Creating a Virtual Village for People Aging With HIV During COVID-19
Primary Purpose
Hiv, Depression in Old Age, Isolation, Social
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Village
Sponsored by
About this trial
This is an interventional other trial for Hiv
Eligibility Criteria
Inclusion Criteria:
- English or Spanish speaking adults
- Living with HIV
- residing in Palm Springs, Los Angeles, or Tampa Bay Florida
- age 50 or older
Exclusion Criteria:
- not able to read English or Spanish
Sites / Locations
- UC Riverside
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study participants
Arm Description
No participants will be randomized. All participants will have an opportunity to participate in the study procedures.
Outcomes
Primary Outcome Measures
Change in depression after pilot testing virtual village
Measuring change in depression using PHQ9
Secondary Outcome Measures
Full Information
NCT ID
NCT04747756
First Posted
February 3, 2021
Last Updated
September 27, 2021
Sponsor
University of California, Riverside
Collaborators
University of South Florida, University of Southern California, HIV+Aging Research Project-Palm Springs
1. Study Identification
Unique Protocol Identification Number
NCT04747756
Brief Title
Creating a Virtual Village for People Aging With HIV During COVID-19
Official Title
A Solution to Halt Further Isolation of People Aging With HIV During the COVID-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Riverside
Collaborators
University of South Florida, University of Southern California, HIV+Aging Research Project-Palm Springs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a PCORI-funded project on HIV and aging engagement that was co-led by the study team, the topics of isolation and depressions were identified as priority areas of deep concern among older PLWH. The COVID-19 pandemic has enhanced the urgency to test interventions to mitigate depression and isolation among older PLWH. However, there is scant evidence on effective interventions that help mitigate depression and isolation among older PLWH. While physical distancing and stay at home orders are a necessary strategy to flatten the curve, ease pressure on the healthcare system, and protect the most vulnerable, the order further increases the isolation faced by people aging with HIV, and creates barriers to accessing medications, health services, and other resources. This project will include 6 virtual focus groups and 12 individual interviews with adults ages 50 or older in California (Palm Spring, Los Angeles) and the Tampa-Bay region, Florida to (1): further characterize issues related to depression, isolation, and basic needs of people aging with HIV during the COVID-19 pandemic (2) utilizing results from Aim 1, co-develop ideas for what to include in a virtual village, and (3) create and pilot the virtual village in a group of people aging with HIV. The overall goal of this study is to execute an innovative solution to address issues related to isolation for older PLWH which have been exacerbated during the COVID-19 pandemic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Depression in Old Age, Isolation, Social, Aging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study participants
Arm Type
Other
Arm Description
No participants will be randomized. All participants will have an opportunity to participate in the study procedures.
Intervention Type
Other
Intervention Name(s)
Virtual Village
Intervention Description
The purpose of this study is to create a virtual village for people aging with HIV, and to pilot test the virtual village intervention as a final step.
Primary Outcome Measure Information:
Title
Change in depression after pilot testing virtual village
Description
Measuring change in depression using PHQ9
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English or Spanish speaking adults
Living with HIV
residing in Palm Springs, Los Angeles, or Tampa Bay Florida
age 50 or older
Exclusion Criteria:
not able to read English or Spanish
Facility Information:
Facility Name
UC Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92521
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Creating a Virtual Village for People Aging With HIV During COVID-19
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