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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033550
• Other study ID #: H-34457
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: July 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• HPV-Related Carcinoma
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cervical cancer screening rate	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	through study completion, an average of 1 year
Primary	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	Patient knowledge and provider-patient communication	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;	over 6 months
Secondary	provider communication about HPV vaccine	greater provider communication about HPV vaccine : Unit of measure- the number of participants who responded yes to provider communication about HPV vaccine	through study completion, an average of 1 year