Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

The intervention is a participatory learning and action cycle of 20 meetings, during which women's groups open to other community members identify and prioritise maternal and newborn health problems in their area, identify strategies to address these, implement these strategies and evaluate the entire process. This cycle was adapted from an earlier intervention tested during the Ekjut trial and in other settings [27, 28]. Specific adaptations based on lessons from the Ekjut trial included a minimum recruitment of pregnant women into groups and an emphasis on care for newborns during winter, as a strong increase in neonatal deaths was observed in the study areas during this season. The team also prioritized materials to be used (e.g. picture cards) by selecting the most important maternal and newborn problems with ASHAs. The cycle consisted of fortnightly meetings for the first four months (Phase 1 and Phase 2), following by monthly meetings after this, as described in Table 3. In the first phase, consisting of three meetings, the ASHA will introduce the project, then help the group identify and prioritise local maternal and newborn health problems. In the second phase, consisting of four meetings, groups discuss causes and solutions to prioritized problems through participatory games and using picture cards, then identify and prioritise strategies for addressing the problems. At the end of this phase the groups prepare to hold a community meeting in which they share their thoughts, problems and strategies with other community members, including men, traditional birth attendants, mothers-in-law and Community Health Workers. In phase three, the groups implement their strategies and carry out practical role-plays focusing on care-seeking and emergencies. Finally, in phase four the groups evaluate each of the phases and progress on their prioritized strategies. The intervention is expected to run for 24 months (20 meetings, two community meetings and two additional months to make up for any cancellations of meetings).

In each district we approached district-level ASHA coordinators and Village Health Committees (VHCs), explained the women's group intervention and asked VHCs to identify suitable ASHAs to facilitate the groups. These ASHAs had to be functional according to government criteria: they needed to have undergone at least three training sessions and be village-based. We identified problems that could arise whilst working with ASHAs during the course of the intervention and agreed on strategies to address these. In order to assist the ASHAs, we appointed a co-facilitator who was given an incentive of Rs 50 per meeting to help with record keeping. This co-facilitator was not given training to conduct meetings, and ASHAs were left in charge of facilitation. Should an ASHA not be accepted by her village, we agreed that the district-based intervention team would seek to help her, and, if unsuccessful, ask the co-facilitator to conduct meetings after training. In the event that an ASHA should drop out of the intervention permanently the VHC and women's group would decide whether a new ASHA should be trained, or whether a co-facilitator should take over and be paid the full incentive. The intervention team designed four training sessions for selected ASHAs, one for each phase of the intervention. One cluster coordinator employed by Ekjut is posted in each district. ASHAs are given an incentive of Rs100 per day as in government trainings (US$2) and Rs200 per meeting. A total of 149 ASHAs were selected to implement the intervention.

Community involvement in monitoring health services is an essential component of the NRHM programme. Village health and sanitation committees (VHSCs or VHCs) are mandated to monitor local services as well as disseminate information about rights and entitlements to healthcare. We will undertake three main activities related to strengthening health services in both intervention and control areas. First, we will carry out at least one village health committee meeting about rights and entitlements in each village during the study period. Second, we will organise meetings with government officials and hospital management committees to inform the provision of appropriate care for mothers and newborns in facilities in the study districts. Finally, we will carry out at least one meeting with ASHAs using the appreciative inquiry method [29] to strengthen their job motivation and help them further enhance their work performance.

A sample size calculation was carried out in June 2010 using 11 months of available data on birth outcomes from the study areas prior to the creation of clusters. Baseline mortality data collected from the study areas between 1^st February 2009 and 31^st December 2009 indicated an NMR of 66 per 1000. We estimated k (the between cluster correlation coefficient) at 0.1 on the basis of data from the Ekjut trial as well as baseline data from the JOHAR trial areas. On the basis of surveillance from existing clusters, for an average cluster population of 5000, we expect an estimated 100 livebirths per cluster per year. We aim to assess the impact of the intervention using a total of 2 years of birth outcomes. We used formulae from Hayes and Bennett to estimate the power of the study [30]. Assuming a more conservative baseline mortality rate estimate of 55 per 1000, with 100 livebirths per cluster per year in 30 clusters, the study will have between 76.6% and 79.6% power to detect a 30% reduction in the NMR (from 55 per 1000 to 38.5 per 1000) over 24 months.

A monitoring team independent from the intervention team was established to collect information on births and deaths to women of reproductive age and on events during the antenatal, delivery and postnatal periods through a surveillance system adapted from a previous study, covering a total population of around 158,053 [31] and described in Figure 3. One key informant (a community member) reports all births and deaths to women of reproductive age to an interviewer. The informant is visited on a monthly basis by an interviewer from the surveillance team. The interviewer checks the report, pays the informant an incentive of Rs30 for an identification and another Rs 50 for conducting an interview with the identified mother around six weeks after the delivery. The collected questionnaires are examined by District Monitoring Coordinators with guidance from District Managers. Completed questionnaires are then entered into a database designed in Microsoft Access. Baseline data on birth outcomes were collected for a full year from 1^st September 2009 to 31^st August 2010.

Due to the nature of the intervention, the intervention team or participants cannot be blinded to the allocation however the analysts will be blinded to the allocation for the data safety and monitoring board and until the definitive analysis is performed. The intervention and monitoring team hold their meetings on separate days, and the content of the intervention is not discussed with monitoring team members. We shall analyse data for the primary and secondary endpoints for a data safety and monitoring board (DSMB) to be held in late 2011. The DSMB will be undertaken according to the principles stated in the DAMOCLES statement [32]. We will carry out intention-to-treat analyses using individual level data, adjusting for clustering using either logistic regression with random effects or generalised estimating equations [33]. In this data safety and monitoring board we will analyse data for the period from 1^st September 2010 till 31^st June 2011 (10 months of data). The DSMB will have three objectives:

Because previous trials of women's groups in Nepal and eastern India have shown a strong effect of groups on neonatal mortality, we aim to stop the trial and introduce groups into the control area after the DSMB if we observe a reduction in the NMR of 40% or more after adjusting for differences observed at baseline, or if we observe a reduction inferior to 40% but with improvements in secondary indicators (home care or care seeking practices) consistent with a reduction, and satisfactory implementation quality indicators (70% or more of ASHAs have conducted all meetings at the time of the DSMB; % of women who gave birth in the study area who received information from a group member; % of women of reproductive age in group meetings).

We will compare the proportion of women who received postnatal home visits by an ASHA and the proportion of women who delivered in institutions among areas with and without ASHA-led mobilisation.

We will use a mix of quantitative and qualitative methods to address each of these objectives, as described in Table 4. The process evaluation will aim to identify factors that would facilitate scale up.

Individual consent will be sought from each mother approached as a result of a birth or death identification, and consent recorded through a signature or thumbprint.

Because the women's group intervention has demonstrated an impact on neonatal mortality in a similar setting, we have put in place stopping rules in order to introduce the intervention to control areas if positive results are observed at the first data safety and monitoring board. In addition, activities such as strengthening of Village Health Committees and Appreciative Inquiry workshops with ASHAs will be conducted in both intervention and control clusters.

The study team will encourage referral to an appropriate health facility if they identify minor, acute or chronic illness in mothers or infants in either intervention or control areas.

All information will be confidential. Access to information will be limited to interviewers and monitors in the field and main office and then to data entry management staff. No publications, analyses or reports will include the names of participants.

One key objective of the study is to identify mechanisms for scaling up the intervention. We will share implementation plans and findings with NRHM implementers in Jharkhand and Orissa. The intervention will be introduced immediately into the control areas if a positive impact is observed at the first Data Safety and Monitoring board. We shall invite a representative of the Indian Council of Medical Research to join the data safety monitoring group.

Ethical approval for the study is being sought through an independent ethical research committee chaired by Dr AK Debdas in Jamshedpur, India. The study was approved by the Research Ethics Committee of University College London (UK) with project identification number 1488/001.