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
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Vaccines||Behavioral: Community Pharmacists Vaccinating Against Cancer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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)|
|Official Title:||Community Pharmacists Vaccinating Against Cancer (CPVAC): A Pilot Randomized Controlled Trial Aimed at Increasing Human Papillomavirus Vaccine Completion Rates Among Racially/Ethnically Diverse Yout|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
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.
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.
No Intervention: Control group
Control group participants will return to the primary care practitioner to complete the HPV vaccine series (usual care).
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072159
|Contact: Alexis M Koskan, PhDfirstname.lastname@example.org|
|Contact: Suganya Karuppana, MDemail@example.com|
|United States, Arizona|
|Adelante Healthcare Mesa||Recruiting|
|Mesa, Arizona, United States, 85201|