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Clinical Trials/NCT03346915
NCT03346915
Completed
N/A

Integrating a Health Information Technology System With a Web-based Mobile Health Educational Intervention to Support More Effective Provider-patient Communication and HPV Vaccine Utilization

Boston Medical Center1 site in 1 country60 target enrollmentAugust 14, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Human Papilloma Virus
Sponsor
Boston Medical Center
Enrollment
60
Locations
1
Primary Endpoint
HPV vaccine series start and completion
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The project aims to increase HPV vaccination and cervical cancer screening through a web-based mobile health education program called, Wheel of Wellness (WoW) and a brief negotiated interview (BNI). The in-person BNI and WoW system will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening.

Detailed Description

WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The researchers will conduct a single armed proof of concept where the participants will be actively using WoW. The in-person BNI will empower participants to have positive behavioral changes in regards to their health by giving them appropriate health information as well as answering their questions and concerns about cervical cancer prevention and screening.

Registry
clinicaltrials.gov
Start Date
August 14, 2018
End Date
April 19, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parent/guardian with a child between the ages of 9 to 17 who receives primary care at one of the participating sites and their male child.
  • Parent/guardian with a male child who provides consent to have child's HPV vaccination status checked in EMR.
  • Parent/guardian with a male child who has neither initiated the HPV vaccine nor completed the series
  • Parent/guardian and male child with the ability to read and write in English.
  • Parent/guardian and male child have access to a smartphone.

Exclusion Criteria

  • Parent/guardian's eligible child is pregnant.
  • Parent/guardian's has begun or completed the HPV series.
  • Parent/guardian, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent.

Outcomes

Primary Outcomes

HPV vaccine series start and completion

Time Frame: 6 months

The primary outcome of interest is receipt of the first dose and completion of the three-dose or two-dose series of HPV vaccine by participants within six months of intervention by EMR review.

Secondary Outcomes

  • HPV and Cervical Cancer awareness and knowledge(6-12 months)
  • Provider-patient communication about HPV vaccine and cervical cancer(one week after provider visit throughout the duration of the study)
  • Wheel of Wellness (WoW) feasibility(12 months)

Study Sites (1)

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