ImmunosuppresionNCT06596148
Improving Shingrix Vaccination Among US Veterans Receiving Immunosuppression
A study testing Access to Shingrix dashboard in people with Immunosuppresion, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immunosuppresion
- What is being tested?
- Access to Shingrix dashboard
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 30 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to be included in the study, clinicians need to work at a VHA facility and have access to the electronic health record.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: VA Quality Improvement Research and Training Initiative
The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities.
The main question[s] it aims to answer is: Will vaccination rates improve more rapidly for facilities with access to the dashboard compare to facilities without access? VA facility personnel will be granted access to the dashboard and outcomes (vaccination rates) will be measured using electronic health record data.
Read the detailed description
Assignment of the intervention will occur at the facility level. Outcomes (vaccination) will be assessed for patients cared for at each facility.
- Conditions
- Immunosuppresion
- Being tested
- Access to Shingrix dashboard
- Keywords
- Wait-list control randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Shingrix dashboardOther
The investigators will build and grant access to a clinical dashboard that exists behind the VA firewall. The dashboard will identify Veterans from each VA facility who are receiving immunosuppressants (prescribed via the VA). The dashboard will also provide information about the number of Shingrix vaccines each patient has received (which have been documented within the VA electronic health record). VA clinicians will have access to view information about patients based on their VA electronic health record permissions.
| Study group | Role | What they receive |
|---|---|---|
| Early dashboard access | Experimental | The early dashboard access arm will receive access to the Shingrix dashboard as soon as the study begins. Receives: Other: Access to Shingrix dashboard |
| Wait list control arm | Other | The wait list control arm will receive no intervention for 6-9 months; after this period, this arm will also receive access to the Shingrix dashboard. Receives: Other: Access to Shingrix dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least 1 Shingrix vaccine documented, by facility
Percentage of patients with at least 1 Shingrix vaccinations documented, by facility
Measured: From enrollment until end of follow up at 18 months.
Secondary outcomes (1)
Percentage of patients with at least 2 Shingrix vaccinations documented, by facility
Percentage of patients with at least 2 Shingrix vaccinations documented, by facility
Measured: From enrollment until end of follow up at 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppresionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will use a wait-list control design; clinicians from VA facilities will be randomized to receive access to the dashboard early vs. after a 6-9 month delay. The investigators will compare Shingrix vaccination rates in the two groups of facilities.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- Gabriela Schmajuk, MD MS, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596148
- Sponsor's protocol ID
- 15-18358- SHINGRIX
- Other IDs
- I50HX003266
- Status last verified
- Apr 2025
- First submitted
- 9 Sep 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: VA data is only available to VA investigators with specific permission under DUA.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VA Quality Improvement Research and Training Initiative
- ClinicalTrials.gov ID
- NCT06596148
- Acronym / sponsor ID
- 15-18358- SHINGRIX
- Conditions
- Immunosuppresion
- Keywords
- Wait-list control randomized trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities.
The main question[s] it aims to answer is: Will vaccination rates improve more rapidly for facilities with access to the dashboard compare to facilities without access? VA facility personnel will be granted access to the dashboard and outcomes (vaccination rates) will be measured using electronic health record data.
Detailed description
Assignment of the intervention will occur at the facility level. Outcomes (vaccination) will be assessed for patients cared for at each facility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a wait-list control design; clinicians from VA facilities will be randomized to receive access to the dashboard early vs. after a 6-9 month delay. The investigators will compare Shingrix vaccination rates in the two groups of facilities.
| Arm | Type | Receives |
|---|---|---|
| Early dashboard access | Experimental | Other: Access to Shingrix dashboardThe early dashboard access arm will receive access to the Shingrix dashboard as soon as the study begins. |
| Wait list control arm | Other | Other: Access to Shingrix dashboardThe wait list control arm will receive no intervention for 6-9 months; after this period, this arm will also receive access to the Shingrix dashboard. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- In order to be included in the study, clinicians need to work at a VHA facility and have access to the electronic health record.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Access to Shingrix dashboardThe investigators will build and grant access to a clinical dashboard that exists behind the VA firewall. The dashboard will identify Veterans from each VA facility who are receiving immunosuppressants (prescribed via the VA). The dashboard will also provide information about the number of Shingrix vaccines each patient has received (which have been documented within the VA electronic health record). VA clinicians will have access to view information about patients based on their VA electronic health record permissions. | Other | Early dashboard access, Wait list control arm |
Primary outcome
Percentage of patients with at least 1 Shingrix vaccine documented, by facility
Time frame: From enrollment until end of follow up at 18 months.
Percentage of patients with at least 1 Shingrix vaccinations documented, by facility
1 secondary outcome
Percentage of patients with at least 2 Shingrix vaccinations documented, by facility
Time frame: From enrollment until end of follow up at 18 months.
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 6 Apr 2025.
- Individual participant dataSharing planned: No. VA data is only available to VA investigators with specific permission under DUA.
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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.
Gabriela Schmajuk, MD MS principal investigator
San Francisco VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to Shingrix dashboard in people with Immunosuppresion, 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with at least 1 Shingrix vaccine documented, by facility (time frame: From enrollment until end of follow up at 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.