EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger
      trial focused on determining efficacy. Feasibility will be measured using the RE-AIM
      framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants
      who are successfully recruited and attend at least one group session; Effectiveness:
      retention rate in the intervention; Implementation: fidelity to the intervention protocol;
      Maintenance: intervention sustainability based on continued engagement from the participants.
    

Detailed description: 
      Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB),
      delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term
      neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB
      (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm
      labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for
      future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to
      the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive
      care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity
      Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor
      intensive with requirements ranging from daily medications, weekly clinic visits, painful
      injections or invasive ultrasounds.

      Given the increased rate so of PTB among NHB women and some suggestion of decreased adherence
      in this population1, we previously conducted qualitative studies with NHB women to uncover
      patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with
      prior preterm birth felt that stress and lack of support were key barriers to preterm birth
      prevention adherence. Stress and limited support made women feel isolated from their peers
      and community. Based on these data we worked with a stakeholder group to develop a
      patient-centered, community-involved intervention that will increased adherence to an
      individualized prematurity prevention plan using community-level social supports. The
      resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To
      an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led
      group social support.
    

Intervention name(s): Facebook discussions and Virtual group meetings
Intervention type(s): Behavioral
Intervention description(s): Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Intervention model: Single Group Assignment
Intervention model description: Intervention Arm
Masking: None (Open Label)
Primary purpose: Prevention