VA Video Connect in HIV Care

HIV Clinical Trial

Official title:

VA Video Connect to Improve Access to Multi-disciplinary Specialty Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055207
• Other study ID #: IIR 18-077
• Secondary ID: I01HX002645
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Jan A Lindsay, PhD
• Phone: (713) 440-4482
• Email: Jan.Lindsay2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. 2023 Sep 27. doi: 10.1111/jrh.12799. Online ahead of print. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AUDIT	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
Other	Patient Health Questionnaire depression scale (PHQ-9)	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
Other	Posttraumatic Disorder Checklist (PCL-5) total	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
Other	Montreal Cognitive Assessment (MoCA)	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
Other	CD4 cell count	Last recorded value in medical record during 12 month period	12 months
Other	HIV viral load	Last recorded value in 12 months period.	12 months
Primary	Constancy retention in care measure	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	Adherence retention in care measure	Percentage of scheduled HIV clinic appointments attended over the year	12 months
Secondary	Completed visits for adherence counseling	Number of completed visits for counseling, mental health, and social services during the year.	12 months
Secondary	HIV suppression	Percentage of Veterans with HIV on ART whose most recent viral load during the 12-month period was <200c/mL	12 months
Secondary	Adherence to ART medications	Number of ART medication pills dispensed from pharmacy over the year divided by days in year.	12 months