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

NCT03346915 | Completed

• 1 other identifier: H-36669
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (4)

• 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

  6 months

• Wheel of Wellness (WoW) feasibility

  12 months

Study Arms (1)

Subjects receiving WoW and BNI

EXPERIMENTAL

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.

Behavioral: WoW and BNI

Interventions

WoW and BNI BEHAVIORAL

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.

Subjects receiving WoW and BNI

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Oropharyngeal Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Anus Neoplasms; Penile Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Vaginal Diseases; Vulvar Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Penile Diseases; Male Urogenital Diseases

Study Officials

• Natalie Joseph, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 20, 2017
• Study Start: August 14, 2018
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)