NCT04323176

Brief Summary

This study evaluates implementation of the Village Model to support older people living with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3.6 years

First QC Date

March 24, 2020

Last Update Submit

February 17, 2023

Conditions

Keywords

HIVAgingLonelinesssocial isolationmulti-morbidityLGBTcommunity

Outcome Measures

Primary Outcomes (1)

  • Theoretical Framework Acceptability Scale

    A 7 question survey the investigators developed based on the Theoretical Framework of Acceptability. This likert scale includes answers on a 1-5 scale for each 7 questions. The range will be from 5-35 with higher scores indicating higher acceptability.

    12 months.

Secondary Outcomes (1)

  • Social Network Inventory

    1, 3, 6, and 12 months

Other Outcomes (2)

  • Engagement with the Village

    12 months

  • Engagement with the hyperlocal social app

    12 months

Study Arms (1)

Village Model

EXPERIMENTAL

Participate as a member of the Village using a website for 12 months.

Other: Village Model implementation

Interventions

Participate in the Village Model using a website

Village Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lives in Central San Diego
  • Consents to participate
  • Willing to sign Village social contract
  • No plans to move out of Central San Diego in the next year
  • Speaks English

You may not qualify if:

  • Severely cognitively impaired as indicated by \< 10 on mini mental state examination
  • History of a violent felony or fraud in the past 10 years
  • Not willing to consent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The San Diego Lesbian Gay Bisexual Transgender Center

San Diego, California, 92103, United States

Location

University of California San Diego

San Diego, California, 92103, 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
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Implementation of Village Model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

June 1, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

On completion of the study, we will provide coded IDP to other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At study completion
Access Criteria
Please email study PI for requests. We will review to ensure work is not duplicative of ongoing analyses and that the intent of the work is not to exploit study participants.

Locations