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NCT Number: NCT03346915

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

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.

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Key information

Conditions

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

Age range

9 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. HPV and Cervical Cancer awareness and knowledge

    Time frame: 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.

  2. Provider-patient communication about HPV vaccine and cervical cancer

    Time frame: 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.

  3. Wheel of Wellness (WoW) feasibility

    Time frame: 6 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.

  4. Wheel of Wellness (WoW) feasibility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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