1. An overview of PrEP trials Bea Vuylsteke Institute of tropical Medicine, Antwerp, Belgium Marrakech, IUSTI 2016

3. Clinical Trials: Protective effect varies

4. 4 PrEP around sex “event-driven” does it work? 24 H 2-24 H Protection 86% Molina, 2015

6. High concentration of TDF in rectal tissue

7. > 3 per 100 years

8. Remaining questions

9. AVAC

10. ONGOING DEMONSTRATION PROJECTS WITH ORAL PREP IN AFRICA

11. PrEP demonstration projects and implementation studies in Africa Senegal, SW Benin, SW Mozambique, miners wives Zimbabwe, SW South Africa: SW, MSM Botswana, heterosexual men + women Kenya: SW, MSM, Young women, SDC Uganda, SDC Nigeria, SDC

12. PrEP demonstration projects: common elements PrEP integrated in a combination prevention strategy Daily, oral Truvada Study design: single group assignment, open label Objective: feasibility, uptake, adherence

13. PrEP demonstration projects targeting FSW BeninSenegalSouth AfricaZimbabweKenya Name Study Benin Demo. Project Senegal Demo. ProjectTAPS Demo.SAPPH-ire LVCT Health and SWOP Kenya Site(s)CotonouDakarPretoria, Hilbrow 7 highway sites Nairobi Target N25015004001000-15002100 (*) Start dateOct 2014July 2015April 2015July 2014July 2015 Expected completion Jan 2017Late 2016April 2017Mid 2016Dec 2016 * FSW, MSM, young women at high risk

14. PrEP demonstration projects targeting MSM South Africa Kenya Name Study Sibanye Health Project Health4Men Initiative LVCT Health and SWOP Kenya Site(s)Cape Town & Port Elisabeth Cape TownNairobi Target N2003002100 (*) Start dateFeb 2015Dec 2015July 2015 Expected completion May 2016?Dec 2016 * FSW, MSM, young women at high risk Other studies planned: Coh-MSM in Mali, Burkina Faso, Côte d’Ivoire and Togo Other studies planned: Coh-MSM in Mali, Burkina Faso, Côte d’Ivoire and Togo

15. PrEP demonstration projects targeting serodiscordant couples NigeriaKenya & Uganda Name Study Nigerian National Agency for the Control of AIDS Partners Demonstration Project Target N1200 couples1000 couples Start dateLate 2015 Expected completion Late 20172016

16. Mugo, CROI 2016

17. PrEP demonstration projects targeting adolescents and young women South AfricaSouth Africa Kenya KenyaSouth Africa Name Study CAPRISA 082POWERMP3-YouthCHAMPS SpecificsOnly females on PrEP 3 pilots, incl PrEP “Pluspills” Target popAdolescent girls (18-24) & women (25-30) Adolescent girls (16-24) & women (25-30) Adolescent men & women (15-24) Adolescent men & women (15-19) Start dateMarch 2016July 2015Nov 2014 Expected completion April 2021June 2020Nov 2016Oct 2016 Other studies planned: HPTN 082 in South Africa & Zimbabwe; EMPOWER in South Africa & Tanzania; IMPAACT in Zimbawe Other studies planned: HPTN 082 in South Africa & Zimbabwe; EMPOWER in South Africa & Tanzania; IMPAACT in Zimbawe

18. Seasonal use of PrEP in Mozambique Cremin, 2015

19. OTHER PRESENTATIONS OF PREP

20. Delivery systems PrEP AVAC Infogram

21. ASPIRERing study Overall HIV reduction 27%31% > 21 yrs 56%37% J. Baeten, A. Nel, CROI 2016

22. South Africa (2 sites), Uganda, Zimbabwe N=300 Objectives: safety, adherence Nair, 2015

24. MDP 401 A pragmatic randomized open-label wait-listed trial to evaluate the effectiveness of tenofovir (PrEP) to reduce the risk of HIV acquisition among women at high risk of HIV in Mozambique, Rwanda, Tanzania and Uganda.

25. MDP programme Conduct an intensive PREPARATORY STUDY to inform which of three tenofovir products to test in the clinical trial. Followed by an open-label wait-listed randomised CLINICAL TRIAL designed to evaluate the preferred tenofovir product whereby women are randomised to receive the product immediately or after a deferred period of 12 months.

26. MDP 401 Preparatory Study: Randomised cross over design 2 months per Tenofovir product HIV, STI and pregnancy testing at enrolment 2 monthly HIV testing Monthly self-reported adherence (non-use) Weekly vaginal swabs – PK evaluation Product counts 100 Key Informants women at high risk Gel TableRing Monthly Participatory Action Research (PAR) workshops Tablet Ring Gel Ring GelTablet Steering Committee Review: Product preference Adherence data (SR, PK, counts) Relevant new evidence National implementation priorities Preferred Tenofovir product to evaluate in the MDP 401 clinical trial Develop risk-adherence assessment tool (BMQ-P) Develop study material

27. Conclusions Proven efficacy of PrEP in clinical trials is only the first step Remaining questions about feasibility and adherence to be answered Africa plays an important role in PrEP demonstration projects