VA Video Connect in HIV Care

January 8, 2025 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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

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

  • United States
    • 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.
Other: VVC
Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
Other Names:
  • VA Video Connect
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: 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.
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 the year
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
Percentage of Veterans with HIV on ART whose most recent viral load during the 12-month period was <200c/mL
12 months
Adherence to ART medications
Time Frame: 12 months
Number of ART medication pills dispensed from pharmacy over the year divided by days in year.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months
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.
12 months
CD4 cell count
Time Frame: 12 months
Last recorded value in medical record during 12 month period
12 months
HIV viral load
Time Frame: 12 months
Last recorded value in 12 months period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

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

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

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.

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