Evaluation of the Implementation and Effectiveness of IPP-HPV

NCT ID: NCT02994290

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 817 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-10-31

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.

Detailed Description

Administration of the HPV vaccine during the inpatient postpartum hospital stay has the potential to be an innovative intervention to improve HPV immunization rates. Following onset of pregnancy, the postpartum period becomes the next available opportunity to immunize with the HPV vaccine, which is safe in breastfeeding women. The benefits of such an intervention include a focus on women engaged with the health care system who are often highly motivated to invest in their personal health.

Specific Aims Aim 1: To evaluate receptivity and concerns of postpartum women with receiving the HPV vaccine during the inpatient postpartum admission as part of the Inpatient Postpartum HPV Immunization Quality Improvement Program (IPP-HPV).

Aim 2: To evaluate receptivity and concerns of healthcare providers with inpatient postpartum HPV immunization as part of IPP-HPV and to identify facilitators of and barriers to its implementation.

Aim 3: To assess the uptake and effectiveness of a Pilot Quality Improvement Program to increase HPV vaccine uptake (IPP-HPV) for Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients ≤ 26 years of age who deliver at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC).

Conditions

HPV Vaccination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

receive inpatient HPV vaccine

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.

Group Type: EXPERIMENTAL

HPV vaccine

Intervention Type: 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.

Inpatient Postpartum HPV Immunization Quality Improvement Program

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Inpatient Postpartum HPV Immunization Quality Improvement Program

Intervention Type: 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.

Interventions

HPV vaccine

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.

Intervention Type: DRUG

Inpatient Postpartum HPV Immunization Quality Improvement Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

OR

• 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

Exclusion Criteria

-

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangini Sheth, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital, Women's Center

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K07CA230234-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000020062

Identifier Type: -

Identifier Source: org_study_id