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Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention

Primary Purpose

Human Papilloma Virus, Cervical Cancer, Human Papillomavirus Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WoW and BNI
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring HPV vaccinaton, Cervical cancer screening, Web-based mobile health education, brief negotiated interview (BNI

Eligibility Criteria

9 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. Parent/guardian with a male child who provides consent to have child's HPV vaccination status checked in EMR.
  3. Parent/guardian with a male child who has neither initiated the HPV vaccine nor completed the series
  4. Parent/guardian and male child with the ability to read and write in English.
  5. Parent/guardian and male child have access to a smartphone.

Exclusion Criteria:

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects receiving WoW and BNI

Arm Description

The behavioral intervention (WoW and BNI) will supplement the subject's standard of care by incorporating interactive messaging, reminders, patient education, and enhanced provider communication.

Outcomes

Primary Outcome Measures

HPV vaccine series start and completion
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 Outcome Measures

HPV and Cervical Cancer awareness and knowledge
Change in knowledge of HPV vaccination and cervical cancer will be measured using a survey, which is under development, that includes questions about HPV and HPV vaccination. It will be administered before and again after the intervention and changes in responses will be compared.
Provider-patient communication about HPV vaccine and cervical cancer
Based on participants' entries onto the WoW website, a list of their concerns and questions about HPV vaccine and cervical cancer will be created and this list will be brought to a clinical visit with their providers. Following the clinical visit, participants will be asked whether providers addressed their questions and concerns about HPV vaccine and cervical cancer using a short questionnaire with a 5 point likert scale where 1=completely addressed and 5= not at all addressed. Lower scores are favorable.
Wheel of Wellness (WoW) feasibility
The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.
Wheel of Wellness (WoW) feasibility
The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.

Full Information

First Posted
November 14, 2017
Last Updated
October 8, 2019
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03346915
Brief Title
Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Cervical Cancer, Human Papillomavirus Infection, Oropharyngeal Cancer, Vaginal Cancer, Vulvar Cancer, Anal Cancer, Penile Cancer
Keywords
HPV vaccinaton, Cervical cancer screening, Web-based mobile health education, brief negotiated interview (BNI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We are proposing a single arm proof of concept. We will recruit 30 parents/guardians and their age-eligible child for the single arm proof of concept. For this proof of concept/pilot trial, we will assess the feasibility and impact of WOW to improve provider communication about HPV vaccination and increase the initial and complete vaccination rates for both boys and girls aged 9-17 and to enhance knowledge and awareness about risks and benefits of HPV vaccine among dyads. The power of our proposed pilot for determining intervention effects is limited. However, because we are proposing a proof of concept pilot and feasibility study, in our experience and that of others, our proposed sample size generally provides sufficient data to estimate subject retention, distribution of variables and feasibility as we plan for a larger-multi-site RCT of the proposed study. We expect our intervention to demonstrate feasibility of the intervention in a clinic setting.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving WoW and BNI
Arm Type
Experimental
Arm Description
The behavioral intervention (WoW and BNI) will supplement the subject's standard of care by incorporating interactive messaging, reminders, patient education, and enhanced provider communication.
Intervention Type
Behavioral
Intervention Name(s)
WoW and BNI
Intervention Description
The Text/web based health information technology system, WoW, will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening. 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 brief negotiated interview will encourage and empower participants to have positive behavioral changes in regards to their health.
Primary Outcome Measure Information:
Title
HPV vaccine series start and completion
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HPV and Cervical Cancer awareness and knowledge
Description
Change in knowledge of HPV vaccination and cervical cancer will be measured using a survey, which is under development, that includes questions about HPV and HPV vaccination. It will be administered before and again after the intervention and changes in responses will be compared.
Time Frame
6-12 months
Title
Provider-patient communication about HPV vaccine and cervical cancer
Description
Based on participants' entries onto the WoW website, a list of their concerns and questions about HPV vaccine and cervical cancer will be created and this list will be brought to a clinical visit with their providers. Following the clinical visit, participants will be asked whether providers addressed their questions and concerns about HPV vaccine and cervical cancer using a short questionnaire with a 5 point likert scale where 1=completely addressed and 5= not at all addressed. Lower scores are favorable.
Time Frame
one week after provider visit throughout the duration of the study
Title
Wheel of Wellness (WoW) feasibility
Description
The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.
Time Frame
6 months
Title
Wheel of Wellness (WoW) feasibility
Description
The feasibility of WoW will be assessed by using a short questionnaire that measures both how easy the WoW site is to navigate and how frequently participants used the WoW site.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Joseph, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrating a Health Information Technology System for Primary and Secondary Cervical Cancer Prevention

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