Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings
Condition: HPV-Related Carcinoma
MeSH terms: Neoplasm Metastasis
Study type: Interventional

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.
    

Intervention name(s): brief negotiated mobile application
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccination; Cervical cancer screening; Primary care setting; Primary prevention of cervical cancer; Secondary prevention of cervical cancer; Mobile health information