Enhancing Innate Anti-Viral Resistance Through a Community-Based Intervention - Generation Xchange
- Conditions
- Virus Infection, RNA
- Interventions
- Behavioral: GenX intergenerational mentoring program
- Registration Number
- NCT05534425
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 160
- 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
- Any health condition that would put participant at risk by enrollment/participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate GenX GenX intergenerational mentoring program Participants immediately commence GenX program activity (intergenerational mentoring) Delayed GenX GenX intergenerational mentoring program Participants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months
- Primary Outcome Measures
Name Time Method Concentration of Type I interferon antiviral activity (bioassay International Units / mL) 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 Outcome Measures
Name Time Method Respiratory virus antibody concentration (WHO international units BAU/mL) 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.
Pro-inflammatory cytokine concentration (pg/mL) 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.
Trial Locations
- Locations (1)
UCLA School of Medicine
🇺🇸Los Angeles, California, United States