- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323176
2nd AC+: New Village Model (2nd AC+)
2nd AC+: Leveraging Technology to Create Communities of Care Around Older People Living With HIV
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- University of California San Diego
-
San Diego, California, United States, 92103
- The San Diego Lesbian Gay Bisexual Transgender Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Village Model
Participate as a member of the Village using a website for 12 months.
|
Participate in the Village Model using a website
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1, 3, 6, and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement with the Village
Time Frame: 12 months
|
Total count of times each study participant engaged in a Village request or event.
|
12 months
|
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
|
12 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 182147
- Age Positively (Other Identifier: Gilead Sciences)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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