NCT04747756

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

February 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

February 3, 2021

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in depression after pilot testing virtual village

    Measuring change in depression using PHQ9

    3 months

Study Arms (1)

Study participants

OTHER

No participants will be randomized. All participants will have an opportunity to participate in the study procedures.

Other: Virtual Village

Interventions

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 participants

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English or Spanish speaking adults
  • Living with HIV
  • residing in Palm Springs, Los Angeles, or Tampa Bay Florida
  • age 50 or older

You may not qualify if:

  • not able to read English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Riverside

Riverside, California, 92521, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial Isolation

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 10, 2021

Study Start

March 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations