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

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ClinicalTrials.gov Identifier: NCT03033550
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Natalie Pierre-Joseph, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date July 9, 2018
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review [ Time Frame: up to 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Patient knowledge and provider-patient communication [ Time Frame: over 6 months ]
    The secondary outcomes are: (a) Change in knowledge of HPV, HPV vaccination, and cervical cancer screening as evaluated by pre/post intervention survey: unit of Measure: based on a 1-10 point scale, with 10 being the highest score;
  • provider communication about HPV vaccine [ Time Frame: through study completion, an average of 1 year ]
    greater provider communication about HPV vaccine : Unit of measure- the number of participants who responded yes to provider communication about HPV vaccine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2017)
Cervical cancer screening rate [ Time Frame: through study completion, an average of 1 year ]
Cervical cancer screening rate as evaluated by Electronic Medical Review review: Unit of Measure: Number of participants who has cervical cancer screening within the time guideline ( as measured and reported as percentage who screened within the pap smear guideline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings
Official Title  ICMJE A Single-arm Proof of Concept, Open Trial Clinical Study Investigating the Feasibility and Efficacy of Integrating Behavioral and Mobile Health Educational Interventions for Primary and Secondary Prevention in the Primary Care Setting
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.

Detailed Description

Background: Nearly 80 million people in the US are infected with HPV and 14 million new cases are diagnosed annually. There is an increasing HPV prevalence among women through the young adult years. Although the body clears many HPV infections persistent infections can progress to cancer and other HPV-related diseases. Cervical cancer is the most common cancer caused by HPV.

Many of the HPV-associated cancers are preventable with a series of safe and effective HPV vaccines. To date, no state has attained the 80% target vaccination rate for HPV. Despite the proven benefits and safety of HPV vaccine, usage remains suboptimal (only 38% had completed the three-dose series) and lower than other recommended adolescent vaccines.

Objective/Hypothesis: Our short term objective is to increase HPV vaccine initiation and completion rates among all age-eligible adolescent girls for whom vaccine is not contraindicated; and explore and examine acceptability of providing HPV vaccination to female youth during her adult female guardian's (AFG) cervical cancer screening appointment.

The investigators hypothesize that a combined intervention which includes (1) a motivational web-based education aimed at AFGs and youth females in their Primary Care site; and (2) text message reminders and an informational web-link on HPV vaccine and cervical cancer screening will increase HPV vaccination rates among youth females and will increase cervical cancer screening rates among their respective AFGs.

The investigators propose the following Aim:

Specific Aim: Conduct a single-arm proof of concept, open trial clinical study investigating the feasibility and efficacy of integrating primary and secondary prevention model for HPV and cervical cancer: a mobile educational and automated electronic interactive messaging intervention that will remind AFG and youth females of scheduled and missed second and third HPV vaccination appointments, and deliver brief text and video educational messaging on HPV, HPV vaccine, and cervical cancer screening.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HPV-Related Carcinoma
Intervention  ICMJE Behavioral: brief negotiated mobile application
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.
Study Arms  ICMJE Experimental: single
single arm- behavioral educational intervention of a brief negotiated mobile application
Intervention: Behavioral: brief negotiated mobile application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 8, 2018
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033550
Other Study ID Numbers  ICMJE H-34457
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Natalie Pierre-Joseph, Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Natalie Joseph, MD MPH Boston Medical Center
PRS Account Boston Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP