Evaluation of the Implementation and Effectiveness of IPP-HPV

Yale University

Status: Completed

Conditions: HPV Vaccination

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02994290

1K07CA230234-01 (U.S. NIH Grant/Contract)

2000020062

Details and patient eligibility

About

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.

Full 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).

Enrollment: 817 patients

Sex: Female

Ages: 15 to 26 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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817 participants in 2 patient groups

receive inpatient HPV vaccine

Experimental group

Description:

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.

Treatment:

Drug: HPV vaccine

Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program

decline the inpatient dose

Experimental group

Description:

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.

Treatment:

Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program