Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)
Condition: Infant Mortality; Infant Death; Racial Bias; Prenatal Stress; Prenatal Care; Maternal Child Health; Health Problems in Pregnancy; Adverse Childhood Experiences; Mental Health; Support Groups; Minority Health; Healthcare Disparities; Maternal-child Health Services; Social Determinants of Health; Trust; Physician-Patient Relations; Quality of Care
MeSH terms: Infant Death
Study type: Interventional

Summary: 
      This pilot project aims to implement and investigate the feasibility and acceptability of a
      unique community based prenatal care and support model for African American women and infants
      in Dane County. The model, the "Today Not Tomorrow Pregnancy and Infant Support Program
      (TNT-PISP)" builds on emerging evidence about how to effectively implement and sustain
      prenatal care in black communities. It combines three approaches-community-based doula
      programs; group-based models of prenatal care, such as Centering Pregnancy; and
      community-based pregnancy support groups-into once monthly group sessions held during the
      prenatal and immediate postpartum period. The project is based at the Today Not Tomorrow
      Family Resource Center in Madison's East Side Community Center, and carried out in close
      collaboration with Project Babies, Harambee Village Doulas, and the African American
      Breastfeeding Alliance of Dane County, Inc.
    

Detailed description: 
      Wisconsin leads the nation in the number of African American babies dying before their 1st
      birthday. These deaths are primarily due to complications of prematurity - babies being born
      too early and too soon. Additionally, Wisconsin's black infant mortality rate is
      significantly higher than that of whites and represents a serious health inequity that is
      critical for local research and advocacy efforts to address. The factors leading to
      inequities in preterm birth and infant mortality are complex and multifactorial; therefore,
      multidisciplinary and innovative approaches to prenatal and inter conception care are
      critical to improve these outcomes.

      Previous research and feedback from black women living in Dane County has shown that lack of
      social support and culturally relevant models of preconception, prenatal, and
      inter-conception care has been a barrier to optimal quality of care and maternal child health
      outcomes. Further research has demonstrated that evidence based intervention approaches used
      nationally such as a) community-based doula programs, b) group-based models of prenatal care
      such as Centering Pregnancy, and c) community-based pregnancy and inter conception support
      groups hold promise as relevant prevention strategies, yet there are many barriers to their
      effective adoption in communities of color.

      In response to the current birth outcome inequities that exist in Wisconsin, the objective of
      the current proposal is to implement and investigate a novel approach that combines aspects
      of all three of the above-mentioned evidence-based models and builds upon emerging evidence
      about how to effectively implement and sustain prenatal care interventions in Black
      communities: the TNT-PISP. The TNT-PISP approach is based on increasing evidence that models
      of prenatal care that are community driven, group based, culturally relevant, family
      centered, and include enhanced social support have the potential to significantly decrease
      African American prematurity rates and improve other maternal and infant health measures.

      TNT-PISP is a collaborative community-based support group uniquely designed to serve black
      women and infants through once monthly group sessions delivered prenatally and in the
      immediate postpartum period. Each 2 hour TNT-PISP session will be held at the Today Not
      Tomorrow Family Resource Center located on Madison's Eastside and will be led by local
      African American community-based doulas supported by and in collaboration with a host of
      other community partners and healthcare professionals from diverse backgrounds. Each session
      will consist of food, hands on learning activities, peer to peer socio-emotional support,
      guest speakers, relationship building activities, and dynamic discussions on a host of
      pregnancy and newborn care related topics. In addition to group sessions, participants will
      be additionally have the option to be enrolled in a community based doula program to receive
      support outside the group sessions, and culturally sensitive mental health and case
      management support services on an as-needed basis. Via partnerships with various healthcare
      providers and systems, there are also tentative plans for future expansion so that select
      participants will additionally be able to receive their prenatal care exams on site.

      Assessments with individual participants in each study arm will occur at three contact
      points: At start of pregnancy, around time of birth/early postpartum and ~ 6 months
      postpartum. At each time of contact, they will be asked to complete a series of
      questionnaires and participate in a semi-structured interview with PI. If additionally
      consented, medical records of all study participants will be analyzed to assess secondary
      outcomes.

      This is a pilot study. As the study transition to larger scale efficacy trials in future, it
      will be important to be able to link to and review patient perinatal outcomes. Feasibility
      questions asked in this study are 1) Will it be obvious who meets and who does not meet our
      eligibility criteria? Are the eligibility criteria sufficient or too restrictive? 2) Will our
      study questionnaires and data collection tools be easy to understand and user friendly? 3)
      What systems levels facilitators and barriers will contribute to the implementation and
      success of this pilot program? 4) Will participants be pleased with the curriculum/design of
      the TNT-PISP pilot intervention? Is delivering prenatal care on site something participants
      would find beneficial in addition to group education/support sessions? 5) Will our team have
      the capacity to implement and maintain the TNT-PISP program? Part of the feasibility trial of
      this study is assessing how receptive mothers are to us accessing their medical records and
      data retrieval logistics. Additionally, semi structured interviews with up to 10 key
      academic/community based stakeholders involved in the implementation process of TNT-PISP
      program will be obtained and evaluated via thematic analysis. Interviews with these key
      stakeholders will not be compensated and will be on a volunteer basis. These interviews will
      collect information on the facilitators and barriers to implementing and maintaining the
      program from their standpoint.

      Finally, two focus groups will occur over the course of the study period. The first focus
      group will involve self-identified black women living in Dane County interested in providing
      feedback on the ideal design of a culturally relevant community based prenatal care and
      support program such as the TNT-PISP pilot. The second focus group will be limited to
      research participants who participated in the TNT PISP intervention for at least 1 session
      and will provide feedback on facilitators and barriers to its acceptability and feasibility
      as well as preliminary feedback on maternal child health outcomes and attitudes impacted as a
      result of the program. All individuals involved in conducting one on one interviews/focus
      groups will be women of color on the research team to facilitate comfort and trust for the
      participants.

      All focus groups and individual interviews will be audio recorded.

      One on one interviews will occur either on the phone or at a comfortable public location of
      the subject's desire (ex: library or at the TNT Family Resource Center). One on one
      interviews will take place in a private room to ensure as much privacy as possible. Subjects
      will also have the option for the interview to occur in their home and if that occurs, they
      will be made aware that the interviewer is a mandatory reporter if any concerning activities
      in the home were to be observed.

      The focus groups will take place at the TNT-Family Resource Center. All one on one interviews
      will be conducted by Dr. Zapata. All focus groups will be conducted by Dr. Zapata in
      collaboration with other research team members listed in the protocol.
    

Intervention name(s): Today Not Tomorrrow Pregnancy and Infant Support Program
Intervention type(s): Other
Intervention description(s): The Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP) is a collaborative community-based support group uniquely designed to serve black women and infants through once monthly group sessions delivered prenatally and in the immediate postpartum period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A longitudinal, quasi-experimental design with two study arms will be used. Study arm 1 will consist of self-identified pregnant black women who are enrolled in the TNT-PISP intervention and Study arm 2 will consist of self-identified pregnant black women who are not enrolled in the TNT-PISP intervention. During the recruitment process, potential study participants will be able to self- select which study arm they would like to be in after each arm is described in detail. Although self-selection is traditionally discouraged in research, given the vulnerable population the investigator will be working with and historic distrust with medical community, investigator believe there is power in giving women of color choice in how they wish to navigate and engage with this study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TNT-PISP