Clinical trial NCT03033550: Integrating Primary & Secondary Interventions for Cervical Cancer Prevention in Primary Care Settings
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who received the first dose and completed the vaccine series as measured electronic medical record review
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient knowledge and provider-patient communication
timeFrame: over 6 months
measure: provider communication about HPV vaccine
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Cervical cancer screening rate
timeFrame: through study completion, an average of 1 year
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Natalie Joseph, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: