July 11, 2014
Male-to-female transgender women (TGW) are the most affected by the HIV/AIDS epidemic. However, little data have been generated on the efficacy of new HIV prevention technologies in this community, and concerns have been raised regarding the participation of TGW in HIV prevention research. I want to share some reflections, based on my experience planning and organizing community education, recruitment and retention of men who have sex with men (MSM) and TGW in HIV/AIDS research in Peru, Ecuador and the U.S. for the past 14 years. I will also try to provide an explanation of why TGW do not participate in HIV prevention research, and recommendations to improve participation.
There has been a lot of theorizing about sexuality, gender and sexual orientation in the past several decades. However, these discussions have not necessarily been incorporated into the training curriculum of health care providers.
The term transgender was defined in 2007 to describe a range of individuals who have a different sex, gender identity, and/or gender expression than the one assigned to them at birth. Research done before that time had several categories to collect sexual behavior data. In Peru, we used these categories before 2011:
Thus, most of the data reported on TGW have been described under the transvestite category.
Health care providers should be trained in sex, sexuality and gender issues. Data collection instruments should incorporate sexual orientation and gender identity, as recommended elsewhere.
Observational studies and clinical trials describe factors affecting the vulnerability of TGW's health, but sample sizes of TGW are not large enough to provide statistically significant conclusions.
Participation of TGW in HIV/AIDS research in Peru has roughly reached 15% in sentinel surveillance, observational cohort studies and HIV prevention trials. Other studies report modest enrollment of TGW or do not report the proportion of TGW participants at all. TGW were not considered at the time of estimating the sample calculations to allocate a representative sample to arrive at definitive conclusions.
Researchers should consider TGW in the calculation of the study sample size to arrive at statistically significant conclusions about TGW participants in the studies.
Most studies on MSM consider TGW as a variant of the male-male sexual behavior and not as a gender identity. Protocol titles and inclusion criteria mention "men" or "men who have sex with men," which excludes people who might have a different gender identity.
Research protocols should include TGW in the title and as a part of the inclusion criteria. Study procedures should be adapted to the needs of participants who identify as TGW. Investigators should include TGW from the beginning of the trial design process in order to have a better understanding on how to address their requirements and needs.
Accessibility and distance from the research site are barriers to participation in research for some TGW who live far from the research facility. Some TGW work late at night or overnight, making it difficult for them to keep track of their study appointments.
In addition, most TGW are affected by housing problems and are constantly moving, and their phone numbers frequently change due to lost or stolen phones.
Finally, researchers need to prevent participants from becoming lost to follow-up because it would affect the analysis of the data. So enrollment strategies need to consider the potential mobility of participants and exclude those more likely to be hard to follow.
Research sites should be accessible from where TGW live or work and should have special hours of operation for them.
HIV prevalence among TGW is high. HIV prevention trials require HIV-negative participants. Most TGW screen out due to their HIV status.
Participation in clinical research requires application of informed consent, rigorous data collection, blood draws, exams, interviews, reports, etc., that take a long time during the study visits. All of this requires commitments that participants are not willing to make.
Some TGW may feel that they will not benefit from the intervention even if it were successful because they have had experiences of marginalization in health services due to their gender identity, so participating in research will not make a difference.
Researchers should optimize study procedures and reduce the burden on participants' time. They should work with the ethics committee and the community advisory board to write simpler, easier-to-fill-out informed consents. Clinicians and counselors should work with TGW to address self-esteem issues. Finally, researchers should make sure that study participants benefit from the intervention after the trial is over.
These are not the only factors affecting the participation of TGW in research, but are, from my experience, the most relevant ones.
I want to take this opportunity to express my gratitude to Maricielo Peña and Jana Villayzan, trans activists and leaders from Lima, Peru, for their input on the first draft of this text.