1. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Comparison of Adherence among Partners’ PrEP Participants on Placebo before and after Release of Trial Results – Kisumu, Kenya B. Wamuti, J. Odoyo, B. Rono, C. Cohen, E. Bukusi Kenya Medical Research Institute University of Washington University of California, San Franscisco

2. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence crucial for success of any clinical drug trial and/or treatment Effective HIV treatment and prevention requires good compliance to medication Reduction of HIV acquisition by the HIV negative individual: PrEP PrEP studies with high adherence show greater efficacy in reduction of transmission Adherence has been the key issue with PrEP INTRODUCTION

3. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Partners’ PrEP Kisumu site INTRODUCTION

4. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 3 arms: Tenofovir, Tenofovir/Emtricitabine (Truvada) and placebo Kisumu participants: 630 HIV sero-discordant couples HIV –ve partner: Randomized to PrEP HIV +ve partner: Not eligible for HAART at enrolment INTRODUCTION

5. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Definition: Compliance to once-a-day dose of PrEP Assessed by pill count Blood drug levels not available Strategies to improve adherence 1.Monthly adherence counseling: By nurse counselor, clinician, pharmacist and social worker 2.Pill reminders ADHERENCE

6. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 July 2011: Release of the preliminary results by the Data Safety Monitoring Board (DSMB) Reduction of HIV transmission 63% (Tenofovir), 75% (Truvada) Recommended re-assignment of placebo participants to active arms BACKGROUND

7. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 BACKGROUND Tenofovir arm Truvada arm Placebo arm 2011: Re-assignment as per DSMB recommendation 20082008 20122012 Tenofovir/Truvada Study start Study close-out

8. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 To compare adherence to the study medication before and after release of the preliminary results of the clinical trial among PrEP participants on placebo OBJECTIVE

9. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Compared adherence at month 1, 6 and 12 before and after re-randomization Reviewed by pill counts Blood drug levels not yet available METHODS

10. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Challenges to adherence: “If I am not sick, aren’t these drugs just accumulating in my system?” Source: http://theplantpaper.wordpress.com/category/features/page/2/ METHODS

11. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence counseling http://irma-rectalmicrobicides.blogspot.com/2011_04_01_archive.html METHODS

12. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Pill reminders http://www.elderdepot.com/catalog/product_1617_7Sided_Weekly_Pill_Reminder.html METHODS

13. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Placebo participant numbers 45 clients not reassigned RESULTS TIME PERIODNo. of participantsPercentage At start of the study (2008)210100% At placebo stop (July 2011)19894.2% At re-enrolment (Sep 2011)15377.3%

14. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Reasons for not being reassigned *Jailed, abnormal renal function, abnormal liver function RESULTS Reasons for IneligibilityNumber Declined participation25 Pregnant4 Not located8 Sero-converted1 Other reasons*10

15. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Adherence levels RESULTS Visit MonthAdherence Before Re- randomization Adherence After Re- randomization P-Value 196% 0.816 696%97%0.104 1295% 0.822

16. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 High adherence reported before and after re- randomization Likely resulted from intensive, ongoing adherence counselling Possibly also from focus on sero-discordant couples Adherence results from this study are encouraging DISCUSSION

17. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Develop intensive, cost-effective counselling curricula that result in excellent adherence PrEP demonstration projects - way forward RECOMMENDATION

18. www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 ACKNOWLEDGEMENTS 1.Partners‘ PrEP Kisumu study participants, site staff 2.Kenya Medical Research Institute – Research Care and Training Program 3.University of Washington, USA 4.University of California San Franscisco, USA 5.Gilead (study drug) 6.Bill and Melinda Gates Foundation (study funder)