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. Author manuscript; available in PMC: 2022 Feb 12.
Published in final edited form as: N Engl J Med. 2021 Aug 12;385(7):595–608. doi: 10.1056/NEJMoa2101016

Table 1.

Demographic and Clinical Characteristics of the Participants at Baseline.*

Characteristic Overall (N = 4566) Cabotegravir Group (N = 2282) TDF-FTC Group (N = 2284)
Cohort — no. (%)
 MSM 3992 (87.4) 2013 (88.2) 1979 (86.6)
 Transgender women who have sex with men 570 (12.5) 266 (11.7) 304 (13.3)
 Participant preferred not to answer 4 (0.1) 3 (0.1) 1 (<0.1)
Age category — no. (%)
 18–29yr 3080 (67.5) 1572 (68.9) 1508 (66.0)
 30–39yr 1048 (23.0) 498 (21.8) 550 (24.1)
 40–49 yr 315 (6.9) 145 (6.4) 170 (7.4)
 50–59yr 110 (2.4) 60 (2.6) 50 (2.2)
 ≥60 yr 13 (0.3) 7 (0.3) 6 (0.3)
Median age (IQR) — yr 26 (22–32) 26 (22–32) 26 (22–32)
Latinx or Hispanic ethnic group, according to geographic region — no./total no. (%)
 United States
  Yes 303/1698 (17.8) 149/849 (17.6) 154/849 (18.1)
  No 1394/1698 (82.1) 700/849 (82.4) 694/849 (81.7)
  Data missing 1/1698 (<0.1) 0 1/849 (0.1)
 Latin America
  Yes 1806/1964 (92.0) 894/980 (91.2) 912/984 (92.7)
  No 158/1964 (8.0) 86/980 (8.8) 72/984 (7.3)
SexPro score, according to geographic region — no./total no. (%)
 United States
  ≤16 1447/1698 (85.2) 729/849 (85.9) 718/849 (84.6)
  >16 251/1698 (14.8) 120/849 (14.1) 131/849 (15.4)
 Latin America
  ≤16 1675/1964 (85.3) 825/980 (84.2) 850/984 (86.4)
  >16 289/1964 (14.7) 155/980 (15.8) 134/984 (13.6)
Geographic region — no. (%)
 United States 1698 (37.2) 849 (37.2) 849 (37.2)
 Latin America
  Argentina 337 (7.4) 169 (7.4) 168 (7.4)
  Brazil 796 (17.4) 395 (17.3) 401 (17.6)
  Peru 831 (18.2) 416 (18.2) 415 (18.2)
 Asia
  Thailand 553 (12.1) 275 (12.1) 278 (12.2)
  Vietnam 199 (4.4) 100 (4.4) 99 (4.3)
 Africa 152 (3.3) 78 (3.4) 74 (3.2)
Race, according to geographic region — no./total no. (%)
 United States
  Black 845/1698 (49.8) 411/849 (48.4) 434/849 (51.1)
  Non-Black 851/1698 (50.1) 437/849 (51.5) 414/849 (48.8)
  Data missing 2/1698 (0.1) 1/849 (0.1) 1/849 (0.1)
 Latin America
  Black or mixed 392/1964 (20.0) 198/980 (20.2) 194/984 (19.7)
  Indigenous 862/1964 (43.9) 435/980 (44.4) 427/984 (43.4)
  Asian 8/1964 (0.4) 6/980 (0.6) 2/984 (0.2)
  White 659/1964 (33.6) 319/980 (32.6) 340/984 (34.6)
  Other 43/1964 (2.2) 22/980 (2.2) 21/984 (2.1)
 Asia
  Asian 749/752 (99.6) 374/375 (99.7) 375/377 (99.5)
  Other 3/752 (0.4) 1/375 (0.3) 2/377 (0.5)
 Africa
  Black 119/152 (78.3) 62/78 (79.5) 57/74 (77.0)
  Other 5/152 (3.3) 2/78 (2.6) 3/74 (4.1)
  Mixed 28/152 (18.4) 14/78 (17.9) 14/74 (18.9)
Marital status — no. (%)
 Married, civil union, or legal partnership 177 (3.9) 79 (3.5) 98 (4.3)
 Living with primary or main partner 292 (6.4) 138 (6) 154 (6.7)
 Have primary or main partner, not living together 335 (7.3) 171 (7.5) 164 (7.2)
 Single, divorced, or widowed 3751 (82.2) 1888 (82.7) 1863 (81.6)
 Other 11 (0.2) 6 (0.3) 5 (0.2)
Educational level — no. (%)
 No schooling 8 (0.2) 2 (0.1) 6 (0.3)
 Primary school 70 (1.5) 28 (1.2) 42 (1.8)
 Secondary school 1012 (22.2) 490 (21.5) 522 (22.9)
 Technical training 375 (8.2) 187 (8.2) 188 (8.2)
 College or university or higher 3101 (67.9) 1575 (69.0) 1526 (66.8)
*

Percentages may not sum to 100 because of rounding. IQR denotes interquartile range, MSM men who have sex with men, and TDF–FTC tenofovir disoproxil fumarate–emtricitabine.

Race and ethnic group were reported by the participant.

SexPro is a Web-based tool that provides a sexual health promotion score. It is validated to predict the 6-month risk of HIV acquisition on the basis of sexual behaviors, sexual networks, substance use, history of sexually transmitted infections, race or ethnic group (United States only), and age. Additional background on the SexPro tool is provided in the protocol. Scores range from 1 to 20, with higher scores indicating a lower risk of acquiring HIV infection.