In Mexico, transphobic violence and discrimination has become generalized and is part of the social fabric, such that transwomen experience it in various spheres of their daily lives. It restricts access to services and prohibits full human development. In the development of clinical studies, Morales (2019) also noticed the problems that generate this discriminatory phenomenon, since trans people are often excluded, or their participation may have a low priority in the inclusion criteria during the recruitment phase. The scientific community continues to postpone the inclusion of the trans population and their experiences and needs, and as a consequence, there is little understanding of how this directly affects the physical and mental health of the population. As a result, it is not always possible to generate solutions to their problems.

On the other hand, when studies have appropriate inclusion criteria, the research can take the trans population into account, and they can be recruited. Now the issue of adherence to the clinical program arises: are the requirements of the study compatible with trans people’s realities? This question has arisen due to the experience we have had with trans women who enrolled in the MOSAICO Study at the Mexico City CRS, where we have witnessed the difficulties that have sometimes limited or made it impossible for them to attend protocol visits. We enrolled 10 trans women who met all the inclusion criteria and chose to join the study. They generally attended their visits in a timely manner and were quite committed to their participation, despite the fact that most of them invested more than 3 hours in transportation transfers to get to the clinic and back to their homes or workplaces afterward.

First, from the recruitment stage where screening interviews were held to verify if female candidates met the inclusion criteria, the site’s hours of operation were not compatible with the times of day the transwomen were available, because many of them engaged in sex work as their main source of income. The schedules of this job are often nocturnal, but the interviews and study visits were scheduled first thing in the morning. These participants often came to appointments using the time they would otherwise spend resting from their prior evening’s work or take care of personal matters. It was not realistic to think that good adherence to the protocol would be achieved, both because of the scheduling issues, but also because of the participants’ limited economic resources to travel to the site, located on the eastern outskirts of the city. Many of these participants lived on the northern outskirts, requiring an investment of time and money to attend their appointments. Although financial support was offered to cover travel expenses, for many the financial support offered was not enough to cover their actual expenses.

The visits to the site over the duration of the study allowed a trusting relationship to be built with the participants, and they gradually felt comfortable enough to share some aspects of their everyday lives. For example, some of them reported that they did sex work because they did not have opportunities to be employed in the field they had studied, because they were isolated in their jobs, or because they were unable to access services (because of the cost of those services). Some have felt that their gender identity or expression was being dismissed. Their sex work activities generally occur in environments where there is consumption of substances (sometimes illicit). They participate in this dynamic, prolonging their consumption, which affects their everyday activities. Toward the end of the protocol, site staff noticed the effects of this consumption among both trans and MSM participants, some of them coming to their visits under the influence of a substance.

Another situation that caught the attention of the Community and Involvement team was acts of transphobia that participants reported as occurring every day. This put retention in the study at risk and violated the dignity and humanity of the participants. Transgender participants reported being exposed to situations of discrimination in public health services, and they feared that this situation would be repeated with the staff of MOSAICO. Some participants requested that their study visits only be done with female staff members, because they feared discrimination or violence by the male members of the team like they had experienced elsewhere. Fortunately, this was addressed by making sure that participants felt as comfortable as possible, the site staff were responsive to their requests, and the site required frequent training for MOSAICO staff on the topics of sex, gender, and creating safe spaces for the LGBTQIA+ community.

This trusting relationship between the Community and Involvement team and the transwomen in the study allowed us to understand the consequences of transphobia on the mental health of the participants. Some of them reported having periods where they felt depressed or anxious, and on one occasion this made it impossible for study visits to be carried out in a timely manner, requiring them to be rescheduled. While mental health issues in general could be addressed by linking the participants to psychology and psychiatry services, in the case of the trans women only one accessed the services. A frequent reason they gave for not accepting the services was lack of time, while others commented that they would seek remedies on their own.

One of the trans participants was discontinued from the study because she suffered trans-femicide violence and requested political asylum in a foreign country. The HVTN did not have research clinics there, so her participation in the study could not be continued. It is important to note how close trans-femicide violence is, since 2 of the10 trans participants in the study experienced this type of attack on their integrity and their lives. Another participant was able to finish all her visits, but the last one had to be done outside the visit window because she received death threats and had to flee her place of residence and “disappear” for a while to stay safe. Fortunately, she was able to contact us to let us know about this situation and asked for our understanding and special support for moving from this other location to return for the last study visit. When she came to the site, she was calm because she was able to get to safety, however, she said that it is not the first time she had received death threats or been harassed because of gender.

In contrast, we asked participants about any benefits they experienced while participating in the study. They reported that being able to know the clinic was a space where they did not have to worry about being mistreated by the staff was very important. They also valued the linkages to other health services including annual vaccination campaigns, being able to contribute to clinical studies and their analysis, having access to testing for sexually transmitted infections, being able to access PEP and PrEP, and that their visits were compensated with travel allowances.

In conclusion, how can we facilitate the inclusion of trans people in clinical studies? It is evident that the financial support to cover travel expenses to the site was not enough, so it is important to consider how to better address the real needs of potential transgender participants. This unmet need made it impossible to recruit more trans women.

It is also important for clinic staff to educate themselves about how transphobia manifests in different ways in the community, and the impact it can have on the development and implementation of clinical studies. To address this situation, it is not enough to include the trans population within eligibility criteria, and it is not enough to ensure their adherence to the study visit schedule. It is essential that clinical and community personnel who are in contact with the transgender population sensitize themselves to the lived realities that trans participants face, continue to receive training, and be constantly updated about the specific needs of the population, and in particular their need for mental health services. It is recommended that the community teams continue creating spaces for coexistence and building trust; that they remain open and receptive to the experiences of visitors to the clinic; that they seek links to people, programs and services that could positively impact the lives of trans participants; and that they ensure that the clinic is a space for attentive listening.

The scientific community must make room for trans voices to be heard in order for them to be included in clinical trials and for them to have opportunities to lead research when appropriate. It is essential that trans people are included in research teams, contributing to the design, implementation, and analysis of clinical studies. Their participation should not only be as subjects of investigation. It is urgent that trans people have access to clinical studies and the results so that they can synthesize, understand, and communicate what the results mean for their own community.