432 - Mommy&Me: enrolling Black moms and babies in clinical research

Publication Number: 432.5695

Diedtra Henderson, Developing Brain Institute at Children's National Hospital, Washington, DC, United States; Nickie Andescavage, Children's National Health System, Washington, DC, United States; Jennifer Mendillo Keller, The George Washington University School of Medicine and Health Sciences, Washington, DC, United States; Maariya Bassa, Children's National Health System, Bethesda, MD, United States; Esther Adegbulugbe, Childrens National Medical Center, Washington, DC, United States; Camille Brechot, Children's National Health System, Washington, DC, United States; Huynh-Nhu Le, George Washington University, Washington, DC, United States; Catherine Limperopoulos, Children's National Health System, Washington DC, DC, United States

Background: Perinatal mood and anxiety disorders are linked to risk for adverse maternal-infant outcomes. Despite overrepresentation of Black people in the perils of pregnancy, it is challenging to recruit them in research aimed to reduce risk.

Objective: Develop innovative approaches to recruit and retain Black pregnant people and infants in a perinatal behavioral health clinical trial.

Design/Methods: Mommy&Me is a randomized controlled trial comparing standard prenatal care with a bundle to improve perinatal mental health for under-resourced Black pregnant people. Interventions, informed by insights from Black mothers, integrate patient navigation, cognitive-behavioral therapy and peer support sessions created and led by Black moms. Primary outcomes include postnatal perinatal mental health scores and infant developmental outcomes.

Results: We enrolled 650 Black women-infant dyads over 25 months. We credit a myriad of strategies, including well-trained recruiters committed to a respectful, patient-first approach. One especially powerful site-specific strategy was warm handoffs: trusted caregivers at a federally qualified health center relayed real-time information about potential participants to research staff with opportune callback times to enable same-day calls by recruiters. Additional site-specific process improvements included permissions to directly tap electronic health records and reassigning staff for on-site recruiting at an obstetrics setting on days with more appointments. Similarly, we expanded the ranks of study champions through lunch-and-learns, Grand Rounds and other presentations for care providers, and we shared participants’ positive comments as thanks for referring patients. We distributed Mommy&Me flyers and postcards and displayed the same visual (a Black mom and baby) at recruiting tables, culturally attuned imaging that appealed to recruits. Research coordinators sent thank you notes, study reminders for participants consented early in pregnancy and digital greeting cards. Retention strategies included providing financial incentives for study-related tasks, and we advocated for funding to increase remuneration for more study timepoints and shifted funding to safeguard our recruiting site champions’ protected time.

Conclusion(s): Despite a legacy of distrust for research, we recruited high numbers of participants into a prospective RCT for pregnant Black people and infants. Continuous improvement enabled our research team to meet an ambitious recruitment goal. Empowering messaging and empathetic actions are part of ongoing efforts to maintain retention throughout the pregnancy continuum.

Mommy&Me recruiting table
During in-person events, we distributed Mommy&Me flyers and postcards and displayed the same visual (a Black mom and baby) at recruiting tables, culturally attuned imaging that resonated with potential participants.