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. Author manuscript; available in PMC: 2024 Mar 1.
Published in final edited form as: Clin Pharmacol Ther. 2022 Dec 21;113(3):557–564. doi: 10.1002/cpt.2801

Table 1.

Summary of Phase 3 clinical trials in HIV pharmacologic prevention interventions inclusive of transgender women, transgender men, or nonbinary people

iPrEx (36, 37) DISCOVER (44) HPTN 083 (48) PURPOSE-2 (52)
Countries Peru, Ecuador, Thailand, Brazil, South Africa, US Austria, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, the UK, Canada, and US Argentina, Brazil, Peru, South Africa, Thailand, Vietnam, US Brazil, Peru, South Africa, US
Intervention(s) Daily oral FDC F/TDF vs. placebo Daily oral FDC F/TAF vs. F/TDF Oral/injectable CAB (oral lead-in) vs. F/TDF Oral/injectable LEN (oral lead-in) vs. F/TDF
% TGD people in study population (total enrolled population) 14% (2599) – transgender women only 1% (5387) – transgender women only 12.5% (4566) – transgender women only 20% (3000) – transgender women (transgender men and nonbinary people eligible)
Enriched for TGD people? No No Yes Yes

Abbreviations: CAB, cabotegravir; FDC, fixed-dose combination; F/TAF, emtricitabine/tenofovir alafenamide fumarate; F/TDF, emtricitabine/tenofovir disoproxil fumarate; LEN, lenacapavir; TGD, transgender and gender diverse; UK, United Kingdom; US, United States