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GLOBVAC-Global helse- og vaksin.forskn

Equity and financial household impact in randomised controlled trials, implementation research and cohort studies in India (EQUIFINANCE)

Alternative title: Rettferdig fordeling av helsegevinster og finansiell risikobeskyttelse i epidemiologiske studier i India (EQUFINANCE)

Awarded: NOK 12.0 mill.

When countries aim to achieve the SDGs, it is important to ensure equal access to health care and to prevent medical induced poverty. The EquiFinance project is supported by RCN and evaluates whether poor families get the same effect from health care as rich ones and how much their personal finances are affected by starting treatment of children and newborns in five studies in India: (1) "Equity and Poverty impact of Kangaroo Mother Care (ciKMC)". This is an extension of the large ciKMC study that used data from newborns in 8402 families in India. KMC focus on teaching the mother/father how to hug the baby and breastfeed immediately after birth, the training takes place at home where the families live and not in hospitals. This reduces neonatal mortality by 25%. In the EquiFinance project, two scientific articles from ciKMC have been published (one in International Journal for Equity in Health (https://doi.org/10.1186/s12939-021-01605-0), and one in BMJ Global Health (http://dx.doi.org/10.1136/bmjgh-2022-010000)). ciKMC was found to reduce household health expenses and prevent poverty in families, and the poorest families seem to have the greatest health impact. (2) "Health care expenditure survey in India". This is a large observational study that looks at access to health care, healthcare expenditures, and economic consequences for families. In India, about 17% of families have catastrophic health expenses, hence it is important to know more precisely how illness and health care affect families' finances. Around 3,000 families will be followed over one year (Nov 2023 - Nov 2024) and the incidence of nearly 100 diseases and health expenses for these will be mapped in each family. This study will provide important and detailed information on families' health expenses, productivity loss due to illness, the proportion of households that experience catastrophic health expenses and poverty due to seeking health care. Analysis of baseline data has started, and we are eagerly awaiting the follow-up results. (3) "Equity and financial benefits of zinc supplementation to management of sepsis". This pharmaceutical study (randomized, double-blind, placebo controlled RCT) has recently been completed and we have looked at whether 10 mg of zinc given orally daily to neonates (up to 2 months) treated in hospital with clinically severe infection could increase survival. 2913 infants with clinically severe infection from 5 hospitals in India were enrolled. The EquiFinance extension of the primary study included 702 participants. Analyses are now ongoing, and we are looking more closely at whether admission to intensive care units for children with severe infection entails a major economic risk for poor families and whether there are differences in survival between poor and rich families. (4) "High-risk infant follow-up". The hospital-based Garbh-ini Pregnancy Cohort is a large and comprehensive registry for mothers and newborns in India. Several clinical and biological data have been recorded on 11173 mothers and newborns throughout the gestation period and after childbirth. In the EquiFinance expansion of this study, we will improve socioeconomic parameters and equity analyses of these. A birth cohort that is at high risk for developmental disorders will be followed. Factors related to pregnancy, childbirth and postpartum that affect growth and development in infants until they reach 2 years of age will be analyzed. We take a closer look at the economic and health benefits of doing a good neurological assessment during the first 2 years of life. To date, 696 babies have been registered before 10 weeks of age and are followed monthly (follow-up frequency of 99%). (5) "ACTION III Trial". Corticosteroids are given late in pregnancy to prevent premature birth; it is usually injected between weeks 34 and 37 of pregnancy. Unfortunately, there is insufficient evidence of the effect of this. Therefore, the WHO-led ACTION III study will look at the effects of corticosteroids. The study is conducted in several countries and is a pharmaceutical trial (randomized, double-blind, placebo controlled RCT). One of the locations where the study is being conducted is in India, where EquiFinance is part of ACTION-III. Steroid injections are given to women at high risk of premature birth (weeks 34-37 of pregnancy) and the hypothesis is that the incidence of premature births will be reduced. The recruitment of participants started in August 2022, 162 enrolled. In the EquiFinance section of the study, we will take a closer look at the effect of steroid injections on family finances and whether there are differences in effect between rich and poor families. We expect cost savings because antenatal corticosteroids reduce the risk of severe disease by decreasing the chances of premature birth. This also reduces the risk of large financial outlays from household due to lower chances of expensive spending in neonatal intensive care units.

The main idea behind the EQUIFINANCE project is to develop and evaluate new methods to assess equity and economic impact (financial risk protection) of health care interventions. Impact on equity and economic return for households of neonatal and child health interventions will be assessed in five ongoing primary high quality studies in India: Three randomised controlled trials (community-initiated kangaroo mother care, zinc supplementation to antibiotic treatment of severe infections, antenatal corticosteroids for late preterm birth), one study with implementation research design (integrated community case management for pneumonia) and one pregnancy cohort study (high-risk infant follow-up). EQUIFINANCE will be an add on study to these Results from the EQUIFINANCE are expected to be relevant for SDG 3.8. Methods of Extended cost-effectiveness analysis (ECEA), Concentration Index and Concentration Curves, financial household impact analysis, and CONSORT-Equity 2017 guidance will be applied and developed to all primary studies. EQUIFINANCE has therefore a high potential for scientific impact, with the establishment of a leading research group on equity and poverty impact methods in randomised controlled trials, implementation research and cohort studies. EQUIFINANCE is a collaboration between Centre for Health Research and Development, Society for Applied Sciences (SAS) in New Delhi (with expertise in conducting large community based trials), Translational Health Science and Technology Institute (THSTI) in New Delhi (with experience in conducting large facility based trials), Centre for Intervention Science in Maternal and Child Health (CISMAC) in Bergen (NRC centre of excellence on maternal and child health randomised controlled trials) and Bergen Centre of Ethics and Priority Setting (BCEPS) (with expertise in equity impact studies and development of national essential health care packages for universal health coverage in low- and middle income countries).

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GLOBVAC-Global helse- og vaksin.forskn