IntroductionSouth Africa’s evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at their first antenatal visit either overweight or obese in urban South Africa (SA), the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and NCDs.Methods and analysisBukhali is the first individual randomised controlled trial in Africa to test the efficacy of a complex continuum of care intervention and forms part of the Healthy Life Trajectories Initiative (HeLTI) consortium implementing harmonised trials in Canada, China, India and SA. Starting preconception and continuing through pregnancy, infancy and childhood, the intervention is designed to improve nutrition, physical and mental health and health behaviours of South African women to offset obesity-risk (adiposity) in their offspring. Women aged 18–28 years (n=6800) will be recruited from Soweto, an urban-poor area of Johannesburg. The primary outcome is dual-energy X-ray absorptiometry derived fat mass index (fat mass divided by height2) in the offspring at age 5 years. Community health workers will deliver the intervention randomly to half the cohort by providing health literacy material, dispensing a multimicronutrient supplement, providing health services and feedback, and facilitating behaviour change support sessions to optimise: (1) nutrition, (2) physical and mental health and (3) lay the foundations for healthier pregnancies and early child development.Ethics and disseminationEthical approval has been obtained from the Human Ethics Research Committee University of the Witwatersrand, Johannesburg, South Africa (M1811111), the University of Toronto, Canada (19-0066-E) and the WHO Ethics Committee (ERC.0003328). Data and biological sample sharing policies are consistent with the governance policy of the HeLTI Consortium (https://helti.org) and South African government legislation (POPIA). The recruitment and research team will obtain informed consent.Trial registrationThis trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871).Protocol version20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.
The Integrated Management of Childhood Illness (IMCI) strategy has been adopted by 102 countries including South Africa, as the preferred primary health care (PHC) delivery strategy for sick children under 5 years. Despite substantial investment to support IMCI in South Africa, its delivery remains sub-optimal, with varied implementation in different settings. There is scarce research globally, and in the local context, examining the effects of health system characteristics on IMCI implementation. This study explored key determinants of IMCI delivery in a South African province, with a specific focus on health system building blocks using a health system dynamics framework. In-depth interviews were conducted with 38 districts, provincial and national respondents involved with IMCI co-ordination and delivery, exploring their involvement in, and perceptions of, IMCI strategy implementation. Identified barriers included poor definition of elements of a service package for children and how IMCI aligned with this, incompetence of trained nurses exacerbated by inappropriate rotation practices, use of inappropriate indicators to track progress, multiple cadres coordinating similar activities with poor role delineation, and fragmented, vertical governance of programmes included within IMCI, such as immunization. Enabling practices in one district included the use of standardized child health records incorporating IMCI activities and stringent practice monitoring through record audits. Using IMCI as a case study, our work highlights critical health system deficiencies affecting service delivery for young children which need to be resolved to reposition IMCI within the broader child 'survive, thrive and transform' agenda. Recommendations for appropriate health system strengthening include the need for redefining IMCI within a broader PHC service package for children, prioritizing post-training supervision and mentoring of practitioners through appropriate duty allocation and rotation policies, strengthening IMCI monitoring with a specific focus on quality of care and building stronger clinical governance through workforce allocation, role delineation and improved accountability.
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