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The Need for Including Trans & Gender Diverse Persons Assigned Female at Birth in Contraceptive R&D

Author: Lee Sims, Biomedical Program Advisor, USAID

(Photo credit: The Harvard Business Review)

Amid continued high rates of unmet need for contraception, contraceptive product developers are working to bring new products to the market that appeal to a diverse group of potential users. By designing new and refined contraceptive products that are responsive to factors affecting use and continuation, product developers aim to expand the contraceptive method mix, thereby increasing use. However, a population that continues to be marginalized in these efforts is that of trans and gender diverse individuals assigned female at birth (TGD AFAB) - persons whose sex assigned at birth was female and identify as a men or outside of the man/woman gender binary. To date, TGD AFAB populations remain unrepresented in contraceptive R&D, with their reproductive health needs being primarily thought of in the context of HIV/STI prevention and treatment. It is crucial for contraceptive product developers to begin to center TGD AFAB populations in the research and development process and consider them as stakeholders of an expanded method mix.

Despite the paucity of research globally on reproductive health and contraceptive use among TGD AFAB persons, increased research efforts over the past decade demonstrates there is an unmet need for contraceptive products that are designed with TGD AFAB populations in mind from the beginning. Using mixed methods research, investigators across North America and Europe have observed contraceptive use ranging from 20-60% among TGD AFAB persons, with contraceptive decision making often being done in the context of limited information. This and other misconceptions act as barriers to use, including the salient concern that use of hormonal contraceptives will impact gender affirming hormone (GAH) therapy, even though there is evidence to the contrary. Another misconception purported by healthcare providers is that testosterone, taken as GAH therapy, acts as a contraceptive agent. Although testosterone taken in this way does impede ovulation, evidence does not indicate that use of testosterone would result in a complete halt in ovulation, leaving potential for unintended pregnancies to occur. Furthermore, due to inconsistent access to medications, potential for breakthrough ovulation while on GAH therapy is high among TGD AFAB. Taken together, there is strong evidence to make the case for more concerted efforts to include TGD AFAB persons and considerations of their needs in contraceptive product development.

When designing new contraceptive products, it is imperative to consider factors that may affect use, such as desired duration, route of administration, and side effects. This is even more pertinent for TGD AFAB populations, who may have unique and differing needs from cisgender persons. A key example of this is the role in which contraceptives play in heightening or diminishing a TGD AFAB person’s experience of gender dysphoria - distress resulting from incongruence of a person’s sex assigned at birth and gender identity. The use of contraceptive methods that present physiologic and anatomic reminders of one’s sex (such as barrier methods, like diaphragms or methods requiring intravaginal placement, like an IUD) can increase experiences of gender dysphoria and lead to discontinuation or non-use. That being said, there are also non-contraceptive attributes of some contraceptive products that could be appealing to TGD AFAB persons, such as contraceptive-induced menstrual changes that result in amenorrhea (or a pause in bleeding). Given these complexities among the variety of factors that can impact contraceptive use, it is critical that TGD AFAB persons become more centered in contraceptive product development from the beginning.

Product developers and researchers have a unique upstream opportunity to develop products with users in mind. By engaging with and including users in the development process, researchers are able to maximize the potential for impact of new and refined contraceptive products. Given the unmet need for contraception among TGD AFAB populations, it behooves product developers to begin including them in the process. There are straightforward steps product developers can take towards achieving more inclusive product development. These include:

  • use of inclusive language when developing target product profiles (TPP),

  • utilizing inclusive language for research study design and implementation, and

  • engaging TGD AFAB persons in acceptability and human centered design research.

When developing a new or refined product, the TPP acts as the roadmap, setting parameters for the development process. It is at this stage early in the development process that target users are identified. Although this may seem like a relatively benign step, if the language used to define target users is not inclusive, the likelihood of those who were excluded from the TPP being included in the R&D process is greatly reduced. Changing the language for target users (e.g., from ‘women of reproductive age’ to ‘persons with the potential to become pregnant’) is a simple step yet it changes the lens through which the product is developed and includes all those who might benefit. Similarly, using inclusive language when designing and implementing research studies is critical. Inclusive research design (e.g., using inclusive language for the study inclusion criteria) creates the opportunity for TGD AFAB populations, as well as other marginalized groups, to participate in the research process. Designing studies without inclusivity in mind from the beginning restricts the pool of potential participants.

These two steps create space for TGD AFAB populations to be included in the research process. They are, however, passive steps. Product developers can be more active in their approach by engaging with TGD AFAB populations in acceptability and human centered design research. Conducting this type of research with TGD AFAB persons allows for product developers to solicit input on contraceptive product design and take into consideration the unique needs of TGD AFAB persons. By actively engaging from the beginning, product developers create the opportunity to iteratively refine their products in a way that is responsive to the needs of all users, including TGD AFAB populations.

In addition to these steps, it is also important to empower TGD researchers and seek out active participation from the TGD community in research design and implementation. The mantra “nothing about us without us”, first popularized during the international disability rights movement, is key to remember. Research on marginalized and made-vulnerable communities should be conducted with members of those communities having an active voice in the design and implementation.

The field of reproductive health and contraception is just beginning to center the historically marginalized TGD community. It behooves contraceptive product developers to become active members in this process by conducting product development research that is inclusive of TGD AFAB persons and considers their needs. It is evident there is an unmet need for contraceptive products that are designed with TGD AFAB persons in mind, and product developers are uniquely positioned to be inclusive of the TGD AFAB population and other marginalized groups from the beginning. By taking the steps outlined above, product developers can move toward achieving a contraceptive method mix that is inclusive and responsive to the diverse needs of all potential users from the beginning.

The content of this blog post is based on a recently published perspective piece in the European Journal of Contraception and Reproductive Health Care, titled: “Contraceptive Technology Research & Development: A Call for Inclusion of Trans and Gender Diverse Individuals Assigned Female at Birth”.

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