Clinical trial NCT03346915: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HPV vaccine series start and completion
timeFrame: 6 months
Secondary outcomes:
measure: HPV and Cervical Cancer awareness and knowledge
timeFrame: 6-12 months
measure: Provider-patient communication about HPV vaccine and cervical cancer
timeFrame: one week after provider visit throughout the duration of the study
measure: Wheel of Wellness (WoW) feasibility
timeFrame: 6 months
measure: Wheel of Wellness (WoW) feasibility
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Natalie Joseph, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: