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INTRODUCTION

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 . INTRODUCTION.

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INTRODUCTION

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  1. 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. INTRODUCTION 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

  3. INTRODUCTION Partners’ PrEP Kisumu site

  4. INTRODUCTION 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

  5. ADHERENCE Definition: Compliance to once-a-day dose of PrEP Assessed by pill count Blood drug levels not available Strategies to improve adherence Monthly adherence counseling: By nurse counselor, clinician, pharmacist and social worker Pill reminders

  6. BACKGROUND 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

  7. BACKGROUND Tenofovir arm 2008 2012 Truvada arm Placebo arm Tenofovir/Truvada 2011: Re-assignment as per DSMB recommendation Study start Study close-out

  8. OBJECTIVE To compare adherence to the study medication before and after release of the preliminary results of the clinical trial among PrEP participants on placebo

  9. METHODS Compared adherence at month 1, 6 and 12 before and after re-randomization Reviewed by pill counts Blood drug levels not yet available

  10. METHODS • 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/

  11. METHODS Adherence counseling http://irma-rectalmicrobicides.blogspot.com/2011_04_01_archive.html

  12. METHODS Pill reminders http://www.elderdepot.com/catalog/product_1617_7Sided_Weekly_Pill_Reminder.html

  13. RESULTS Placebo participant numbers 45 clients not reassigned

  14. RESULTS Reasons for not being reassigned *Jailed, abnormal renal function, abnormal liver function

  15. RESULTS Adherence levels

  16. DISCUSSION 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

  17. RECOMMENDATION Develop intensive, cost-effective counselling curricula that result in excellent adherence PrEP demonstration projects - way forward

  18. ACKNOWLEDGEMENTS Partners‘ PrEP Kisumu study participants, site staff Kenya Medical Research Institute – Research Care and Training Program University of Washington, USA University of California San Franscisco, USA Gilead (study drug) Bill and Melinda Gates Foundation (study funder)

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