HPV VaccinationNCT02994290
Evaluation of the Implementation and Effectiveness of IPP-HPV
A study testing HPV vaccine and Inpatient Postpartum HPV Immunization Quality Improvement Program in people with HPV Vaccination, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 26 years, women only
- Conditions the study is for
- HPV Vaccination
- What is being tested?
- HPV vaccine and Inpatient Postpartum HPV Immunization Quality Improvement Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital, Women's Center
New Haven, Connecticut, 06520
About this study
Official title: Evaluation of the Implementation and Effectiveness of a Pilot Quality Improvement Program to Increase HPV Vaccine Uptake: Inpatient Postpartum HPV Immunization (IPP-HPV) Program
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.
Read the 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
- Being tested
- HPV vaccine, Inpatient Postpartum HPV Immunization Quality Improvement Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineDrug
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: up to 6 weeks postpartum
Secondary outcomes (3)
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.
Measured: 12 months postpartum
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.
Measured: up to 12 months
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HPV VaccinationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sangini Sheth, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994290
- Sponsor's protocol ID
- 2000020062
- Other IDs
- 1K07CA230234-01
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2016
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation and Effectiveness of a Pilot Quality Improvement Program to Increase HPV Vaccine Uptake: Inpatient Postpartum HPV Immunization (IPP-HPV) Program
- ClinicalTrials.gov ID
- NCT02994290
- Acronym / sponsor ID
- 2000020062
- Conditions
- HPV Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Posted 9 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receive inpatient HPV vaccine | Experimental | Drug: HPV vaccine, Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement ProgramWe 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. |
| decline the inpatient dose | Experimental | Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement ProgramWe 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. |
Who may qualify
- Ages
- 15 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccineAfter 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. | Drug | receive inpatient HPV vaccine |
| Inpatient Postpartum HPV Immunization Quality Improvement ProgramThe 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. | Behavioural | decline the inpatient dose, receive inpatient HPV vaccine |
Primary outcome
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine
Time frame: 12 months
Data gathered via medical charts for which participants agreed to receive a dose and which did not
HPV Vaccine Receptivity Thematic Interview
Time frame: 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.
Barriers to Receiving the HPV Vaccine Thematic Interview
Time frame: 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.
3 secondary outcomes
Number of Participants Who Received or Did Not Receive a Dose of Vaccine
Time frame: 12 months postpartum
Receptivity of Healthcare Providers Thematic Interviews
Time frame: up to 12 months
Concerns of Healthcare Providers Thematic Interview
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HPV Vaccination
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HPV Infection
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Human Papillomavirus Infection
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
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PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangini Sheth, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV vaccine and Inpatient Postpartum HPV Immunization Quality Improvement Program in people with HPV Vaccination, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.