Share your thoughts on this presentation with #IAS2019 The ImPrEP Experience Valdilea G. Veloso @Valdilea Good afternoon. I am Valdilea Veloso and it is my great pleasure to present to you initial results of the ImPrEP Study, a demonstration project of same day PrEP initiation among MSM and TGW in Brazil, Mexico and Peru. . In particular, I will be presenting data on safety, early continuation, adherence and HIV incidence. This study is being funded by Unitaid with the support of each country Ministry of Health. Share your thoughts on this presentation with #IAS2019

48,000 new infections per year. HIV epidemic in Latin America In 2016, 860,000 people living with HIV. 48,000 new infections per year. 6.1M+ 2.1M – 6.1M 1.6M – 2.1M < 1.6M No data UNAIDS Estimates 2017 The HIV epidemic in Latin America persists unabated among men who have sex with men (MSM) and transgender women (TGW). PrEP implementation in the region has been very limited. Same day PrEP initiation can increase PrEP uptake where access to services for key populations is scarce.

WHO on HIV Pre-exposure prophylaxis (PrEP) 2012 PrEP for SDC, MSM and TG in the context of demo projects (conditional recommendation) WHO PrEP implementation tool – an enabling document http://www.who.int/hiv/pub/prep/en/ 2014 PrEP for MSM (strong recommendation) Other KP (conditional) 2015 PrEP for people at substantial HIV risk (≈3 per 100 person years) (strong recommendation) 2017 PrEP drugs oEML (TDF/FTC; TDF/3TC; TDF); WHO PrEP Implementation tool Global PrEP Coalition 2018 WHO PrEP implementation tool. Update on adolescents and M&E. Despite the concentrated epidemic among key populations predominantly MSM and TGW, Pre-exposure prophylaxis (PrEP) implementation in the region has been very limited

PrEParedness for the Rollout of Effective HIV Prevention among Key Affected Populations in Brazil, Peru and Mexico Objective: assess uptake, acceptability and feasibility of same day PrEP (TDF/FTC orally once a day) for MSM and TGW in the context of HIV combination prevention. Design: multi-site prospective, open-label demonstration/implementation study, daily oral PrEP. Countries: Brazil (Fiocruz - Coordination), Peru and Mexico. Population: 7500 MSM/TGW (Brazil: 3,000; Mexico: 3,000; Peru: 1,500). Sites: Public Health services and NGOs. Regional Exchange Platform on PrEP Working Group on Drug Licensing and Costing Substudies (seroincidence, economic and mathematical modelling studies, etc). Brazil: 14 sites in 12 cities Mexico: 6 sites in 3 cities Peru: 10 sites in 7 cities Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Community Engagement and Participation

B. Online Survey - Among MSM and TGW Completed Total of 43,687 MSM started and 19,457 completed the questionnaire (11,043 in Brazil; 2,037 in Peru; 6,779 in Mexico) 03 posters presented at CROI 2019 (awareness of PrEP, barriers for PrEP use; willingness to use HIV self-testing) 01 article submitted to publication Online survey among TGW deployed by May 2018 in Brazil, Peru, and Mexico. 319 valid responses. Data has not been analyzed yet New online survey on long acting, implantables, STI and HIV Self-Test

Survey Flow Chart

Resultados: Disposición a PrEP, barreras y facilitadores Variable Brasil México Perú Total p Conocimiento de PrEP 7794 (68.8%) 3796 (64.1%) 1002 (46.6%) 12592 (64.9%) <0.001 Uso previo de PrEP (nunca) 10875 (95.7%) 5735 (97.0%) 2075 (96.8%) 18685 (96.2%) Disposición a usar PrEP 7099 (62.5%) 4158 (70.1%) 1241 (57.6%) 12498 (64.2%) Compensación de riesgo 2325 (20.5%) 1380 (23.3%) 543 (25.2%) 4248 (21.8%) Uso de PrEP si fuera público 5814 (51.2%) 4113 (69.3%) 1165 (54.0%) 11092 (57.0%) Preferencia de tipo de PrEP Oral diario 3802 (33.5%) 2260 (37.9%) 719 (33.4%) 6771 (34.8%) A demanda 2494 (21.9%) 1491 (25.1%) 553 (25.7%) 4538 (23.3%) Inyectable 5071 (44.6%) 2193 (37.0%) 884 (41.0%) 8148 (41.9%) Barreras para uso de PrEP (Información) Temor de efectos a corto plazo 6805 (59.9%) 4126 (69.5%) 1614 (74.9%) 12545 (64.5%) Temor de efectos a largo plazo 7601 (66.9%) 4601 (77.5%) 1721 (79.8%) 13923 (71.6%) Temor a ineficacia de TARAA 6522 (57.4%) 5031 (84.8%) 1810 (84.0%) 13363 (68.7%) Temor a no estar 100% protegido 7831 (68.9%) 4900 (82.6%) 1794 (83.2%) 14525 (74.7%)

Resultados: factores asociados a disposición de uso de PrEP Variable México AOR (95% IC)* Conocimiento de PrEP (sí vs. no) 2.05 (1.79-2.34) Compensación del riesgo (sí vs. no) 1.37 (1.17-1.59) Barreras: Información (Media, D.E.) b Barreras: Comportamiento (Media, D.E.) 0.94 (0.92-0.95) Barreras: Creencias (Media, D.E.) 0.95 (0.93-0.97) Facilitadores (Media, D.E.) 1.11 (1.09-1.12)

C. HIV self-testing to increase combination prevention demand in the ImPrEP project MAIN OBJECTIVE: To evaluate the feasibility and effectiveness of HIVST secondary distribution by individuals using PrEP in increasing demand for HIV combination prevention among high risk MSM and TGW DESIGN: Adaptative randomized trial in Lima and Rio de Janeiro INTERVENTION: MSM/TGW enrolled to ImPrEP will be 1:1 randomized to receive 5 HIVST+voucher or 5 vouchers alone to distribute into their MSM/TGW network + Intervention Arm Control Arm

Demonstration/implementation Study, Brasil, Mexico, Peru Objective: assess uptake, acceptability and feasibility of same day PrEP (TDF/FTC orally once a day) for MSM and TGW in the context of HIV combination prevention. Design: multi-site prospective, open-label demonstration/implementation study, daily oral PrEP. Countries: Brazil (Fiocruz - Coordination), Peru and Mexico. Population: 7500 MSM/TGW (Brazil: 3,000; Mexico: 3,000; Peru: 1,500). Sites: Public Health services and NGOs. Brazil: 14 sites in 12 cities Mexico: 6 sites in 3 cities Peru: 10 sites in 7 cities Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Demonstration/Imprementation Study Main outcomes were: PrEP early continuation defined as attendance to the first 2 follow-up visits within 120 days of PrEP initiation PrEP adherence, measured using pharmacy refill data defined as having at least 16 days of PrEP medication filled per 30-day period (medication possession ratio ≥0.53).

Study procedures by visitas ENROLLMENT 30 DAYS QUARTELY Adverse events evaluation Signs and symptoms for HIV acute viral infection Sexual behavior assessment Adherence self report for the last 30 days Review of the exams collected at enrollment HIV Rapid Test DBS collection 90 tablets of TDF / FTC Behaviour assessment Signs and symptoms for HIV acute viral infection assessment HIV Viral Load Renal Function Shyphilis ; hepatitis B and C tests; anal swabs for chlamydia and ghonorhea 30 tablets of TDF / FTC Adherence Self report for the last 30 days HIV rapid test and syphilis serology Renal function DBS collection (twice per year) Participants were screened and enrolled on the same day and received a 30 days’ supply of TDF/FTC. Creatinine, hepatitis B, C and STI testing were performed.

PrEP Monitoring System in SICLOM (ARV logistic system)

Brazil – 14 sites in 12 cities Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Mexico – 6 sites in 3 cities Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Peru – 10 sites in 7 cities Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Brazil – 14 sites in 12 cities Enrolled by June 2019 3.466 Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Mexico – 6 sites in 3 cities Enrolled by June 2019 736 Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Peru – 10 sites in 7 cities Enrolled by June 2019 736 Eligible participants were HIV uninfected MSM and TGW ≥18 years old at high risk for HIV infection . Participants were screened and enrolled on the same day at 15 sites in Brasil 8 sites in Mexico and 10 sites in Peru and received a 30 days’ supply of TDF/FTC.

Acknowledgments ImPrEP teams Study participants Thanks to our sponsors

Thank You !