Engagement in Hypertension and Diabetes Clinical Trials at Federally Qualified Health Centers: A Systematic Review

Federally qualified community health centers (FQHCs) are potential partners in the quest to increase diversity in clinical trials. Despite this opportunity, there is limited knowledge about FQHC engagement in clinical trials.

To assess levels of FQHC engagement in hypertension and type 2 diabetes (T2D) clinical trials and identify FQHC characteristics associated with engagement in the US.

Six literature databases were searched for protocols and reports of clinical trials addressing hypertension or T2D among adults at FQHCs in the US, published between January 1, 2013, and November 6, 2023. Guided by a framework on community-engaged research, 4 levels of FQHC engagement in clinical trials were defined, ranging from level 1 (FQHC informed) to level 4 (FQHC driven). An ordinal regression analysis was conducted to investigate the association between FQHC organizational and patient demographic characteristics and levels of engagement in hypertension and T2D clinical trials using the publicly available data from Uniform Data System (UDS) for all identifiable FQHCs.

The initial literature search identified 4552 articles. Following deduplication, title and abstract screening, full-text review, data extraction, and matching with available information in UDS, a total of 33 clinical trials were included. Together, these clinical trials engaged 67 FQHCs. In most cases, FQHC engagement occurred at level 1 (15 clinical trials engaging 19 FQHCs) or level 2 (8 clinical trials engaging 38 FQHCs). A higher ratio of full-time equivalent physicians to patients was associated with 54% (odds ratio [OR], 1.54; 95% CI, 1.06-2.23) higher odds of having a higher level of FQHC engagement in hypertension and T2D clinical trials. A higher ratio of full-time community and patient education specialists to patients was associated with 41% (OR, 1.41; 95% CI, 1.03-1.94) higher odds of having a higher level of FQHC engagement in hypertension and T2D clinical trials.

In this systematic review of FQHC engagement in clinical trials, lower levels of engagement in hypertension and T2D clinical trials were found. Further research is required to identify clinical trial design and implementation strategies that promote FQHC participation in clinical trials and research capacity building.