- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747756
Creating a Virtual Village for People Aging With HIV During COVID-19
September 27, 2021 updated by: University of California, Riverside
A Solution to Halt Further Isolation of People Aging With HIV During the COVID-19 Pandemic
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Riverside, California, United States, 92521
- UC Riverside
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Study participants
No participants will be randomized.
All participants will have an opportunity to participate in the study procedures.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression after pilot testing virtual village
Time Frame: 3 months
|
Measuring change in depression using PHQ9
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
February 3, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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