20th International AIDS Conference - Melbourne, Australia


LBPE24 - Poster Exhibition

Inclusion of transgender persons in pre-exposure prophylaxis (PrEP) research: a review

D.J. Escudero1, T. Kerr2, D. Operario1, M.E. Socias3, O. Sued3, B.D. Marshall1

1Brown University, Providence, United States, 2British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada, 3Fundación Huésped, Buenos Aires, Argentina

Background: Pre-exposure prophylaxis (PrEP) has been found to be efficacious in preventing HIV acquisition among several high-risk populations, including men who have sex with men (MSM), serodiscordant couples, and people who inject drugs. Although PrEP trial results have spurred recommendations for the use of PrEP among these high-risk groups, research involving (and specific recommendations for) transgender populations have been largely absent, despite the fact that many transgender individuals are at increased risk of HIV acquisition. We conducted this review to assess the extent to which transgender persons have been eligible for and included in previously conducted PrEP efficacy trials, and to determine the potential for sub-groups analyses in this population.
Methods: We reviewed all published results from PrEP trials that included an analysis of oral PrEP (i.e., tenofovir or tenofovir/emtricitabine). The online clinical trial registry, www.clinicaltrials.gov, was used where appropriate to supplement published information. For incomplete or halted trials, available descriptions of study enrollment criteria were used to determine inclusion of transgender persons in these studies. When information was not available, attempts were made to contact the study corresponding author.
Results: Despite identification of seven trials analyzing efficacy for combinations of oral PrEP, only one trial was confirmed to have enrolled transgender participants. This study (iPrex) was a multinational PrEP trial involving 2499 MSM and transgender women, 29 (1.2%) of whom were reported to identify as transgender at baseline. The other six eligible trials did not report any enrollment of transgender persons. Based on the small number of transgendered individuals identified as participating in these trials, sub-group efficacy analysis was not deemed feasible.
Conclusions: Inclusion of transgender persons in PrEP trials has been minimal. Given the growing evidence of PrEP efficacy in MSM and other populations, a specific efficacy trial for transgender persons may not be needed. We do recommend, however, that in order to ensure optimal uptake of PrEP among transgender individuals, efforts should be made to include this population in acceptability, implementation, and evaluation studies. Such studies will be critical to informing clinical, programmatic and policy decisions regarding the use of PrEP in transgender populations.

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