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Enrolling by Invitation

NCT Number: NCT05534425

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

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.

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Key information

Conditions

Virus Infection, RNA Infections RNA Virus Infections Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA School of Medicine

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GenX intergenerational mentoring program

Behavioral

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Respiratory virus antibody concentration (WHO international units BAU/mL)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Antiviral cell prevalence

    Time frame: 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

    Time frame: 10 months

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

  3. Well-being

    Time frame: 10 months

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

  4. Loneliness

    Time frame: 10 months

    Surveys will measure loneliness, social isolation, and social support

  5. Depressive symptoms

    Time frame: 10 months

    Surveys will measure symptoms of depression

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: GenX

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2022
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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