VaccineNCT02993965
State Immunization Information Systems to Improve HPV Vaccination Rates
A study testing Vaccine Reminder/Recall in people with Vaccine and Human Papiloma Virus Vaccine, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine, Human Papiloma Virus Vaccine, HPV Vaccine
- What is being tested?
- Vaccine Reminder/Recall
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77,716 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 11 through 17 years of age (trial 1)
- 11 through 14 years of age (trial 2)
- defaulted to our selected clinics within CIIS
- is either due for an HPV dose at baseline according to Advisory Committee on Immunization Practices (ACIP) guidelines, or
- has initiated but not yet completed the HPV series at baseline
Who cannot join
- Has completed the HPV vaccine series according to Advisory Committee on Immunization Practices (ACIP) guidelines
- Any child whose parents have requested removal from the immunization registry
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).
Read the detailed description
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve HPV vaccination rates among adolescents ages 11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has recently been recommended. The investigators will extend previous research on effectiveness of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of centralized R/R in two states--one with and one without mandated reporting of vaccinations to IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV vaccine R/R model in which partnerships of public health systems and primary care practices in two states (NY, CO) collaborate to remind parents about HPV vaccination.
Specific Aims and hypotheses:
Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for centralized R/R for other vaccines to fit HPV vaccine IIS R/R.
Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2 or #3)] among teens.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this study). The investigators will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.
Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.
Aim #3: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) R/R using autodialer (phone) or mail in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2)] and decreasing time to completion among teens 11-14.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) R/R using either autodialer (phone) or postcard (mail) in increasing initiation and completion rates for the newly implemented HPV vaccine 2 dose series in adolescents ages 11-14 years. We will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R using either an autodailer or postcards (up to 2 reminders per dose needed) compared to usual care (0 reminders from this study). We will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 3a: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care.
Hypothesis 3b: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 3c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care. IIS-C R/R using autodialer will be more cost effective than IIS-C R/R using postcards.
Aim #4: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other IISs [Yr. 4].
By the end of the study investigators will have a feasible, sustainable, cost-effective model for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other HPV-related cancers.
- Conditions
- Vaccine, Human Papiloma Virus Vaccine, HPV Vaccine, Immunization, Health Registry, Adolescent Health
- Being tested
- Vaccine Reminder/Recall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Reminder/RecallOther
The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Control 11-17 | No intervention | No additional intervention done aside from usual care for 11-17 year olds |
| 1 R/R per Dose 11-17 | Experimental | Sending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds Receives: Other: Vaccine Reminder/Recall |
| 2 R/R per Dose 11-17 | Experimental | Sending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds Receives: Other: Vaccine Reminder/Recall |
| 3 R/R per Dose 11-17 | Experimental | Sending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds Receives: Other: Vaccine Reminder/Recall |
| Control 11-14 | No intervention | No additional intervention done aside from usual care for 11-14 year olds |
| Phone R/R 11-14 | Experimental | Sending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds Receives: Other: Vaccine Reminder/Recall |
| Mail R/R 11-14 | Experimental | Sending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds Receives: Other: Vaccine Reminder/Recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Measured: 5 months
Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Measured: 5 months
Secondary outcomes (4)
Differences between arms - initiation
Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group.
Measured: 5 months
Differences between arms - completion
Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group. For 11-14 year olds, completion is 2 doses. For 15-17 year olds, completion is 3 doses.
Measured: 20 months
Differences between modalities - initiation
Are mail or phone reminders most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested with the 11-14 year old group only.
Measured: 5 months
Differences between modalities - completion
Are mail or phone reminders most effective and cost effective for completion. This will be tested only in the 11-14 year old group, so completion will equal 2nd dose. Because the second dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 17 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start21 Feb 2017
- Primary completion15 Mar 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccineStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77,716 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Kempe, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993965
- Sponsor's protocol ID
- 15-1560
- Other IDs
- 1R01CA187707-01A1
- Status last verified
- Aug 2020
- First submitted
- 29 Nov 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual data with other researchers
Publications
Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.
PubMed 33846054
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State Immunization Information Systems to Improve HPV Vaccination Rates
- ClinicalTrials.gov ID
- NCT02993965
- Acronym / sponsor ID
- 15-1560
- Conditions
- Vaccine, Human Papiloma Virus Vaccine, HPV Vaccine, Immunization, Health Registry, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77,716 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Cancer Institute (NCI)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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 overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).
Detailed description
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve HPV vaccination rates among adolescents ages 11-17, and additionally look at the 11-14 year old subset for whom a new 2 dose series has recently been recommended. The investigators will extend previous research on effectiveness of centralized R/R to a new population--adolescents due for HPV vaccine-- and test the use of centralized R/R as a cancer-prevention strategy. Investigators will assess the effect of centralized R/R in two states--one with and one without mandated reporting of vaccinations to IISs, and disseminate IIS R/R to other states. Investigators will implement, evaluate (using the RE-AIM framework 31-36), and disseminate a collaborative, IIS-based centralized HPV vaccine R/R model in which partnerships of public health systems and primary care practices in two states (NY, CO) collaborate to remind parents about HPV vaccination.
Specific Aims and hypotheses:
Aim #1: Adapt IIS messages and delivery systems (e.g., algorithms) previously developed for centralized R/R for other vaccines to fit HPV vaccine IIS R/R.
Aim #2: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2 or #3)] among teens.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) autodialer (phone) R/R in increasing initiation and completion rates for the HPV vaccine series in adolescents ages 11-17 years. The investigators will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R (1, 2, or 3 reminders per dose) compared to usual care (0 reminders from this study). The investigators will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 2a: IIS-C R/R will result in higher HPV vaccination rates than usual care.
Hypothesis 2b: IIS-C R/R will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 2c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care.
Aim #3: Assess the impact and cost-effectiveness of centralized IIS-based (IIS-C) R/R using autodialer (phone) or mail in increasing vaccine rates [initial dose (HPV#1) and a complete series (HPV#2)] and decreasing time to completion among teens 11-14.
Conduct a pragmatic trial, to assess the impact and cost effectiveness of centralized IIS-based (IIS-C) R/R using either autodialer (phone) or postcard (mail) in increasing initiation and completion rates for the newly implemented HPV vaccine 2 dose series in adolescents ages 11-14 years. We will use a within-practice design, randomizing patients within randomly selected primary care practices to IIS-C R/R using either an autodailer or postcards (up to 2 reminders per dose needed) compared to usual care (0 reminders from this study). We will apply the RE-AIM framework to evaluate the reach, effectiveness/cost effectiveness, adoption, and implementation of IIS-C R/R.
Hypothesis 3a: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care.
Hypothesis 3b: IIS-C R/R (either modality) will result in higher HPV vaccination rates than usual care in key subgroups (males and females, younger and older teens, urban//rural teens).
Hypothesis 3c: IIS-C R/R will be more cost-effective (cost/vaccine received) than usual care. IIS-C R/R using autodialer will be more cost effective than IIS-C R/R using postcards.
Aim #4: Disseminate IIS-C R/R across NY and CO and pilot in four IISs: (a) Develop an IIS-C HPV R/R toolkit, (b) Use a technical advisory group, (c) Initiate IIS-C R/R in four other IISs [Yr. 4].
By the end of the study investigators will have a feasible, sustainable, cost-effective model for HPV vaccine reminders that can be used nationally to prevent cervical cancer and other HPV-related cancers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Control 11-17 | No intervention | –No additional intervention done aside from usual care for 11-17 year olds |
| 1 R/R per Dose 11-17 | Experimental | Other: Vaccine Reminder/RecallSending up to one recall notice per dose of HPV vaccine needed for 11-17 year olds |
| 2 R/R per Dose 11-17 | Experimental | Other: Vaccine Reminder/RecallSending up to two recall notices per dose of HPV vaccine needed for 11-17 year olds |
| 3 R/R per Dose 11-17 | Experimental | Other: Vaccine Reminder/RecallSending up to three recall notices per dose of HPV vaccine needed for 11-17 year olds |
| Control 11-14 | No intervention | –No additional intervention done aside from usual care for 11-14 year olds |
| Phone R/R 11-14 | Experimental | Other: Vaccine Reminder/RecallSending up to two recall notices per dose of HPV vaccine needed via autodialer for 11-14 year olds |
| Mail R/R 11-14 | Experimental | Other: Vaccine Reminder/RecallSending up to two recall notices per dose of HPV vaccine needed via mailed postcards for 11-14 year olds |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 11 through 17 years of age (trial 1)
- 11 through 14 years of age (trial 2)
- defaulted to our selected clinics within CIIS
- is either due for an HPV dose at baseline according to Advisory Committee on Immunization Practices (ACIP) guidelines, or
- has initiated but not yet completed the HPV series at baseline
Key exclusion criteria (2 listed)
- Has completed the HPV vaccine series according to Advisory Committee on Immunization Practices (ACIP) guidelines
- Any child whose parents have requested removal from the immunization registry
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 |
|---|---|---|
| Vaccine Reminder/RecallThe investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination. | Other | 1 R/R per Dose 11-17, 2 R/R per Dose 11-17, 3 R/R per Dose 11-17, Mail R/R 11-14, Phone R/R 11-14 |
Primary outcome
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)
Time frame: 5 months
Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)
Time frame: 5 months
Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry.
4 secondary outcomes
Differences between arms - initiation
Time frame: 5 months
Differences between arms - completion
Time frame: 20 months
Differences between modalities - initiation
Time frame: 5 months
Differences between modalities - completion
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Derived from this study: PubMed 33846054Gurfinkel D, Kempe A, Albertin C, Breck A, Zhou X, Vangala S, Beaty B, Rice J, Tseng CH, Campbell JD, Valderrama R, Rand C, Humiston SG, Roth H, Arora S, Szilagyi P. Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial. J Adolesc Health. 2021 Oct;69(4):579-587. doi: 10.1016/j.jadohealth.2021.02.023. Epub 2021 Apr 10.
- Individual participant dataSharing planned: No. We will not be sharing individual data with other researchers
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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. This study is not recruiting at the moment.
Allison Kempe, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Reminder/Recall in people with Vaccine and Human Papiloma Virus Vaccine, run by University of Colorado, Denver 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry) (time frame: 5 months). 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 NCT02993965, which also lists 1 linked publication.
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 20 Aug 2020.