Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2).

BACKGROUND: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh. METHODS/DESIGN: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2. DISCUSSION: This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial. TRIAL REGISTRATION: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.

Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

BACKGROUND: Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh. METHODS/DESIGN: This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020. DISCUSSION: In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial. TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.

Community health promotion and medical provision for neonatal health-CHAMPION cluster randomised trial in Nagarkurnool district, Telangana (formerly Andhra Pradesh), India.

BACKGROUND: In the mid-2000s, neonatal mortality accounted for almost 40% of deaths of children under 5 years worldwide, and constituted 65% of infant deaths in India. The neonatal mortality rate in Andhra Pradesh was 44 per 1,000 live births, and was higher in the rural areas and tribal regions, such as the Nagarkurnool division of Mahabubnagar district (which became Nagarkurnool district in Telangana in 2014). The aim of the CHAMPION trial was to investigate whether a package of interventions comprising community health promotion and provision of health services (including outreach and facility-based care) could lead to a reduction of the order of 25% in neonatal mortality. METHODS AND FINDINGS: The design was a trial in which villages (clusters) in Nagarkurnool with a population < 2,500 were randomised to the CHAMPION package of health interventions or to the control arm (in which children aged 6-9 years were provided with educational interventions-the STRIPES trial). A woman was eligible for the CHAMPION package if she was married and <50 years old, neither she nor her husband had had a family planning operation, and she resided in a trial village at the time of a baseline survey before randomisation or married into the village after randomisation. The CHAMPION intervention package comprised community health promotion (including health education via village health worker-led participatory discussion groups) and provision of health services (including outreach, with mobile teams providing antenatal check-ups, and facility-based care, with subsidised access to non-public health centres [NPHCs]). Villages were stratified by travel time to the nearest NPHC and tribal status, and randomised (1:1) within strata. The primary outcome was neonatal mortality. Secondary outcomes included maternal mortality, causes of death, health knowledge, health practices including health service usage, satisfaction with care, and costs. The baseline survey (enumeration) was carried out between August and November 2007. After randomisation on 18 February 2008, participants, data collectors, and data analysts were not masked to allocation. The intervention was initiated on 1 August 2008. After an inception period, the assessment start date was 1 December 2008. The intervention ended on 31 May 2011, and data collection was completed on 30 November 2011. Primary analyses followed the intention to treat principle. In all, 14,137 women were enrolled in 232 control villages, and 15,532 in 232 intervention villages. Of these, 4,885 control women had 5,474 eligible pregnancies and gave birth to 4,998 eligible children. The corresponding numbers in intervention villages were 5,664 women, 6,351 pregnancies, and 5,798 children. Of the live-born babies, 343 (6.9%) in the control arm and 303 (5.2%) in the intervention arm died in their first 28 days of life (risk ratio 0.76, 95% CI 0.64 to 0.90, p = 0.0018; risk difference -1.59%, 95% CI -2.63% to -0.54%), suggesting that there were 92 fewer deaths (95% CI 31 to 152) as a result of the intervention. There were 9 (0.16%) maternal deaths in the control arm compared to 13 (0.20%) in the intervention arm (risk ratio 1.24, 95% CI 0.53 to 2.90, p = 0.6176; 1 death was reported as a serious adverse event). There was evidence of improved health knowledge and health practices including health service usage in the intervention arm compared to the control arm. Women in the intervention arm were more likely to rate their delivery and postnatal care as good or very good. The total cost of the CHAMPION interventions was US$1,084,955 ($11,769 per life saved, 95% CI $7,115 to $34,653). The main limitations of the study included that it could not be masked post-randomisation and that fetal losses were not divided into stillbirths and miscarriages because gestational age was not reliably reported. CONCLUSIONS: The CHAMPION trial showed that a package of interventions addressing health knowledge and health seeking behaviour, buttressing existing health services, and contracting out important areas of maternal and child healthcare led to a reduction in neonatal mortality of almost the hypothesized 25% in small villages in an Indian state with high mortality rates. The intervention can be strongly justified in much of rural India, and is of potential use in other similar settings. Ongoing changes in maternal and child health programmes make it imperative that a similar intervention that establishes ties between the community and health facilities is tested in different settings. TRIAL REGISTRATION: ISRCTN registry ISRCTN24104646.