Evaluation of the Implementation and Effectiveness of IPP-HPV

NCT02994290 | Completed Results

• 2 other identifiers: 20000200621K07CA230234-01
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed pilot study is to assess the implementation of IPP-HPV immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and facilitators of this intervention to optimize its feasibility and effectiveness. It is imperative that innovative interventions be developed to achieve comprehensive utilization of this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and other HPV associated cancers, and address cancer disparities.

Conditions

HPV Vaccination

Outcome Measures

Primary Outcomes (3)

• Count of Eligible Patients Agreeing to Receive a Dose of Vaccine

  Data gathered via medical charts for which participants agreed to receive a dose and which did not

  12 months

• HPV Vaccine Receptivity Thematic Interview

  In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.

  up to 6 weeks postpartum

• Barriers to Receiving the HPV Vaccine Thematic Interview

  In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.

  up to 6 weeks postpartum

Secondary Outcomes (3)

• Number of Participants Who Received or Did Not Receive a Dose of Vaccine

  12 months postpartum

• Receptivity of Healthcare Providers Thematic Interviews

  up to 12 months

• Concerns of Healthcare Providers Thematic Interview

  up to 12 months

Other Outcomes (1)

• Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.

  12 months postpartum

Study Arms (2)

receive inpatient HPV vaccine

EXPERIMENTAL

We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.

Drug: HPV vaccine; Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program

decline the inpatient dose

EXPERIMENTAL

We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.

Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program

Interventions

HPV vaccine DRUG

After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.

receive inpatient HPV vaccine

Inpatient Postpartum HPV Immunization Quality Improvement Program BEHAVIORAL

The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed.

decline the inpatient dose; receive inpatient HPV vaccine

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women participating in the IPP-HPV Quality Improvement Program:
• Postpartum YNHH Women's Center and CWHM patients
• ≤ 26 years at time of delivery who deliver at YNHH YSC or SRC
• Have not already received 3 doses of the HPV vaccine at time of delivery
• Fluent in English or Spanish
• Able and willing to provide consent
• AND
• Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients
• ≤ 26 years of age
• Delivered at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC) in the first year of the IPP-HPV program or in the one year preceding implementation of the program
• YNHH inpatient postpartum nurses or Women's Center outpatient postpartum nurses or inpatient or outpatient obstetric providers affiliated with the Women's Center or Center for Women's Health and Midwifery
• Able and willing to provide consent

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale New Haven Hospital, Women's Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Sangini Sheth
• Organization: Yale University

Sangini.Sheth@yale.edu

203-785-5545

Study Officials

• Sangini Sheth, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: January 1, 2017
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 9, 2023
• Results First Posted: January 9, 2023

Record last verified: 2022-12

Locations

US (1)