HivNCT04747756
Creating a Virtual Village for People Aging With HIV During COVID-19
A study testing Virtual Village in people with Hiv and Depression in Old Age, run by University of California, Riverside at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Depression in Old Age, Isolation, Social
- What is being tested?
- Virtual Village
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English or Spanish speaking adults
- Living with HIV
- residing in Palm Springs, Los Angeles, or Tampa Bay Florida
- age 50 or older
Who cannot join
- not able to read English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hiv, Depression in Old Age, Isolation, Social, Aging
- Being tested
- Virtual Village
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual VillageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Other | No participants will be randomized. All participants will have an opportunity to participate in the study procedures. Receives: Other: Virtual Village |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression after pilot testing virtual village
Measuring change in depression using PHQ9
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Mar 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Riverside
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, University of Southern California, HIV+Aging Research Project-Palm Springs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747756
- Sponsor's protocol ID
- 60304
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Solution to Halt Further Isolation of People Aging With HIV During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04747756
- Acronym / sponsor ID
- 60304
- Conditions
- Hiv, Depression in Old Age, Isolation, Social, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, RiversideUniversity, hospital or other
- Collaborators
- University of South Florida, University of Southern California, HIV+Aging Research Project-Palm Springs
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Other | Other: Virtual VillageNo participants will be randomized. All participants will have an opportunity to participate in the study procedures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or Spanish speaking adults
- Living with HIV
- residing in Palm Springs, Los Angeles, or Tampa Bay Florida
- age 50 or older
Key exclusion criteria (1 listed)
- not able to read English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual VillageThe 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. | Other | Study participants |
Primary outcome
Change in depression after pilot testing virtual village
Time frame: 3 months
Measuring change in depression using PHQ9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Village in people with Hiv and Depression in Old Age, run by University of California, Riverside at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression after pilot testing virtual village (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.