Virus Infection, RNAGenXNCT05534425
Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange
A study testing GenX intergenerational mentoring program in people with Virus Infection, RNA, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virus Infection, RNA
- What is being tested?
- GenX intergenerational mentoring program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any health condition that would put participant at risk by enrollment/participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA School of Medicine
Los Angeles, California, 90095
About this study
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.
Read the 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.
- Conditions
- Virus Infection, RNA
- Being tested
- GenX intergenerational mentoring program
- Medical subject headings
- RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenX intergenerational mentoring programBehavioural
Also called GenX
GenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills.
| Study group | Role | What they receive |
|---|---|---|
| Immediate GenX | Experimental | Participants immediately commence GenX program activity (intergenerational mentoring) Receives: 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 Receives: Behavioral: GenX intergenerational mentoring program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start26 Sep 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus Infection, RNAStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Steve Cole, Ph.D., University of California, Los Angeles
- Investigators
- Steven Cole, Ph.D., Principal investigator, Professor of Medicine & PsychiatryTeresa E Seeman, Ph.D., Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534425
- Sponsor's protocol ID
- 21-001388
- Other IDs
- R01AG073053
- Acronym
- GenX
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
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.
PubMed 31589939
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Innate Anti-Viral Resistance Through A Community-Based Intervention - Generation Xchange
- ClinicalTrials.gov ID
- NCT05534425
- Acronym / sponsor ID
- GenX / 21-001388
- Conditions
- Virus Infection, RNA
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized to Immediate GenX intervention vs. Waitlist Control delayed intervention
| Arm | Type | Receives |
|---|---|---|
| Immediate GenX | Experimental | Behavioral: GenX intergenerational mentoring programParticipants immediately commence GenX program activity (intergenerational mentoring) |
| Delayed GenX | Active comparator | Behavioral: GenX intergenerational mentoring programParticipants engage in parallel training/educational activities, and subsequently commence GenX program activity after 3 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any health condition that would put participant at risk by enrollment/participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenX intergenerational mentoring programAlso: GenXGenX trains older adults to collaborate with K-3rd grade teachers in mentoring high-need elementary school students in core reading and math skills. | Behavioural | Delayed GenX, Immediate GenX |
Primary outcome
Concentration of Type I interferon antiviral activity (bioassay International Units / mL)
Time frame: 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.
2 secondary outcomes
Respiratory virus antibody concentration (WHO international units BAU/mL)
Time frame: 10 months
Pro-inflammatory cytokine concentration (pg/mL)
Time frame: 10 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 31589939Seeman 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.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Cole, Ph.D. principal investigator
Professor of Medicine & Psychiatry
Teresa E Seeman, Ph.D. principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GenX intergenerational mentoring program in people with Virus Infection, RNA, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Type I interferon antiviral activity (bioassay International Units / mL) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.