ± 13.35
Statistical analysis
  • VVC Option vs Usual Care · Regression, Linear · p = 0.51 · Regression coefficient: -1.04
  • VVC Option vs Usual Care · Regression, Linear · p = 0.63 · Regression coefficient: -0.77
Other pre-specifiedCD4 Cell Count Greater Than or Equal to 200

Last recorded value in medical record during 12 month period

Time frame:
12 months
Reported as:
Count of participants · Participants
CD4 Cell Count Greater Than or Equal to 200
ParticipantsVVC OptionUsual Care
> = 200107
< 20000

Adverse events

Collected over From enrollment to end of follow-up period, up to 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VVC Option3/154 (1.9%)42/154 (27.3%)62/154 (40.3%)
Usual Care4/152 (2.6%)38/152 (25%)61/152 (40.1%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
EventVVC OptionUsual Care
Hospital AdmissionSurgical and medical procedures8/1548/152
Hospital AdmissionPsychiatric disorders0/1544/152
Hospital AdmissionRenal and urinary disorders4/1544/152
Hospital admissionCardiac disorders4/1543/152
Hospital AdmissionGeneral disorders4/1542/152
Hospital AdmissionInfections and infestations4/1542/152
Hospital AdmissionGastrointestinal disorders3/1542/152
Hospital AdmissionNervous system disorders3/1542/152
Hospital AdmissionBlood and lymphatic system disorders1/1542/152
Hospital AdmissionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1542/152
Most frequent other events
Showing 10 of 22
Most frequent other events
EventVVC OptionUsual Care
Emergency Room VisitRespiratory, thoracic and mediastinal disorders12/15413/152
Emergency Room VisitGeneral disorders8/15411/152
Emergency Room VisitMusculoskeletal and connective tissue disorders9/1549/152
Emergency Room VisitInfections and infestations7/1544/152
Emergency Room VisitNervous system disorders0/1544/152
Emergency Room VisitInjury, poisoning and procedural complications4/1542/152
Crisis CallPsychiatric disorders2/1543/152
Emergency Room VisitGastrointestinal disorders2/1543/152
Emergency Room VisitRenal and urinary disorders3/1543/152
Emergency Room VisitVascular disorders3/1541/152

Baseline characteristics

Age, Continuous
Age, Continuous(years)VVC OptionUsual CareTotal
Mean57.36 ± 12.5958.16 ± 12.9357.76 ± 12.74
Sex/Gender, Customized
Sex/Gender, Customized(Participants)VVC OptionUsual CareTotal
Female448
Male150147297
Transgender011
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VVC OptionUsual CareTotal
Hispanic or Latino131730
Not Hispanic or Latino139133272
Unknown or Not Reported224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VVC OptionUsual CareTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander123
Black or African American10292194
White5053103
More than one race000
Unknown or Not Reported145
Region of Enrollment
Region of Enrollment(Participants)VVC OptionUsual CareTotal
United States154152306
Rural zip code
Rural zip code(Participants)VVC OptionUsual CareTotal
Rural141327
Not rural139139278
OEF/OIF Status
OEF/OIF Status(Participants)VVC OptionUsual CareTotal
OEF/OIF6763130
Not OEF/OIF8687173
Drive time to MEDVAMC
Drive time to MEDVAMC(minutes)VVC OptionUsual CareTotal
Mean37.43 ± 29.3337.49 ± 31.3637.46 ± 30.30

10 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Michael E. DeBakey VA Medical Center, Houston, TX
    Houston, Texas 77030-4211, United States
09

References and documents

Publications

  • 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. PubMed 36566509 ↗
  • 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. PubMed 37759376 ↗
  • 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. PubMed 41417131 ↗
  • 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. PubMed 34841420 ↗

Study documents

  • Protocol and statistical analysis plan · May 1, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04055207
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Aug 13, 2019
Start date
Jul 1, 2021
Primary completion
Oct 31, 2024
Completion
Dec 31, 2024
Results posted
Aug 26, 2026
Last update
Aug 26, 2026

Study contacts

Jan Alexandra Lindsay, PhD
principal investigator · Michael E. DeBakey VA Medical Center, Houston, TX

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

VA Office of Research and Development

Start the discussion