From our understanding of user and contextual issues, we identified the following set of requirements for our (or any) device:

Low Cost:
The device should be affordable to the mother (or family). This probably means a running cost of significantly less than a dollar per day.

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. Particularly with regard to areas where HIV associated stigma is significant, the device needs to minimize the visibility of practices that identify mothers as HIV positive.

Acceptable by the baby:
The device must be 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.

Fast:
The time required for HIV treatment must be minimized; use of the device cannot take up a large proportion of the mother’s time during the day which otherwise might be spent working.

No Nutritional side effects:
It is crucial that the nutritional contents breast milk are not affected and that use of the device does not impede with the feeding process.

In collaboration with public health charity FHI and PATH a user acceptability study was conducted in Kenya, using modified nipple shields developed by the JustMilk team. This was presented at the AIDS 2010 conference. The poster can be found here.

Due to the novelty of our device, no context specific studies regarding the use of nipple shields in HIV affected regions have taken place in the past. We therefore sought to initially analyze our market by contacting representative authorities in affected regions and gathering testimonials to provide an indication of the desirability and viability of proposed solutions. The anecdotal evidence gathered was from various regions in Sub-Saharan Africa, comprising 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 in Malawi is strictly no breast-feeding. This means that if mothers are financially incapable of purchasing their own formula, they’re forced to source it from either hospitals or NGO’s. This situation introduces a variety of problems, including that many babies die due to diarrhea and malnutrition brought on by insufficient formula and the 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, she will draw unwanted attention to herself for not following the norm, which could result 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 children. 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 to uptake and acceptance, should the device be disseminated.

Mrs. Gloria Sangiwa, the Senior Technical Adviser for HIV/AIDS care and treatment for FHI, 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 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 breast milk is the best source of nutrition for their children. 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.