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This presentation shares the findings and results of the ImPrEP project, which aimed to assess the uptake, acceptability, and feasibility of same-day PrEP for MSM and TGW in Brazil, Peru, and Mexico. The project also evaluated the effectiveness of using HIV self-testing to increase demand for HIV combination prevention among high-risk populations.
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The ImPrEP Experience Valdilea G. Veloso @Valdilea Share your thoughts on this presentation with #IAS2019
HIV epidemic in Latin America In 2016, 860,000 people livingwith HIV. 48,000 new infectionsper year. 6.1M+ 2.1M – 6.1M 1.6M – 2.1M < 1.6M No data UNAIDS Estimates 2017
WHO on HIV Pre-exposure prophylaxis (PrEP) 2018 WHO PrEP implementation tool. Update on adolescents and M&E. 2017 • PrEP drugs oEML • (TDF/FTC; TDF/3TC; TDF); • WHO PrEP Implementation tool • Global PrEP Coalition 2015 PrEP for people at substantial HIV risk (≈3 per 100 person years) (strong recommendation) 2014 PrEP for MSM (strong recommendation) Other KP (conditional) WHO PrEP implementation tool – an enabling document 2012 PrEP for SDC, MSM and TG in the context of demo projects (conditional recommendation) http://www.who.int/hiv/pub/prep/en/
PrEParedness for the Rollout of Effective HIVPrevention among Key Affected Populations inBrazil, 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
B. Online Survey - Among MSM and TGW Completed • Total of 43,687 MSM startedand19,457 completedthequestionnaire(11,043 in Brazil; 2,037 in Peru; 6,779 in Mexico) • 03 posterspresentedat CROI 2019 (awarenessofPrEP, barriers for PrEP use; willingnessto use HIV self-testing) • 01 articlesubmittedtopublication • Online surveyamong TGW deployedby May 2018 in Brazil, Peru, andMexico. 319 valid responses. Data hasnotbeenanalyzedyet • New online surveyonlongacting, implantables, STI and HIV Self-Test
C. HIV self-testing to increase combination prevention demand in the ImPrEP project • MAIN OBJECTIVE: To evaluate the feasibility and effectivenessof HIVST secondary distribution by individuals using PrEP in increasing demand for HIV combination preventionamong 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 + ControlArm InterventionArm
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
Demonstration/ImprementationStudy • 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 • 30 DAYS • QUARTELY • ENROLLMENT • Behaviour assessment • Signsandsymptoms for HIV acute viral infection assessment • HIV Rapid Test • HIV Viral Load • Renal Function • Shyphilis ; hepatitis B and C tests; anal swabs for chlamydiaandghonorhea • 30 tablets of TDF / FTC • Adverse eventsevaluation • Signsandsymptoms for HIV acute viral infection • Sexual behavior assessment • Adherence Self report for thelast 30 days • HIV rapidtestandsyphilisserology • Renal function • DBS collection (twice per year) • 90 tablets of TDF / FTC • 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
PrEPMonitoring System in SICLOM (ARV logistic system)
Brazil – 14 sites in 12 cities EnrolledbyJune 2019 3.466
Mexico – 6 sites in 3 cities EnrolledbyJune 2019 736
Peru – 10 sites in 7 cities EnrolledbyJune 2019 736
Acknowledgments ImPrEPteams Studyparticipants Thankstooursponsors