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2nd AC+: New Village Model (2nd AC+)

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ClinicalTrials.gov Identifier: NCT04323176
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
The San Diego LGBT Community Center
Information provided by (Responsible Party):
Maile Young Karris, University of California, San Diego

Study Description
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Brief Summary:
This study evaluates implementation of the Village Model to support older people living with HIV.

Condition or disease Intervention/treatment Phase
Aging Hiv Loneliness Social Isolation Other: Village Model implementation Not Applicable

Detailed Description:

Understanding that older people living with HIV are facing uniques challenges as they age (lack of peer set due to extreme loss during the AIDS epidemic, ongoing HIV and age stigma, high rates of multi-morbidity) this study explores the acceptability and feasibility of implementing the Village Model in Central San Diego.

The Village Model started when several older members of Boston's Beacon Hill realized they were aging and may need more help as they aged to thrive in their own homes. The Village Model involves members of a community paying annual fees to support a village administrator that organizes regular socialization events and helps coordinate needs of individual members using the skill sets of other members within the community. From that first experience a few decades ago, today over 200 Villages exist across the country to enhance the ability of older adults to age in place.

However limitations of this model exists that may threaten the long term implementation and sustainability of the Village Model. Specifically the requirement to pay annual fees for an administrator, the lack of diversity (in age, race, sexuality etc), and difficulty in meeting member's needs in real-time.

This project proposes to pilot the Village Model in Central San Diego and will implement the following adaptions to address limitations. Members will not be required to pay annual fees but instead depend on a well-funded, long-established diverse organization (The San Diego LGBT Center) to serve as the administrator. This Village will allow participation of persons within the community at all ages, race, economic status. Lastly, the project proposes to pilot the acceptability of using a website to display and respond to community needs in real time.

To achieve this, the investigators will 1) perform questionnaires to understand the needs in the community by collecting needs assessments. 2) The investigators will explore the meaning of community and explore barriers and facilitators of Village Model implementation. 3) Lastly the investigators will pilot the Village model using a website.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Implementation of Village Model
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 2nd AC+: Leveraging Technology to Create Communities of Care Around Older People Living With HIV
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Village Model
Participate as a member of the Village using a website for 12 months.
 Other: Village Model implementation
Participate in the Village Model using a website


Outcome Measures
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Primary Outcome Measures :
  1. Theoretical Framework Acceptability Scale [ Time Frame: 12 months. ]
    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.


Secondary Outcome Measures :
  1. Social Network Inventory [ Time Frame: 1, 3, 6, and 12 months ]
    We will enumerate the social network of persons across four domains of support: emotional, material, social, and service. This will be done asking a series of questions about each persons named


Other Outcome Measures:
  1. Engagement with the Village [ Time Frame: 12 months ]
    Total count of times each study participant engaged in a Village request or event.

  2. Engagement with the hyperlocal social app [ Time Frame: 12 months ]
    Total count of times each study participant utilized the social app to request or provide a Village service


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323176


Contacts
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Contact: Jordan Silva 619-543-3198 jsilva@health.ucsd.edu
Contact: Maile Karris, MD 619-543-5039 m1young@health.ucsd.edu

Locations
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United States, California
The San Diego Lesbian Gay Bisexual Transgender Center Recruiting
San Diego, California, United States, 92103
Contact: Sarah Merk-Benitez    619-692-2077 ext 214    smerkbenitez@thecentersd.org   
Contact: Robert Rochin    619-692-2077 ext 205    rrochin@thecentersd.org   
University of California San Diego Recruiting
San Diego, California, United States, 92103
Contact: Jordan Silva    619-543-3198    jsilva@health.ucsd.edu   
Contact: Maile Karris, MD    619-543-5039    m1young@health.ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
The San Diego LGBT Community Center
More Information
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Responsible Party: Maile Young Karris, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04323176    
Other Study ID Numbers: 182147
Age Positively ( Other Identifier: Gilead Sciences )
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: On completion of the study, we will provide coded IDP to other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maile Young Karris, University of California, San Diego:
HIV
Aging
Loneliness
social isolation
 multi-morbidity
LGBT
community