Papillomavirus VaccinesAFIXNCT02370459
AFIX to Improve HPV Vaccination
A study testing AFIX in-person consultation and AFIX webinar consultation in people with Papillomavirus Vaccines and Adolescent Health Services, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial summary
The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Vaccines, Adolescent Health Services
- What is being tested?
- AFIX in-person consultation and AFIX webinar consultation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2015to Nov 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI with
- at least 500 active records for patients, ages 11-17, in their states' immunization information systems.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Michigan Department of Community Health
Lansing, Michigan, 48909
Washington State Department of Health
Olympia, Washington, 98504
Illinois Department of Public Health
Springfield, Illinois, 62761
About this study
Official title: Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.
- Being tested
- AFIX in-person consultation, AFIX webinar consultation
- Keywords
- Papillomavirus Vaccines, Immunization, Quality Improvement, Adolescent Health Services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFIX in-person consultationOther
Also called AFIX, Assessment, Feedback, Incentives, and eXchange Program
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
AFIX webinar consultationOther
Also called AFIX, Assessment, Feedback, Incentives, and eXchange Program
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation. |
| AFIX in-person consultation | Experimental | This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff. Receives: Other: AFIX in-person consultation |
| AFIX webinar consultation | Experimental | This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff. Receives: Other: AFIX webinar consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex
Measured: Six months
Secondary outcomes (35)
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.
Measured: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).
Measured: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
HPV vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
HPV vaccination (3 doses), 13-17 year olds
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
Tdap vaccination, 13-17 year olds
Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
Tdap vaccination, 11-12 year olds
Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
HPV vaccination (3 doses), 13-17 year olds
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
Tdap vaccination, 13-17 year olds
Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Measured: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
HPV vaccination (3 doses), 11-12 year olds
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
Tdap vaccination, 11-12 year olds
Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
HPV vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
HPV vaccination (3 doses), 13-17 year olds
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
Tdap vaccination, 13-17 year olds
Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
Tdap vaccination, 11-12 year olds
Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
HPV vaccination (3 doses), 13-17 year olds
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
Tdap vaccination, 13-17 year olds
Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus VaccinesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Washington State, Department of Health, Illinois Department of Public Health, Michigan Department of Community Health, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Melissa B Gilkey, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)Noel T Brewer, PhD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370459
- Sponsor's protocol ID
- 13-3599
- Other IDs
- 71272
- Acronym
- AFIX
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2015
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No raw data will be shared with the general public or other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
- ClinicalTrials.gov ID
- NCT02370459
- Acronym / sponsor ID
- AFIX / 13-3599
- Keywords
- Papillomavirus Vaccines, Immunization, Quality Improvement, Adolescent Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Washington State, Department of Health, Illinois Department of Public Health, Michigan Department of Community Health, Harvard Medical School (HMS and HSDM)
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Feb 2015 (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 University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation. |
| AFIX in-person consultation | Experimental | Other: AFIX in-person consultationThis arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff. |
| AFIX webinar consultation | Experimental | Other: AFIX webinar consultationThis arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 |
|---|---|---|
| AFIX in-person consultationAlso: AFIX, Assessment, Feedback, Incentives, and eXchange ProgramThe adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components. | Other | AFIX in-person consultation |
| AFIX webinar consultationAlso: AFIX, Assessment, Feedback, Incentives, and eXchange ProgramThe adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components. | Other | AFIX webinar consultation |
Primary outcome
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex
35 secondary outcomes
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Time frame: Six months
Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
Time frame: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 13-17 year olds
Time frame: Six months
HPV vaccination (3 doses), 13-17 year olds
Time frame: Six months
Tdap vaccination, 13-17 year olds
Time frame: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Time frame: Twelve months
Tdap vaccination, 11-12 year olds
Time frame: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Time frame: Twelve months
HPV vaccination (3 doses), 13-17 year olds
Time frame: Twelve months
Tdap vaccination, 13-17 year olds
Time frame: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Time frame: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
HPV vaccination (3 doses), 11-12 year olds
Time frame: Six months
Tdap vaccination, 11-12 year olds
Time frame: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 13-17 year olds
Time frame: Six months
HPV vaccination (3 doses), 13-17 year olds
Time frame: Six months
Tdap vaccination, 13-17 year olds
Time frame: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
Time frame: Twelve months
Tdap vaccination, 11-12 year olds
Time frame: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Time frame: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Time frame: Twelve months
HPV vaccination (3 doses), 13-17 year olds
Time frame: Twelve months
Tdap vaccination, 13-17 year olds
Time frame: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Time frame: Twelve 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 24 Feb 2017.
- Individual participant dataSharing planned: No. No raw data will be shared with the general public or 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.
Melissa B Gilkey, PhD principal investigator
Harvard Medical School (HMS and HSDM)
Noel T Brewer, PhD principal investigator
University of North Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFIX in-person consultation and AFIX webinar consultation in people with Papillomavirus Vaccines and Adolescent Health Services, run by University of North Carolina, Chapel Hill at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
HPV vaccination (≥1 dose), 11-12 year olds (time frame: Six 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 24 Feb 2017.