Older Adults Without Any Specific Clinical ConditionNCT07171164
A Study to Evaluate Community-Based Measures to Increase RSV Vaccine Use Among Latino Adults
A study testing Motivate Aim: CHW text message reminders and counseling, Motivate Aim: CHW text message reminders only and Activate Aim: CHW text message reminders and counseling in people with Older Adults Without Any Specific Clinical Condition and Social Networks, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults Without Any Specific Clinical Condition, Social Networks, RSV Immunization
- What is being tested?
- Motivate Aim: CHW text message reminders and counseling, Motivate Aim: CHW text message reminders only and Activate Aim: CHW text message reminders and counseling
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94110
RSV Uptake Study Coordinator, 415-608-8339, informatevrs@ucsf.edu
About this study
Official title: Motivate Vaccinate Activate: An Effectiveness-Implementation Trial to Assess the Impact of a Multi-Component Community-Based Intervention to Increase RSV Vaccine Uptake Among Latino Older Adults
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).
Read the 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
- Being tested
- Motivate Aim: CHW text message reminders and counseling, Motivate Aim: CHW text message reminders only, Activate Aim: CHW text message reminders and counseling, Activate Aim: CHW text message reminders only
- Keywords
- RSV, RSV vaccine, Social networks, Counseling, Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivate Aim: CHW text message reminders and counselingBehavioural
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 onlyBehavioural
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 counselingBehavioural
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 onlyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Motivate Aim: CHW text message reminders and counseling | Experimental | Not described Receives: Behavioral: Motivate Aim: CHW text message reminders and counseling |
| Motivate Aim: CHW text message reminders only | Active comparator | Not described Receives: Behavioral: Motivate Aim: CHW text message reminders only |
| Activate Aim: CHW text message reminders and counseling | Experimental | Not described Receives: Behavioral: Activate Aim: CHW text message reminders and counseling |
| Activate Aim: CHW text message reminders only | Active comparator | Not described Receives: Behavioral: Activate Aim: CHW text message reminders only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivate Aim Primary Outcome - RSV Vaccine Uptake
RSV vaccine uptake at 60 days per California Immunization Registry (CAIR) or per medical record
Measured: 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
Measured: 60 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start10 Sep 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Older Adults Without Any Specific Clinical ConditionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Mission Language Vocational School
- Responsible party
- Sponsor
- Investigators
- Carina Marquez, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171164
- Sponsor's protocol ID
- Motivate Vaccinate Activate
- Other IDs
- R01MD019749
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30452608Juhn 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.
PubMed 36662530Zheng 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.
PubMed 36280891Mahmud 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.
PubMed 36098112McLaughlin 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.
PubMed 35873302
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivate Vaccinate Activate: An Effectiveness-Implementation Trial to Assess the Impact of a Multi-Component Community-Based Intervention to Increase RSV Vaccine Uptake Among Latino Older Adults
- ClinicalTrials.gov ID
- NCT07171164
- Acronym / sponsor ID
- Motivate Vaccinate Activate
- Conditions
- Older Adults Without Any Specific Clinical Condition, Social Networks, RSV Immunization, Vaccine Uptake
- Keywords
- RSV, RSV vaccine, Social networks, Counseling, Healthy adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Mission Language Vocational School
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivate Aim: CHW text message reminders and counselingParticipants receive both text message reminders and a counseling session, along with information about RSV and the vaccine, to encourage RSV vaccine uptake. | Behavioural | Motivate Aim: CHW text message reminders and counseling |
| Motivate Aim: CHW text message reminders onlyParticipants receive text message reminders along with information about RSV and the RSV vaccine to encourage vaccine uptake, but do not receive the counseling intervention | Behavioural | Motivate Aim: CHW text message reminders only |
| Activate Aim: CHW text message reminders and counselingParticipants 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 | Behavioural | Activate Aim: CHW text message reminders and counseling |
| Activate Aim: CHW text message reminders onlyParticipants 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 | Behavioural | Activate Aim: CHW text message reminders only |
Primary outcome
Motivate Aim Primary Outcome - RSV Vaccine Uptake
Time frame: 60 days from study enrollment
RSV vaccine uptake at 60 days per California Immunization Registry (CAIR) or per medical record
Activate Aim Primary Outcome - Proportion of Contacts with whom RSV Vaccination Discussed
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 30452608Ackerson 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.
- Background: PubMed 36662530Juhn 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.
- Background: PubMed 36280891Zheng 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.
- Background: PubMed 36098112Mahmud 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.
- Background: PubMed 35873302McLaughlin 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.
- CDC RSV-NET Interactive DashboardLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Older Adults Without Any Specific Clinical Condition
Enrolling by invitation
The Effect of Virtual Reality in Older Adults
Older Adults (65 Years and Older), Older Adults Without Any Specific Clinical Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carina Marquez, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivate Aim: CHW text message reminders and counseling, Motivate Aim: CHW text message reminders only and Activate Aim: CHW text message reminders and counseling in people with Older Adults Without Any Specific Clinical Condition and Social Networks, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RSV Uptake Study Coordinator (415-608-8339, informatevrs@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivate Aim Primary Outcome - RSV Vaccine Uptake (time frame: 60 days from study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171164, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.