ABSTRACT
BACKGROUND: High blood pressure is a major public health problem in low- and middle-income countries. Low-sodium salt substitute (LSSS) is a promising population-level blood pressure-lowering intervention requiring minimal behavioral change. The optimal method of delivering LSSS to individuals, however, is currently unknown. Community health workers (CHWs) have successfully been used to implement health interventions in Bangladesh and may provide a venue for the dissemination of LSSS. METHODS: We aim to conduct a cluster-randomized controlled trial involving 309 households in rural Bangladesh previously identified and characterized by the BRAC James P Grant School of Public Health, BRAC University (BRAC JPGSPH). These households will be randomly assigned to three arms: (1) control, i.e., no intervention; (2) information only, i.e., community health workers will provide basic information on high blood pressure, the health consequences of excessive salt consumption, and feedback to the participant on the likely quantity of salt s/he consumes (estimated using a questionnaire); (3) free LSSS arm: the same information as in arm 2 will be provided, but participants will receive 6 months of free low-sodium salt along with education on the benefits of LSSS. One male and one female adult (age ≥ 18 years) in each household will be invited to participate, the exclusion criteria being households with members known to have high serum potassium levels, are taking medications known to elevate potassium levels (e.g., ACE inhibitors, ARBs, potassium-sparing diuretics), are already taking potassium supplements, or those who have known kidney disease or abnormal serum creatinine at baseline. The primary endpoint will be blood pressure at 6 months post-intervention. DISCUSSION: Recent large clinical trials of LSSS in China and India have shown not only blood pressure improvements, but also stroke, major cardiac event, and all-cause mortality reductions. Nevertheless, how to best translate this intervention to population-level effectiveness remains unclear. Our study would test whether a community health worker-based program could be effectively used to disseminate LSSS and achieve measurable blood pressure benefits. TRIAL REGISTRATION: ClinicalTrials.gov NCT05425030. Registered on June 21, 2022.
Subject(s)
Community Health Workers , Hypertension , Adult , Humans , Male , Female , Adolescent , Blood Pressure , Bangladesh , Angiotensin Receptor Antagonists , Treatment Outcome , Angiotensin-Converting Enzyme Inhibitors , Hypertension/diagnosis , Hypertension/prevention & control , Sodium Chloride, Dietary/adverse effects , Sodium , Randomized Controlled Trials as TopicABSTRACT
INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.
Subject(s)
Diabetes Mellitus , Hypertension , Noncommunicable Diseases , Developing Countries , Diabetes Mellitus/therapy , Humans , Hypertension/diagnosis , Hypertension/therapy , Noncommunicable Diseases/therapy , Systems AnalysisABSTRACT
OBJECTIVE: The current study assessed intake of iron-and-folic-acid (IFA) tablet/syrup (grouped into none, < 100 d of IFA consumption or < 100 IFA and ≥ 100 d of IFA consumption or ≥ 100 IFA) among prospective mothers and its association with various stages of low-birth weight (ELBW, extremely low-birth weight; VLBW, very low-birth weight and LBW, low-birth weight) and neonatal mortality (death during day 0-1, 2-6, 7-27 and 0-27) in India. DESIGN: The cross-sectional, nationally representative, 2015-2016 National Family Health Survey (NFHS-4) data were used. Weighted descriptive analysis and multiple binary logistic regression modelling were used. SETTING: NFHS-4 covered 640 districts from thirty-seven states and union territories of India. PARTICIPANTS: A total of 120 374 and 143 675 index children aged 0-59 months were included to analyse LBW and neonatal mortality, respectively. RESULTS: Overall, 30·7 % mothers consumed ≥ 100 IFA in 2015-2016, and this estimate ranged from 0·0 % in Zunheboto district of Nagaland state to 89·5 % in Mahe district of Puducherry of India. Multiple regression analysis revealed that children of mothers who consumed ≥ 100 IFA had lower odds of ELBW, VLBW, LBW and neonatal mortality during day 0-1, as compared with mothers who did not buy/receive any IFA. Consumption of IFA (< 100 IFA and ≥ 100 IFA) had a protective association with neonatal death during day 7-27 and 0-27. Consumption of IFA was not associated with neonatal death during day 2-6. CONCLUSIONS: While ≥ 100 IFA consumption during pregnancy was found to be associated with preventing select types of LBW and neonatal mortality, a large variation in coverage of ≥ 100 IFA consumption across 640 districts is concerning.
Subject(s)
Iron , Perinatal Death , Birth Weight , Child , Cross-Sectional Studies , Dietary Supplements , Female , Folic Acid , Humans , India/epidemiology , Infant Mortality , Infant, Newborn , Mothers , Pregnancy , Prospective StudiesABSTRACT
BACKGROUND: The World Health Organization's (WHO) antiretroviral therapy (ART) guidelines have generally been adopted rapidly and with high fidelity by countries in sub-Saharan Africa. Thus far, however, WHO has not published specific guidance on nutritional care and support for (non-pregnant) adults living with HIV despite a solid evidence base for some interventions. This offers an opportunity for a case study on whether national clinical guidelines in sub-Saharan Africa provide concrete recommendations in the face of limited guidance by WHO. This study, therefore, aims to determine if national HIV treatment guidelines in sub-Saharan Africa contain specific guidance on nutritional care and support for non-pregnant adults living with HIV. METHODS: We identified the most recent national HIV treatment guidelines in sub-Saharan African countries with English as an official language. Using pre-specified criteria, we determined for each guideline whether it provides guidance to clinicians on each of five components of nutritional care and support for adults living with HIV: assessment of nutritional status, dietary counseling, micronutrient supplementation, ready-to-use therapeutic or supplementary foods, and food subsidies. RESULTS: We found that national HIV treatment guidelines in sub-Saharan Africa generally do not contain concrete recommendations on nutritional care and support for non-pregnant adults living with HIV. CONCLUSIONS: Given that decisions on nutritional care and support are inevitably being made at the clinician-patient level, and that clinicians have a relative disadvantage in systematically identifying, summarizing, and weighing up research evidence compared to WHO and national governments, there is a need for more specific clinical guidance. In our view, such guidance should at a minimum recommend daily micronutrient supplements for adults living with HIV who are in pre-ART stages, regular dietary counseling, periodic assessment of anthropometric status, and additional nutritional management of undernourished patients. More broadly, our findings suggest that countries in sub-Saharan Africa look to WHO for guidance in translating evidence into clinical guidelines. It is, thus, likely that the development of concrete recommendations by WHO on nutritional interventions for people living with HIV would lead to more specific guidelines at the country-level and, ultimately, better clinical decisions and treatment outcomes.