Effectiveness and safety of a New Standardised TrEatment Protocol based on initial/early therapy with single-pill combinations of blood pressure-lowering drugs for improving blood pressure control (NewSTeP): Rationale, design of a randomized clinical trial and baseline characteristics of the trial participants
- 1The George Institute for Global Health, Hyderabad, Telangana, India; Prasanna School of Public Health, Manipal Academy of Higher Education, India; The George In
Abstract
BackgroundHypertension is the leading modifiable risk factor for cardiovascular disease (CVD). Despite availability of blood pressure (BP)-lowering therapies, BP control rates remain suboptimal. Reluctance to initiate treatment with combination therapy and delayed treatment intensification contribute to poor control. Early use of single-pill combinations (SPCs) within standardised treatment protocols (STPs) may improve outcomes, but evidence from India is limited.
ObjectiveTo evaluate the effectiveness and safety of a new STP incorporating initial or early use of SPCs compared with usual care among adults with hypertension.
MethodsThe New Standardised TrEatment Protocol (NewSTeP) trial is a pragmatic, multicentre, randomized, parallel-group, open-label trial conducted in tertiary healthcare centres in India. Adults with hypertension who are untreated or receiving one BP-lowering drug and require treatment initiation or intensification (n = 300) will be randomized 1:1 to either a new STP incorporating early SPC therapy or usual care. Participants will be followed for 6 months. The primary effectiveness outcome is change in home-measured mean systolic BP from randomization to month 6. The primary safety outcome is discontinuation of trial drug due to adverse events. Secondary outcomes include proportion of participants achieving BP control, change in diastolic BP, incidence of adverse events of special interest, treatment adherence, treatment modification, and time to BP control. A process evaluation will assess reach, implementation, acceptability, and sustainability, while an economic evaluation will assess cost-effectiveness.
ResultsBetween October 2025 and March 2026, 300 participants were randomized across nine sites (150 to New STP; 150 usual care) from 360 screened individuals. Final follow-up is expected in September 2026, with results anticipated in October 2026.
ConclusionsThe NewSTeP trial will provide evidence on the effectiveness, safety, implementation, and cost-effectiveness of an SPC-based STP for hypertension management in India and inform future hypertension control strategies and policies.
Trial RegistrationThe trial is registered with the Clinical Trials Registry-India (CTRI/2025/07/091649).
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BibTeX
@misc{dhurjati2026effectiveness,
title = {{Effectiveness and safety of a New Standardised TrEatment Protocol based on initial/early therapy with single-pill combinations of blood pressure-lowering drugs for improving blood pressure control (NewSTeP): Rationale, design of a randomized clinical trial and baseline characteristics of the trial participants}},
author = {R. Dhurjati and R. Pant and A. Kumar and A. Mittal and K. Chappidi and G. Satheesh and P. Puri and S. K. Tiruttani and S. Rajaram and A. Basheer and P. kaur and A. Moran and A. Rosende and P. Subramani and S. Mahajan and N. Lalvani and S. Bansal and D. Prabhakaran and J. P. Balagopalan and S. Jan and M. D. Huffman and V. Jha and A. Salam},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.10.26362712},
url = {https://www.medrxiv.org/content/10.64898/2026.09.10.26362712v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Effectiveness and safety of a New Standardised TrEatment Protocol based on initial/early therapy with single-pill combinations of blood pressure-lowering drugs for improving blood pressure control (NewSTeP): Rationale, design of a randomized clinical trial and baseline characteristics of the trial participants
AU - R. Dhurjati
AU - R. Pant
AU - A. Kumar
AU - A. Mittal
AU - K. Chappidi
AU - G. Satheesh
AU - P. Puri
AU - S. K. Tiruttani
AU - S. Rajaram
AU - A. Basheer
AU - P. kaur
AU - A. Moran
AU - A. Rosende
AU - P. Subramani
AU - S. Mahajan
AU - N. Lalvani
AU - S. Bansal
AU - D. Prabhakaran
AU - J. P. Balagopalan
AU - S. Jan
AU - M. D. Huffman
AU - V. Jha
AU - A. Salam
PY - 2026
DA - 2026/09/10
PB - medRxiv
DO - 10.64898/2026.09.10.26362712
UR - https://www.medrxiv.org/content/10.64898/2026.09.10.26362712v1
AB - BackgroundHypertension is the leading modifiable risk factor for cardiovascular disease (CVD). Despite availability of blood pressure (BP)-lowering therapies, BP control rates remain suboptimal. Reluctance to initiate treatment with combination therapy and delayed treatment intensification contribute to poor control. Early use of single-pill combinations (SPCs) within standardised treatment protocols (STPs) may improve outcomes, but evidence from India is limited. ObjectiveTo evaluate the effectiveness and safety of a new STP incorporating initial or early use of SPCs compared with usual care among adults with hypertension. MethodsThe New Standardised TrEatment Protocol (NewSTeP) trial is a pragmatic, multicentre, randomized, parallel-group, open-label trial conducted in tertiary healthcare centres in India. Adults with hypertension who are untreated or receiving one BP-lowering drug and require treatment initiation or intensification (n = 300) will be randomized 1:1 to either a new STP incorporating early SPC therapy or usual care. Participants will be followed for 6 months. The primary effectiveness outcome is change in home-measured mean systolic BP from randomization to month 6. The primary safety outcome is discontinuation of trial drug due to adverse events. Secondary outcomes include proportion of participants achieving BP control, change in diastolic BP, incidence of adverse events of special interest, treatment adherence, treatment modification, and time to BP control. A process evaluation will assess reach, implementation, acceptability, and sustainability, while an economic evaluation will assess cost-effectiveness. ResultsBetween October 2025 and March 2026, 300 participants were randomized across nine sites (150 to New STP; 150 usual care) from 360 screened individuals. Final follow-up is expected in September 2026, with results anticipated in October 2026. ConclusionsThe NewSTeP trial will provide evidence on the effectiveness, safety, implementation, and cost-effectiveness of an SPC-based STP for hypertension management in India and inform future hypertension control strategies and policies. Trial RegistrationThe trial is registered with the Clinical Trials Registry-India (CTRI/2025/07/091649).
ER -