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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD019749 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Mission Language Vocational School | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivate Aim: CHW text message reminders and counseling | Experimental |
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| Motivate Aim: CHW text message reminders only | Active Comparator |
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| Activate Aim: CHW text message reminders and counseling | Experimental |
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| Activate Aim: CHW text message reminders only | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivate Aim: CHW text message reminders and counseling | Behavioral | Participants receive both text message reminders and a counseling session, along with information about RSV and the vaccine, to encourage RSV vaccine uptake. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Motivate Aim Inclusion Criteria:
Motivate Aim Exclusion Criteria:
Motivate Aim Inclusion Criteria:
Activate Trial Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RSV Uptake Study Coordinator | Contact | 415-608-8339 | informatevrs@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carina Marquez, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30452608 | Background | 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. | |
| 36662530 | Background | 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. |
| Label | URL |
|---|---|
| CDC RSV-NET Interactive Dashboard | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2025 | Sep 4, 2025 |
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| Motivate Aim: CHW text message reminders only | 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 |
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| Activate Aim: CHW text message reminders and counseling | 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 |
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| Activate Aim: CHW text message reminders only | 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 |
|
| 36280891 | Background | 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. |
| 36098112 | Background | 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. |
| 35873302 | Background | 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. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Aim 2 Motivate Informed Consent Form | Aug 7, 2025 | Sep 4, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Aim 3 Activate Informed Consent Form | Aug 7, 2025 | Sep 4, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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