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Randomized Controlled Trial
. 2025 Jun 27;15(6):e101689.
doi: 10.1136/bmjopen-2025-101689.

Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study

Abdul Salam  1   2   3 , Tracey Laba  4 , Rupasvi Dhurjati  5 , Lakshmi K Josyula  6 , Asita de Silva  7 , Pavithra Godamunne  8 , Rama Guggilla  9 , Stephen Jan  2 , Pallab Kumar Maulik  10 , Nitish Naik  11 , Anushka Patel  2 , Arunasalam Pathmeswaran  12 , Dorairaj Prabhakaran  13   14 , Anthony Rodgers  2 , Vanessa Selak  15 , Ruth Webster Griffiths  16   17
Affiliations
Randomized Controlled Trial

Process evaluation of a randomised trial of a triple low-dose combination pill strategy to improve hypertension control: a qualitative study

Abdul Salam et al. BMJ Open. .

Abstract

Background: High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs ('triple pill') compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Methods: Guided by the UK Medical Research Council's framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Results: Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of 'better than usual' care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill's large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Conclusions: Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

Trial registration number: ACTRN12612001120864, SLCTR/2015/020.

Keywords: Blood Pressure; CARDIOLOGY; Hypertension; Meta-Analysis; Systematic Review.

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Conflict of interest statement

Competing interests: AR is employed by The George Institute for Global Health (TGI) and Imperial College London. TGI has submitted patent applications for low-dose combination products for hypertension, and AR is listed as an inventor. George Medicines Pty (GM) is a subsidiary of TGI, holds a licence for these patents and has received investment to develop these combination therapies. AR is seconded part-time to GM. AR has no financial interest in these patents or in GM. All other authors have no completing interest to declare.

Figures

Figure 1
Figure 1. TRIUMPH trial context, implementation of the intervention and mechanisms of effects and barriers and facilitators to implementation of the triple pill strategy in clinical practice. BP, blood pressure; GP, general practitioner; TRIUMPH, Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension.
See this image and copyright information in PMC

References

    1. Stanaway JD, Afshin A, Gakidou E, et al. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1923–94. - PMC - PubMed
    1. Roth GA, Abate D, Abate KH. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1736–88. doi: 10.1016/S0140-6736(18)32203-7. - DOI - PMC - PubMed
    1. Chow CK, Teo KK, Rangarajan S, et al. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013;310:959–68. doi: 10.1001/jama.2013.184182. - DOI - PubMed
    1. Mills KT, Bundy JD, Kelly TN, et al. Global Disparities of Hypertension Prevalence and Control: A Systematic Analysis of Population-Based Studies From 90 Countries. Circulation. 2016;134:441–50. doi: 10.1161/CIRCULATIONAHA.115.018912. - DOI - PMC - PubMed
    1. Williams B, Mancia G, Spiering W, et al. ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) Eur Heart J. 2018;39:3021–104. - PubMed

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