An HPV Vaccine Provider Intervention in Safety Net Clinics

Uterine Cervical Neoplasms Clinical Trial

Official title:

Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808832
• Other study ID #: U54CA153708
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: September 12, 2016
• Start date: September 2010
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Meharry Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

Description:

In this study the investigators utilized Community Based Participatory Research approaches in combination with our previous and ongoing research, patient and provider education materials available from professional organizations, and qualitative information obtained from provider in-depth interviews and parent/daughter focus groups to develop a provider intervention to encourage receipt of the HPV vaccine, and appropriate cancer screening in African Americans and Hispanics. A focus of the study was the formation of a Community Advisory Board (CAB) which provided input into the development and modification of the provider intervention. Safety net clinics in Nashville and Memphis served as intervention sites, and in Chattanooga and Nashville (Meharry) served as control sites. Mothers and children at the intervention sites viewed a 5-minute video in the exam room during any visit type before seeing the provider, and received an information sheet with a list of suggested questions to ask the provider. Mothers and children at the control sites received usual care. The selected study sites identified cervical cancer screening as a priority area based on the needs assessments conducted as part of the Meharry Medical College Community Health Center-Community Network Program (CHC-CNP). The investigators conducted pre- and post-intervention quantitative surveys with mothers and their children to evaluate whether the provider intervention was effective in improving HPV vaccination coverage, and cervical cancer screening rates. The investigators abstracted medical records and have indicated this in the HIPAA privacy form. After conducting pre- and post-intervention surveys and abstracting medical records, the investigators found that increasing HPV vaccine uptake requires more intensive, multicomponent interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 806
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Being seen as a pediatric patient at a study clinic on the day of enrollment

• Self-identified African American or Hispanic

• Aged 9-18 years (mother accompanying child to clinic visit had no age limit)

• Had received no doses of HPV vaccine or received one shot and was overdue for the second dose (three or more months after the first dose was given) prior to the clinic visit

Exclusion Criteria:

• Already having received two or more doses of HPV vaccine

• Mother or female guardian (referred to as "mother" henceforth) not accompanying the child

• Plans to move away from the clinic catchment area within the next 12 months

• Not completing the baseline assessment prior to entering the exam room

• Mother not providing or unable to give consent

• Child not giving assent.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Human Papillomavirus
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Educational materials
5-minute video and information sheet with a list of suggested questions to ask the provider

Locations

Country	Name	City	State
United States	Meharry Medical College	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Meharry Medical College	Matthew Walker Comprehensive Health Center, Memphis Health Center, Southside/Dodson Avenue Community Health Centers, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children participants who completed the 3-dose HPV vaccine series	Although completion of the 3-dose HPV vaccine series is recommended within 6 months, the investigators measured completion within 12 months.	12 months	No
Secondary	Number of mother participants who received appropriate cervical cancer screening	Cervical cancer screening is no longer recommended annually so the investigators measured receipt of a Pap smear as needed within a 12 month period.	12 months	No