HPV Vaccination
Conditions
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).
Interventions
DRUGHPV 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.
BEHAVIORALInpatient 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.
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 26 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to Receiving the HPV Vaccine Thematic Interview | up to 6 weeks postpartum | 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. |
| Count of Eligible Patients Agreeing to Receive a Dose of Vaccine | 12 months | Data gathered via medical charts for which participants agreed to receive a dose and which did not |
| HPV Vaccine Receptivity Thematic Interview | up to 6 weeks postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concerns of Healthcare Providers Thematic Interview | up to 12 months | The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews. |
| Number of Participants Who Received or Did Not Receive a Dose of Vaccine | 12 months postpartum | Data gathered via medical charts for which participants received vaccine as inpatient and which did not. |
| Receptivity of Healthcare Providers Thematic Interviews | up to 12 months | The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each. | 12 months postpartum | Data gathered via medical charts |
Countries
United States
Participant flow
Recruitment details
787 participants and 30 providers
Participants by arm
| Arm | Count |
|---|---|
| Receive Inpatient HPV Vaccine The investigators 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 a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.
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.
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. | 491 |
| Decline the Inpatient Dose The investigators 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 a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.
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.
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. | 296 |
| Providers 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. | 30 |
| Total | 817 |
Baseline characteristics
| Characteristic | Receive Inpatient HPV Vaccine | Decline the Inpatient Dose | Total | Providers |
|---|---|---|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 2.7 | 22.5 years STANDARD_DEVIATION 2.7 | 22.5 years STANDARD_DEVIATION 2.7 | — |
| Age, Customized Providers age <40 | 0 Participants | 0 Participants | 11 Participants | 11 Participants |
| Age, Customized Providers age 41-60 | 0 Participants | 0 Participants | 13 Participants | 13 Participants |
| Age, Customized Providers age 61+ | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Age, Customized Providers age Did not report | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Preferred Language English | 244 Participants | 190 Participants | 434 Participants | 0 Participants |
| Preferred Language Other | 46 Participants | 33 Participants | 79 Participants | 0 Participants |
| Preferred Language Spanish | 168 Participants | 47 Participants | 215 Participants | 0 Participants |
| Preferred Language Unknown | 33 Participants | 26 Participants | 59 Participants | 0 Participants |
| Providers Job Title Advanced Practice Registered Nurse | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Providers Job Title Certified Nurse-Midwife | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Providers Job Title Physician | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Providers Job Title Physician Assistant | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Providers Job Title Registered Nurse | 0 Participants | 0 Participants | 14 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black/African American | 99 Participants | 83 Participants | 183 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic | 265 Participants | 109 Participants | 375 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 48 Participants | 31 Participants | 84 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Unknown | 37 Participants | 29 Participants | 66 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 42 Participants | 44 Participants | 108 Participants | 22 Participants |
| Region of Enrollment United States | 491 participants | 296 participants | 787 participants | 30 participants |
| Sex: Female, Male Female | 491 Participants | 296 Participants | 787 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: up to 6 weeks postpartum
Population: a random sub sample of participants that completed the thematic interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | Barriers to Receiving the HPV Vaccine Thematic Interview | 5 themes |
| Decline the Inpatient Dose | Barriers to Receiving the HPV Vaccine Thematic Interview | 5 themes |
Primary
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
Time frame: 12 months
Population: 787 total eligible participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | Count of Eligible Patients Agreeing to Receive a Dose of Vaccine | Agreed to Receive IPP-HPV | 686 participants |
| Eligible to Receive Inpatient HPV Vaccine | Count of Eligible Patients Agreeing to Receive a Dose of Vaccine | Did not agree to receive IPP-HPV Dose | 101 participants |
Primary
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.
Time frame: up to 6 weeks postpartum
Population: a random sub sample of overall participants that completed the thematic interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | HPV Vaccine Receptivity Thematic Interview | 5 themes |
| Decline the Inpatient Dose | HPV Vaccine Receptivity Thematic Interview | 5 themes |
Secondary
Concerns of Healthcare Providers Thematic Interview
The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.
Time frame: up to 12 months
Population: 30 providers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | Concerns of Healthcare Providers Thematic Interview | 2 themes |
Secondary
Number of Participants Who Received or Did Not Receive a Dose of Vaccine
Data gathered via medical charts for which participants received vaccine as inpatient and which did not.
Time frame: 12 months postpartum
Population: 787 total eligible participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | Number of Participants Who Received or Did Not Receive a Dose of Vaccine | Received IPP-HPV Dose | 491 participants |
| Eligible to Receive Inpatient HPV Vaccine | Number of Participants Who Received or Did Not Receive a Dose of Vaccine | Did not receive IPP-HPV Dose | 296 participants |
Secondary
Receptivity of Healthcare Providers Thematic Interviews
The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.
Time frame: up to 12 months
Population: 30 providers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eligible to Receive Inpatient HPV Vaccine | Receptivity of Healthcare Providers Thematic Interviews | 5 themes |
Other Pre-specified
Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.
Data gathered via medical charts
Time frame: 12 months postpartum
Population: data was not collected for this outcome