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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Virus Infection, RNA
• Intervention / Treatment: Behavioral: GenX intergenerational mentoring program

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiviral cell prevalence	Levels of key antiviral immune cells (e.g., dendritic cells, CD8+ T cells, etc.) will be assessed in blood samples by flow cytometry	10 months
Antiviral gene regulation	Activity of antiviral genes (RNA) and transcription factors will be assessed in blood cells	10 months
Well-being	Surveys will measure eudaimonic well-being and hedonic well-being	10 months
Loneliness	Surveys will measure loneliness, social isolation, and social support	10 months
Depressive symptoms	Surveys will measure symptoms of depression	10 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: 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

Publications and helpful links

General Publications

• Seeman T, Merkin SS, Goldwater D, Cole SW. Intergenerational mentoring, eudaimonic well-being and gene regulation in older adults: A pilot study. Psychoneuroendocrinology. 2020 Jan;111:104468. doi: 10.1016/j.psyneuen.2019.104468. Epub 2019 Sep 27.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; RNA Virus Infections
• Other Study ID Numbers: 21-001388; R01AG073053 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No