1. PrEP uptake and associated factors among MSM and TGW in the PrEP Brasil demonstration project Brenda Hoagland, Valdilea G. Veloso, Raquel B. De Boni, José Valdez Madruga, Esper G. Kallas, Nilo Martinez Fernandes, Ronaldo I. Moreira, Albert Y. Liu and Beatriz Grinsztejn for the PrEP Brasil Study Team IAS 2015- Vancouver

2. Disclosures Research recipient from Gillead, BMS, GSK/ViiV, Merck Current or recent participation in clinical trials sponsored by GSK/ViiV, Merck, BMS, Gillead, Janssen

3. Funding Gilead Sciences. Inc. donated Truvada®

4. WHO recommends PrEP to prevent HIV

5. HIV prevalence in Brasil Kerr et al. AIDS. 2013 Veras et al. AIDS and Behavior. 2014

6. Demonstration project – Clinicaltrials.gov NCT01989611 Main Objectives – Assess uptake, safety and feasibility of PrEP implementation provided at no cost for hjgh risk MSM and TGW in the context of the Brazilian public health system Secondary objectives – PrEP awareness – Adherence pattern TDF levels in DBS – Social harm – Risk compensation – Adherence patterns PrEP Brasil

7. Method Sites Fiocruz Referral Center for HIV treatment (CRT/SP) University of São Paulo (USP) Inclusion criteria – MSM and TGW, ≥ 18 years, presenting sexual risk for HIV infection (reported ≥ 2 male condomless anal sex partners OR ≥ 2 anal sex episodes with HIV positive partner OR STD diagnosis in last 12 months) Exclusion criteria – HIV positive result, HIV acute infection, HBsAG positive, urine protein, creatinine clearence <60, using ARV, using interferon, severe medical comorbidity, unable to return within 45 days

8. Method Social and other media used for advertising the project

9. This presentation aims to describe PrEP Brasil uptake and associated factors

10. Method Approach Individuals assessed at FIOCRUZ-RJ. CRT-SP and USP-SP Fiocruz and CRT: self-referred or assessed for participation during HIV-testing or PEP USP: participants were self-referred Potentially Elegible Reported Sexual Risk ( ≥ 2 male condomless anal sex partners OR ≥ 2 anal sex episodes with HIV positive partner OR STD in last 12 months) HIV rapid test = negative Screen visit Behavior assessment HIV RNA pool Clinical assessment Renal function HBV testing +HIV testing Enrollment visit Within 45 days after screening Behavior+ clinical assessment + STD testing+ HIV testing HIV RNA pool Pre-screening visit

11. Method Statistical Analysis – PrEP uptake = proportion of enrolled individuals/potentially eligible – Chi-square tests were used to test the difference of PrEP uptake – Poisson regression model with robust estimate of variance was performed to evaluate PrEP uptake associated factors – R was used for analysis – Individuals who had used PrEP before (iPrEX and iPrEX OLE) were excluded

12. Results Refused=21 Ineligible (n=188) N=106 w/out sexual risk N=82 HIV positive RefusedN=19 Unable to return within 45 days 18 Unknown1 IneligibleN=13 HIV positive result3 Severe medical comorbidity 4 Creatinine clearence <60mL/min 1 Unable to provide contact 1 HBsAG positive1 Urine protein3 Approached N=986 Potentially elegible N=798 Screen visit N=490 Enrollment visit N=422 Enrolled N=409 Reason for refusalN= 21 Dont have time6 Fear side effects6 Prefer other prevention methods 4 Worry with my privacy 2 Dont want take medication 2 Dont want to answer1 RefusedN=1 2 Reason for refusal Not interested in study 7 Dont have time3 Dont want to answer1 Other1 IneligibleN=1 Severe medical comorbidity 1 Did not show up N=287 Did not show up N=36 RefusedN=12 Reason for refusal Not interested in study7 Dont have time3 Dont want to answer1 Other1

13. Uptake Approached N=986 Potentially elegible N=798 Screened N=490 Enrolled N=409 % uptake= # Enrolled *100 # Potentially eligible 51.25%

14. Characteristics and PrEP uptake Approached N(%) Potentially Eligible N(%) Enrolled N(%) Declined N(%) PrEP uptake p- value* Overall98679840936551.25 Site location<0.001 FIOCRUZ622 (63.1)455 (57.0)175 (42.8)282 (77.3)38.5 CRT-SP225 (22.8)216 (27.1)135 (33.0)57 (15.6)62.5 USP-SP139 (14.1)127 (15.9)99 (24.2)26 (7.1)78.0 Age0.26 18-25 years335 (34.0)266 (33.3)127 (31.0)128 (35.1)47.7 26-35 years435 (44.1)358 (44.9)189 (46.2)165 (45.2)52.8 36-45 years160 (16.2)124 (15.5)62 (15.2)57 (15.6)50 >45 years56 (5.7)50 (6.3)31 (7.6)15 (4.1)62 Gender0.06 Male942 (95.5)762 (95.5)385(94.1)351(96.2)50.5 TGW44 (4.5)36 (4.5)24 (5.9)14 (3.8)66.7 Color/Race0.05 White455 (46.1)399 (50)219 (53.6)161 (44.1)54.9 Non-white531 (53.9)399 (50)190 (46.4)204 (55.9)47.6 Schooling0.06 <12 years89 (9.0)66 (8.3)26 (6.4)42 (11.5)39.4 ≥12 years897 (91.0)732 (91.7)383 (93.6)323 (88.5)52.3 Steady partner<0.001 Yes472 (47.9)385 (48.3)223 (54.5)149 (40.8)57.9 No514 (52.1)413 (51.7)186 (45.5)216 (59.2)45.0 *chi-square for bivariate analyses

15. Characteristics and PrEP uptake(cont.) Approached N(%) Potentially Eligible N(%) Enrolled N(%) Declined N(%) PrEP uptake p-value Perceived likelihood of getting HIV in the next year<0.001 0-25% 569 (57.7)437 (54.8)189 (46.2)237 (64.9)43.2 50-100% 417 (42.3)361 (45.2)220 (53.8)128 (35.1)60.9 Previous HIV test (12 months) <0.001 Yes 657 (66.6)575 (72.1)334 (81.7)219 (60)58.1 No 329 (33.4)223 (27.9)75 (18.3)146 (40)33.6 Prior PrEP awareness <0.001 Yes 594 (60.4)498 (62.6)296 (72.5)183 (50.4)59.4 No 389 (39.6)297 (37.4)112 (27.5)180 (49.6)37.7 # Male condomless anal sex partners (last 12 months) <0.001 <2 512 (51.9)370 (46.4)143 (35)222 (60.8)38.6 2 or more 474 (48.1)428 (53.6)266 (65)143 (39.2)62.1 Anal sex with HIV-positive partners(12 months) <0.001 Yes 346 (35.1)324 (40.6)208 (50.9)104 (28.5)64.2 No 211 (21.4)87 (10.9)41 (10.0)44 (12.0)47.1 I do not know 429 (43.5)387 (48.5)160 (39.1)217 (59.5)41.3 History of STD diagnosis (12 months)0.01 Yes 138 (14)128 (16)79 (19.3)39 (10.7)61.7 No 848 (86)670 (84)330 (80.7)326 (89.3)49.2 *chi-square for bivariate analyses

16. Predictors of uptake aOR95%CIp-value Age (per year increase) 1.011.001.010.11 Schooling 12 years 0.950.701.290.74 Site CRT-SP vs. FIOCRUZ 1.221.041.440.02 USP-SP vs. FIOCRUZ 1.691.451.98<0.01 Steady partner Yes vs. No 1.211.051.390.01 Gender TGW vs. Male 1.641.302.08<0.01 Perceived likelihood of getting HIV on the next year 50-100% vs. 0-25% 1.171.031.330.01 Previous HIV test (last 12 months) Yes vs. No 1.231.021.490.03 Prior PrEP awareness Yes vs. No 1.301.111.52<0.01 # Male condomless anal sex partners (last 12 months) 2 or more vs. < 2 1.771.532.04<0.01 Anal sex with HIV-positive partners(12 months) Yes vs. No 1.401.101.780.01 I do not know vs. No 0.890.701.120.31

17. Conclusions In this first PrEP demonstration project for MSM and TGW without prior PrEP experience in a middle-income country, PrEP uptake was high. Interest on PrEP was high in the MSM community. Targeted Trans community education activities and a Trans friendly environment can play a major role in getting Trans people to access PrEP services. The higher uptake among those at higher risk and prior PrEP awareness emphasizes the importance of establishing strategies to improve HIV risk perception and PrEP awareness in the MSM and TGW communities in Brasil.

18. Acknowlegdments All study participants Sponsors Gilead Study team Sites personell Arco Íris Rio de Janeiro and Sao Paulo States AIDS Programs Stephanie Cohen -UCSF