Cardiovascular disease remains a leading cause of preventable mortality in Aotearoa New Zealand (NZ), with Māori continuing to experience earlier onset, higher hospitalisation rates and greater mortality than non-Māori. Despite this inequity, community-based data describing cardiac structure, function and circulating cardiovascular biomarkers in older Māori are very limited, particularly for those over 65 years. The Hauora Manawa mō ngā Kaumātua me ngā Whānau (Heart Health of Older Māori and Families; Kaumātua Manawa) study aims to examine associations between ethnicity and age on cardiac structure, function and plasma cardiovascular biomarkers in Māori and to evaluate the suitability of current clinical reference standards.

Kaumātua Manawa is a community-based, co-designed study comprising a baseline assessment of cardiac structure, function and biomarkers, combined with prospective ascertainment of hospitalisation, all-cause mortality, pharmaceutical dispensing and clinical laboratory outcomes via ongoing linkage to national administrative health data held by the Ministry of Health and Te Whatu Ora | Health NZ. The study is conducted in partnership with Māori communities in Canterbury, NZ, with study clinics conducted at marae to ensure cultural safety for participants. Adults aged ≥18 years are recruited using convenience sampling, with a primary focus on Māori aged ≥65 years. Participants undergo nurse assessment (demographics, medical history, cardiovascular risk factors), 12-lead ECG, comprehensive transthoracic echocardiography following American Society of Echocardiography guidelines and non-fasting blood sampling. Biomarkers include N-terminal pro-B-type natriuretic peptide, high-sensitivity troponin T, growth differentiation factor-15 and lipoprotein(a). Descriptive statistics will summarise cardiac measures overall and by marae. Associations between biomarkers and demographic and clinical variables will be examined using regression modelling. Echocardiographic parameters indexed according to international and NZ-specific recommendations will be compared with existing NZ European cohorts. This methodology paper uses the principles of the CONSolIDated CritERia for Strengthening the Reporting of Health Research Involving Indigenous Peoples statement (CONSIDER).

Ethics approval has been obtained from the NZ Health and Disability Ethics Southern Committee (2022 EXP 11434), and the protocol is registered at the Australian NZ Clinical Trials Registry. The study is governed by a dedicated Māori Governance Rōpū (Group) to ensure alignment with tikanga Māori (Māori protocols) and community priorities. Meetings will be conducted with participating marae and communities to discuss findings prior to publication. Results will be disseminated through open-access peer-reviewed publications and via presentations.

ACTRN12626000348358.

Hypertensive disorders of pregnancy, such as pre-eclampsia (PE), are one of the leading causes of maternal and perinatal deaths in low- and middle-income countries (LMICs). Although clinical practice guidelines (CPGs) for PE prevention and management are available, there is limited information on their implementation in LMIC contexts. This realist synthesis therefore aims to uncover the causal explanations underpinning the implementation of CPG recommendations for PE prevention and management in Eastern, Central and Southern African contexts. By developing and refining initial programme theories (IPTs), we will generate a pragmatic evidence base explaining how contextual factors trigger mechanisms that lead to intended and unintended outcomes and why implementation varies across the different settings.

We conceptualise the implementation of CPGs for PE prevention and management as complex social interventions operating within complex adaptive systems. The realist synthesis method will be employed to systematically review the literature for evidence synthesis. The review process will be conducted in five phases, each iteratively building on the previous phase to uncover generative causation and refine the IPTs. We will identify articles through iterative purposive searching in six electronic databases and search engines (Google Scholar, PubMed, Cochrane, MEDLINE, EMBASE Global Health) and through screening WHO sources. Advisory group consultations will be held to formulate, prioritise and refine IPTs. To conceptualise our realist theories through generative causation, we will analyse the data using a retroductive approach, an integration of inductive, deductive and abductive reasoning. We will inductively examine theoretical insights related to five established care moments and explore how CPGs operate during these moments, including where and how they fail to work as intended. The five care moments are: (1) Risk assessment/prevention, (2) Diagnosing disease, (3) Management of PE without severe features, (4) With severe features and (5) Decision making around birth. Deductive reasoning will support sense-making of evidence-based theories through the lens of theories that have been used to explain the adoption of guidelines in healthcare settings. Lastly, abductive reasoning, centring researcher hunches, will help to unearth mechanisms that have been insufficiently detailed in the literature. The intervention-context-actor-mechanism-outcome heuristic will be used to configure programme theories and articulate the theories using the if-then statements.

This project is part of the larger PREvention of Severe Hypertensive Adverse events (PRESHA) project, which aims to improve the detection, prevention and management of PE in Tanzania. PRESHA has ethical clearance from the Regional Ethics Board in Norway and the National Health Research Ethics Committee in Tanzania. Findings of the review will support the contextual development of CPGs for the prevention and management of PE, which will be implemented within the context of the PRESHA trial.

Iron-folic acid (IFA) supplementation in pregnancy is recommended by the WHO, with a dose of 60 mg of iron in contexts where anaemia remains a severe public health problem. Iron-containing supplements may cause side effects that affect acceptability and adherence in a dose-response manner. Maternal multiple micronutrient supplements (MMS), which include iron and folic acid plus additional micronutrients, are also recommended in the context of rigorous research, and programmes are considering transitioning from IFA to MMS containing 30 mg of iron. We will evaluate the effect of iron dose in MMS on maternal acceptability, side effects, adherence and preferences.

The Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial is an individually randomised, quadruple-blind, non-inferiority crossover trial of daily antenatal MMS supplementation formulations that contain 60 mg, 45 mg and 30 mg elemental iron among pregnant women in Dar es Salaam, Tanzania. A total of 156 pregnant participants will be randomised to a sequence in which they receive each of the three MMS formulations for 1 month. Participants, investigators, outcome assessors and data analysts will be blinded to the treatment sequence. The primary trial outcome is participant-reported acceptability of each MMS formulation, measured on a Likert scale. Secondary and tertiary outcomes include preferred and least preferred formulation, identification of MMS formulation, reported side effects and adherence assessed by pill count. Regression analyses will be used to assess differences between formulations and will account for sequence and period effects of the crossover trial design. Qualitative in-depth interviews from a subsample of participants will be conducted to understand women’s perceptions and experiences taking the different MMS formulations.

The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board (IRB), the Ifakara Health Institute IRB, the Muhimbili University of Health and Allied Sciences IRB, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Results will be shared through publications and presentations at the local, regional and international levels.

ClinicalTrials.gov Identifier: NCT06069869.