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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

3. 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.

4. 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
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

5. 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.

6. Community Engagement and Participation

7. 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

8. Survey Flow Chart

9. 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%)

10. Resultados: factores asociados a disposición de uso de PrEP
Variable
México
AOR (95% IC)*
Conocimiento de PrEP (sí vs. no)
2.05 ( )
Compensación del riesgo (sí vs. no)
1.37 ( )
Barreras: Información (Media, D.E.) b
Barreras: Comportamiento (Media, D.E.)
0.94 ( )
Barreras: Creencias (Media, D.E.)
0.95 ( )
Facilitadores (Media, D.E.)
1.11 ( )

11. 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

12. 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.

13. 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).

14. 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.

15. PrEP Monitoring System in SICLOM
(ARV logistic system)

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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.

22. Acknowledgments
ImPrEP teams
Study participants
Thanks to our sponsors

23. Thank You !