NCT03501992

Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

Completed NA Results posted Last updated 24 October 2024

What this trial tests

NA trial testing Current care in Papillomavirus Vaccines in 9,242 participants. Completed in 1 September 2023.

Timeline

1 April 2018

Primary endpoint
31 August 2022

1 September 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	9,242
Start date	1 April 2018
Primary completion	31 August 2022
Estimated completion	1 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Current care
• Reminder-recall
• Audit-and-feedback
• Combined reminder-recall and audit-and-feedback

Conditions studied

• Papillomavirus Vaccines — all drugs for Papillomavirus Vaccines →

Sponsor

Mayo Clinic

Who can join

Adults 11 to 12, any sex, with Papillomavirus Vaccines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Human Papillomavirus or HPV-vaccine-dose Receipt Primary · The dose had to have been received during the 12-month-long study step.

The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.

Group	Value	95% CI
Usual Care	782
Parent Reminder-Recall Letter	578
Provider Audit-Feedback Intervention.	408
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	1056

Initiation Secondary · The initiating dose had to have been received during the 12-month-long study step.

The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their first doses of the HPV vaccine series in the study step who received the first dose of HPV vaccine dose due by the end of the study step, thus initiating the HPV vaccine series.

Group	Value	95% CI
Usual Care	482
Parent Reminder-Recall Letter	329
Provider Audit-Feedback Intervention.	251
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	490

Completion Secondary · The final dose had to have been received during the 12-month-long study step.

The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their final doses of the HPV vaccine series in the study step who received the final dose of HPV vaccine dose due by the end of the study step, thus completing the HPV vaccine series.

Group	Value	95% CI
Usual Care	300
Parent Reminder-Recall Letter	249
Provider Audit-Feedback Intervention.	157
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	566

HPV-vaccine-dose Receipt in Females Secondary · The dose had to have been received during the 12-month-long study step.

The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible females in the study step who received the dose of HPV vaccine dose due by the end of the study step.

Group	Value	95% CI
Usual Care	385
Provider Audit-Feedback Intervention.	296
Parent Reminder-Recall Letter	188
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	517

HPV-vaccine-dose Receipt in Males Secondary · The dose had to have been received during the 12-month-long study step.

The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males in the study step who received the dose of HPV vaccine dose due by the end of the study step.

Group	Value	95% CI
Usual Care	397
Provider Audit-Feedback Intervention.	282
Parent Reminder-Recall Letter	220
Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions	539

Sponsor's own description

Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been disappointingly low and lags behind other adolescent vaccines. This study seeks to test interventions targeting health care system, provider, and patient factors to improve the population uptake of the HPV vaccine.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial.
   Finney Rutten LJ, Griffin JM, St Sauver JL, MacLaughlin K, et al · · 2024 · cited 14× · PMID 37983062 · DOI 10.1001/jamapediatrics.2023.4932
2. Parent-reported Barriers and Parental Beliefs Associated with Intentions to Obtain HPV Vaccination for Children in a Primary care Patient Population in Minnesota, USA.
   Zhu X, Jacobson RM, MacLaughlin KL, Sauver JS, et al · · 2023 · cited 13× · PMID 36920709 · DOI 10.1007/s10900-023-01205-9
3. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial.
   Finney Rutten LJ, Radecki Breitkopf C, St Sauver JL, Croghan IT, et al · · 2018 · cited 10× · PMID 30001723 · DOI 10.1186/s13012-018-0778-x
4. Multilevel Intervention and Human Papillomavirus Vaccination Disparities: A Secondary Analysis of a Cluster Randomized Trial.
   Kong WY, Finney Rutten LJ, Herrin J, St Sauver JL, et al · · 2025 · cited 1× · PMID 40622715 · DOI 10.1001/jamanetworkopen.2025.18895
5. Impact of Interventions to Improve Human Papillomavirus Vaccine Uptake on Other Vaccines Due: A Secondary Analysis of a Randomized Trial.
   Jacobson RM, Herrin J, Jenkins G, Griffin JM, et al · · 2025 · cited 1× · PMID 40490190 · DOI 10.1016/j.acap.2025.102870
6. Evaluation of parent reminder-recall letters to promote human papillomavirus vaccination.
   Griffin JM, Zhu X, Kong WY, Jacobson RM, et al · · 2025 · cited 1× · PMID 39758286 · DOI 10.1016/j.pmedr.2024.102942
7. Provider Perceptions and Use of Audit-Feedback and Communication Strategies to Improve Human Papillomavirus Vaccine Uptake.
   Zhu X, Jacobson RM, Griffin JM, MacLaughlin KL, et al · · 2025 · cited 1× · PMID 39395612 · DOI 10.1016/j.acap.2024.10.005
8. Trial-Based Costs for Interventions to Improve HPV Vaccine Uptake.
   Hung A, Finney Rutten LJ, Griffin JM, MacLaughlin KL, et al · · 2025 · PMID 41632129 · DOI 10.1001/jamanetworkopen.2025.50657