NCT07171164

Brief Summary

In collaboration with community-based organizations, this study will focus on increasing RSV vaccine use among Latinos. The study will determine how effective community health worker counseling and text-message approaches are to (1) increase RSV vaccine use among older adults (Motivate phase) and (2) encourage younger adults to discuss RSV vaccination with their older friends and family members (Activate phase).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Sep 2025Nov 2028

First Submitted

Initial submission to the registry

September 5, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

3.1 years

First QC Date

September 5, 2025

Last Update Submit

September 24, 2025

Conditions

Older Adults Without Any Specific Clinical ConditionSocial NetworksRSV ImmunizationVaccine Uptake

Keywords

RSVRSV vaccineSocial networksCounselingHealthy adults

Outcome Measures

Primary Outcomes (2)

  • Motivate Aim Primary Outcome - RSV Vaccine Uptake

    RSV vaccine uptake at 60 days per California Immunization Registry (CAIR) or per medical record

    60 days from study enrollment

  • Activate Aim Primary Outcome - Proportion of Contacts with whom RSV Vaccination Discussed

    Self-reported average proportion of social network contacts 50 years or older with whom participant discussed RSV vaccination at 60 days

    60 days after study enrollment

Study Arms (4)

Motivate Aim: CHW text message reminders and counseling

EXPERIMENTAL
Behavioral: Motivate Aim: CHW text message reminders and counseling

Motivate Aim: CHW text message reminders only

ACTIVE COMPARATOR
Behavioral: Motivate Aim: CHW text message reminders only

Activate Aim: CHW text message reminders and counseling

EXPERIMENTAL
Behavioral: Activate Aim: CHW text message reminders and counseling

Activate Aim: CHW text message reminders only

ACTIVE COMPARATOR
Behavioral: Activate Aim: CHW text message reminders only

Interventions

Motivate Aim: CHW text message reminders and counselingBEHAVIORAL

Participants receive both text message reminders and a counseling session, along with information about RSV and the vaccine, to encourage RSV vaccine uptake.

Motivate Aim: CHW text message reminders and counseling
Motivate Aim: CHW text message reminders onlyBEHAVIORAL

Participants receive text message reminders along with information about RSV and the RSV vaccine to encourage vaccine uptake, but do not receive the counseling intervention

Motivate Aim: CHW text message reminders only
Activate Aim: CHW text message reminders and counselingBEHAVIORAL

Participants receive both text message reminders and a counseling session, along with information about RSV and the vaccine, to encourage discussion of RSV vaccine uptake among older adults in their social networks

Activate Aim: CHW text message reminders and counseling
Activate Aim: CHW text message reminders onlyBEHAVIORAL

Participants receive text message reminders along with information about RSV and the vaccine to encourage discussion of RSV vaccine uptake among older adults in their social networks, but do not receive the counseling intervention

Activate Aim: CHW text message reminders only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 years or older
  • Self-identify as Latino/a/x and/or indigenous groups from Latin America
  • Eligible for RSV vaccination per current CDC/ACIP recommendations
  • Fluent in Spanish or English
  • Has not received the RSV vaccine
  • Has a cell phone
  • Lives or works in San Francisco or Daly City
  • Able to provide informed consent

You may not qualify if:

  • Intent to move outside of San Francisco or Daly City in the next year
  • Nursing home resident
  • Household member participating in Aim 1 or 2
  • Unable to provide consent
  • Age 18-49 years
  • Self-identify as Latino/a/x and/or indigenous groups from Latin America
  • Fluent in English or Spanish
  • Has \>1 family member or friend 50 years or older who they have seen or spoken to for \>15 minutes in the last 6 months and who lives in the United States
  • Household member enrolled in Aim 1 or 2
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

RECRUITING

Related Publications (5)

  • Ackerson B, Tseng HF, Sy LS, Solano Z, Slezak J, Luo Y, Fischetti CA, Shinde V. Severe Morbidity and Mortality Associated With Respiratory Syncytial Virus Versus Influenza Infection in Hospitalized Older Adults. Clin Infect Dis. 2019 Jul 2;69(2):197-203. doi: 10.1093/cid/ciy991.

    PMID: 30452608BACKGROUND

  • Juhn YJ, Wi CI, Takahashi PY, Ryu E, King KS, Hickman JA, Yao JD, Binnicker MJ, Natoli TL, Evans TK, Sampathkumar P, Patten C, Luyts D, Pircon JY, Damaso S, Pignolo RJ. Incidence of Respiratory Syncytial Virus Infection in Older Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2023 Jan 3;6(1):e2250634. doi: 10.1001/jamanetworkopen.2022.50634.

    PMID: 36662530BACKGROUND

  • Zheng Z, Warren JL, Shapiro ED, Pitzer VE, Weinberger DM. Estimated incidence of respiratory hospitalizations attributable to RSV infections across age and socioeconomic groups. Pneumonia (Nathan). 2022 Oct 25;14(1):6. doi: 10.1186/s41479-022-00098-x.

    PMID: 36280891BACKGROUND

  • Mahmud SM, Xu L, Hall LL, Puckrein G, Thommes E, Loiacono MM, Chit A. Effect of race and ethnicity on influenza vaccine uptake among older US Medicare beneficiaries: a record-linkage cohort study. Lancet Healthy Longev. 2021 Mar;2(3):e143-e153. doi: 10.1016/S2666-7568(20)30074-X. Epub 2021 Feb 18.

    PMID: 36098112BACKGROUND

  • McLaughlin JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. eCollection 2022 Jul.

    PMID: 35873302BACKGROUND

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Carina Marquez, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RSV Uptake Study Coordinator

CONTACT

415-608-8339informatevrs@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

September 10, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)