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

Not Applicable

Completed

• Conditions: Cervical Cancer; Human Papillomavirus Infection; Anal Cancer; Human Papilloma Virus; Vaginal Cancer; Vulvar Cancer; Oropharyngeal Cancer; Penile Cancer
• Interventions: Behavioral: WoW and BNI

• Registration Number: NCT03346915
• Lead Sponsor: Boston Medical Center

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.

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-20
• Study Start: 2018-08-14
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects receiving WoW and BNI	WoW and BNI	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.

Primary Outcome Measures

Name	Time	Method
HPV vaccine series start and completion	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 Outcome Measures

Name	Time	Method
HPV and Cervical Cancer awareness and knowledge	6-12 months	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	one week after provider visit throughout the duration of the study	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	12 months	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.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States