HPV-Related Carcinoma Clinical Trial
Official title:
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
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.
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.
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