HIVNCT04055207

VA Video Connect in HIV Care

A study testing VVC in people with HIV, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV
What is being tested?: VVC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2021to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211

Other trials in United States

About this study

Official title: VA Video Connect to Improve Access to Multi-disciplinary Specialty Care

Conditions: HIV
Being tested: VVC
Keywords: HIV, Telemedicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VVCOther
Also called VA Video Connect
Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.

Study groups in NCT04055207
Study group	Role	What they receive
VVC	Experimental	Option to receive VA Video Connect (VVC) delivery of HIV care. Receives: Other: VVC
Usual Care	No intervention	All HIV care available at MEDVAMC will be delivered as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From enrollment to the end of follow-up at 12 months

Secondary outcomes (4)

Adherence Retention in Care Measure
Percentage of scheduled HIV clinic appointments attended over 12 months
Measured: 12 months
Completed Visits for Adherence Counseling
Number of completed visits for counseling, mental health, and social services during the year.
Measured: 12 months
HIV Suppression
Number of Veterans with HIV on ART whose most recent viral load during the 12-month period was <200c/mL
Measured: 12 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202131 Dec 2024

First posted13 Aug 2019
Study start1 Jul 2021
Primary completion31 Oct 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04055207
Sponsor's protocol ID: IIR 18-077
Other IDs: I01HX002645
Status last verified: Aug 2026
First submitted: 24 Jul 2019
Last updated: 26 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza

All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VA Video Connect to Improve Access to Multi-disciplinary Specialty Care
ClinicalTrials.gov ID: NCT04055207
Acronym / sponsor ID: IIR 18-077
Conditions: HIV
Keywords: HIV, Telemedicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Jul 2021 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 13 Aug 2019 (actual)
Results: Posted 26 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
VVC	Experimental	Other: VVCOption to receive VA Video Connect (VVC) delivery of HIV care.
Usual Care	No intervention	–All HIV care available at MEDVAMC will be delivered as usual.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VVCAlso: VA Video ConnectTelehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.	Other	VVC

Primary outcome

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.

4 secondary outcomes

Adherence Retention in Care Measure
Time frame: 12 months
Completed Visits for Adherence Counseling
Time frame: 12 months
HIV Suppression
Time frame: 12 months
Percent ART Medication Dispensed (as a Proxy for Medication Adherence)
Time frame: 12 months

Results and safety

Results posted to the registry on 26 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VVC Option	154	149
Usual Care	152	148

Primary outcome: Constancy Retention in Care Measure

Time frame: From enrollment to the end of follow-up at 12 months. Count of participants. Unit: Participants

Measure	VVC Option n = 154	Usual Care n = 152
Value	99	94

VVC Option vs Usual Care: Odds Ratio (OR): 1.09 (95% CI 0.68 to 1.75), p = 0.71, Regression, Logistic

Population analysed: The full 306 participants were included in all analyses.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of follow-up period, up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VVC Option	42 of 154 (27.3%)	62 of 154 (40.3%)	3 of 154
Usual Care	38 of 152 (25%)	61 of 152 (40.1%)	4 of 152

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36566509Thompson 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.
Background: PubMed 37759376Sheinfil 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.
Results publication: PubMed 41417131Sheinfil 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.
Derived from this study: PubMed 34841420Gloston 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.
Individual participant dataSharing planned: No

Related trials for HIV

RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Enrolling by invitationObservational study
Analysis of HIV-1 Replication During Antiretroviral Therapy
HIV
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan Alexandra Lindsay, PhD principal investigator

Michael E. DeBakey VA Medical Center, Houston, TX

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VVC in people with HIV, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Constancy Retention in Care Measure (time frame: From enrollment to the end of follow-up at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04055207, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.