Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings

NCT03033550 | Completed

• 1 other identifier: H-34457
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a mobile health educational intervention for Human PapillomaVirus (HPV) Vaccination promotion and cervical cancer screening in Primary Care settings is a feasible behavioral intervention to integrate as a primary and secondary cervical cancer prevention approach.Study Design: The investigators will conduct an open feasibility proof-of-concept trial using a single experimental group with all subjects receiving the behavioral intervention being studied. Outcome measures. The primary outcome of interest is receipt of the first dose and completion of the three-dose series of HPV vaccine within 6 month of intervention, this will be evaluated by Electronic medical review review.

Conditions

HPV-Related Carcinoma

Keywords

HPV vaccination; Cervical cancer screening; Primary care setting; Primary prevention of cervical cancer; Secondary prevention of cervical cancer; Mobile health information

Outcome Measures

Primary Outcomes (1)

• Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review

  The primary outcome of interest is receipt of the first dose and completion of the three or two-dose series of HPV vaccine by participants within 6 month of intervention, this will be evaluated by Electronic Measure Review. Unit of measure: Number of participants who received the first doses and who competed the total number of does based - recorded as percentage who receive the first dose, and completed the two or 3 doses.

  up to 6 months

Secondary Outcomes (2)

• Patient knowledge and provider-patient communication

  over 6 months

• provider communication about HPV vaccine

  through study completion, an average of 1 year

Other Outcomes (1)

• Cervical cancer screening rate

  through study completion, an average of 1 year

Study Arms (1)

single

EXPERIMENTAL

single arm- behavioral educational intervention of a brief negotiated mobile application

Behavioral: brief negotiated mobile application

Interventions

brief negotiated mobile application BEHAVIORAL

The intervention will supplement the standard of care with the following steps: (1) mobile- based brief negotiated Intervention ( BNI); (2) a customized companion communication vaccine report to be given before AFG sees provider; and (3) automated interactive Electronic Recall/Reminder Messages (Text messaging), including text messaging and access to a website which includes information about HPV, HPV Vaccine, and cervical cancer screening guideline.

single

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• AFG ages 30 years and older who receive primary care at the study sites.
• AFG consent to have cervical cancer screening status checked in Electronic Medical Record.
• AFG has a daughter between the ages of 11 to 17 who receive primary care at either
• Family Medicine or Pediatric and Adolescent primary care clinic at Boston Medical Center.
• AFG consent to have daughter's HPV vaccination status checked in Electronic Medical Record.
• AFG's daughter has neither initiated the HPV vaccine nor completed the three vaccine series
• AFG and daughter have the ability to read and write in English.
• AFG and daughter each have a cell phone with text messages capabilities.

You may not qualify if:

• The investigators will exclude based on the following criteria:
• AFG being seen for a sick visit.
• AFG has an adolescent daughter who is pregnant or is a mother.
• AFG has a daughter who has completed the three dose HPV vaccine series.
• AFG, in the opinion of the clinical staff, is cognitively impaired and unable to give informed consent and may not participate.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 27, 2017
• Study Start: May 8, 2017
• Primary Completion: May 21, 2018
• Study Completion: June 8, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)