Barriers to randomized trials of integrated care for adolescent mothers in the Caribbean: lessons from the THRIVE trial and the Project Amai in Barbados.

Adolescent mothers in the Caribbean represent a high-need, under-served population facing overlapping reproductive, mental health, and social challenges. Despite the urgency of these needs, few randomized controlled trials (RCTs) target this group using culturally tailored, integrated care models. The Teen motHers' ReproductIve and behaVioral health intErvention (THRIVE) was conceptualized in Barbados in April 2024 as a randomized trial to evaluate such a model. However, as of today, THRIVE has not launched due to prolonged Institutional Review Board (IRB) delays and cultural sensitivities surrounding adolescent pregnancy-barriers that reflect broader systemic challenges common across low- and middle-income country (LMIC) contexts. In response, a parallel initiative-the Project Amai-was launched as a community-driven, service-based intervention outside the traditional RCT framework. Prioritizing cultural responsiveness, youth engagement and leadership, and low-barrier access, Amai reached a cohort of marginalized adolescent mothers and achieved high retention, program graduation, and improvements in agency and well-being within 8 months. This commentary contrasts the stalled progress of THRIVE with the rapid implementation of Amai to examine how institutional, infrastructural, and cultural factors shape the feasibility of equity-focused trials. We draw lessons for trialists working in under-resourced settings and suggest that advancing diversity, equity, and inclusion in trials requires adaptive strategies-including pragmatic designs, regional ethics collaboration, and broader outcome measures in the Caribbean. These insights contribute to emerging models of inclusive global health research and offer actionable guidance for designing trials and programs that are not only methodologically rigorous but also socially just and accessible to those most in need.