The trial will attempt to reduce neonatal mortality in the intervention villages through a multi-level program: community health promotion and contracting out primary and secondary health services to non-public providers. All the services described below will be provided free to pregnant women and neonates in the intervention communities.
To stimulate both adoption of healthy practices and demand for care, the trial will implement a concerted effort to promote health knowledge of communities in the intervention arm. The three main components of this are as follows:
• Training Village Health Workers and Midwives to deliver antenatal services
The trial will select and train local women in the intervention villages to serve as Village Health Workers (VHWs). The person selected as VHW will usually be an Auxiliary Nurse Midwife (ANM) or Traditional Birth Attendant (TBA) already resident in the village. The person chosen will be the most highly skilled available who is acceptable to the communities in the village.
The VHW will be extensively trained by doctors and other health professionals in domiciliary mother and baby care along with postnatal and infant care. They will also be trained in how to deliver antenatal care and conduct safe deliveries at home. They will make home visits to pregnant women and to mothers with neonates. They will also assist with home deliveries.
Approximately every two weeks, teams of two midwives will visit intervention villages offering a package of antenatal care and services (referred to below as "fixed-day services"). Midwives will be trained by doctors to deliver clear, correct pregnancy and neonate-related health information to mothers and their health care providers. They will be trained in community mobilization and the use of communication tools to address deep seated superstitions and practices that have negative impacts on the health of both mother and child. One midwife will act as the main medium for communication of sound health information to women in intervention villages. The other midwife will deliver antenatal health checks and identify high risk pregnancies. She will also give advice to the women, relatives and friends who accompany them on antenatal health care issues and birth planning.
These midwives will supervise VHWs, offer guidance, and conduct emergency deliveries if they occur during their visits to the villages. In case of complications, the midwife will be responsible for referring the mother/neonate in distress to the next level of care.
Midwives based in NPHCs will organise and oversee transportation for referred women.
The intervention team will train a total of approximately 250 VHWs (at least one for every village, in certain villages we may have to train more than one) and approximately 20 midwives (16 midwives delivering fixed day services in teams of two and 4 midwives based at NPHCs). They will go through a orientation program and training of not less than 10 days. This residential training will have both theoretical and practical components. It will be given by experts in the field of maternal and neonatal health care.
Additionally midwives will be trained to update a trial-specific health card provided to all eligible women in intervention villages. These cards will track the various services each woman in the intervention group has received under the programme, including immunizations, participation in health groups, regular checkups and hospitalisation. The VHWs and midwives will ensure that these cards are filled correctly and on time by the various health care providers. The midwives will also keep a record of the number of visits they have made to the village, the number of women they have met, the number of emergency deliveries with which they have assisted and the number of cases they have referred to the NPHCs. Midwives will also keep records of the nature of care they provide to each mother and child attended.
For reinforcement of messages, the VHWs and midwives will be given a manual to refer to for review. Regular meetings will be held to allow them to share knowledge regarding their work and problems encountered.
• Providing health education through a public information campaign
One of the most important contributors to poor maternal and neonatal health is a lack of good health information. This problem is particularly apparent in the local delivery and infant rearing practices which are often in contradiction of evidence-based good practice.
Health knowledge and awareness will be generated through frequent village meetings and community events. A health education campaign including theatre, films, focus groups and other media will be launched to promote key themes related to maternal and child health in each village. Folk culture in the form of song and dance will also be adapted to convey important messages to communities. All members of the community, not just women eligible for the trial, will be targeted by these campaigns.
As part of this campaign, VHWs will also make one to one contact through home visits with mothers, providing them with information related to their pregnancy and the health status of their child. These visits will be conducted on a periodic basis and will help reinforce good health care and practice in women and children. During fixed-day services, midwives will also answer health related queries that the women may have during the course of her pregnancy.
Midwives will also conduct regular village health meetings during the days on which fixed-day services take place. During these they will facilitate discussions, show films and use posters, flip charts and flash cards with the aim of promoting good health practices during and after pregnancy. The exact nature and duration of communication exposure will be designed by a health communications expert.
• Organising women's participatory discussion groups
As there is strong evidence that participatory women's groups can rapidly facilitate community-wide adoption of hygienic practices, a vital responsibility of the VHWs in intervention villages will be to facilitate good attendance at group discussions on issues related to maternal and neonatal health [
6,
7].
VHWs will organize eligible women from each village into participatory discussion groups of a maximum size between 15 and 20 individuals, creating multiple groups if necessary to maintain appropriate group size. These groups will meet during the day when fixed-day services take part. The midwives will conduct these approximately 1–2 hour sessions at a time and venue suitable to a majority of the women. Each session will contain ice-breakers, a review of the last meeting's content, presentation of new themes, reinforcement of themes through activities, demonstrations, games and a small assignment. These discussions will also be a forum where women can encourage each other to access the trial services. Finally, the participatory group will also serve as a group that provides valuable feedback about the various interventions.
Content for these sessions will include discussion of risk factors for the baby and mother, safe delivery techniques, causes of any recent deaths of neonates and mothers in nearby regions, and other issues that are important in the villages. The objective of these meetings is to improve mothers' health knowledge, to encourage greater use of fixed day services and other available health services, to encourage safe delivery techniques and delivery of high risk babies at the referral centre, and to give mothers a forum to discuss solutions to important issues in maternal and newborn health. This approach has been shown to be very successful in a trial in Nepal [
6].
Contracting out primary and secondary health services to non-public institutions
As outlined in the trial justification, the supply of primary health care in the trial area is inadequate. Required improvements to the public sector were estimated to be prohibitively expensive, and evidence suggests the private sector may be able to provide primary care which is superior to that provided by the public, and potentially at a lower cost [
11].
To increase supply of health services, the trial's intervention will designate up to 5 NPHCs to provide primary and secondary level care, made accessible through enhanced emergency transportation. NPHCs will be selected which are equipped with sufficient infrastructure and human resources. It is imperative to provide women in the intervention arm with quality services which are otherwise unavailable or inadequate, as it is expected that the educational component of the intervention will lead to greater awareness of the need for health services, and thus greater uptake of these services.
The list of candidate NPHCs will be drawn-up based on professional capability, existing infrastructure, and public perception of the facility (public perception serves as a way to introduce community participation in the selection process and to render the process transparent). Tie-ups with such facilities will initially be for the period of 3 months after which a favourable review would lead to a 6 month renewal of the contract. Any kind of primary or secondary service that an expectant mother would require during her pregnancy and for one month of the life of her baby would be covered by these facilities. By virtue of the contractual agreement, these NPHCs would be expected to provide around-the-clock service, admission to the general ward, food for the patient and one attendant, drugs, and disposables.
This contract will be subject to a per-patient cost ceiling. A rigorous monitoring system will buttress against over-billing and over-provision of services by the NPHCs.
Transportation will not be part of this contracting system, but will be provided directly at the village level for pick-up and drop off of patients at the NPHCs.
A detailed third party assessment of the quality of the services by the NPHCs will be conducted periodically by a committee of health and other professionals.