GenX: Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange

Sponsor
University of California, Los Angeles (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534425
Collaborator
National Institute on Aging (NIA) (NIH)
160
1
2
59
2.7

Study Details

Study Description

Brief Summary

This randomized controlled trial will test whether a recently developed community-based intergenerational mentoring program known as Generation Xchange (GenX) can enhance antiviral resistance in older African-American women and men in a low-SES urban community. Additional studies will identify the biological processes that promote resistance to respiratory virus infections and viral disease in older African-American women and men.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: GenX intergenerational mentoring program
N/A

Detailed Description

This randomized controlled intervention trial (planned n=160) will test whether participation in the Generation Xchange (GenX) intergenerational mentoring program can reduces vulnerability to respiratory virus infections (COVID, influenzas, colds), increase antiviral immune activity (Type I interferon responses), and reduce inflammatory immune activity in older African-American women and men living in a socioeconomically disadvantaged urban community. Blood samples will also be collected to determine which biological factors are most important in protecting older African-Americans from respiratory virus infection, and which of those factors is affected by the GenX intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized to Immediate GenX intervention vs. Waitlist Control delayed interventionRandomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
Masking:
Single (Investigator)
Masking Description:
All data collected, assayed, coded, and analyzed by researchers blind to study condition and participant identity
Primary Purpose:
Basic Science
Official Title:
Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate GenX

Participants immediately commence GenX program activity (intergenerational mentoring)

Behavioral: GenX intergenerational mentoring program
GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.
Other Names:
  • GenX
  • Active Comparator: Delayed GenX

    Participants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months

    Behavioral: GenX intergenerational mentoring program
    GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.
    Other Names:
  • GenX
  • Outcome Measures

    Primary Outcome Measures

    1. Concentration of Type I interferon antiviral activity (bioassay International Units / mL) [10 months]

      Blood cell production of Type I interferon activity will stimulated by exposure to a fixed dose of model viral protein (TruCulture Resiquimod R848 tubes) and quantifying Type I interferon concentration in the cell culture supernatant fluid using the standard Armstrong bioassay (Armstrong, J.A. Cytopathic effect inhibition assay for interferon: microculture plate assay. Methods in enzymology 78, 381-387 (1981).) Antiviral activity is quantified as International Units of Interferon activity / mL.

    Secondary Outcome Measures

    1. Respiratory virus antibody concentration (WHO international units BAU/mL) [10 months]

      Respiratory virus infection (cold, influenza, COVID) will be assessed by multiplex IgG serological assay (MesoScale Discovery V-PLEX COVID-19 Respiratory Panel 2; https://www.mesoscale.com/products/covid-19-respiratory-panel-2-igg-k15372u/). Concentrations are quantified as WHO international Binding Antibody Units / mL.

    2. Pro-inflammatory cytokine concentration (pg/mL) [10 months]

      Blood plasma and blood cell culture supernatant fluids will be assayed for expression of pro-inflammatory cytokines (e.g., IL1B, IL6, TNF) using the MesoScale Discovery U-PLEX Macrophage M1 Combo 1 hu assay (https://www.mesoscale.com/products/u-plex-macrophage-m1-combo-1-human-k15336k/). Measurement units are pg of cytokine / mL.

    Other Outcome Measures

    1. Antiviral cell prevalence [10 months]

      Levels of key antiviral immune cells (e.g., dendritic cells, CD8+ T cells, etc.) will be assessed in blood samples by flow cytometry

    2. Antiviral gene regulation [10 months]

      Activity of antiviral genes (RNA) and transcription factors will be assessed in blood cells

    3. Well-being [10 months]

      Surveys will measure eudaimonic well-being and hedonic well-being

    4. Loneliness [10 months]

      Surveys will measure loneliness, social isolation, and social support

    5. Depressive symptoms [10 months]

      Surveys will measure symptoms of depression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Participating in the GenX intergenerational mentoring program

    • All GenX mentors > 50 years of age are eligible to participate in this research

    • GenX program participation requires:

    • Reside in neighborhood of GenX schools (South-Central Los Angeles)

    • Pass basic literacy and cognitive function tests

    Exclusion Criteria:
    • Any health condition that would put participant at risk by enrollment/participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA School of Medicine Los Angeles California United States 90095

    Sponsors and Collaborators

    • University of California, Los Angeles
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Steven Cole, Ph.D., Professor of Medicine & Psychiatry
    • Principal Investigator: Teresa E Seeman, Ph.D., Professor of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Steve Cole, Ph.D., Professor of Medicine and Psychiatry & Biobehavioral Sciences, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT05534425
    Other Study ID Numbers:
    • 21-001388
    • R01AG073053
    First Posted:
    Sep 9, 2022
    Last Update Posted:
    Sep 9, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2022