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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Virus Infection, RNA

Intervention / Treatment
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* Behavioral: GenX intergenerational mentoring program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate GenX<br>Participants immediately commence GenX program activity (intergenerational mentoring) | Behavioral: GenX intergenerational mentoring program<br>* GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.<br>* Other names: GenX;|
| Active Comparator: Delayed GenX<br>Participants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months | Behavioral: GenX intergenerational mentoring program<br>* GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.<br>* Other names: GenX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Type I interferon antiviral activity (bioassay International Units / mL) | 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. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory virus antibody concentration (WHO international units BAU/mL) | 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. | 10 months | 
| Pro-inflammatory cytokine concentration (pg/mL) | 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. | 10 months |