Clinical trial NCT02808832: An HPV Vaccine Provider Intervention in Safety Net Clinics
Official title: Development of an HPV Vaccine and Cervical Cancer Screening Provider Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Uterine Cervical Neoplasms
Keywords: Human papillomavirus (HPV) vaccine
Cervical cancer screening
Provider intervention
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: Matthew Walker Comprehensive Health Center
name: Memphis Health Center
name: Southside/Dodson Avenue Community Health Centers
First posted: 2016-06-22
Enrollment: 806
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of children participants who completed the 3-dose HPV vaccine series
timeFrame: 12 months
Secondary outcomes:
measure: Number of mother participants who received appropriate cervical cancer screening
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
affiliation: Meharry Medical College
name: Maureen Sanderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics. BMC Public Health. 2017 Feb 2;17(1):158. doi: 10.1186/s12889-017-4094-1.