Implementation of Single-Pill Combination Therapy Through Team-Based Care for Hypertension Control in Resource-Constrained Settings: A Cluster Randomized Clinical Trial

Importance: Single-pill combination therapy improves medication adherence and hypertension control. However, limited evidence is available on its implementation in routine clinical practice. Objective: To assess the long-term effectiveness, implementation, and sustainability of single-pill combination therapy through team-based care for blood pressure reduction among patients with uncontrolled hypertension in primary care settings in Colombia and Jamaica. Design, Setting, and Participants: Multicountry, unblinded, pragmatic, cluster randomized clinical trial. Twenty primary care clinics in Jamaica and 20 in Colombia were randomly assigned to either the single-pill combination therapy group or the standard care group. A total of 1706 adults with uncontrolled hypertension were enrolled between February 23, 2023, and September 12, 2024. The final follow-up visit occurred on September 9, 2026. Interventions: In the intervention group (n = 869), a team-based care approach that included physician and nurse training, health coaching, home blood pressure monitoring, and blood pressure audit and feedback was used to implement single-pill combination therapy. Single-pill combinations were purchased locally and provided to patients. In the standard care group (n = 837), patients received monotherapy or polytherapy with guideline-recommended medications covered by health insurance or government programs. The intervention lasted 18 months, with additional follow-up at 24 months. Main Outcomes and Measures: The primary outcome was the between-group difference in change in systolic blood pressure from baseline to 18 months. Three blood pressure measurements were obtained at each of 2 visits at each time point using a standard protocol. Results: Among the 1706 enrolled participants, at baseline, the mean age was 61.4 years, 69.9% of participants were female, and 98.2% were taking antihypertensive medications. Among the 1574 participants included in the primary analysis, systolic blood pressure decreased by 19.1 mm Hg, from 145.9 mm Hg at baseline to 126.8 mm Hg at 18 months, in the intervention group and by 9.0 mm Hg, from 145.0 mm Hg to 136.1 mm Hg, in the standard care group, with a between-group difference of -10.1 mm Hg (95% CI, -13.3 to -6.9 mm Hg; P < .001). At 18 months, 69.5% of patients in the intervention group and 29.2% in the standard care group achieved systolic blood pressure less than 130 and diastolic blood pressure less than 80 mm Hg. Serious adverse events (death and hospitalization) occurred at similar frequencies in the intervention (7.9%) and standard care (9.9%) groups. Conclusions and Relevance: Implementing single-pill combination therapy through team-based care significantly reduced blood pressure over 18 months among adults with uncontrolled hypertension in Colombia and Jamaica. This comprehensive strategy integrating single-pill combination therapy with team-based care could be widely adopted and scaled up for hypertension control, particularly in resource-constrained settings. Trial Registration: ClinicalTrials.gov Identifier: NCT05405920.