A Study to Evaluate Community-Based Measures to Increase RSV Vaccine Use Among Latino Adults

Not Applicable

Not yet recruiting

• Conditions: Older Adults Without Any Specific Clinical Condition; Social Networks; RSV Immunization; Vaccine Uptake

• Registration Number: NCT07171164
• Lead Sponsor: University of California, San Francisco

Brief Summary

In collaboration with community-based organizations, this study will focus on increasing RSV vaccine use among Latinos. We 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).

Detailed Description

In this type 1 hybrid-implementation study we will utilize a well-established community-academic partnership to achieve multiple aims. In the Motivate phase, we will randomize 400 Latino older adults to community health worker (CHW) counseling and text message nudges vs. CHW delivered RSV vaccine vs. text-message nudges alone. The primary outcome in the Motivate phase is RSV vaccine uptake. In the Activate phase, using a parallel design we will randomize 350 Latino adults (18-49 years) to CHW 'activation' counseling to encourage them to discuss RSV vaccine with people over 50 and older in their network plus text-message nudges, vs. text-message nudges alone. The primary outcome for the Activate phase is the average proportion of older adults in participants' social network with whom they discussed RSV vaccination. Interventions in both phases will be adapted using community-based participatory research principles.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-05
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Primary Completion: 2028-11
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• 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

Motivate Aim

Exclusion Criteria

• 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

Motivate Aim Inclusion Criteria:

• 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

Activate Trial Exclusion Criteria:

• Household member enrolled in Aim 1 or 2
• Unable to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Motivate Aim Primary Outcome	60 days from study enrollment	RSV Vaccine uptake at 60 days per California Immunization Registry (CAIR) or per medical record
Activate Aim Primary Outcome	60 days after study enrollment	Self-reported average proportion of social network contacts 50 years or older with whom participant discussed RSV vaccination at 60 days

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States