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| ID | Type | Description | Link |
|---|---|---|---|
| I01HX002645 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVC | Experimental | Option 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVC | Other | Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence retention in care measure | Percentage of scheduled HIV clinic appointments attended over the year | 12 months |
| Completed visits for adherence counseling | Number of completed visits for counseling, mental health, and social services during the year. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Health Questionnaire depression scale (PHQ-9) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Alexandra Lindsay, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36566509 | Background | 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. | |
| 37759376 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2024 | Dec 4, 2024 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
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.
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| 12 months |
| HIV suppression | 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 | Number of ART medication pills dispensed from pharmacy over the year divided by days in year. | 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 | 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) | 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 | Last recorded value in medical record during 12 month period | 12 months |
| HIV viral load | Last recorded value in 12 months period. | 12 months |
| 34841420 | Derived | 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. |