NCT05534425

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Sep 2022Aug 2027

First Submitted

Initial submission to the registry

August 31, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

4.8 years

First QC Date

August 31, 2022

Last Update Submit

August 27, 2025

Conditions

Virus Infection, RNA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    10 months

  • Pro-inflammatory cytokine concentration (pg/mL)

    10 months

Other Outcomes (5)

  • Antiviral cell prevalence

    10 months

  • Antiviral gene regulation

    10 months

  • Well-being

    10 months

  • +2 more other outcomes

Study Arms (2)

Immediate GenX

EXPERIMENTAL

Participants immediately commence GenX program activity (intergenerational mentoring)

Behavioral: GenX intergenerational mentoring program

Delayed GenX

ACTIVE COMPARATOR

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

Behavioral: GenX intergenerational mentoring program

Interventions

GenX intergenerational mentoring programBEHAVIORAL

GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.

Also known as: GenX
Delayed GenXImmediate GenX

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

    PMID: 31589939BACKGROUND

MeSH Terms

Conditions

RNA Virus Infections

Condition Hierarchy (Ancestors)

Virus DiseasesInfections

Study Officials

  • Steven Cole, Ph.D.

    Professor of Medicine & Psychiatry

    PRINCIPAL INVESTIGATOR

  • Teresa E Seeman, Ph.D.

    Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
All data collected, assayed, coded, and analyzed by researchers blind to study condition and participant identity
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Psychiatry & Biobehavioral Sciences

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 9, 2022

Study Start

September 26, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations

US(1)