Human PapillomavirusNCT02377843
Making Effective Human Papillomavirus (HPV) Vaccine Recommendations
A study testing Participatory and Efficient in people with Human Papillomavirus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Participatory and Efficient
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 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
Who may be able to join
- Eligible clinics are pediatric and family medicine practice clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics must have at least one pediatric or family medicine physician who provides HPV vaccine to adolescents ages 11-12.
Who cannot join
- Ineligible clinics include those that have participated in a quality improvement study to increase HPV vaccination rates in the last 6 months or plan to participate in such a study in the next 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Making Effective HPV Vaccine Recommendations
Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide effective recommendations for the vaccine using participatory or efficient communication strategies.
This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric and family medicine clinics receiving a participatory communication training, efficient communication training, or no training. Ten clinics will be randomly assigned to each study arm for a total of 30 clinics. The primary outcome of this study is to compare the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV vaccination initiation coverage in 13-17 year old adolescents.
- Conditions
- Human Papillomavirus
- Being tested
- Participatory, Efficient
- Keywords
- vaccine, physician training, adolescent health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParticipatoryBehavioural
The participatory intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
- Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
- Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making
- Practice using the communication strategy via role play
- Discussion on applying the communication strategy to medical practice
EfficientBehavioural
The efficient intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
- Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
- Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines
- Practice using the communication strategy via role play
- Discussion on applying the communication strategy to medical practice
| Study group | Role | What they receive |
|---|---|---|
| Participatory | Experimental | This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the participatory study arm will receive a 1-hour in-person communication training. Receives: Behavioral: Participatory |
| Efficient | Experimental | This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the efficient study arm will receive a 1-hour in-person communication training. Receives: Behavioral: Efficient |
| Control | No intervention | This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the control study arm will not receive a 1-hour in-person communication training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds
Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).
Measured: Baseline, month 6
Secondary outcomes (37)
6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
Analysis controlling for sex. Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
Vaccination as measured by NCIR.
Measured: Baseline, month 6
Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm
3-item knowledge scale (low vaccine coverage, vaccine effectiveness, recommendation impact on vaccine uptake).
Measured: Pre-training, Post-training
Change in clinician self-efficacy, efficient arm vs. participatory arm
2-item self-efficacy scale (effectively recommending HPV vaccination, addressing parents' concerns).
Measured: Pre-training, Post-training, week 2
Change in clinician recommendation quality, efficient arm vs. participatory arm
4-item recommendation quality scale (urgency, consistency, timeliness, strength of endorsement) (Gilkey et al.).
Measured: Pre-training, week 2
Change in clinician communication of routine use, efficient arm vs. participatory arm
1 item on communicating HPV vaccination as part of routine adolescent care.
Measured: Pre-training, Post-training, week 2
Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory
1 item on communicating HPV vaccination as cancer prevention.
Measured: Pre-training, Post-training, week 2
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
Vaccination as measured by NCIR.
Measured: Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
Vaccination as measured by NCIR.
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), North Carolina Department of Health and Human Services, Pfizer
- Responsible party
- Sponsor
- Investigators
- Noel T Brewer, PhD, Principal investigator, University of North Carolina, Chapel HillMelissa B Gilkey, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377843
- Sponsor's protocol ID
- 14-1873
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Malo TL, Hall ME, Brewer NT, Lathren CR, Gilkey MB. Why is announcement training more effective than conversation training for introducing HPV vaccination? A theory-based investigation. Implement Sci. 2018 Apr 19;13(1):57. doi: 10.1186/s13012-018-0743-8.
PubMed 29673374Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161764. doi: 10.1542/peds.2016-1764. Epub 2016 Dec 5.
PubMed 27940512
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Effective HPV Vaccine Recommendations
- ClinicalTrials.gov ID
- NCT02377843
- Acronym / sponsor ID
- 14-1873
- Conditions
- Human Papillomavirus
- Keywords
- vaccine, physician training, adolescent health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), North Carolina Department of Health and Human Services, Pfizer
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Mar 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.
Coverage of HPV vaccination among US teens is low, far below Healthy People 2020 goals. A central reason for low coverage is infrequent and inadequate healthcare provider recommendation of HPV vaccine. The proposed intervention aims to train clinicians to provide effective recommendations for the vaccine using participatory or efficient communication strategies.
This study will evaluate the effectiveness of two communication trainings to increase HPV vaccination coverage among adolescent patients. We will compare HPV vaccination for pediatric and family medicine clinics receiving a participatory communication training, efficient communication training, or no training. Ten clinics will be randomly assigned to each study arm for a total of 30 clinics. The primary outcome of this study is to compare the change in clinics' levels of HPV vaccination initiation coverage among 11-12 year old adolescent patients from baseline to 6 month follow-up. Secondarily, we will compare the change in HPV vaccination initiation coverage in 13-17 year old adolescents.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participatory | Experimental | Behavioral: ParticipatoryThis arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the participatory study arm will receive a 1-hour in-person communication training. |
| Efficient | Experimental | Behavioral: EfficientThis arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the efficient study arm will receive a 1-hour in-person communication training. |
| Control | No intervention | –This arm includes 10 pediatric or family medicine clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics randomized to the control study arm will not receive a 1-hour in-person communication training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible clinics are pediatric and family medicine practice clinics located within a 2-hour driving distance of Chapel Hill, NC, and have 100 or more 11-12 year old patients with active records in the NCIR. Clinics must have at least one pediatric or family medicine physician who provides HPV vaccine to adolescents ages 11-12.
Key exclusion criteria (1 listed)
- Ineligible clinics include those that have participated in a quality improvement study to increase HPV vaccination rates in the last 6 months or plan to participate in such a study in the next 6 months.
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 |
|---|---|---|
| ParticipatoryThe participatory intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components: 1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine 2. Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making 3. Practice using the communication strategy via role play 4. Discussion on applying the communication strategy to medical practice | Behavioural | Participatory |
| EfficientThe efficient intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components: 1. Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine 2. Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines 3. Practice using the communication strategy via role play 4. Discussion on applying the communication strategy to medical practice | Behavioural | Efficient |
Primary outcome
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds
Time frame: Baseline, month 6
Analysis controlling for sex. Vaccination as measured by North Carolina Immunization Registry (NCIR).
37 secondary outcomes
6 month % change in HPV vaccination (≥ 1 dose), efficient arm vs. participatory arm, 11-12 year olds
Time frame: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 6
3 month % change in tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, control arm vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 11-12 year olds
Time frame: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 6
3 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 3
6 month % change in Tdap vaccination, control arm vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 6
3 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 3
6 month % change in meningococcal vaccination (≥ 1 dose), control arm vs. each intervention arm, 13-17 year olds
Time frame: Baseline, month 6
Change in clinician HPV vaccine knowledge, efficient arm vs. participatory arm
Time frame: Pre-training, Post-training
Change in clinician self-efficacy, efficient arm vs. participatory arm
Time frame: Pre-training, Post-training, week 2
Change in clinician recommendation quality, efficient arm vs. participatory arm
Time frame: Pre-training, week 2
Change in clinician communication of routine use, efficient arm vs. participatory arm
Time frame: Pre-training, Post-training, week 2
Change in clinician communication of HPV vaccination as cancer prevention, efficient arm vs. participatory
Time frame: Pre-training, Post-training, week 2
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
Time frame: Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
Time frame: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old females
Time frame: Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 11-12 year old males
Time frame: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
Time frame: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
Time frame: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old females
Time frame: Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 11-12 year old males
Time frame: Baseline, month 6
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
Time frame: Baseline, month 3
3 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
Time frame: Baseline, month 3
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old females
Time frame: Baseline, month 6
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm, 13-17 year old males
Time frame: Baseline, month 6
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
Time frame: Baseline, month 3
3 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
Time frame: Baseline, month 3
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old females
Time frame: Baseline, month 6
6 month % change in HPV vaccine completion (3 doses), control vs. each intervention arm, 13-17 year old males
Time frame: Baseline, month 6
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 12 Sep 2016.
- Derived from this study: PubMed 29673374Malo TL, Hall ME, Brewer NT, Lathren CR, Gilkey MB. Why is announcement training more effective than conversation training for introducing HPV vaccination? A theory-based investigation. Implement Sci. 2018 Apr 19;13(1):57. doi: 10.1186/s13012-018-0743-8.
- Derived from this study: PubMed 27940512Brewer NT, Hall ME, Malo TL, Gilkey MB, Quinn B, Lathren C. Announcements Versus Conversations to Improve HPV Vaccination Coverage: A Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161764. doi: 10.1542/peds.2016-1764. Epub 2016 Dec 5.
- Individual participant dataSharing planned: No
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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.
Noel T Brewer, PhD principal investigator
University of North Carolina, Chapel Hill
Melissa B Gilkey, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participatory and Efficient in people with Human Papillomavirus, run by University of North Carolina, Chapel Hill 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: finished, as of the sponsor's last update on 12 Sep 2016. 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?
6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds (time frame: Baseline, month 6). 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 NCT02377843, which also lists 2 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 12 Sep 2016.