[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05534425":3,"trial-entities:NCT05534425":91,"trial-summary:NCT05534425":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":63,"locations":66,"central_contacts":76,"overall_officials":77,"references":85,"see_also_links":90},"NCT05534425","21-001388","Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange","ENROLLING_BY_INVITATION","2027-08","2025-08","2025-09-04","2022-09-26","University of California, Los Angeles","OTHER",false,"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.","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.",[18],"Virus Infection, RNA",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},160,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":35},"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.",[33,34],"Delayed GenX","Immediate GenX",[36],"GenX",[38],{"measure":39,"description":40,"timeFrame":41},"Concentration of Type I interferon antiviral activity (bioassay International Units \u002F 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 \u002F mL.","10 months",[43,46],{"measure":44,"description":45,"timeFrame":41},"Respiratory virus antibody concentration (WHO international units BAU\u002FmL)","Respiratory virus infection (cold, influenza, COVID) will be assessed by multiplex IgG serological assay (MesoScale Discovery V-PLEX COVID-19 Respiratory Panel 2; https:\u002F\u002Fwww.mesoscale.com\u002Fproducts\u002Fcovid-19-respiratory-panel-2-igg-k15372u\u002F). Concentrations are quantified as WHO international Binding Antibody Units \u002F mL.",{"measure":47,"description":48,"timeFrame":41},"Pro-inflammatory cytokine concentration (pg\u002FmL)","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:\u002F\u002Fwww.mesoscale.com\u002Fproducts\u002Fu-plex-macrophage-m1-combo-1-human-k15336k\u002F). Measurement units are pg of cytokine \u002F mL.","ALL","50 Years",null,true,{"inclusion":54,"exclusion":60,"raw_text":62},[55,56,57,58,59],"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",[61],"Any health condition that would put participant at risk by enrollment\u002Fparticipation","Inclusion Criteria:\n\n* Participating in the GenX intergenerational mentoring program\n* All GenX mentors \\> 50 years of age are eligible to participate in this research\n* GenX program participation requires:\n* Reside in neighborhood of GenX schools (South-Central Los Angeles)\n* Pass basic literacy and cognitive function tests\n\nExclusion Criteria:\n\n* Any health condition that would put participant at risk by enrollment\u002Fparticipation",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"UCLA School of Medicine","Los Angeles","California","90095","United States",{"lat":74,"lon":75},34.05223,-118.24368,[],[78,82],{"name":79,"affiliation":80,"role":81},"Steven Cole, Ph.D.","Professor of Medicine & Psychiatry","PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":84,"role":81},"Teresa E Seeman, Ph.D.","Professor of Medicine",[86],{"pmid":87,"type":88,"citation":89},"31589939","BACKGROUND","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\u002Fj.psyneuen.2019.104468. Epub 2019 Sep 27.",[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"RNA Virus Infections",[],{"nct_id":4,"found":14,"summary":51,"prompt_version":51}]