Clinical trial NCT05534425: Enhancing Innate Anti-Viral Resistance Through a Community-Based Intervention - Generation Xchange
Official title: Enhancing Innate Anti-Viral Resistance Through a Community-Based Intervention - Generation Xchange
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Virus Infection, RNA
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-09-09
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of Type I interferon antiviral activity (bioassay International Units / mL)
timeFrame: 10 months
Secondary outcomes:
measure: Respiratory virus antibody concentration (WHO international units BAU/mL)
timeFrame: 10 months
measure: Pro-inflammatory cytokine concentration (pg/mL)
timeFrame: 10 months
Other outcomes:
measure: Antiviral cell prevalence
timeFrame: 10 months
measure: Antiviral gene regulation
timeFrame: 10 months
measure: Well-being
timeFrame: 10 months
measure: Loneliness
timeFrame: 10 months
measure: Depressive symptoms
timeFrame: 10 months
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
Study officials:
affiliation: Professor of Medicine & Psychiatry
name: Steven Cole, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine
name: Teresa E Seeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.