Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04100577 |
| Other study ID # |
2019-0684 |
| Secondary ID |
A536784SMPH\PEDI |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 3, 2019 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
