Trial Outcomes & Findings for Evaluation of the Implementation and Effectiveness of IPP-HPV (NCT NCT02994290)

NCT ID: NCT02994290

Last Updated: 2023-01-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

817 participants

Primary outcome timeframe

12 months

Results posted on

2023-01-09

Participant Flow

787 participants and 30 providers

Participant milestones

Participant milestones
Measure	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 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. 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.	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 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. 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.	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.
Overall Study STARTED	491	296	30
Overall Study COMPLETED	491	296	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

this is for patient participants

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months

Population: 787 total eligible participants

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

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=787 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine Agreed to Receive IPP-HPV	686 participants	—
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine Did not agree to receive IPP-HPV Dose	101 participants	—

PRIMARY outcome

Timeframe: up to 6 weeks postpartum

Population: a random sub sample of overall participants that completed the 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.

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=18 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose n=6 Participants The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
HPV Vaccine Receptivity Thematic Interview	5 themes	5 themes

PRIMARY outcome

Timeframe: up to 6 weeks postpartum

Population: a random sub sample of participants that completed the thematic interview

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=18 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose n=6 Participants The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
Barriers to Receiving the HPV Vaccine Thematic Interview	5 themes	5 themes

SECONDARY outcome

Timeframe: 12 months postpartum

Population: 787 total eligible participants

Data gathered via medical charts for which participants received vaccine as inpatient and which did not.

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=787 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
Number of Participants Who Received or Did Not Receive a Dose of Vaccine Received IPP-HPV Dose	491 participants	—
Number of Participants Who Received or Did Not Receive a Dose of Vaccine Did not receive IPP-HPV Dose	296 participants	—

SECONDARY outcome

Timeframe: up to 12 months

Population: 30 providers

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.

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=30 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
Receptivity of Healthcare Providers Thematic Interviews	5 themes	—

SECONDARY outcome

Timeframe: up to 12 months

Population: 30 providers

Outcome measures

Outcome measures
Measure	Eligible to Receive Inpatient HPV Vaccine n=30 Participants The investigators will select a purposive sample of postpartum women eligible to receive the inpatient HPV vaccine into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose. Participants will be interviewed until a thematic saturation is reached (anticipated to occur with about 8-10 individuals per group). 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.	Decline the Inpatient Dose The investigators will select a purposive sample of postpartum women into two groups to interview until thematic saturation is reached: those who receive inpatient HPV vaccine and those who decline the inpatient dose. 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.
Concerns of Healthcare Providers Thematic Interview	2 themes	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months postpartum

Population: data was not collected for this outcome

Data gathered via medical charts

Outcome measures

Outcome data not reported

Adverse Events

Eligible to Receive Inpatient HPV Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sangini Sheth

Yale University

Phone: 203-785-5545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Receive Inpatient HPV Vaccine n=491 Participants 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.	Decline the Inpatient Dose n=296 Participants 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.	Providers n=30 Participants 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.	Total n=817 Participants Total of all reporting groups
Age, Continuous	22.5 years STANDARD_DEVIATION 2.7 • n=491 Participants • this is for patient participants	22.5 years STANDARD_DEVIATION 2.7 • n=296 Participants • this is for patient participants	—	22.5 years STANDARD_DEVIATION 2.7 • n=787 Participants • this is for patient participants
Age, Customized Providers age · <40	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	11 Participants n=30 Participants • this data was only collected for providers	11 Participants n=30 Participants • this data was only collected for providers
Age, Customized Providers age · 41-60	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	13 Participants n=30 Participants • this data was only collected for providers	13 Participants n=30 Participants • this data was only collected for providers
Age, Customized Providers age · 61+	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers
Age, Customized Providers age · Did not report	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	1 Participants n=30 Participants • this data was only collected for providers	1 Participants n=30 Participants • this data was only collected for providers
Sex: Female, Male Female	491 Participants n=491 Participants • was not collected for providers	296 Participants n=296 Participants • was not collected for providers	0 Participants was not collected for providers	787 Participants n=787 Participants • was not collected for providers
Sex: Female, Male Male	0 Participants n=491 Participants • was not collected for providers	0 Participants n=296 Participants • was not collected for providers	0 Participants was not collected for providers	0 Participants n=787 Participants • was not collected for providers
Race/Ethnicity, Customized Race · Black/African American	99 Participants n=491 Participants	83 Participants n=296 Participants	1 Participants n=30 Participants	183 Participants n=817 Participants
Race/Ethnicity, Customized Race · White	42 Participants n=491 Participants	44 Participants n=296 Participants	22 Participants n=30 Participants	108 Participants n=817 Participants
Race/Ethnicity, Customized Race · Hispanic	265 Participants n=491 Participants	109 Participants n=296 Participants	1 Participants n=30 Participants	375 Participants n=817 Participants
Race/Ethnicity, Customized Race · Other	48 Participants n=491 Participants	31 Participants n=296 Participants	5 Participants n=30 Participants	84 Participants n=817 Participants
Race/Ethnicity, Customized Race · Unknown	37 Participants n=491 Participants	29 Participants n=296 Participants	0 Participants n=30 Participants	66 Participants n=817 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=491 Participants	0 Participants n=296 Participants	1 Participants n=30 Participants	1 Participants n=817 Participants
Region of Enrollment United States	491 participants n=491 Participants	296 participants n=296 Participants	30 participants n=30 Participants	787 participants n=817 Participants
Preferred Language English	244 Participants n=491 Participants • this data was only collected for participants	190 Participants n=296 Participants • this data was only collected for participants	0 Participants this data was only collected for participants	434 Participants n=787 Participants • this data was only collected for participants
Preferred Language Spanish	168 Participants n=491 Participants • this data was only collected for participants	47 Participants n=296 Participants • this data was only collected for participants	0 Participants this data was only collected for participants	215 Participants n=787 Participants • this data was only collected for participants
Preferred Language Other	46 Participants n=491 Participants • this data was only collected for participants	33 Participants n=296 Participants • this data was only collected for participants	0 Participants this data was only collected for participants	79 Participants n=787 Participants • this data was only collected for participants
Preferred Language Unknown	33 Participants n=491 Participants • this data was only collected for participants	26 Participants n=296 Participants • this data was only collected for participants	0 Participants this data was only collected for participants	59 Participants n=787 Participants • this data was only collected for participants
Providers Job Title Registered Nurse	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	14 Participants n=30 Participants • this data was only collected for providers	14 Participants n=30 Participants • this data was only collected for providers
Providers Job Title Certified Nurse-Midwife	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers
Providers Job Title Physician	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers
Providers Job Title Physician Assistant	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	1 Participants n=30 Participants • this data was only collected for providers	1 Participants n=30 Participants • this data was only collected for providers
Providers Job Title Advanced Practice Registered Nurse	0 Participants this data was only collected for providers	0 Participants this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers	5 Participants n=30 Participants • this data was only collected for providers