Breast milk purged of HIV virus by Nipple Shield+Chemical
A simple nipple shield that prevents HIV transmission from a breast-feeding mother to her child has been devised by a Cambridge University engineer.
Stephen Gerrard, a chemical engineer, has helped devise the shield that can disinfect milk as it leaves the breast.
The device uses a detergent used by biochemists to denature proteins for analysis.
A layer of cotton-wool soaked in the chemical is added to a conventional shield and this deactivates the virus.
The layer deals with the virus without having to go through heat treatment which is the normal treatment to deactivate the HIV virus.
The International Design Development Summit (IDDS) in the United States brought together engineers and field workers to work on research projects aimed at developing prototype designs.
Mr Gerrard, together with a team of five others, was assigned the task of creating a practical design for heating breast milk to deactivate the virus.
"We quickly established this may be too lengthy a process for many women in developing countries so they might not have the time for it," he said.
"Research has shown that copper and copper compounds can work but another approach, carried out by a group at Drexel University seemed more promising.
"Their research has focused on sodium dodecyl sulphate (SDS), which can kill the HIV virus quickly and in fairly non-toxic concentrations."
Their project could also have benefits beyond prevention of HIV.
"We were concerned that using our nipple shield could be stigmatizing, since it would identify a mother as HIV infected," said Mr Gerrard.
"We're considering marketing it as a way to deliver medicines or micronutrient supplements to aid breast feeding. For example, they can also be used for iron or iodine deficiency."
EWB-UK volunteer contributes to HIV prevention research
The International Design Development Summit (IDDS), a unique set-up drawing on the experiences of development practitioners from different countries and backgrounds, led to a path-breaking development, which promises to take research on HIV prevention a step further.
A team of five students and an experienced medical doctor devised a method for disinfecting breast milk involving modification of an existing nipple shield to prevent the transmission of the HIV virus from mother to child during breastfeeding.
Stephen Gerrard, a chemical engineer from Cambridge University and an EWB-UK volunteer, Tombo Banda, a mechanical engineer from Imperial college, Geoff Galgon from California Institute of Technology (Caltech), Ryan Hubbard a systems engineer from Olin College, Elizabeth Kneen, a mechanical engineer from Olin College and David Sokal, an experienced physician and public health specialist from Family Health International (FHI), participated in a month-long workshop (IDDS) at the Massachusetts Institute of Technology (MIT) this August.
"IDDS brought together 60 participants from 22 countries comprising both engineers and field workers, amateurs and professionals, and gave us an opportunity to work together in teams on different research projects," says Gerrard, who will now be starting his Masters in Chemical Engineering at Cambridge University. Besides Gerrard, four other EWB-UK volunteers also participated in the summit.
IDDS is not strictly an academic conference, nor is it a technology training workshop. "Unlike most academic conferences, its emphasis is on the development of prototypes, not papers and proceedings," according to course founder Amy Smith. It draws inspiration from several current models of innovation, design, community empowerment and co-creation.
The principle of co-creation is what sets IDDS apart. Gerrard explains, "The concept of co-creation implies that it is better to provide communities with the skills and tools to become innovators and develop new technologies themselves than to simply provide the technologies externally. IDDS, thus, encouraged and saw the participation of many people of different occupations from developing countries. For instance, masons from Guinea or welders from Honduras also participated in the summit as their contribution is significant."
Gerrard and his team came together because of their common interest in HIV prevention. The project also strongly benefited from the viewpoints and experiences of other participants from developing nations with a non-scientific background. Although, prevention of the transmission of the HIV virus from mother to child during breast-feeding is currently being researched upon by some research groups, it is still a very new subject area.
"For instance, a research group at Berkley, California has been working on heat treatment to deactivate the virus, which suggests extraction and heating of the mother's milk before feeding it to the baby," explains Gerrard.
Taking on from current research in the field, the team of six, was given the assignment of devising a practical design for heating the milk for deactivating the virus.
"We quickly established the concern that this may be too lengthy for many women in developing countries so they might not have the time for it," says Gerrard.
The group looked at other research besides heat treatment that was being carried out in the world, particularly in Israel, England, Boston, Philadelphia and California. They came across a couple of research groups working on compounds that could be used to deactivate the HIV virus in breast milk.
"Research has shown that copper and copper compounds can deactivate the HIV virus," says Gerrard , "But another approach, carried out by researchers at Drexel University in Philadelphia seemed to be more promising and further along. The research group at the Drexel lab has focused on a compound called Sodium Dodecyl Sulphate (SDS), which can kill the HIV virus pretty quickly and in fairly non-toxic concentrations," he adds.
Drexel University collaborated with the IDDS team to take the research further. "They identified the compound and have been studying it for use in a filter in a baby bottle, but we came up with a way to make its use much more practical," says Gerrard. " Because our approach might have other uses than HIV prevention, such as giving medicines to babies, we submitted a provisional patent to the US Patent Office before the end of the IDDS meeting," he adds.
Gerrard and his team-mates came up with a unique approach by slightly modifying an existing nipple shield , so that it could be used to add SDS to breast milk.
"We found that if we added a non-woven material like cotton-wool or felt containing SDS to the nipple shield and had the baby feeding on that, the HIV virus could be de-activated without having to go through the heat treatment," says Gerrard.
However, although a definite break-through, more research needs to be done to establish that the majority of HIV virus is de-activated in the time during which the milk passes through the cotton-wool. "Researchers at Drexel are currently testing our samples to establish this," says Gerrard.
The path ahead for this two month old project depends on these initial results. "If results are encouraging, we will think of the next step, or else we will have to go back to re-thinking the entire implementation mechanism," he adds.
The project, as it exists now, aims to use this modification of the nipple shield since it is cost effective and simple in use. "All the mother needs to do is to replace the cotton-wool on a daily basis," says Gerrard.
Yet another aspect of the project that the team worked on was the social implication of the Nipple shield.
"Using the nipple shield could be stigmatizing as it will immediately identify the HIV infected mother," says Gerrard. "So we are considering marketing it as a way to deliver medicines or micronutrient supplements to aid breast feeding. This broadens the spectrum as medicinal supplements could be for other things as well; for example, they can also be used for iron or iodine deficiency," he adds.
The project has the potential to turn into a full-fledged PhD project for a student at Drexel University. The IDDS team also aims to identify and involve more partners in future. Studies of new methods HIV prevention are extremely complex and usually take years, but in the meantime, the IDDS team's idea might provide a relatively quick way to improve how doctors give medicines to babies. Their invention provides a low-cost alternative to the use of syrups, which are expensive and usually require refrigeration. After the official end of the workshop, the IDDS team made a preliminary contact with the Institute for Pediatric Innovation in Boston, and hopes to identify pharmaceutical companies that might be interested in this use of their invention.
"There is a long way to go but it definitely will make a big difference if it finally works. I too plan to research on it at Cambridge alongside my Masters," says Gerrard.
Due to the sudden demise of the head of Drexel lab, the team is currently in the process of identifying a suitable lab to test their device. The possibility for the project to be developed into a PhD for a student at Drexel University has also been dropped at the moment.
Contact the team at firstname.lastname@example.org.
Breast Milk HIV Shield
IDDS Project Page in Progress
This page is a project page in progress by participants in IDDS. Please refrain from making edits unless you are a member of the project team, but feel free to make comments using the discussion tab. Check back for the finished version on September 10th, 2008. Our main website justmilk.org is being updated during September 2008.
Our work provides the foundation for what we hope might become a possible solution for reducing the transmission of HIV from mother to child via breast milk.This report summarizes some of the current research aimed at reducing this transmission and develops several novel approaches to the problem. Sodium Dodecyl Sulfate is identified as a promising compound to deactivate HIV in breast milk, though copper filtration and flash heating are also considered. The team is currently working to identify laboratories to test the efficacy of the nipple shield and thus the next step depends on these initial results.
For further information, send us an email: email@example.com.
* 1 Abstract
* 2 Background and Need
* 3 Methods of Breast Milk Deactivation
o 3.1 Flash Heating
o 3.2 Copper
o 3.3 Sodium Dodecyl Sulfate (SDS)
* 4 Contextual Considerations
* 5 Design Requirements
* 6 Initial Concept Devices
o 6.1 Flash Heating
o 6.2 Filtering Device
* 7 Final Concept Device
* 8 Testing of Devices
* 9 Team Information
* 10 Media and Publications
* 11 References
* 12 Further Sources
Background and Need
Of the almost 25 Million people living with HIV in Sub-Saharan Africa, about 60% are women, leading to roughly 10 million HIV-infected potential mothers living in the region. 700,000 children are then born each year to HIV-positive mothers 
Without any intervention, 30-35% of mother-to-child transmission (MTCT) cases are due to breastfeeding. The remaining portion of MTCT cases occur in utero and at childbirth. This is called perinatal transmission. As the total percentage of MTCT ranges from between 15-45% by region, it's expected that a child born to an HIV-positive mother has a 5-10% chance of acquiring the virus via breastfeeding . Therefore, 50,000 babies each year will acquire HIV via breastfeeding.
Several studies suggest that treatment with ARV's can be effective at reducing the risk of perinatal transmission. For example, a 2004 study showed that taking antiretroviral therapy and giving birth by cesarean section leads to a transmission rate of only 1% . Unfortunately, the implementation of programs to prevent perinatal transmission has been slow. So even though the percentage of HIV-positive pregnant women in low- and middle-income countries that have access to ARV's has increased from 10% in 2004 to 23% in 2006, coverage varies significantly by country, with, for example, only 7% coverage in West and Central Africa in 2006 . Indeed, Dr. Arletty Pinel, the Chief of UNFPA Reproductive Health Branch said in 2006 that, "these programmes (to prevent perinatal transmission) have been a failure. Despite the fact that the global HIV response is now awash in funding, pregnant women still donft have access to the drugs that will prevent them from passing the virus on to their children." So although progress has been made since 2006, programs in most countries still have to work to increase coverage.
However, programs to prevent post-natal transmission of HIV through breast feeding have not been evaluated as widely as the programs to prevent perinatal transmission, and the latest WHO recommendations leave the majority of women in low-resource settings with difficult choices and some uncertainty as what is best to do, since formula feeding is not a realistic option for most women.
The WHO policy states that, "when replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected mothers is recommended. Otherwise, exclusive breastfeeding is recommended during the first months of life." . This is because using formula in low-resource settings has been shown to decrease infant survival due to increased numbers of deaths from diarrhea and malnutrition . In terms of specific breast-feeding recommendations, the situation is also ambiguous. Some of the most recent published data from a study of exclusive breast feeding followed by rapid weaning in Zambia  has shown no benefit for the intervention group compared to a control group that followed traditional breast feeding practices. About 7% of infants in both groups became HIV infected via breast milk between four and 24 months of age.
So, given the difficulties and lack of certainty regarding prevention methods for MTCT through breastfeeding, we've identified a definite and significant need for an appropriate breast milk treatment system.
Methods of Breast Milk Deactivation
Flash heating, as well as pretoria pasteurization (longer duration heating), have been shown to effectively remove HIV from milk. Procedurally, using the flash-heating method, a mother first expresses 75-150 mL of breast milk into a glass jar. The jar is then placed in a pot of water, which is brought to a boil. At this point the milk can be removed, and fed to the baby once it cools to an acceptable temperature .
Flash heating utilizes materials that are already found around the home, which could put the mother's upfront cost of the device at virtually zero. Furthermore, daily cooking is done by most families, so that the boiling of the milk might be incorporated into everyday life. Again, both the flash heating and pretoria pasteurization methods have been proven to effectively remove HIV from milk . Additional research has also been conducted into the degree to which these methods damage the vitamin content of breast milk. Broadly speaking, no significant damage to the nutritional content of the milk was detected, though flash heating seemed slightly more nutritionally preservative .
However, the flash heating method could require more boiling than is typical for a mother's routine, which might require increased time, effort, and money to acquire the extra fuel. Even if the heating were somehow incorporated entirely into the daily cooking, performing the acts of manually expressing enough milk (often 600mL/day), storing the milk, and finally delivering the milk to the child are simply not practical for many women. Furthermore, by blatantly not breastfeeding a child, a woman is often subject to the stigma of being HIV+, a reality that many women and their families are reluctant to admit. Acceptability studies looking into the heat treatment of breast milk in Zimbabwean society have been performed . The results indicate that it would be acceptable if correctly introduced and understood, however this acknowledgment required a resource intensive small-group discussion even in the study. Many people were hesitant of the methodfs effectiveness and the inconveniences of having to boil water on a frequent basis.
Research has shown that impregnating fibers and/or polypropylene filters with a copper-oxide mixture (70% Cu2O and 30% CuO, >99% purity ) can be used as a biocidal method of removing HIV-1. Work has not yet been done in putting this into a user-oriented device for a breastfeeding application.
Copper, along with copper impregnated fibers, is very cheap  We also suspect that copper-based filters might be more easily marketed ("all-natural") than chemical microbicide based ones. However, possible effects of copper on breast milk constituents have not been well researched. Indeed, neither in-vivo nor even comprehensive in-vitro studies have been carried out. However, copper filtration does look promising, and if proven effective and appropriate, our final design could easily incorporate a copper-based filter.
Sodium Dodecyl Sulfate (SDS)
Sodium dodecyl sulfate (SDS), also known as Sodium lauryl sulfate (SLS), is a surfactant commonly found in toothpaste, shampoo, etc. Recent in-vitro work has shown that SDS, in concentrations as low as .1%, is highly effective at eliminating HIV-1 . An in-vivo study involving goats is ongoing. SDS is also extremely inexpensive.
However, similar to copper, possible nutritional side effects of infant SDS intake via breast milk have not been extensively researched. In this case though, nutritional in-vitro studies have been carried out, and in-vivo research is further along. SDS can also cause skin irritation, depending on the concentration and duration of contact. There are also concerns of SDS affecting taste. Similar to drinking orange juice after brushing your teeth, SDS has been shown to temporarily decrease the reception of sweet tastes.
Time constraints dictated that we could not undertake formal studies of our potential market; in addition the innovative nature of our device means that no context specific studies have taken place in the past by other parties. We therefore sought to analyze our market by contacting representative authorities in affected regions and gathering testimonials that would provide an indication of the desirability and viability of the project. The anecdotal evidence gathered was from various regions in Sub-Saharan Africa, including Malawi, Tanzania and Zimbabwe.
Our primary contact in Malawi, Mrs. Stella Chiphangwi, a senior matron at Open Arms Malawi (a care home for children affected by HIV) informed us that the official Government line for HIV positive mothers was strictly no breast-feeding, to prevent MTCT. This means that mothers are forced to source formula from either hospitals or NGO's, if they are financially incapable of purchasing their own. This introduces a variety of problems, including that many babies die after contracting diarrhea and malnutrition, due to insufficient formula and use of contaminated water for mixing. On a more personal level, if a mother is visibly not breastfeeding her new-born, a very natural and culturally open practice in Malawi, this has the effect of drawing unwanted attention to the mother for not following the norm, and results in some stigmatization if it is revealed that she is HIV positive. More crucially, the mothers are highly concerned about not being able to provide enough nutrition for their child. It was from this perspective that Mrs. Chipangwe added that these mothers would indeed love to breastfeed their children, and that a proposed discreet device such as the nipple shield would be highly desirable. However, she emphasized that the role of education on the effectiveness and practicality of the device would be crucial on the uptake and acceptance, should the device be disseminated.
Mrs. Gloria Sangiwa, the Senior Technical Adviser for HIV/AIDS care and treatment for FHI (Family Health International), provided us with insight for the current status of HIV and breastfeeding in Tanzania. In contrast to Malawi, the official government policy is exclusive breastfeeding for six months followed by non-abrupt weaning. She encouraged us to explore the feasibility of different systems such as the maternity bra and breast-shield concept in different settings, as uptake would vary from region to region, considering the cultural and customary practice differences present. She also underlined that currently nobody in Tanzania was using the flash-heating method for de-activating HIV, and she considers that it is 'culturally impossible' to adopt this method as the main approach for preventing MTCT. On the other hand, she was very optimistic of the viability of the nipple-shield concept, and recommended that this was an avenue we should continue to explore.
Mrs. Ruth Mufute of Africare provided us with input more specific to Zimbabwe. According to her, most mothers in rural settings often breastfeed for up to a year or more because they can't afford formula and breastmilk is their best source of nutrition. She also informed us that the whole community was involved in decisions where breast-feeding was concerned, indicating that like Malawi it is not considered a private practice at all. Due to this public nature she recommended that it might be convenient if the mother is wearing the treatment device all day, to prevent the drawing of unnecessary attention to her if she is required to apply and remove it during every feed. Regarding how we might consider disseminating the proposed technology, she suggested the use of midwives to distribute the technology, as well using them as agents to advise, promote and inform the HIV mothers about the efficacy and value of using such a device. In addition, she added that we may choose to market the nipple shield as a tool to be used by both HIV negative and HIV positive mothers, making the concept more acceptable and less alienating.
With the above considerations, we need something that fulfills the following requirements:
* The device should (after possible subsidization) be of sufficiently low cost to be affordable to be bought by the mother (or family) without detrimental effects to the mother's livelihood or health.
Convenient and acceptable for the mother to use
* The device should be quick and relatively unobtrusive for use by the mother. It must be able to be used outside the home environment. There is a need to minimize the display of the device to avoid the mother being identified as having HIV. This will be community specific depending on the stigma of HIV in specific regions.
Acceptable by the baby
* The device must in a form so that intake is readily accepted by the baby. Mimicking the breast feeding experience as closely as possible is ideal.
Easy to clean/maintain
* The device must be quick and easy to clean. It should have as little an effect as possible on the daily routine of the mother.
* The time that the process of treating the HIV takes must be minimized; it cannot take up a large proportion of the mother's time during the day which may be spent working.
No nutritional side effects
Initial Concept Devices
* Integrated bottle/heater (wire mesh around outside)
* Thermal storage heating
* Phase changing materials/gels
* Bottle/heater that hooks around cooking pot
* Low cost breast pump to ease what would have to be manual expression
* Filtering column/straw that increases contact time of milk to Copper/SDS. Might require extra pressure (hand pump, etc.)
* A reservoir for storing SDS, drip into another reservoir for mixing SDS and milk, etc. Might be incorporated into "super bra". Such a two-stage system could also be used with copper particulates, as opposed to fiber-impregnated SDS or copper.
* Small filter (multi-stage or single stage) incorporated directly into nipple shield.
Final Concept Device
Given our research regarding the gravity of some of the contextual challenges that devices which required significant amounts of time or effort to operate would face, we decided that the small nipple-shield filter device is the only design which could possibly be successfully implemented.
Our intention is to prototype several different designs in this general fashion, which we expect will have different flow rates, requisite suction power, SDS impregnation statistics, etc. Below are renderings of some possibilities (coming soon).
* SDS at 20% concentration and 99%+ purity was available.
* Measuring concentration of SDS.
- Refractive Index
- Surface tension
- Flash point?
* Tombo Banda, Mechanical Engineering, Imperial College, UK
* Geoff Galgon, Mathematics and Economics, California Institute of Technology, USA
* Stephen Gerrard, Chemical Engineering, Cambridge University, UK
* Ryan Hubbard, Systems Engineering, Olin College, USA
* Elizabeth Kneen, Mechanical Engineering, Olin College, USA
* David Sokal MD, Scientist, Behavioral and Biomedical Research, Family Health International, USA
Media and Publications
* Engineers Without Borders - UK 
1. _ UNAIDS, 2006. 2006 Report on the global AIDS epidemic. Rep.No. 10. .
2. _ UNAIDS 2001 (b). HIV and Infant Feeding, 
3. _ Coovadia H (2004). "Antiretroviral agents-how best to protect infants from HIV and save their mothers from AIDS". N. Engl. J. Med. 351 (3): 289-292. PMID 15247337.
4. _ UNICEF Australia, "Children and Aids: Second Stocktaking Report", 
5. _ World Health Organization. 2001. "New data on the prevention of mother-to-child transmission of HIV and their policy implications"
6. _ Brahmbhatt, H., and R. H. Gray. 2003. "Child mortality associated with reasons for non-breastfeeding and weaning: is breastfeeding best for HIV-positive mothers?" J. AIDS 17:879-88
7. _ Kuhn, L. et al. 2008. "Effects of Early, Abrupt Weaning on HIV-free Survival of Children in Zambia". J N ENGL J Med 359:2 130-141.
8. _ Isreal-Ballard, Kiersten, et al. 2007. "Flash-Heat Inactivation of HIV-1 in Human Milk: A Potential Method to Reduce Postnatal Transmission in Developing Countries." J Acquir Immune Defic Syndr 45: 318-23.
9. _ Isreal-Ballard, Kiersten, et al. 2005. "Viral, Nutritional, and Bacterial Safety of Flash-Heated and Pretoria-Pasteurized Breast Milk to Prevent Mother-to-Child Transmission of HIV in Resource-Poor Countries A Pilot Study" Journal of Acquired Immune Deficiency Syndromes Volume 40 (2), 1 October 2005, pp 175-181.
10. _ Isreal-Ballard, Kiersten, et al. 2008. "Vitamin Content of Breast Milk From HIV-1-Infected Mothers Before and After Flash-Heat Treatment." Journal of Acquired Immune Deficiency Syndromes Volume 48(4), 1 August 2008, pp 444-449.
11. _ Isreal-Ballard, Kiersten, et al. 2006. " Acceptability of Heat Treating Breast Milk to Prevent Mother-to-Child Transmission of Human Immunodeficiency Virus in Zimbabwe: A Qualitative Study." Journal of Human Lactation Volume 22 (1), 2006, pp 48-60.
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Isreal-Ballard, Kiersten, et al. 2007. "Flash-Heat Inactivation of HIV-1 in Human Milk: A Potential Method to Reduce Postnatal Transmission in Developing Countries." J Acquir Immune Defic Syndr 45: 318-23.
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Isreal-Ballard, Kiersten, et al. 2005. "Viral, Nutritional, and Bacterial Safety of Flash-Heated and Pretoria-Pasteurized Breast Milk to Prevent Mother-to-Child Transmission of HIV in Resource-Poor Countries A Pilot Study" Journal of Acquired Immune Deficiency Syndromes Volume 40 (2), 1 October 2005, pp 175-181.
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