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

NCT ID: NCT07171164

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2028-11-30

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).

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Motivate Aim: CHW text message reminders and counseling

Group Type: EXPERIMENTAL

Motivate Aim: CHW text message reminders and counseling

Intervention Type: BEHAVIORAL

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 only

Group Type: ACTIVE_COMPARATOR

Motivate Aim: CHW text message reminders only

Intervention Type: BEHAVIORAL

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

Activate Aim: CHW text message reminders and counseling

Group Type: EXPERIMENTAL

Activate Aim: CHW text message reminders and counseling

Intervention Type: BEHAVIORAL

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 only

Group Type: ACTIVE_COMPARATOR

Activate Aim: CHW text message reminders only

Intervention Type: BEHAVIORAL

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

Interventions

Motivate Aim: CHW text message reminders and counseling

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

Intervention Type: BEHAVIORAL

Motivate Aim: CHW text message reminders only

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

Intervention Type: BEHAVIORAL

Activate Aim: CHW text message reminders and counseling

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

Intervention Type: BEHAVIORAL

Activate Aim: CHW text message reminders only

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Mission Language Vocational School

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carina Marquez, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

RSV Uptake Study Coordinator

Role: CONTACT

informatevrs@ucsf.edu

415-608-8339

Facility Contacts

RSV Uptake Study Coordinator

Role: primary

informatevrs@ucsf.edu

415-608-8339

References

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.

Reference Type: BACKGROUND

PMID: 30452608 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36662530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36280891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36098112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35873302 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Aim 2 Motivate Informed Consent Form

View Document

Document Type: Informed Consent Form: Aim 3 Activate Informed Consent Form

View Document

Other Identifiers

R01MD019749

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Motivate Vaccinate Activate

Identifier Type: -

Identifier Source: org_study_id