VA Video Connect in HIV Care
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04055207|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: VVC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||VA Video Connect to Improve Access to Multi-disciplinary Specialty Care|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||December 31, 2023|
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 Name: VA Video Connect
No Intervention: Usual Care
All HIV care available at MEDVAMC will be delivered as usual.
- 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.
- Adherence retention in care measure [ Time Frame: 12 months ]Percentage of scheduled HIV clinic appointments attended over the year
- Completed visits for adherence counseling [ Time Frame: 12 months ]Number of completed visits for counseling, mental health, and social services during the year.
- 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
- Adherence to ART medications [ Time Frame: 12 months ]Number of ART medication pills dispensed from pharmacy over the year divided by days in year.
- 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.
- 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.
- 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.
- 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.
- CD4 cell count [ Time Frame: 12 months ]Last recorded value in medical record during 12 month period
- HIV viral load [ Time Frame: 12 months ]Last recorded value in 12 months period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055207
|Contact: Thomas P Giordano, MD MPH||(713) 794-8682||Thomas.Giordano@va.gov|
|Contact: Jan A Lindsay, PhD||(713) 440-4482||Jan.Lindsay2@va.gov|
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Contact: Thomas P Giordano, MD MPH 713-794-8682 Thomas.Giordano@va.gov|
|Principal Investigator: Thomas P. Giordano, MD MPH|
|Principal Investigator:||Thomas P. Giordano, MD MPH||Michael E. DeBakey VA Medical Center, Houston, TX|