This is how we ensure the safety of a vaccine

A young girl is held by another girl.

To ensure a vaccine is safe and effective, it must be carefully studied in the laboratory and go through several rigorous phases of clinical trials. If safety is not assured at any point, the vaccine candidate simply does not advance. Photo: PATH/Gabe Bienczycki.

Before a drop of an oral immunization reaches a newborn’s mouth or a syringe delivers a first shot, vaccines have cleared a multitude of hurdles, each carefully designed to ensure that they are safe and effective.

“It takes a village to raise a child,” the saying goes, and one of the first instances of collective care a child receives is immunization. Bringing a vaccine through research and into the clinic or field takes a veritable village of scientists, experts, and ethicists, and a rigorous process that ensures they collaborate at the highest standards.'From the initial stages of early research and clinical development through regulatory approval and use, vaccines are painstakingly evaluated for safety and efficacy.' -John Donnelly

My role as director of the Vaccine Development Program at PATH, and a long career in vaccine research and development, have afforded me valuable insight on the need for vaccines throughout the world and the commitment of scientists in making sure vaccines safely protect our children.

From the initial stages of early research and clinical development through regulatory approval and use, vaccines are painstakingly evaluated for safety and efficacy. By the time a physician prepares an injection and administers it to stimulate a child’s immune system, the vaccine contained within has been carefully studied in the laboratory and through several phases of clinical trials.

Each phase builds on the information received from the previous one, and if safety is not assured at any point, the vaccine candidate simply does not advance. Continue reading »

Friday Think: this $20 device could save a mother’s life

A pregnant woman cradles her stomach with her hands.

Maternal mortality rates around the world could be cut by 70,000 lives each year with a new diagnostic. Photo: PATH/Evelyn Hockstein.

A lifesaver that replicates a traffic light

A new technology has been given a green light in England. And a red and yellow light as well. It’s a device that could deliver lifesaving impact to thousands of women during childbirth. Using simple traffic light signals, health care workers are alerted if a woman needs additional care during childbirth: Green means a woman is doing fine; yellow means that her blood pressure is elevated; red means she should be moved to a hospital immediately for lifesaving care.

When new technologies emerge that are easy to use and affordable, they eventually become part of a larger toolkit of solutions that can save lives in rural and low-income areas. As Charlie Cooper reports in the Independent, these devices also help identify warning signs that might go unnoticed by busy health workers.

Invented by doctors at one of London’s leading hospitals, the device is the first in the world that can detect whether a woman is likely to go into shock after blood loss during childbirth.

High blood pressure during pregnancy can be an early-warning sign of pre-eclampsia, which is potentially fatal for mother and baby. In the UK [and other rich countries], regular blood pressure checks identify those at risk, who are then carefully monitored and given medication. But in more remote towns and villages in the developing world, stretched health workers may miss warning signs. . . .

For inventor Professor Shennan, the device is the culmination of 20 years’ work. “We’re very proud of this device,” he said. “Not only can it accurately detect when a woman is in danger from high blood pressure or shock, but it also indicates to untrained people when to act on this. I use it in my clinic, as it is superior to most existing devices for measuring blood pressure.” Friday Think logo

You can read the article in its entirety at the Independent.

Each week, we scour the news for the hottest stories on innovation. Our weekly feature, The Friday Think, highlights one we’ve found particularly fascinating.

In Ethiopia, a PATH leader strives for health equity

Meet Tirsit Grishaw Legesse, PATH’s new country program leader in Ethiopia. She serves on the Ethiopia Ministry of Health’s working groups on sexual and reproductive health.

Tirsit Grishaw Legesse.

Tirsit Grishaw Legesse is PATH’s new country program leader in Ethiopia. Photo: PATH/Patrick McKern.

Q: You have many years of experience addressing health inequity in a variety of arenas. Are there any factors that you think are overlooked or misunderstood?

A: Increasing access to health services is critical to improving the health of women and children in low-income countries like Ethiopia. Often, when we talk about access, we look at services provided in a particular geographic area. We measure success by comparing the location and number of health facilities to the population served.

However, the physical availability of health facilities doesn’t always guarantee that they are used. Factors such as transportation and community perceptions about services, cost, and waiting times can deter people. Their use of services is influenced by a variety of factors, such as which services are offered at which location, the direct and indirect costs of health care (e.g., service fees and the costs people pay to travel to health facilities), cultural issues, and providers’ attitudes and competencies. Continue reading »

Friday Think: what Disney World and systems strengthening have in common

Last week, Bill Gates penned an op-ed for the New York Times discussing how the global health community was ill-prepared to respond to the Ebola epidemic and remains ill-prepared to respond to similar global health epidemics in the future.

Kate Wilson

Guest contributor is Kate Wilson, director of Digital Health Solutions at PATH. Photo: PATH.

His concerns resonated with me as they are fundamentally cross-cutting systems issues that deal with national infrastructure—the same ones that the Digital Health Solutions and other groups at PATH are working to overcome. We regularly ask, how can we help countries identify and implement integrated health systems?

“The problem isn’t so much that the system didn’t work well enough. The problem is that we hardly have a system at all.” —Bill Gates

Walt Disney World Cinderella Castle.

Walt Disney World Cinderella Castle. Photo: Katie Rommel-Esham.

This is where Disney World comes in

Before leaving the private sector, I was an early employee developing a large online gaming platform. The analogy we used when envisioning this future system was Disney World. When people think about Disney, they focus on the rides, the food, maybe the ticket cost, but they don’t think about the underlying infrastructure–everything just works. Continue reading »

Task-shifting: an effective way to protect expecting mothers from malaria

A woman's hand next to a newborn infant lying on a bed.

When a pregnant woman has access to preventive malaria care, it can lead to improved health outcomes for her and her newborn. Photo: PATH/Gabe Bienczycki.

Malaria is a life-threatening illness for anyone. But what are the consequences when a pregnant woman gets malaria?

During pregnancy, it can cause serious, life-threatening risks for a woman and her baby. Common problems include maternal anemia, miscarriage, prematurity, stillbirth, and low birthweight in newborns.

Safe and effective treatment to prevent malaria in pregnancy is available, but it is often out of reach for those at risk. Task-shifting—or moving specific tasks from trained medical providers to community health workers—is a low-cost, effective way to improve access to health services that save lives.

Women hold insecticide-treated nets in a lobby; a woman getting tested for malaria; a woman standing outside.

Clockwise from left: Women receive insecticide-treated nets during antenatal care visits; a woman gets tested for malaria using a rapid diagnostic test; a woman from Kisumu West makes her way to a health facility for antenatal care. Photos: PATH/Gena Morgan, PATH/Gena Morgan, PATH/Eric Becker.

In Kenya, a pilot study in Kisumu West sub-county is showing the positive impact of new policies that allow health workers to provide health services and administer certain medicines at the community level to better protect expecting mothers and their newborns from malaria.

Protective malaria treatment is often out of reach

Sulfadoxine-pyrimethamine (IPTp-SP) is a safe and effective intervention that can be administered during antenatal care visits to reduce malaria-caused health complications in expecting mothers and their newborns. Unfortunately, long distances to health facilities and a lack of access to high-quality care can deter many pregnant women in resource-limited settings from seeking early care or completing four recommended health care visits.

In Kenya, where many women remain at risk of malaria in pregnancy, current policies limit IPTp-SP administration to skilled health workers. As a result, critical antimalarial treatment remains out of reach for many mothers who have difficulty accessing facility-level care.

The success of a new task-shifting policy in one area could improve the situation.

Health system innovation for improved community care

Task-shifting extends the reach of the health system, successfully bridging the gap between communities and health facilities.

Through the pilot study in Kenya, PATH (in partnership with USAID-funded APHIAplus and the Bill & Melinda Gates Foundation) has shown that community health workers can effectively deliver treatment and care to expecting mothers to better prevent malaria.

Report cover of "Policies and Actions for Improved Malaria in Pregnancy Efforts in Communities."

Download Policies and Actions for Improved Malaria in Pregnancy Efforts in Communities, which details the results of a pilot program addressing malaria in pregnancy. Photo: PATH.

The pilot study has already demonstrated an increase in the number of women receiving IPTp-SP preventive treatment. And, in pilot health clinics where community health workers administered the medicine, 25% more women completed the recommended four antenatal care visits for a safer pregnancy.

Evidence for advocacy impact

Similar research has emerged from other regions of Kenya and multiple sub-Saharan African countries.

In order to share this new evidence and build support for community-based approaches to prevent malaria in pregnancy, PATH hosted a stakeholders’ forum in Nairobi, which brought together technical experts, government officials, and civil society representatives. After presentations on global recommendations and country-level research, participants identified policy change recommendations that—if implemented—would ensure a community-centered approach to safeguarding women from malaria in pregnancy.

The results of the forum—detailed in the newly released report Policies and Actions for Improved Malaria in Pregnancy Efforts in Communities—will be shared with key Ministry of Health leaders in Kenya to demonstrate the positive health impact of community distribution of IPTp-SP.

PATH is committed to engaging with decision-makers and carrying this agenda forward with our partners; we believe that by turning the emerging evidence into policy action, we can ensure that no woman is left unprotected from malaria in pregnancy.

This post was written by guest contributor Wanjiku Manguyu, family health advocacy officer at PATH in Kenya.

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On World Water Day, PATH celebrates the Water for the World Act

Our guest contributors—Amie Batson, chief strategy officer at PATH, and Jennifer Foster, WASH portfolio lead at PATH—are celebrating World Water Day by applauding the recent passage of the Water for the World Act. Following is an excerpt from their post on the Defeat DD blog.

Women carrying containers of water.

If every child under five had access to safe drinking water, hundreds of thousands of deaths due to diarrhea could be prevented. Photo: PATH.

On World Water Day, remembering the true compass for our water policies and programs

One year ago this month, advocates raised their glasses in a virtual toast to celebrate the lifesaving impact of safe drinking water, sanitation, and hygiene (WASH). Then in December, members of Congress clinked their glasses in return through the unanimous passage of the Water for the World Act, which:

  • More effectively targets US funds to communities with greatest need.
  • Promotes coordination across US government agencies working on WASH, including integration with other health and development areas.
  • Creates more robust monitoring and evaluation measures to ensure that resources are invested in the most impactful way possible.
A child washes his hands at a hand-washing station.

A hand-washing station design gets tested at the community level in Tanzania. Photo: PATH.

As we mark World Water Day on March 22, we applaud the US government for prioritizing this important policy. The improved targeting of US funds for WASH will doubtlessly buoy maternal, newborn, and child health outcomes. Consider the simple fact that if every child under five had access to safe drinking water, hundreds of thousands of deaths due to diarrhea could be prevented.

The policy also acknowledges that creative approaches to on-the-ground implementation are just as important as innovative health tools, a priority that we also share. A relentless focus on results and the practical implementation of what works for the world’s poorest communities are woven into PATH’s DNA.

PATH develops WASH technologies, but these tools are not the core compass of our program. The hallmark of our market-based safe water and sanitation programs is user-centered design and testing; our truest laboratory is the community itself. Do the water filters that people are using promote correct and consistent use? Is this newly designed water filter a practical (and appealing) solution for Taramma, a mother in Vavilala, India? What features do villagers in Tanzania want in a hand-washing station? How can we redesign a water filter in Cambodia to make it more appealing to customers? How can we make a latrine that is inexpensive, faster to build, and still considered pucca by end-users in India? We test, incorporate feedback, and test again until we have a product people will buy and consistently use.

To learn more about PATH’s work toward providing access to safe water for everyone, read this post in its entirety on the Defeat DD blog.

Friday Think: a “clinic on wheels” packs a punch at poverty

Map showing Medicaid birth rates in Gainesville by ZIP code.”

After a Gainesville doctor tracked birth rates to ZIP codes, she started noticing some disturbing health trends. Map: Census Block Group and University of Southern Florida.

When Gainesville, Florida, doctor Nancy Hardt and Alachua County Sheriff Sadie Darnell first met, they had an unusual “aha” moment. Both had been mapping out the same area in Gainesville, only for different reasons: high crime rates and poverty birth rates.

A colleague suggested they meet and compare maps. What they saw was an area or “hotspot” that both maps shared. It was enough to launch them into action.

“We kind of blinked at each other,” Hardt says. “And — simultaneously — we said, ‘We’ve got to do something.'”

Here’s an excerpt from Laura Starecheski’s story that aired on NPR‘s public health blog Shots.

"Clinic on wheels" bus parked at an apartment complex.

Dr. Nancy Hardt’s free “clinic on wheels,” gets about 5,000 visits from patients each year. Photo: Bryan Thomas for NPR.

The hotspot is dotted with isolated, crowded apartment complexes with names like Majestic Oaks and Holly Heights. The first time she visited, on a ride-along with Sheriff Darnell’s deputies, Hardt tallied up all things that make it hard for kids here to grow up healthy.

And there were quite a few things Dr. Hardt noticed: substandard housing, hunger, and a lack of medical care services for the uninsured. The story continues:

She mapped it out and determined that the closest place to get routine medical care if you’re uninsured — which many people here are — is the county health department. It’s almost a two-hour trip away by bus. Each way.

The “clinic on wheels” first made it out to the hotspot in 2010, parking right inside one apartment complex there. Patients could walk in without an appointment and get treatment free of charge, approximating the experience of a house call. Today, the mobile clinic gets an average of 5,000 visits from patients per year, in under-served areas all over Gainesville.

Friday Think logo You can listen to this story or read the transcript in its entirety at NPR.org.

Each week, we scour the news for the hottest stories on innovation. Our weekly feature, The Friday Think, highlights one we’ve found particularly fascinating.

Cleaner water, higher quality goods, better lives, by design

Mother stands with two young daughters next to household water filter.

PATH’s user-centered design process resulted in standardized home water filters that fit multiple water systems. We then worked with manufacturers and partners to make these water systems affordable through a microfinance program. Photo: PATH/Gabe Bienczycki.

How do you get a new product to people who are in an underserved market, who may live on just a few dollars a day, have little access to credit, and are hard to reach via conventional distribution channels?

This is the story of how a user-centered design process in India positively impacted the health of communities, benefited manufacturers, strengthened the marketplace, and empowered lives.

Developing products that can impact individual, family, and community health at multiple levels, by design

At PATH, we practice user-centered design as we develop new technologies for people who live in low-resource settings around the world. Our process extends far beyond our lab and product development workshop—to the field, people’s homes, and sometimes manufacturing facilities, to name a few. It incorporates input from multiple stakeholders and includes partnerships that shift depending on which stage of innovation we’re in.

“Imagine a map with very little detail. By defining a need and anticipating who will use it, you develop a better map. Successive approximation and iterative work makes the journey route clearer and clearer. The navigation to innovation is rarely linear.” —Glenn Austin, senior advisor of Product Development at PATH.

Designing for cleaner water and for better lives: bringing field tests into homes

In India, we started with the people and their need for safer water. To better understand how low-income people might use water treatment and safe storage products, we enlisted the help of 20 households to “road test” five existing models to share what they liked and didn’t like. Up until then, water filters among participants were novel products, and few people had seen, let alone used them.

“There’s a difference between designing a functional water filter and designing a water filter that people will use.” —Jesse Schubert, senior program associate in Devices and Tools at PATH.

Woman in her home standing proudly between a blue water storage barrel and a water filter.

In Vavilala, India, Taramma got a water filter during a PATH pilot project. Photo: PATH/Gabe Bienczycki.

Over a period of months, each household weighed in on what might influence their adoption and use of water filters. For instance, a bigger water system was initially perceived as better. Hard-to-reach surfaces were seen as problematic to clean. Steel containers were considered aesthetically pleasing. And price made a big difference on whether they would buy replacement filters. All these observations informed our own prototype design.

Through multiple cycles of feedback, PATH’s water filter prototype evolved and improved until we landed on a design that met the needs of our household testers while providing safe water and making a positive impact on their health. The testers essentially became codesigners with PATH and their input helped inform design guidelines for more effective devices.

The design becomes a blueprint for a new user: the manufacturer

When developing solutions, we design for sustainability to ensure manufacturers can keep costs as low as possible while still making a fair profit. In this case, we found our initial prototype was too costly to build.

PATH worked with manufacturers to remain true to our user guidelines, modifying materials to ensure high quality at sustainable production costs. Together, we were able to develop affordable water filters for underserved populations in low-resource settings. The end result: a product that people found attractive, beneficial, and useable.

Getting the product to the people: a new distribution model

Our involvement didn’t end at the physical product; getting the water systems to these areas was another story. Traditional methods of distribution were too expensive for manufacturers to support.

PATH helped develop a new distribution channel. We linked microfinance organizations to the manufacturers so local groups of consumers could purchase these products through affordable loans that were easier to repay.

A woman standing next to a water filtration device holds a child.

Creating a distribution network to villages is costly for water filtration manufacturers and drives the price up. This slideshow shows how microfinance loans helped get filters into rural homes. Photo: PATH/Gabe Bienczycki.

What we really do is user-centered “development”

The Journey of Innovation: learn moreIt’s a longer game that’s played well when all the stakeholders and steps are included along the way.

From the start, PATH enlists a team that covers technology, public health, commercialization, and, depending on where we’re at in the development process, experts who help us customize solutions for the local environment.

Refining technologies by leveraging partnerships and resources can help define new industry standards. The result: lower costs, higher quality, and expanded health access. And that’s really the end game.

This post is part of a multi-part series, Mapping the Journey, which explores how PATH turns ideas into solutions that bring equity, dignity, and health to women, children, and families worldwide. This is the third installment of the series.

Other posts in this series

Strength in numbers: the power behind peer learning networks

A group of participants from the Joint Learning Network (JLN) members share ideas.

We’re finding that one of the best ways to problem solve and distill information is to share experiences with your peers. Photo: PATH.

Around the world, a large percentage of the global health community still records data and tracks medical inventories by hand using paper forms. Yet by studying India and Thailand’s health insurance information systems, Ghana and Kenya were able to develop their own e-claims standard and automate their payment processes.

As technological advances make accessing and sharing data a practical activity, it’s easy to lose sight of how effective it is to simply ask someone to share their lessons and what’s worked for them.

Two African men look at a cell phone that one is holding, while standing in a conference setting with devices around them.

When people cross borders to collaborate with their peers in other countries, the result can be new and novel approaches, models, and examples of implementation. Photo: Flickr/Maker Faire Africa.

Today, this type of sharing reflects a paradigm shift in global health programs as we see the development of national experts who can connect emergent experiences.

Sometimes, the best solutions have a deceptively simple approach

It’s called peer-to-peer learning. And through this model, a fresh set of voices and views are creating effective solutions to global health challenges from the ground up.

Peer-to-peer working groups are made up of those leading the way at the national level. Medical practitioners, health officials, service engineers, purchasing decision-makers, and others—all of whom come together across borders to share their knowledge and find common solutions, together.

Joint Learning Network: a global health network for sharing knowledge

The Joint Learning Network (JLN) is one example of how an innovative country-led program can achieve success through the power of knowledge exchange among peers.

In this video, JLN Information Technology (IT) track members work together to determine and document common requirements for IT systems that support national health insurance information scenarios. Video: JLN.

By removing the silos that policy makers and practitioners often operate in and offering opportunities to share their successes, even failures, JLN members are finding innovative solutions that can be put to work more quickly than those developed through more traditional channels.

Sam Adjei, executive director at the Centre for Health and Social Services Ltd in Ghana, gives this example:

“We had to do things on our own, learning by doing. But when we start connecting with people and we start diving into details of how to do things—enrollment, registration, IT, provider payment—then it’s critical to have this exchange with other people and get to know how did they do it.”

This is how Ghana and Kenya were able to take their new e-claims systems a step further and make them available for other countries to use.

PATH’s role as a trusted matchmaker

PATH helps to match participants across countries who can share knowledge, analyze user needs and requirements, and use this new information as a tool to develop and iterate solutions in their own countries.

By learning from the successes and failures in other countries, and building new solutions together, countries can make faster progress than they can alone.

One of the greatest challenges in forming peer networks is making sure participants receive executive support for their work. This covers everything from supporting volunteer participants as they take time away to attend learning groups, to the investment they’ll need to implement new programs and systems.

“We ask countries to support these collaborative cross-country teams,” says Kate Wilson, director of Digital Health Services at PATH and one of the founding members of the JLN IT group. “People are busy. And the participants who are most driven to make change need permission to invest the time it takes to learn what made other projects successful and apply that knowledge at home.”

Wilson highlights another example of bringing efficiencies to country-wide health systems: the Better Immunization Data (BID) Initiative. Supported by a grant from the Bill & Melinda Gates Foundation, the BID Initiative was developed to help countries strengthen their immunization programs through improved data quality, collection, and use by identifying practical, country-owned, country-led digital health solutions.

“There’s power in bringing countries together to design solutions, see them implemented in a few places, and then take it and adapt it to their own situation,” says Wilson. “Like the new e-claims systems in Ghana and Kenya, we expect that members of the BID Learning Network will design the standards and solutions that will be used for generations to deliver lifesaving impact.”

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Friday Think: the innovative catch of the day is a fish bandage

A tilapia fish.

Proteins from the skin of the tilapia fish are said to help speed up wound healing. Photo: Peter Griffin.

What does a little collagen, some electrospun fibers, and fish skin get you? Apparently a bandage made from fish that researchers claim will speed up the healing time in skin wounds. And they say it has commercial possibilities.

In China, a group of researchers and scientists were able to extract collagen from tilapia to make a flexible weave that could cover wounds with the added benefit of faster healing times. We’ll resist throwing in the fishing metaphors, and let this article by Andrew Turley in Chemistry World speak for itself.

It might not sound terribly appealing, but the best way to heal skin wounds could be to apply some fish skin protein. That, at least, is the claim of a group of researchers in China who were able to speed up skin wound healing on mice using collagen obtained from the skin of tilapia fish.

To investigate further, a team led by Jiao Sun at Shanghai Jiaotong University School of Medicine, extracted collagen chemically from tilapia to create a sponge, which they spun into nanofibres.

There are many applications for this bandage, one of which may be a good low-cost solution for people with chronic wound care.

Tests showed that the nanofibres had the right physical characteristics for use in wound healing, including a high tensile strength, which suggested they would retain structural integrity as the skin moved around. They were also hydrophilic and thermally stable – the constituent fish collagen was found to have a high denaturation temperature of 45°C, meaning it will not lose its form at body temperature (38°C). Friday Think logo

You can read this article in its entirety at Chemistry World.

Each week, we scour the news for the hottest stories on innovation. Our weekly feature, The Friday Think, highlights one we’ve found particularly fascinating.