Applicators are crucial to success of microbicides

Ana lives in the Dominican Republic with her two children, who she is raising alone. She suspects that her boyfriend is cheating on her, but he gives her much-needed extra money to use for food and clothes, and she feels powerless to change the relationship. She knows that his cheating places her at risk for HIV but is too afraid to ask him to use a condom. Her friends have been beaten or accused of cheating when they asked their boyfriends or husbands to wear condoms.

Economic and social factors like those Ana faces leave women and girls in developing countries powerless to protect themselves against AIDS. A topical microbicide that reduces transmission of sexually transmitted infections, including HIV, when applied vaginally could help these women—when such a microbicide becomes available, they will have a new option for protection against HIV. But these microbicides will only be fully effective if they are delivered in a device that is affordable and acceptable. PATH is searching for a microbicide applicator that is suitable for developing-country needs.

Asking about applicators

How much difference can an applicator really make? If the applicator causes pain or irritation, adds too much to the cost of the microbicide, or is difficult to clean, women may reject it and the microbicide that comes with it. The scientists, product developers, and other experts that PATH consulted at the beginning of our research highlighted these three areas—safety, cost, and usability—as important issues that would affect the accessibility of microbicide products for women in developing countries and influence the use of microbicides packaged with an applicator.

Design in the balance

One of the problems that all designers confront is conflict between desired features. In the case of microbicide applicators, the conflict is between the convenience and the higher cost of a prefilled, single-use applicator, which doesn’t need to be cleaned, and the lower cost associated with a user-filled applicator that could be reused but would require cleaning after every use.

PATH started by looking at applicators that are already on the market (for other products) or being used in current microbicides trials. We evaluated the safety of various applicator designs, compared the effectiveness of different washing methods for reusable applicators, and analyzed the cost of prefilled (single-use) and user-filled (single-use or reusable) applicators. We found that both single-use and reusable designs were safe and did not cause significant irritation, which means that both are viable options. Of these two designs, user-filled, reusable applicators turned out to be the least costly way to deliver microbicides.

We still needed to find out whether the convenience of a single-use applicator or the low cost of a reusable design was more desired by women in developing countries. Our team used a marketing tool that is usually the domain of the private sector: conjoint analysis. Instead of asking consumers to rate a list of features one by one, this kind of research offers them “packages” that combine different features and then asks about their preferences. The answers tell us what kind of trade-offs consumers are willing to make.

Working in collaboration with the Institute of Population and Development Studies at Profamilia in Santo Domingo, Dominican Republic, and with the Reproductive Health Research Unit in Durban, South Africa, we interviewed almost a thousand women. The women in each of these settings were overwhelmingly in favor of single-use applicators, even when they were “packaged” at higher prices. One of the reasons for this choice was their concern that reusable applicators could spread infection.

Our research gave us a better understanding of what women in these two groups value and need to make a microbicide applicator acceptable. No single applicator design will be appropriate for all women in all areas of the world; but the more we learn about women’s preferences, the better able we are to make sure that women in developing countries have a variety of options, so that they can choose the microbicide and applicator that best fit their needs.

Timed to meet the market

Our focus now is on finding out how new applicators that meet women’s needs can enter the regulatory process quickly and efficiently. We want to make sure that a range of FDA-approved applicators are available when microbicides hit the market. PATH’s work on microbicide applicators has brought much-needed attention to the importance of applicator design in the success of microbicides and protecting women against HIV.

Photo: Adriane Berman.