A Model for the Distribution of Misoprostol
I started a project called EMM with my friends to End Maternal Mortality. EMM aims to reduce the maternal mortality rate in Jigawa State, Nigeria by 20–30% through the distribution of a life-saving drug.
My role at EMM involves building out our model. I work on answering questions like:
- How are we going to get the misoprostol (drug) to those who need it most?
- How do we keep track of a drug in a low-resource and rural area?
- How do we involve the community to ensure the model is sustainable long-term?
In developing the model, learning about monitoring and evaluation, and data collection, EMM’s pipeline has changed several times and continues to improve; when we know better, we do better.
This article is a collection of all of our current model details from our plans for the pilot study all the way to post-pilot analysis.
P.S. There are a few acronyms used throughout this article related to public health in Nigeria. Here is a guide to all the acronyms used.
This model report was made possible with contributions and feedback from the EMM team, including Isabella Grandic, Navya Riju, Christina Wang, Joshua Payne, and Ammielle Wambo Becker.
If you are interested in receiving the full version of the model report, contact ruhani.walia@gmail.com to request a copy.
Overview
Mothers are needlessly dying while giving life.
Maternal mortality is a tragedy that affects far too many women around the world, particularly in Africa and South Asia [source]. Northern Nigeria is afflicted by some of the highest maternal mortality ratios (MMRs) in the world. For example, Jigawa State, in North-Western Nigeria, has an MMR of 1,012 deaths per 100,000 live births [source]. To reach the Sustainable Development Goal (SDG) 3.1 set by the United Nations, Jigawa must lower its MMR by 93% [source].
Strong maternal healthcare systems are a benefit to more than just mothers; strong maternal healthcare is a step towards a stronger healthcare system for families, and ultimately, resilient communities for all. The tools necessary to reduce maternal mortality exist; they are simply not accessible or affordable to those who need them the most.
Our intervention, Ending Maternal Mortality (EMM), aims to supply women in rural areas with misoprostol, a drug that reduces the onset of postpartum hemorrhaging, to reduce the rate of maternal mortality deaths in Jigawa by 20–31.5%.
Our first pilot is planned to take place in Jigawa State, Nigeria. With support from the Ministry of Health, EMM hopes to further this project to states beyond Jigawa.
Framework
The EMM framework has two overarching pillars: Distribution and Training. We have created a simple and effective system to distribute misoprostol to remote villages and are developing a training curriculum to improve the quality of informal healthcare.
Distribution: The proposed misoprostol distribution system begins at our supplier’s warehouse, DKT International. The misoprostol then moves to a distribution centre. Our model outlines two options for this centre, a Primary Healthcare Centre (PHC) or a Proprietary Patent Medical Vendor (PPMV) shop. A Community Health Extension Worker delivers the misoprostol from the distribution centre to a Traditional Birth Attendant (TBA). After each delivery, a TBA will administer the misoprostol to the woman. In the case of a birthing complication, a TBA may need to refer the woman to a healthcare facility to save her life.
Training: The second pillar refers to the educational curriculum we have developed to train TBAs on the use of misoprostol, safe delivery tactics, antiseptic practices, and the care of newborn babies. If we train 100 TBAs to administer misoprostol after delivery, we would reach approximately 7,200 women (TBAs have, on average, 72 deliveries/year [source]). The training curriculum is still under development, but EMM’s analysis of TBA training programmes can be found here.
Project Objective
We started this project out of passion and a desire to reduce inequalities in healthcare access. Focusing on building a robust and scalable model that localized stakeholders can maintain ensures that we can reach the most people possible.
In the next five years, we want misoprostol to be readily available across Nigeria and in at least two other countries. EMM aims to help pioneer an international policy and strategy to reduce maternal mortality through a community-first distribution model that leverages female entrepreneurs and community health workers.
We additionally aim to combine the informal medical sector, including stakeholders like TBAs, and the formal sector, including Primary Healthcare Centres. By incorporating existing infrastructure into our model, we hope to rapidly integrate misoprostol and medical upskilling to low-resource, remote communities.
To begin tackling this wide vision, we are conducting a pilot in Jigawa State, Nigeria with the support of the Ministry of Health. The focus of the pilot is to test the efficacy and sustainability of the EMM intervention by identifying areas of improvement within our training curriculum and logistics plan. The purpose of the pilot is to reduce the number of cases of postpartum hemorrhaging by 85–90% through the improved distribution of misoprostol.
Below are the specific objectives of the 3-month pilot:
This pilot is a crucial step in gaining further perspective about the effectiveness of our model on-ground. The feedback and data collected will inform future iterations of the EMM model.
About Postpartum Hemorrhage and Misoprostol
Maternal mortality disproportionately affects low and middle-income populations. Nearly 100% of global maternal deaths occur in developing countries, with over half of these deaths occurring in Sub-Saharan Africa [source]. Approximately 20% of all global maternal deaths occur in Nigeria, with Nigerian women possessing a 1 in 22-lifetime risk of dying during pregnancy, childbirth, or postpartum/post-abortion [source]. Reasons for this disparity include lack of access to healthcare, the inability to afford a healthcare specialist and geographic isolation. These factors are no more prevalent than for impoverished women located in remote areas, for the WHO comments that they are “least likely to receive adequate healthcare” [source].
Of all maternal deaths, 25–35% are caused by postpartum hemorrhaging (PPH) [source]. This means that PPH affects approximately 5% of all pregnancies [source], effectively making it the leading cause of maternal death worldwide [source]. PPH is an obstetric emergency characterized by excessive bleeding once a mother has given birth. In high-resource environments, treating PPH is a routine protocol during childbirth. However, in rural areas with few resources (human capital, financial capital), facility deliveries are rare. Women in rural areas are 77% more likely to deliver their child outside of a facility [source] and typically use untrained TBAs [source]. In dire cases, mothers may give birth with no one present [source]. In Nigeria, 70–75% of childbirths are conducted outside of a facility with a TBA [source].
Prone to several factors that contribute to a higher risk of PPH for women, Nigeria has some of the highest MMR rates in the world.
EMM aims to distribute misoprostol, a uterotonic oral drug, to stop 85–90% of all PPH cases [source]. Its rapid onset action 9–15 minutes after oral ingestion stimulates the contraction of uterine smooth muscle [source]. Its simplicity of storage and administration makes it an appealing treatment option for PPH in areas with minimal options for comprehensive maternal healthcare during labour. For this reason, it is the preferred alternative to the uterotonic oxytocin in low-resource environments [source].
Evidence projects that misoprostol usage across a group of 150,000 women would decrease the number of hospital referrals for PPH by 4,666 [source]. Amongst the current background of literature is a plethora of data supporting the use of misoprostol as a PPH prevention measure, with studies demonstrating that ingestion of 600µg to the mother immediately after birth reduces the incidence of PPH by 24% [source] and is up to 90% effective in controlling PPH after its diagnosis [source]. Implementing this preventative measure within rural healthcare systems could offset the costs currently associated with maternal mortality and morbidity, opening up the opportunity for net savings in this sector of government spending [source].
Misoprostol is likely to gain widespread support in low and middle-income countries because of its cost-effectiveness. Compared to oxytocin, whose price ranges from $1.86-$25.60 USD [source], [source] per unit of administration, misoprostol ranges from $0.27-$2.21 USD [source], [source] per dose. Each tablet of misoprostol will cost EMM approximately ₦63. A mother requires between 3 and 4 tablets after delivery to prevent and treat PPH. If EMM sells each tablet at ₦90, the total for each mother would be ₦270–360. In comparison, the total cost for the same number of pills from a pharmacy, which would be approximately ₦1000–2000, makes our price 64–87% cheaper.
Locational Analysis
Table of Metrics
Figures and Statistics
Our project pilot will take place in (a) selected local government area (s) in Jigawa, State. A local government area is an administrative section of a country that a local government is responsible for. In Jigawa State, there are 27 local government areas (LGAs).
To initiate the analysis, Demba Ahmad, Deputy Logistics Officer of the Jigawa State Ministry of Health Department of Public Health, has provided us with data for each LGA including:
- Deliveries by skilled birth attendants
- Deaths of women relating to pregnancy
- Causes of maternal death PPH
- Causes of maternal death APH (antepartum hemorrhage: bleeding after 20–24 weeks of pregnancy) [Excluded from analysis as there is minimal relation with the intervention]
To make a more informed decision around an optimal location, we will need to obtain the following data for each LGA:
- Number of total deliveries by TBAs (or % of total deliveries in state done by TBAs)
- Existing PHC referral and transportation systems
- The total number of primary healthcare centres (PHCs) and proprietary patent medical vendors (PPMVs) in each state
- How often misoprostol is taken after birth
There are three general approaches we may take when it comes to selecting the pilot LGAs.
Approach 1: PPMVs/PHCs and Highest MMR Given that data around PHCs and PPMVs is likely most available, we would suggest selecting the LGA(s) based on highest PHC and PPMV availability, as well as those with the highest MMR.
Approach 2: Low Facility Delivery/High TBA Delivery LGAs where facility deliveries are less common and where TBA deliveries are most common would be ideal for this intervention if the data is available.
Approach 3: Low Misoprostol Usage If this data is available, we could select LGAs with low misoprostol access. This could be based on the availability of pharmacies, PHCs or general hospitals, the number of PPMVs that stock misoprostol, or the number of prescriptions given of misoprostol for PPH specifically.
We hypothesize that several LGAs will meet some or all of the criteria outlined above. If this is the case, we can choose the LGA by random selection.
Dr. Kabir Ibrahim Aliyu, Executive Director of the Primary Healthcare Development Agency from the Ministry of Health also recommended Jahun as a pilot LGA because it has a rural and urban settlement. Information that we have received about Jahun includes:
- Jahun has 300 communities which are among the highest facing maternal and neonatal health challenges in Jigawa State
- Has more rural communities compared to Hadejia LGA
- Jahun also has 300 focal persons who are also health workers known as Jakadar Lafiya
- The number of TBAs is typically one per village (meaning 300 TBAs within Jahun)
- There are between 40–50 primary health care workers in Jahun
- 25% of women in the state given birth at facilities while 75% give birth at home
- Voluntary Community Mobilizers (VCMs) are available in Jahun
Although we have this data, we require further input from the Ministry of Health to finalize and select which LGAs will be targeted during the pilot and how many. The Ministry has also stated that they are “ready to provide manpower and some tools” (October 23rd, 2020) to ease selection.
Structure of Healthcare System
A Brief History
Before European explorers set foot in Africa during the mid-nineteenth century, traditional medicine was the only means of health care across the continent. Health practitioners mainly consisted of herbalists, bonesetters, divine healers, midwives, spiritualists, and midwives [source].
Traditional medicine (TM) was the only widely accessible medical system for millions of people in Africa. In a study conducted by the WHO and Health Action International (HAI), public availability of generic medicines in 36 low and middle-income countries, including Nigeria, ranged between just 29.4% to 54.4% across the region [source]. Additionally, the ratio of traditional healers to the population in Africa is 1:500 and 1:40,000 medical doctors [source], most of whom reside in urban areas.
As defined by the WHO, traditional medicine is the “total combination of knowledge and practice, whether explicable or not, used in diagnosing, preventing, or eliminating physical, mental, and social diseases. This practice exclusively relies on experience and observation handed down from generation to generation verbally or in written form” [source]. In many ways, traditional medicine treats the imbalance between spiritual and physical well-being [source].
The causes of imbalance and origins of illnesses are viewed in both a natural and supernatural perspective [source], [source]. African culture understands the causes of disease in several ways, the most popular being that disease is caused by attacks from evil spirits or as punishment from troubled ancestors [source], [source].
Despite the introduction of Western medicine in Africa, most communities continue to favour and rely on TM [source]. The establishment of the Sacred Heart Hospital in the 1860s marked the introduction of the modern health care system to Nigeria [source]. Even after being around for over 150 years, Westernized practices still do not hold a candle to traditional medical practices and their popularity. In fact, a study conducted in 1988 in Benin City, Edo State, found that for every signpost indicating a Westernized-clinic or doctor, there were three signposts for a traditional doctor or healer [source].
It has been found that Western-trained doctors are unsupportive of including TM in the official healthcare system in Africa. For example, a study found that Nigerian medical students were unsupportive of integrating TM into the country’s official healthcare system [source].
While the incorporation of Western-medical practices has been slow, the push for the formalization of traditional medicine (TM) has been consistent. For instance, the Ministry of Health of Nigeria supported the University of Ibadan in 1966 in researching the medicinal properties of local herbs to standardize and regulate TM [source].
Nevertheless, as the Nigerian healthcare system grew and became more complex, a regional Western-style system was established, leading to the beginnings of the Ministry of Health in Lagos. Between 1952 and 1954, control continued to transfer by region. The Ministries of Health in the Western, Eastern and Northern regions, and the Federal Ministry of Health, began to form.
The organization of services has continued to develop as per the Fourth National Development Plan of 1981–1985. This plan was the first to address the issue of providing preventative health services. The plan created a Basic Health Services Scheme (BHSS) that lead to three levels of health care facilities:
- Comprehensive Health Centres (CHCs) — to serve communities of <20,000 people
- Primary Health Centres (PHCs) — to serve 5,000 to 20,000 persons
- Health Clinics (HCs) — to serve 2,000 to 5,000 persons
Alongside these tiers, supporting numerical goals were created. For example, a CHC should have at least one PHC in its area, and a PHC should have at least one local HC. Metrics were also created by Local Government Area (an LGA usually has between 150,000 and 250,000 people [source]), wherein each LGA must have a minimum of 7 PHCs and 30 HCs with at least one CHC. For larger LGAs, a minimum of 12 PHCs and 50 HCs is required. However, Nigeria is far away from achieving these goals. For instance, Taura, an-average sized LGA with a population of 176,200 [source], has just 4 PHCs and 12 HCs [source].
BHSS also formalized CHEWs and Junior CHEWs (JCHEWs), creating a national curriculum and test for the vocations. It also introduced a mandate for PHCs to provide essential services to communities.
General Hierarchy
The health services structure is delegated by three levels of government: Federal, State, and Local Government Area. This flowchart indicates the administrative level with its corresponding health system level.
The Health Service/Entities column lists the governing body at each level. The red column indicates examples of healthcare centres at each level.
Public Health Entities Summary
*While primarily managed by LGAs, “PHC services have been jointly managed by the state ministries of health, ministries of local government affairs, the Local Government Service Commission, the Civil Service Commission, the Ministry of Budget and Planning, state hospitals management boards, faith-based organizations, nongovernmental organizations, zonal and state offices of the National Primary Health Care Development Agency, the Federal Ministry of Health, the National Health Insurance Scheme, development partners and more” [source].
**Nigeria has six geopolitical zones: three in the South and three in the North. The Northern Zones have 3,900 to 6,200 Health Clinics each while the Southern Zones have 2,700 to 3,700 in each [source]. Each zone consists of several states, but the zone does not have one governing body. Instead, the distribution of health clinics is simply measured by geopolitical zone but managed by each state’s SMoH.
Current State of the Healthcare System
Jigawa State follows the same tertiary, secondary and primary model as the rest of the country. The state has one Federal Medical Centre (FMC) in Birnin Kudu [source], 16 general hospitals (which are under the supervision of the state government and may also be considered Primary Health Care Centres), and one specialist hospital (which is considered a Comprehensive Health Care Centre) [source].
The Ministry of Health and Primary Health Care Centres are responsible for forming and executing public health policy in the state. These entities are also in charge of translating Federal policies from English for state-run centres This is because government documents are written in English, the official language of Nigeria, but Hausa is the most widely spoken [source]. The state planned to establish a Primary Healthcare Centre in each ward of the state [source], and as of 2018, the Jigawa State Deputy Governor, Ibrahim Hassan stated that the government built PHCs in each of its 288 political wards. This was part of fulfilling the All Progressives Congress (APC) campaign “One Ward One Health Facility” [source].
Antenatal care (ANC) provides mothers and families with information to have a healthy pregnancy, delivery safely and recovering properly post-birth. The use of ANC in Nigeria is low, only about 61% of pregnant women visited an SBA or trained practitioner at least once during their pregnancy while other lower-middle-income countries have an average of 79% [source], [source]. Moreover, 41% of women who used ANC did not deliver in a PHC or other healthcare facility [source], [source].
Jigawa State has 1.5 doctors per 100,000 people [source], a comparatively low rate of doctors per capita in comparison to the overall rate of 40 doctors per 100,000 people in Nigeria. The WHO recommends a ratio of 167 doctors per 100,000 people. Jigawa would need to increase its number of doctors per capita by over 100 times. This sheds some light on the dangerously low level of trained health practitioners in the country [source]. See table 1 for more metrics in Jigawa/Nigeria.
In terms of maternal healthcare and existing infrastructure for pregnant women, Nigeria has a very low rate of facility births. Less than 40% of births happen at a health centre or facility [source]. Skilled birth attendance (SBA) is very low with only 13% of women delivering with any trained personnel present [source]. Poor health outcomes in Northern Nigeria are often due to the weak health infrastructure, low literacy and poor access (long distances) to health facilities or SBA [source].
Poverty is the underlying root cause of why women avoid facilities. TBAs or other informal and/or traditional medicine workers are more convenient and cost-effective. The EMM intervention aims to supply misoprostol to primary healthcare centres (PHCs) for women who have facility births and to TBAs to increase the safety of at-home births. However, the TBAs will be trained on when to refer a woman to the facility, which aims to increase hospital referrals.
The National Health Information System
Background on Health Information Systems
Health Information Systems gather, store, and transmit healthcare data. This can look like the system managing electronic medical records or even a hospital’s operational management system [source]. They create efficient national planning and encourage thoughtful decision-making for resource allocation, especially in the case of opportunities needing resources to save lives or prevent disease [source], [source].
According to the WHO, the strengthening of an HIS has become increasingly important and has received more attention in many low to middle income countries as of late [source]. The WHO identifies six parts of a country’s HIS [source]:
- HIS Resources: regulatory, legislative, and planning methodologies used to create a functioning HIS, some resources include personnel and information and communications technology (ICT)
- HIS Indicators: predetermined set of targets for health information, includes health system inputs, outputs, and outcomes (national status of health)
- Data Sources: three main sources (1) population-based data such as census or survey results and (2) institution-based data such as service records and (3) community-based organizations (CBOs) may provide research or health surveys
- Data Management: encompasses collection storage, transmission and analysis of data, guidelines for timeliness and frequency of actions are predetermined
- Information Products: converting the data into a more useable form
- Information Use: the dissemination of health information, making it accessible to decision-makers in healthcare
All HIS data is sourced from institutional or population-based sources. The responsibility of managing these data fall to various government Ministries, Departments and Agencies that severely lack intercommunication [source], [source]. The barriers to improving the communication between governing entities may be due to a lack of political will, limited infrastructure and inadequate standards [source].
Routine Health Information Systems (RHIS) provide information at constant intervals throughout the year to meet predictable or pre-set information demands. The RHIS consists of paper based and electronic health records that may be from district information systems or from health care facilities [source].
The development of an improved HIS will be necessary if the FMoH wishes to monitor national progress towards the UN’s Sustainable Development Goals (SDGs) [source].
The Nigerian HIS Review
Nigeria’s NHMISP was flagged by national planners as not producing improvements at an adequate pace. So, in 2013, the FMoH declared a review of the policy [source]. The objectives of the Federal Ministry of Health’s review were to share key insights of the NHMIS Policy, describe the framework used to review the policy and outline content needed to create the new HIS policy. The objectives of the Federal Ministry of Health’s review were to share key insights of the NHMIS Policy, describe the framework used to review the policy and outline content needed to create the new HIS policy.
Studies conducted previously on the HIS identified turf rivalries, unclear hierarchy and assignment or roles, and a lack of financial incentives for external institutions to deliver accurate data as possible reasons for the formation of silos in the HIS and its halted progress [source].
In 2013, Nigeria’s FMoH launched an inter-ministerial review of the National Health Management Information System Policy (NHMISP) originally created in 2006. The FMoH used the World Health Organization’s “Framework and Standards for Country Health Information Systems” to review their policy. The key finding of this review was the lack of governance mechanisms in executing on the policy and the absence of data management. In addition to this, the review committee found duplicative reporting tools that led to an overlap and multiplicity of data.
The new Nigerian NHMISP of 2014 emphasises new standards for data and data collection to encourage the integration of sub-systems in the use of information and communications technology (ICT environment) that include governance structures for external institutions contributing to the system.
The review also highlighted the vitality of “intersectoral collaboration” because health is an issue affecting various stakeholders. Implementation of the proposed changes must engage stakeholders to better ensure that progress is made. As stated by the policy, “Whilst the policy provides an ambitious framework for achieving several HIS goals, this needs to be matched by the political will and funding in order for these targets to be met and sustained” [source].
The review lasted about eleven months, from April 2013 to February 2014. Participants of the review analysed previous RHIS assessments to identify gaps [source]. A WHO Health Metrics network (HMN) was also completed to assess the HIS [source]. Alongside the new HIS policy, a five-year strategic plan was also developed to aid execution.
Stakeholders in the Nigerian Health Information System
The Federal Government of Nigeria (FGN): While they develop health policies for the country, these policies may be used by the states at their discretion. This is because “health” is not one of the exclusive issues that is adjudicated by the FGN [source]. For context, the Nigerian government uses legislative lists to distribute powers, and the federal government is assigned the exclusive legislative list [source].
The Federal Ministry of Health (FMoH): In charge of the NHMIS and uses it for decision making pertaining to healthcare funding, policy development etc. The RHIS is now managed by the District Health Information System (DHIS), which is also overseen by the FMoH.
Federal Ministries: The Ministries and Departments holding responsibility for the health care system include the Federal Ministry of Education, the Federal Ministry of Agriculture (Food and Drugs Services), the Federal Ministry of Budget and National Planning, the National Primary Healthcare Development Agency, the National Population Commission, the National bureau of Statistics and more. Each affects the HIS differently.
Monitoring and Evaluation in the NHMISP: The NHMIS is the foundation for the results achieved from the creation and execution of the National Strategic Health Development Plan (NSHDP). Below is a chart with key quotations supporting EMM’s emphasis on monitoring and evaluation and data collection. All quotations derived from the Nigeria Health Information System Policy published by the Ministry of Health in September 2014 [source].
EMM is currently in the process of learning more about the software capabilities of HMIS across Africa.
Operational Considerations
User Experience Challenges
To successfully launch a pilot, EMM must thoroughly understand the local context surrounding technology literacy and cultural barriers. To address learning more about this and become well-prepared, EMM has created a localization guide.
This document is currently tailored to the pilot program in Nigeria; however, as EMM expands, it will serve as a template for future localization projects. For example, training materials for TBAs should consider the cultural context in which this material will be implemented, such as the stigma surrounding abortion. Given that misoprostol may act as an abortion pill, that would be considered misuse. Thus, we must consider how misoprostol will be perceived among community members and alter our model and community engagement strategies accordingly.
Another use case of the localization guide is the EMM mobile application. The application will be used for data collection and to ensure that the misoprostol follows the correct channels of distribution. One of the user groups includes Community Health Extension Workers (CHEWs) located in rural Nigeria, where broadband access is limited. The guideline outlines the limitations that the user faces. It also addresses best practices for designing applications that accommodate these limitations.
Understanding the culture of the pilot location is crucial to the intervention’s success. EMM aims to avoid asserting an overly Western perspective to designing our solution by harmonizing with existing beliefs and values. To learn more about our Localization Guide, contact Christina Wang at wchristina2512@gmail.com.
Technical Obstacles
1. Poor Telecommunications Networks Rural telecommunication is notorious for being unreliable, slow, and expensive. In Nigeria, the lack of social services, low level of education, and unequal access to income and job opportunities all contribute to poverty. Although telecommunications services have been in Nigeria since 1851, the issues mentioned and the undeveloped terrain obstruct access [source].
Although Africa is home to 13% of the world’s population, the continent has just 2% of the world’s telephone lines and 1% of all internet connectivity [source]. For EMM, creating a PHC referral scheme that requires Traditional Birth Attendants to phone a nearby PHC may prove difficult and faulty. Additionally, EMM’s operating budget cannot afford high-quality or expensive devices, likely making it even more challenging to create a fluent and high-functioning system.
2. Gender Gap in ICT Access Women and girls are even less likely to have access to a mobile phone or device than their male counterparts. Although the Nigerian telecommunications market has seen many regulations aiming to open up the market, it has not directly led to equal access.
Although there is no national collection of gender-based ICT data depicting access patterns, research has revealed the gender gap. Ruth’s community, Ruth being a pseudonym for an interviewed subject, was found to be one of 13 where women had a particular disadvantage digitally.
In addition to the lack of education and the issue of affordability, the role of women in managing a household made it difficult for them to spare time to learn about technology [source]. For EMM, this means a shift in education will be necessary if we expect women in the country to participate.
3. Poor Internet Access for Data Transmission and Integration with the HIS The current standard of integration between even the Local Government to the State Ministry of Health has proven to be highly inadequate. The transmission of data from local to the state government was lacking due to poor internet services, causing not only poor and inaccurate data but also a backlog in data collection [source], [source], [source].
This means that integrating EMM’s collection of data with the existing HIS may prove to be challenging.
Stakeholders
Roles and Responsibilities
To maintain the integrity of our stakeholders and the extreme specifics of the model, further details on our partners, stakeholders, incentives and responsibilities can be requested by emailing ruhani.walia@gmail.com
Pilot Study
A pilot study is a preliminary research effort aimed at investigating if components of the main study, in this case the on-ground pilot, will be feasible [source]. They can be used to determine an appropriate and realistic sample size for the project, such as number of LGAs or villages targeted [source]. A pilot study answers the question: “Can the on-ground pilot reach successful completion as it has been planned or does it require further revisions?” It should conclude with one of the following:
- The pilot is not feasible
- The pilot is feasible if changes are made*
- The pilot is feasible without any necessary changes
- The pilot is feasible with enhanced and close monitoring
*Any recommended changes should be outlined
Pilot studies evaluate four main components [source] of a pilot which are summarized in the graphic below.
Government Survey
HMIS and Existing Data: While EMM is aware of the existing NHMIS in Nigeria, we require further details on:
- Medium: What software is being used?
- Accuracy: How often is it updated? Are there guidelines to ensure data completeness?
- Accessibility: Who currently has access to the HMIS? Are there certifications required/certain position to gain entry to the database?
This information will allow us to better design the data collection for our intervention. Ultimately, we want EMM’s model and training curriculum to be adopted by the government for long-term use and integration into the current healthcare system. To ensure this integration can and will happen, EMM must design a data collection system that connects to the existing HMIS.
Additionally, EMM’s data collection training must be adjusted to include instructions on operating the HMIS and accessibility guidelines.
Availability of Health Workers: As an intervention that will require health personnel on-ground, we must understand the availability of health workers to better estimate how many training resources we will require and to better design our on-ground staff training. Further details on the following will be helpful:
- PHC Workers: What is the list of personnel at all PCHs within potential pilot LGAs? Are they familiar with/have received training on the use of technology for data collection?
- Rotary Schedule: How often are workers transferred between facilities on a rotary schedule? What does staff turnover look like? Are there existing procedures in place to mitigate internal brain drain?
- Gender Distribution: Of all CHWs (nurses, doctors, CHEWs) how many (%) are female?
- Salary: How often are different levels of health workers paid? How much are they paid? Are payments consistent? Over what period are they paid (bi-weekly, monthly, annually)?
- NPHCDA CHEW Curriculum: What is included in the curriculum? Who has access to it?
Knowing this information, EMM will be able to better assess the pool of potential health workers that we may recruit and identify potential barriers (such as a lack of female CHEWs) that may alter our training and recruitment strategy.
COVID-19 Prevention Protocols: Given the pandemic and the nature of our intervention, it is necessary that EMM understand what protocols or guidelines may be in place at health facilities and for health care workers. Further details on the following will be necessary:
- Facility Protocols: Are there sanitation methods in place? What resources do facilities have access to (i.e., sanitizer, wipes) if any? Who supplies these resources?
- Informal Healthcare Protocols: Are there regulations in place for TBAs or midwives such as avoiding physical examinations pre-birth?
On-Ground Resource Review
In addition to the data we require from the government survey about resources available with their support, EMM must also conduct an on-ground resource review of non-government related infrastructure such as:
- TBA Culture: How are TBAs viewed in the community? What is their social circle like? Do they have councils/TBA organizations?
- PPMV Knowledge and Experience: How often does NAPMED update its policies? Do PPMVs receive training? If so, how often? What does the training curriculum include? Have they worked on distribution interventions in the past?
- Internet Network Availability: What are the largest networks in each of the potential pilot LGAs? How much do they charge? Are they reliable?
- Electricity Access: Who has the most consistent access to electricity? What does electricity use look like in each of the potential pilot LGAs? Do/what percentage of health facilities have access to electricity? What do they currently use it for?
Focus Groups
All focus groups will abide by the best practices [source], [source], [source] outlined in the table below. These guidelines apply to both virtual and in-person focus groups.
For further details on adjustments made due to illiteracy or language barriers, reference EMM’s localization guide which can be found here.
TBA and CHEW Digital Literacy Focus Group
Purpose: Confirm if the proposed data collection duties and technology use are feasible. Also, to test the fluidity and understanding of the mobile application’s user interface design and user experience design (UI/UX).
Structure: Both TBAs and CHEWs will participate in focus groups in the pilot study. These focus groups may be conducted virtually with the team in Canada and the groups of TBAs and CHEWs (in separate sessions) or FAYOHI may conduct the focus groups on-ground with their staff.
Familial Sentiments Towards PHCs and CHEWs Focus Group
Purpose: Determine any objections to the PHC referral transport scheme and home visits.
Structure: Families may complete focus groups with other families based on village/geographic area. These focus groups may be conducted virtually with the team in Canada or FAYOHI may conduct the focus groups on-ground with their staff.
Religious and Traditional Leaders Focus Group
Purpose: Identify roadblocks and create solutions to promote community acceptance of the EMM intervention. Also, to begin forming relationships with these leaders.
Structure: Religious and traditional leaders are incredibly influential when it comes to determining what is morally right and wrong in the community. To ensure the EMM intervention is well-received, we will begin engaging these leaders during the pilot study. These focus groups may be conducted virtually with the team in Canada or FAYOHI may conduct the focus groups on-ground with their staff. The religious leaders will attend focus groups by faith (i.e., one focus group for Christian Leaders and another for Islamic Leaders). The traditional leaders will also attend a separate focus group.
Pilot Model
Overview of Pilot Structure
The pilot distribution model has been designed to have multiple options and alternatives. There are a few reasons for this multi-pronged approach:
- To give mothers choice. For many women, this will be their first time participating in a health program run by an NGO, let alone a program dedicated to safe births. To ensure that they feel comfortable, we would like to give mothers options in how they can receive misoprostol, from whom, and to what extent they will receive formal care in addition to informal care (which is mandatory).
- To give the Ministry of Health leeway. In order for this model to remain sustainable long-term, the Ministry of Health must adopt the model and use it long-term in addition to integrating the updated training provided by EMM into the education system for healthcare. Providing multiple options that all lead to the same outcome, more mothers being saved, increases the chances of long-term integration.
- To identify the most optimal paths for long-term use. EMM aims to eventually save mothers in countries beyond Nigeria. Testing several options during the pilot will allow us to identify what works and what does not in rural and low-resource areas. It will provide invaluable data points about cultural acceptance, on-ground friction, and ease of understanding.
The pilot distribution model visual indicates all three pilot structures that may be used.
A detailed description of each alternative alongside a respective visual can be found under the headings below. It is necessary to mention that the model consists of two interdisciplinary systems: the distribution model and the data collection methodology.
The distribution refers to how the misoprostol is physically shipped and made accessible to mothers. The data collection methodology refers to what monitoring and evaluation measures are being taken at each step. For the sake of clarity, these two halves of the EMM model are written separately; however, they operate in tandem.
Pilot Model Option 1
Distribution Outline
- DKT International: The distribution model begins with our misoprostol supplier, DKT International. Based on conversations that EMM has had with DKT and quotes we have received, DKT is willing to provide the initial transport of misoprostol to Nigeria. In this model, DKT will supply misoprostol to a few distribution centres. These distribution centres, which are on-ground, are all formal healthcare centres including Primary Healthcare Centres, Health Clinics, and Health Posts. The latter resembles a dispensary. See Phase 1 under the data collection outline for the monitoring that occurs at this step.
- CHEWs: Community Health Extension Workers are the next to become involved. Once EMM has ensured supply on-ground (which is step one) registration of women can begin. CHEWs will go door-to-door and register all married women. This includes those who are not currently pregnant. The high fertility rate in Nigeria would suggest that most married women give birth eventually, so by pre-registering those who may not yet be pregnant, EMM is more likely to involve more women and save more lives. This concept is known as projection bias and it explains how people are more likely to engage with a program when pre-enrolled because they are more likely to not opt-out than to opt-in. See Phase 2 under the data collection outline for the monitoring that occurs at this step.
- TBAs: Traditional Birth Attendants can now begin to gather a supply of misoprostol for administration now that women have registered for the intervention. Women who are registered by a CHEW will be referred to a TBA. Once a TBA meets the mother and collects her prescription (further explained in the data collection outline), she will travel to the nearest EMM registered health facility to retrieve misoprostol. The prescription will be used to grant the TBA access to misoprostol. To ensure that TBAs do not, however, run out of misoprostol in an emergency (e.g., a mother gives birth prematurely) she will maintain a minimum stock supply as well. Once collected, the TBA will store the misoprostol until the mother’s birth, after which she will administer it. See Phase 3 under the data collection outline for the monitoring that occurs at this step.
Data Collection Outline
- Phase 1: Inbound Misoprostol this phase happens during the first part of the distribution model outline in the previous section.
Data Collected: Inventory Slip (see Pilot Forms for mock-up) which includes the distribution centre’s ID number (which is assigned pre-pilot), the amount of stock received from DKT, the date received, and the geotag/location.
Purpose: To ensure that the distribution centre receives the appropriate amount of misoprostol from DKT and to account for all stock.
Who Collects It: The Inventory Slip is filled out by the focal person (person trained on the intervention) at the distribution centre.
How: The Inventory Slip is likely going to be a digital form on a mobile application.
2. Phase 2: Registration and Prescription this phase happens during the second part of the distribution model outline in the previous section.
Data Collected: Prescription Form (see Pilot Forms for mock-up) which includes the mother’s address, name, contact information, the CHEW’s ID number (assigned pre-pilot) and date. The Registration Form (still under development) is also collected which includes a signed consent form that is read verbally to the mother by the CHEW.
Purpose: The registration form generates a registrant number for the mother that allows her access to health facilities and trained staff of the EMM intervention. The consent form is necessary because a mother must be explained her data protection rights.
Who Collects It: The CHEW collects it while going door-to-door.
How: The CHEW must fill out a paper prescription. The CHEW then takes a photo of the prescription and uploads it to the mobile application to create a digital copy that is then sent to all EMM registered health centres. The mother is given the paper copy (perhaps two copies) to keep in order to give the TBA so that she may collect misoprostol.
3. Phase 3: Outbound Misoprostol this phase happens during the third part of the distribution model outline in the previous section.
Data Collected: Transaction Slip (see Pilot Forms for mock-up) which includes the TBA’s ID number (assigned pre-pilot), the TBA’s contact information, transaction date, and shown prescription number.
Purpose: To ensure that the TBA receives the appropriate amount of misoprostol from the healthcare centre and to account for all stock.
Who Collects It: The Transaction Slip is filled out by the focal person (person trained on the intervention) at the distribution centre who receives the TBA.
How: The Transaction Slip is likely going to be a digital form on a mobile application.
Note: The post-birth procedure includes a data collection methodology as well. The procedure is consistent across each of the model options, so it has been described under its own section at the end of all the model options.
Pilot Model Option 2
Distribution Outline
- DKT International: The distribution model begins with our misoprostol supplier, DKT International. This step is the same as was described for model one. See Phase 1 under the data collection outline for the monitoring that occurs at this step.
- CHEWs: Community Health Extension Workers are the next to become involved. This step is the same as was described for model one. See Phase 2 under the data collection outline for the monitoring that occurs at this step.
- TBAs: Traditional Birth Attendants can now begin to gather a supply of misoprostol for administration now that women have registered for the intervention. Women who are registered by a CHEW will be referred to a TBA. Once a TBA meets the mother and collects her prescription (further explained in data collection outline), she will travel to the nearest EMM registered health facility to retrieve misoprostol. The prescription will be used to grant the TBA access to misoprostol. To ensure that TBAs do not, however, run out of misoprostol in an emergency (e.g., a mother gives birth prematurely) she will maintain a minimum stock supply as well. Once collected, the TBA will store the misoprostol until the mother is seven months pregnant, at which time she will give the misoprostol to the mother for storage until her birth. The purpose of providing the mother with the misoprostol while she is pregnant is so that she does not have to rely on a TBA to show up to the birth on time to receive it and prevent post-partum hemorrhage from happening. However, the issue with this is that the chances of misuse are higher as misoprostol can be used for abortion if taken during pregnancy. To avoid this but still provide mothers with the option of safekeeping the misoprostol, a pricing incentive may be used. Should the mother opt to follow model one, she may receive the misoprostol at a discounted price because she will not have access to the drug until it is safe to use. If she chooses to follow this model and keep the drug ahead of time, she will pay a higher fee. See Phase 3 under the data collection outline for the monitoring that occurs at this step.
Data Collection Outline
- Phase 1: Inbound Misoprostol this phase happens during the first part of the distribution model outline in the previous section. It is the same as described in model one.
- Phase 2: Registration and Prescription this phase happens during the second part of the distribution model outline in the previous section. It is the same as described in model one.
- Phase 3: Outbound Misoprostol this phase happens during the third part of the distribution model outline in the previous section.
Data Collected: Transaction Slip (see Pilot Forms for mock-up) which includes the TBA’s ID number (assigned pre-pilot), the TBA’s contact information, transaction date, and shown prescription number. The Receival Form (still under development) is also collected and includes the mother’s name, registration or prescription number, and the TBAs ID number (assigned pre-pilot).
Purpose: The Transaction Slip ensures that the TBA receives the appropriate amount of misoprostol from the healthcare centre and accounts for all stock. The Receival Form verifies that the mother received misoprostol fat seven months of pregnancy.
Who Collects It: The Transaction Slip is filled out by the focal person (person trained on the intervention) at the distribution centre who receives the TBA. The Receival Form is completed by the focal person as well upon the instruction of a TBA.
How: The Transaction Slip and Receival Form are likely going to be digital forms on a mobile application.
Note: The post-birth procedure includes a data collection methodology as well. The procedure is consistent across each of the model options, so it has been described under its own section at the end of all the model options.
Pilot Model Option 3
Distribution Outline
- DKT International: The distribution model begins with our misoprostol supplier, DKT International. Based on conversations that EMM has had with DKT and quotes we have received, DKT is willing to provide the initial transport of misoprostol to Nigeria. In this model, DKT will supply misoprostol to a few distribution centres. These distribution centres, which are on-ground, are all formal healthcare centres including Primary Healthcare Centres, Health Clinics, and Health Posts. The latter resembles a dispensary. See Phase 1 under the data collection outline for the monitoring that occurs at this step.
- Mothers: Once EMM has ensured supply on-ground (which is step one) registration of women can begin. In this model, women have the option to visit an EMM health facility and register themselves (as opposed to waiting for CHEWs to visit and register them as in previous models). While Primary Healthcare Centres are quite sparse and rural areas, Health Clinics and Health Posts are abundant [source]. See Phase 2 under the data collection outline for the monitoring that occurs at this step.
- TBAs: Traditional Birth Attendants can now begin to gather a supply of misoprostol for administration now that women have registered for the intervention. Women who are registered at a health facility will be referred to a TBA. Once a TBA meets the mother and collects her prescription (further explained in data collection outline), she will travel to the nearest EMM registered health facility to retrieve misoprostol. The prescription will be used to grant the TBA access to misoprostol. To ensure that TBAs do not, however, run out of misoprostol in an emergency (e.g., a mother gives birth prematurely) she will maintain a minimum stock supply as well. Once collected, the TBA will store the misoprostol until the mother’s birth, after which she will administer it. See Phase 3 under the data collection outline for the monitoring that occurs at this step.
Data Collection Outline
- Phase 1: Inbound Misoprostol this phase happens during the first part of the distribution model outline in the previous section. It is the same as described in model one.
- Phase 2: Registration and Prescription this phase happens during the second part of the distribution model outline in the previous section.
Data Collected: Prescription Form (see Pilot Forms for mock-up) which includes the mother’s address, name, contact information, the distribution centre’s ID number (assigned pre-pilot) and date. The Registration Form (still under development) is also collected which includes a signed consent form that is read verbally to the mother by the focal person at the distribution centre.
Purpose: The registration form generates a registrant number for the mother that allows her access to health facilities and trained staff of the EMM intervention. The consent form is necessary because a mother must be explained her data protection rights.
Who Collects It: The Prescription Form and Registration Form are filled out by the focal person (person trained on the intervention) at the distribution centre.
How: The focal person must fill out a paper prescription. They will then take a photo of the prescription and upload it to the mobile application to create a digital copy that is then sent to all EMM registered health centres. The mother is given the paper copy (perhaps two copies) to keep in order to give the TBA so that she may collect misoprostol.
3. Phase 3: Outbound Misoprostol this phase happens during the third part of the distribution model outline in the previous section. It is the same as described in model one.
Note: The post-birth procedure includes a data collection methodology as well. The procedure is consistent across each of the model options, so it has been described under its own section at the end of all the model options.
Post Birth Procedure
Data Collection Outline
- Post-Birth Toll Number: In all versions of the model, a TBA assists a mother in delivering her child and administering the misoprostol. Once a TBA has finished caring for the mother and the newborn(s), she must dial a toll-number to notify a Data Collector. The Data Collector will likely be a trained collector from FAYOHI, EMM’s on-ground partner.
- Post-Birth Data Collection: This collector will have up to two weeks after the birth to collect the following data:
Data Collected: Post-Birth Form (see Pilot Forms for mock-up) which includes the mother’s prescription number, health update (alive or dead), if applicable cause of death, date of delivery, health update for the newborn, whether the mother was referred to a PHC for emergency care, and net promoter scores from the mother and TBA.
Purpose: The Post-Birth Form provides crucial data on how the intervention is performing and whether it is succeeding. The quantitative and qualitative data will indicate whether the intervention is meeting its goals.
Who Collects It: The Post-Birth Form is filled out by the FAYOHI Data Collector.
How: The form will likely be a digital form on a mobile application.
Summarized Advantages and Disadvantages
Pilot Forms
Post-Pilot
Monitoring and Analysis
Baseline vs. Endline Results: Baseline goals are a group of indicators that currently exist in Jigawa State while the endline goals will be what we aim for them to become by the end of the pilot. Post-pilot, it is necessary that we review which endline goals were met and which ones were not.
The purpose of analysing the results is to determine their relevance to the project and next steps. For example, if EMM’s goal was to reduce the MMR by 20%, but instead it reduced by 15%, we might look to other indicators such as number of trained skilled birth attendants post-pilot to determine causation and a plan of improvement. A framework of evaluating these indicators is summarized in the visual below:
Comparison Metrics: To measure the progress of the pilot, EMM will be measuring three pilot goals after three months from the pilot start date. These metrics are listed below:
1. Train 100 TBAs in a maximum 5-day workshop. Conduct a 3-month retention test; compare the delta between their original test (immediately after the workshop) and the retention test.
2. Increase uterotonic use at facility births to (70%) at all of the main health facilities (e.g., primary healthcare centres) within the target local government area and distribute 4 doses of misoprostol to 100
3. Deliver Misoprostol advocacy/community engagement campaigns to 400 women (and/or write 400 prescriptions)
Automated HMIS Updates: This step operates on the assumption that the MoH allows EMM to integrate its data collection with the existing HMIS. Post-pilot, a method by which EMM may monitor the ongoing results of the intervention (should it continue beyond pilot phase in the future) is to receive updates that are added to the HMIS. For example, if after the pilot EMM receives and update that the MMR has decreased a further 10% over 6 months, that indicator will go through the Logic Model Approach described above to identify causation. The system’s updates will act as an ongoing source of information to improve the intervention over-time.
Next Steps and Scalability
Long-Term Vision: As described in the Locational Analysis section of this writeup, there are several reasons why EMM has chosen to pilot in Jigawa State, Nigeria. However, EMM’s long term mission is to distribute affordable healthcare to rural and low-resource communities around the world and build a case for future public policy implementations:
1. Empowering Local Communities: To ensure sustainable change is made wherever we go, targeting ambassadors within local communities is a core part of our model.
2. Impact in a Box: EMM aims to create a model and training curriculum that is easily replicable in all rural and low-resource areas. This misoprostol project has and will continue to teach us a lot about designing scalable models, and we hope to use that knowledge to create a “starter kit.” The product might include:
- A Widely Applicable Training Curriculum and Best Practices
- Guides for Finding Human Resources On-Ground
- Collections of Detailed Procedures for Operating On-Ground
- Suggested Connections to Key Stakeholders (i.e., a supplier)
- Fundraising Resources (i.e., grants, scholarships to apply to)
3. Wide-Spread Knowledge of Life-Threatening Issues: We want to encourage change-making by simplifying how people discover issues in the world that can be tackled immediately. EMM may create a resource hub of all life-saving interventions in the world that may be remedied with the distribution of a low-cost item. A one-stop find a cause shop for social enterprises.
PHC Referral Scheme: Another issue EMM has begun looking into is the low accessibility of PHCs in low-resource and rural areas. Less than 20% of potential patients use PHC services in Nigeria [source]. As described earlier (under the Locational Analysis and Stakeholders heading), PHCs are far and few between. Root causes of this issue include poor roads, lack of transportation methods, and the 3 Delays Model:
- Delay in deciding to seek care
- Delay in reaching a treatment facility
- Delay in receiving adequate treatment at the facility
The purpose of EMM is to hopefully mitigate the first delay by improving community sentiments towards facility births. The third delay is also something we hope to mitigate through the distribution of misoprostol to PHCs. The second delay is what the PHC referral scheme aims to tackle. So far, we have looked at previous interventions and transport schemes [source] that have been used Including:
- Community Mobilization: Creating action groups with village men who transport pregnant women by hammock to the nearest road in hopes of getting her on a vehicle to a facility
- Local Transport Unions: Conduct sensitization workshops to help workers understand the significance of the issue and have them create an emergency fuel fund for drivers helping women reach facilities
- Local Drivers: Pay local drivers a predetermined fee to transport women in the case of an emergency
Data Protection Policy Compliance
EMM is currently developing legal documents surrounding the collection, storage, and analysis of data subject information. The data subjects may include mothers and their families, Traditional Birth Attendants, Community Health Extension Workers, and Data Collectors. A Data Protection Policy is an internal document written to establish company-wide policies, and it is usually made public for transparency.
EMM is committed to data protection and supports the data protection rights of all those with whom it works, including, but not limited to, staff, registered affiliates, training participants, and mothers.
The policy outlines EMM’s responsibility to comply with applicable data protection and privacy laws and rules. It also explains EMM’s adherence to regulations set out by the Nigerian Data Protection Regulations (NDPR), the National Health Act, and the Constitution of the Federal Republic of Nigeria.
The Data Protection Policy is concerned with all personal data collected, processed, and stored by EMM. It explains EMM’s approach to ensuring compliance with applicable data protection laws. The policy ensures that EMM staff and registered affiliates:
- Comply with Data Protection Policies
- Protect data subject rights
- Are open and transparent about how personal data is processed
- Protect EMM from the risks of a data breach.
To learn more about EMM’s Data Protection Policy compliance and other legal considerations, contact Ammielle Wambo Becker at ammiellewb@gmail.com.
Registration and Consent Forms
As described under the Pilot Model section, EMM requires the collection of Registration and Consent Forms. To ethically involve participants in research activities such as this intervention, an informed consent process is required, written and verbal. This involves:
- Giving a data subject adequate information concerning the study
- Providing adequate opportunities for the subject to consider all options
- Responding to the subject’s questions
- Ensuring that the subject has comprehended the information
- Obtaining the subject’s voluntary agreement to participate
- Continuing to provide information as the subject or situation requires.
As part of this education and information exchange between EMM and potential subjects, EMM must, among other compliances:
- Present the information to potential subjects on more than one occasion
- Allow a period to elapse between imparting the information and requesting a signature on the consent form
- Ensure that a subject understands the treatment and the risks and benefits involved
- Ask open-ended and non-directive questions to assess subject comprehension
- Retrieve the subject’s signature and date on the consent form once an agreement to participate in the study has been reached
- Include the signature of an EMM member who has oriented the subject
- Provide the subject with a copy of the consent form as a continual reference for items such as scheduling of procedures and emergency contact information
- Provide a certified translation of the English consent form to consent non-English speaking subjects
To learn more about EMM’s Registration and Consent Forms, contact Ammielle Wambo Becker at ammiellewb@gmail.com
Contact
Our goal is to build an intervention that local communities can sustain. We have a strong emphasis on building and testing the infrastructure to create a foundation conducive to reducing maternal mortality. Focusing on building a robust and scalable model that localized entrepreneurs will maintain ensures we can help the most people possible.
In the next five years, we want misoprostol to be readily available across Nigeria and at least two other countries. This project aims to help pioneer an international policy and strategy to reduce maternal mortality through a community-first distribution model that leverages female entrepreneurs and community health workers.
If you’re interested in learning more about EMM, the model, the training curriculum, anthropology research or have feedback, please email ruhani.walia@gmail.com or reach out via Twitter @Ruhani_Walia.
You can also visit us at emm.health or our Instagram @emm.health