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

University of California San Francisco (UCSF)

Status: Enrolling

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

Treatments: Behavioral: Motivate Aim: CHW text message reminders and counseling; Behavioral: Activate Aim: CHW text message reminders and counseling; Behavioral: Activate Aim: CHW text message reminders only; Behavioral: Motivate Aim: CHW text message reminders only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07171164

Motivate Vaccinate Activate

R01MD019749 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

In this type 1 hybrid-implementation study, the investigators will utilize a well-established community-academic partnership to achieve multiple aims. In the Motivate phase, the study 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, investigators 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Motivate Aim 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 4 patient groups

Motivate Aim: CHW text message reminders and counseling

Experimental group

Treatment:

Behavioral: Motivate Aim: CHW text message reminders and counseling

Motivate Aim: CHW text message reminders only

Active Comparator group

Treatment:

Behavioral: Motivate Aim: CHW text message reminders only

Activate Aim: CHW text message reminders and counseling

Experimental group

Treatment:

Behavioral: Activate Aim: CHW text message reminders and counseling

Activate Aim: CHW text message reminders only

Active Comparator group

Treatment:

Behavioral: Activate Aim: CHW text message reminders only