NCT04055207

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

July 24, 2019

Last Update Submit

January 8, 2025

Conditions

Keywords

HIVTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Adherence retention in care measure

    12 months

  • Completed visits for adherence counseling

    12 months

  • HIV suppression

    12 months

  • Adherence to ART medications

    12 months

Other Outcomes (6)

  • AUDIT

    12 months

  • Patient Health Questionnaire depression scale (PHQ-9)

    12 months

  • Posttraumatic Disorder Checklist (PCL-5) total

    12 months

  • +3 more other outcomes

Study Arms (2)

VVC

EXPERIMENTAL

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

Other: VVC

Usual Care

NO INTERVENTION

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

Interventions

VVCOTHER

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

Also known as: VA Video Connect
VVC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (3)

  • 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.

    PMID: 36566509BACKGROUND
  • 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.

    PMID: 37759376BACKGROUND
  • 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.

Study Officials

  • Jan Alexandra Lindsay, PhD

    Michael E. DeBakey VA Medical Center, Houston, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 13, 2019

Study Start

July 1, 2021

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations