Article Text
PDF
Abstract
Background Melghat, an impoverished rural area in Maharashtra state, India; has scarce hospital services and low health-seeking behaviour. At baseline (2004) the under-five mortality rate (U5MR) (number of deaths in children aged 0–5 years/1000 live births) was 147.21 and infant mortality rate (IMR) (number of deaths of infants aged under 1 year/1000 live births) was 106.6 per 1000 live births. We aimed at reducing mortality rates through home-based child care (HBCC) using village health workers (VHWs).
Methods A cluster-randomised control trial was conducted in 34 randomly assigned clusters/villages of Melghat, Maharashtra state, between 2004 and 2009. Participants included all under-five children and their parents. Interventions delivered through VHWs were patient–public involvement, newborn care, disease management and behaviour change communications. Primary outcome indicators were U5MR and IMR. Secondary outcome indicators were neonatal mortality rate (NMR) (number of neonatal deaths aged 0–28 days/1000 live births) and perinatal mortality rate (PMR) (number of stillbirths and early neonatal deaths/1000 total births). Analysis was by intention-to-treat at the individual level. This trial was extended to a service phase (2010–2015) in both arms and a government replication phase (2016–2019) only for the intervention clusters/areas (IA).
Findings There were 18 control areas/clusters (CA) allocated and analysed with 4426 individuals, and 16 of 18 allocated IA, analysed with 3230 individuals. The IMR and U5MR in IA were reduced from 106.60 and 147.21 to 32.75 and 50.38 (reduction by 69.28% and 65.78%, respectively) compared with increases in CA from 67.67 and 105.3 to 86.83 and 122.8, respectively, from baseline to end of intervention. NMR and PMR in IA showed reductions from 50.76 to 22.67 (by 55.34%) and from 75.06 to 24.94 (by 66.77%) respectively. These gains extended to villages in the service and replication phases.
Interpretation This socio-culturally contextualised model for HBCC through VHWs backed up with institutional support is effective for significant reduction of U5MR, IMR and NMR in impoverished rural areas. This reduction was maintained in the study area during the service phase, indicating feasibility of implementation in large-scale public health programmes. Replicability of the model was demonstrated by a linear decline in all the mortality rates in 20 new villages during the government phase.
Trial registration number NCT02473796.
- Child health
- Health education and promotion
- Hygiene
- Public Health
- Cluster randomized trial
Data availability statement
Data are available upon reasonable request. Aggregate data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) will be shared. Study protocol has been added in the supplementary materials. As per guidelines of Government of India (GOI), individual participant data will not be available. Data will be made available: The beginning 9 months and ending 36 months following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee, the GOI and ethical review by the ICMR and Government of Maharashtra (India), Tribal Section clearance, identified for this purpose. Proposals may be submitted up to 35 months following article publication. After 36 months the data will be available with investigator support.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Data availability statement
Data are available upon reasonable request. Aggregate data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) will be shared. Study protocol has been added in the supplementary materials. As per guidelines of Government of India (GOI), individual participant data will not be available. Data will be made available: The beginning 9 months and ending 36 months following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee, the GOI and ethical review by the ICMR and Government of Maharashtra (India), Tribal Section clearance, identified for this purpose. Proposals may be submitted up to 35 months following article publication. After 36 months the data will be available with investigator support.
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Handling editor Valery Ridde
Twitter @MAHAN
Contributors ARS: visualisation, conceptualisation, funding acquisition, resources, project administration, methodology, training, supervision, literature search, figures, study design, data collection, data interpretation, data curation, formal analysis, investigation, validation, writing the original draft, review and editing. ARS is guarantor. KAS: visualisation, conceptualisation, resources, project administration, supervision, data collection, investigation and writing—review. AB: conceptualisation, resources, methodology, training, study design, writing—review and editing. JP: conceptualisation, methodology, training, study design, writing—review and editing. VD: methodology, training, project administration, supervision, data interpretation, data curation, investigation, validation, literature search, figures, writing—review and editing. DR: training, literature search, figures, study design, data interpretation, data curation, formal analysis, data analysis, software, validation, writing—review and editing. SU: literature search, data interpretation, data curation, analysis, data analysis, software and validation. EAFS: training, literature search, figures, data interpretation, data curation, formal analysis, data analysis, writing—review and editing.
Funding MAHAN trust has obtained funding for the study from: Stichting Geron, Netherlands, Caring Friends (MAHAN1) and Bajaj Holding Investment Limited (2242/BHIL). EAFS and the MAHAN trust have obtained funding from the Bill and Melinda Gates OPP1128468. Technical Support for technical inputs and training for home-based newborn care and acute respiratory infection management was provided by SEARCH, Gadchiroli, Maharashtra, India. We would like to thank the MAHAN Trust Foundation, the staff and data entry team, all the study team the supervisors, counsellors and village health workers who worked tirelessly throughout the study. Dr Shinde was the pediatrician that took care of our study subjects at the MAHAN hospital. We acknowledge with gratitude the assistance of the Honourable District Collector and Additional District Medical Officer, Dr Bobade, the pediatricians at the subdistrict hospital, the village panchayat heads and council members, as well as the local traditional healers and auxiliary nurse midwives and traditional midwives who assisted with the study. Finally, and most importantly, we acknowledge with gratitude all of the families and their young children that participated in the study who graciously let us into their homes and allowed us to follow their babies throughout the study and especially those families with babies that died, to whom we could offer no solace except to know that their participation would help other babies in the future from dying of preventable causes. We are thankful to Dr Dipti Jain, Dr Satchit Balsari and Dr Sehj Kashyap for guiding the article write up.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Author note The reflexivity statement for this paper is linked as an online supplemental file1.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.