Aging2nd AC+NCT04323176
2nd AC+: New Village Model
A study testing Village Model implementation in people with Aging and Hiv, run by University of California, San Diego at 2 sites in United States.
Trial summary
This study evaluates implementation of the Village Model to support older people living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Hiv, Loneliness
- What is being tested?
- Village Model implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2019to 30 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The San Diego Lesbian Gay Bisexual Transgender Center
San Diego, California, 92103
University of California San Diego
San Diego, California, 92103
About this study
Official title: 2nd AC+: Leveraging Technology to Create Communities of Care Around Older People Living With HIV
This study evaluates implementation of the Village Model to support older people living with HIV.
Read the 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.
- Conditions
- Aging, Hiv, Loneliness, Social Isolation
- Being tested
- Village Model implementation
- Keywords
- HIV, Aging, Loneliness, social isolation, multi-morbidity, LGBT, community
- 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.
Village Model implementationOther
Participate in the Village Model using a website
| Study group | Role | What they receive |
|---|---|---|
| Village Model | Experimental | Participate as a member of the Village using a website for 12 months. Receives: Other: Village Model implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months.
Secondary outcomes (1)
Social Network Inventory
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
Measured: 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jun 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Implementation of Village Model
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- The San Diego LGBT Community Center
- Responsible party
- Principal investigator, Maile Young Karris, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323176
- Sponsor's protocol ID
- 182147
- Other IDs
- Age Positively
- Acronym
- 2nd AC+
- Status last verified
- Feb 2023
- First submitted
- 24 Mar 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of the study, we will provide coded IDP to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2nd AC+: Leveraging Technology to Create Communities of Care Around Older People Living With HIV
- ClinicalTrials.gov ID
- NCT04323176
- Acronym / sponsor ID
- 2nd AC+ / 182147
- Conditions
- Aging, Hiv, Loneliness, Social Isolation
- Keywords
- HIV, Aging, Loneliness, social isolation, multi-morbidity, LGBT, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- The San Diego LGBT Community Center
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Mar 2020 (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.
This study evaluates implementation of the Village Model to support older people living with HIV.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Implementation of Village Model
| Arm | Type | Receives |
|---|---|---|
| Village Model | Experimental | Other: Village Model implementationParticipate as a member of the Village using a website for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Village Model implementationParticipate in the Village Model using a website | Other | Village Model |
Primary outcome
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.
1 secondary outcome
Social Network Inventory
Time frame: 1, 3, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Yes. On completion of the study, we will provide coded IDP to other researchers
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Village Model implementation in people with Aging and Hiv, run by University of California, San Diego at 2 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Theoretical Framework Acceptability Scale (time frame: 12 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 21 Feb 2023.