BUILDING BETTER CLINICAL TRIALS

Researchers at the University of Mississippi Medical Center (UMMC) wanted to improve health outcomes in vulnerable populations, specifically pregnant and post-partum adolescents in the Mississippi Delta region. Following the CTTI framework and recommendations for recruitment planning helped UMMC build a robust recruitment protocol that will be used in future intervention studies with perinatal adolescents with high risk for obesity and cardiometabolic diseases.

UMMC wanted to improve health outcomes in vulnerable populations, specifically pregnant and post-partum adolescents in the Mississippi Delta region who have been understudied to date. To that end, the UMMC's Teen Mom Study was designed with two goals: 1) to inform the development of obesity prevention interventions tailored for socioeconomically disadvantaged, predominantly Black perinatal adolescents in the rural Delta region of Mississippi, and 2) to identify successful recruitment strategies to engage these populations.

Recruiting Black, pregnant adolescents in socioeconomically disadvantaged communities for clinical research is a massive hurdle due to a constellation of factors, including stigma associated with adolescent pregnancy, parental consent, and family dynamics. However, these adolescents are also a particularly vulnerable population with high risk for poor health, making clinical interventions crucial. Despite overall national declines in adolescent pregnancy in recent decades, teen birth rates in the Mississippi Delta are the highest in the U.S. and have not declined since 2006. Numerous mitigation efforts to engage these vulnerable groups have been unsuccessful, underscoring the need for better recruitment strategies to achieve more equitable representation in research.

UMMC used CTTI's recommendations for effective clinical trial recruitment planning to guide the development of a recruitment protocol for the target population: 150 adolescent-parent dyads from the pregnant and post-partum community in the Mississippi Delta region. The CTTI framework offered recommendations for trial design and protocol development, trial feasibility and site selection, and recruitment communication. The recommendations were central in helping UMMC identify and mitigate challenges to recruitment during early stages of clinical trial development.

CTTI strongly recommends partnering with stakeholders and engaging them in the design and planning for clinical trials. In the Mississippi Delta, one stakeholder stood out as an important community resource highly regarded by expectant mothers and families with young children: WIC, or the Special Supplemental Nutrition Program for Women, Infants and Children. WIC providers were critically important partners for the Teen Mom Study in part because they recognize the importance of understanding the needs, values and cultures of the clients they serve. UMMC developed a robust recruitment protocol in partnership with WIC, which was highly successful due to WIC's simple commitment to distribute an informational flyer on the Teen Mom Study. 

CTTI also recommends that trialists become familiar with the target population and identify where they seek treatment and relevant information. Following this recommendation fortified a successful protocol comprised of passive recruitment strategies, such as sharing study information by word-of-mouth from trusted sources. In addition, UMMC kept the notion of minimizing participant and partner burden top of mind. As part of UMMC's commitment to establishing organizational and community partnerships, the role of WIC providers and expectations of adolescent WIC clients and their families were kept to a minimum.

Following the CTTI framework and recommendations for recruitment planning led to a robust recruitment protocol that will be used in future intervention studies with perinatal adolescents with high risk for obesity and cardiometabolic diseases. Using passive recruitment strategies grounded in partner and community engagement resulted in an effective protocol that was both community-focused and minimally burdensome to partners and participants. The Teen Mom Study met 96.7 percent of its target recruitment population and was a finalist in Mississippi's 2019 Excellence in Community Engagement Award.

UMMC feels that the amount of time needed for developing strong community partnerships that drive effective recruitment needs to be acknowledged. The partnership with WIC was initiated three years prior to beginning participant recruitment and included collaboration with three different WIC directors. UMMC would like to see it weaved into the tenure criteria for faculty to be successful. Additionally, UMMC found that while collaboration across stakeholder groups is important, who you bring to the table is far more critical than how many people you bring. For example, one WIC stakeholder with a personal passion for the study has brought more value than numerous others who were less invested. 

As for the CTTI recommendations, UMMC thinks of them as the "roots of the tree" that they kept coming back to as reassurance they were grounded and on track. A particular utility of the recommendations was the acceptance early on that there would be unanticipated challenges, allowing UMMC to be prepared to respond as needed. One UMMC investigator compares it to a teacher creating a lesson plan; even if it is perfect, unexpected things in the classroom pop up and it doesn't go as plan – and that's okay, as long as the outcome meets the need.