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Community Pharmacists Vaccinate Against Cancer (CPVAC)

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ClinicalTrials.gov Identifier: NCT04072159
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Adelante Healthcare
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Arizona State University

Tracking Information
First Submitted Date  ICMJE May 28, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
HPV vaccine completion (preliminary efficacy) [ Time Frame: 6 months post baseline ]
Whether child completed HPV vaccine series with pharmacist (self-report on post-test and patient medical record)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Intervention feasibility in participant enrollment/study completion [ Time Frame: 1 year after intervention baseline (March 2020) ]
    Ability to enroll 90 participants into study and retain study participants, ability to retain 90 participants post-intervention (as evidenced by collecting intervention and control group post-tests) - Compare recruitment/enrollment and intervention completion
  • Intervention feasibility in implementation (assessed via in-depth interviews) [ Time Frame: 1 year after intervention baseline (March 2020) ]
    In-depth interviews with providers at intervention clinic, participating pharmacists, and patients in intervention group (to explore potential implementation issues, practicality of the intervention design, any needs for intervention adaptation, ease of integration into current practice, perceived positive or negative effects of intervention on medical practice, and fit of intervention on medical clinic/pharmacy practice)
  • Intervention acceptability (assessed qualitatively via in-depth interviews) Intervention feasibility [ Time Frame: 1 year after intervention baseline (March 2020) ]
    In-depth interviews with patients and caregivers (conducted at same time as feasibility interviews with patients/caregivers) related to acceptability of the intervention, the relative advantage of receiving adolescent vaccines from a pharmacist, and the compatibility and potential complexity of this healthcare delivery approach.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Pharmacists Vaccinate Against Cancer
Official Title  ICMJE Community Pharmacists Vaccinating Against Cancer (CPVAC): A Pilot Randomized Controlled Trial Aimed at Increasing Human Papillomavirus Vaccine Completion Rates Among Racially/Ethnically Diverse Yout
Brief Summary Latino and African American populations have a higher rate of human papillomavirus vaccine initiation of the vaccine; however, they have a significantly less likelihood of completing the vaccine series. Pharmacists are licensed to vaccinate against the HPV virus. However, they are less likely to administer the vaccine. Although past research has recommended incorporating pharmacists to increase adolescent vaccination, no intervention studies, to our knowledge, have tested a healthcare delivery model that incorporates pharmacists to complete the HPV vaccine series. The aims of this pilot randomized controlled trial are to 1) determine the preliminary efficacy of an intervention to increase HPV vaccine series completion with the community pharmacist vs. with the primary care provider among racially/ethnically diverse participants; and 2) assess perceived intervention feasibility and acceptability of the intervention among intervention participants and primary care clinic staff.
Detailed Description Human papillomavirus (HPV) is the most common sexually transmitted infection, and persistent infection with oncogenic HPV strains causes cancer. Commercially available 9-valent HPV vaccines offer the potential of immunity against seven oncogenic strains and the two low-risk strains that cause over 90% of genital warts. The majority of HPV-related cancers and genital warts can be prevented through the timely uptake and completion of the HPV vaccine series. However, in 2016 only 37.5% of boys and 49.5% of girls completed the HPV vaccine series, and racial/ethnic minority youth populations are least likely to complete the vaccine series. More specifically, Latino and African American populations have a higher rate of initiation of the vaccine; however, they have a significantly less likelihood of completing the vaccine series. Past research with Latino and African American populations determined the following patient-level barriers to vaccine completion: caregivers' lack of awareness to receive additional vaccine doses, lack of time to attend an additional vaccine-only primary care clinic appointment, and other structural barriers that prohibit caregivers and their children from returning to primary care clinics for additional vaccine doses. Pharmacists are licensed to vaccinate against the HPV virus. However, they are less likely to administer the vaccine. Although past research has recommended incorporating pharmacists to increase adolescent vaccination, no intervention studies, to our knowledge, have tested a healthcare delivery model that incorporates pharmacists to complete the HPV vaccine series. We propose a randomized controlled pilot study titled Community Pharmacists Vaccinate Against Cancer (CPVAC). In CPVAC, the PI will oversample for ethnic minority (particularly African American and Hispanic) HPV vaccine age-eligible children and their caregivers to take part in the study. Patients will be randomized to intervention or control group. After enrolling in the study, primary care providers of patients in the Intervention Group will contact the patients' community pharmacy and prescribe the remaining HPV vaccine dose(s). The pharmacy will electronically update patients' files and schedule the HPV vaccine "refill" (additional doses) at the appropriate dosing schedule. The pharmacy will contact patients' caregivers when it is time to complete additional HPV vaccine dose(s). Control group participants will receive usual care, returning to their PCPs to complete the additional HPV vaccine doses. The aims of this study are to 1) determine the preliminary efficacy of CPVAC to increase HPV vaccine series completion with the community pharmacist vs. with the primary care provider among racially/ethnically diverse participants; and 2) assess perceived intervention feasibility and acceptability of CPVAC among intervention participants and primary care clinic staff. Findings from this pilot study can be used to inform a larger randomized controlled trial to examine intervention effectiveness and analyze the cost-benefit of working with community pharmacies to enhance HPV vaccine completion among diverse children.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This pilot intervention is a randomized controlled trial that uses a pre-test/post-test design. Caregivers of HPV vaccine age-eligible minors who are patients of a federally qualified health center, Adelante Healthcare Mesa, will be randomized to Intervention Group (pharmacy), or Control Group (usual care).
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human Papillomavirus Vaccines
Intervention  ICMJE Behavioral: Community Pharmacists Vaccinating Against Cancer
Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant. A sample (n=30) of intervention and control group participants will be invited to participate in an in-depth interview to gauge both parents' and children's' acceptability of this intervention.
Study Arms  ICMJE
  • Experimental: Intervention group
    For the intervention group, primary care providers will refer patients who have received the initial HPV vaccine to receive the additional doses at patients' community retail pharmacy.
    Intervention: Behavioral: Community Pharmacists Vaccinating Against Cancer
  • No Intervention: Control group
    Control group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Caregivers of a child between ages 9-18 who has either not received any HPV vaccine doses or has received only initial HPV dose
  • Receives care at Adelante Healthcare Mesa
  • Fluent in English and/or Spanish
  • Willing to provide informed consent

Exclusion Criteria:

  • Caregivers whose child has completed additional HPV vaccine doses
  • Child is over age 18 years (no caregiver consent needed)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alexis M Koskan, PhD 602-827-2792 alexis.koskan@asu.edu
Contact: Suganya Karuppana, MD skaruppana@adelantehealthcare.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04072159
Other Study ID Numbers  ICMJE STUDY00007938
5U54MD002316-12 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Yes Deidentified data related to patient vaccine completion (number of vaccines completed) will be shared. A Microsoft Excel file of deidentified survey results will be shared. When the qualitative data has removed all identifying information, interview data can be shared.
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE
  • Adelante Healthcare
  • National Institute on Minority Health and Health Disparities (NIMHD)
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP