1. Considerations for PrEP Use in Adolescents. Dr. Tajudeen Oyewale, MD, MPH, PhD. HIV Section, UNICEF New York HQ.

2. Clinical, ethical and operational considerations for the implementation of Oral Pre-Exposure Prophylaxis (PrEP) in sexually active older adolescents (aged 15-19) at high risk of HIV infection. Tajudeen Oyewale 1, Craig McClure 1, Chewe Luo 1, Catherine Richey 1, Peter Godfrey-Faussett 2, Rachel Baggaley 3, Mitchell Warren 4, Linda-Gail Bekker 5, Susan Kasedde 1, Chris Collins 2. 1 UNICEF New York, 2 UNAIDS Geneva, 3 WHO Geneva, 4 AVAC, USA, 5 Desmond Tutu Center, UCT, South Africa.

3. Acknowledgements Bill Kapogiannis (NIH, USA), Devasena Gnanashanmugam (NIH, USA), John Stover, (Avenir Health, USA), Participants at the PrEP and Adolescents Consultation in Vancouver, Canada.

4. Outline 1.Context for PrEP in Adolescents. 2.Methodology. 3.Key Considerations: a.Public Health Application. b.Legal, Ethics and Policy. c.Service Delivery. d.Demand Creation. e.Adherence and monitoring. f.Clinical. 4.Next Steps.

5. Context: The Science, The Need, The Momentum. PrEP is the use of antiretroviral medication to prevent people from acquiring HIV. Evidence: Over 10 Trials (RCTs) in different population groups aged 18 years an above indicated that the use of PrEP prevents HIV acquisition by up to 90% depending on adherence level. WHO recommends the use of Oral PrEP (containing TDF) as an additional prevention choice for populations with an HIV incidence threshold of 3% and above. Not restricted by age, race, sexual orientation and gender.

6. Estimated number of new HIV infections among children (aged 0–14), adolescents (aged 15–19), and young people (aged 20–24), 2001–2014. Source: UNAIDS 2014 HIV and AIDS estimates, July 2015. Context: The Science, The Need, The Momentum.

7. ENGAGEMENT Engage, mobilize and support adolescents as leaders and agents of social change. PROGRAMME Sharpen adolescent-specific elements of national AIDS programmes by improving data collection, analysis and use to drive programming and results. ADVOCACY Advocate and communicate at the global, regional and country level to generate political will to invest in adolescent HIV and mobilize resources. INNOVATION Foster innovation in approaches that improve the reach of services for adolescents and increase the impact of prevention, treatment and care programmes. ALL IN Context: The Science, The Need, The Momentum.

8. Methodology. Word Cloud Analysis of the Youth Panel discussion at the PrEP and Adolescent Consultation, July 2015. UNICEF led Consultation involving 58 scientists, researchers, community and development partners, and youth advocates. Presentation focused on considerations for implementation i.e. the ‘HOW TO’

9. Considerations for Public Health Application. 1.Identify and prioritize sexually active adolescents (aged 15 – 19) at substantial risk of HIV acquisition. Invest in sub-national / population based data on HIV incidence. Define context-specific characteristics of adolescents at substantial risk of HIV. 2.Estimate cost implication of delivering PrEP (Cost beneficial in population with HIV incidence of 3% and above†). 3.Ensure PrEP is offered to individuals who have the desire to use it. †Godfrey-Faussett P, et al. Estimated population of sexually active adolescents (15-19) at high risk of HIV infection in need of PrEP and cost implications presentation at PrEP and Adolescent Consultation, Vancouver, 2015

10. Legal and Ethical Considerations. 1.Legal provisions on informed consent for (i) HIV testing, (ii) access to PrEP and (iii) treatment of other consequences of PrEP. 2.Confidentiality in (i) HIV testing vis-a-vis age of consent and (ii) PrEP initiation especially where the cost of PrEP is borne by parents / adult guardians. 3.Address obligation of service providers to report adolescents who are below the legal age for sexual intercourse presenting for PrEP.

11. Policy Considerations. 1.Simplify the information on the evidence for policy makers. 2.Cost analysis and modelled impact of PrEP. 3.Address societal concerns related to PrEP use. 4.Link policy discussion on PrEP with equity & non-discrimination. 5.Knowledge management.

12. Service Delivery Considerations. Integrated Service delivery Deliver PrEP services as part of combination HIV prevention. Address drivers of HIV vulnerabilities among adolescents like early marriage, transactional sex, and hostile environment to adolescent key populations. Identify entry points such as SRH services, post-exposure prophylaxis (PEP) services and family planning clinics, pharmacies, community distribution points and youth centres. Promote community – facility linkage as part of continuum of HIV testing, PrEP use and follow up support. Link PrEP services with complementary health, protection, care and support services to provide risk reduction, optimize adherence and improve wellbeing.

13. Service Delivery Considerations. Service organization 1.Same-day initiation of PrEP to eligible adolescents (where feasible). 2.Task shifting among healthcare providers along the continuum of HIV testing, PrEP dispensing and follow up care will avoid additional burden on the health system. 3.Ensure PrEP is delivered in friendly and safe spaces by providers with the right attitude and capacities.

14. Service Delivery Considerations. Service Delivery Tools 1.Standardize risk-assessment tools for use in determining eligibility of adolescents for PrEP. The tools should be available to both care providers and adolescents. 2.Develop operational guidance on the use of HIV self-testing as a tool to simplify initiation and monitoring of PrEP use among eligible adolescents. 3.Outline protocols for follow up support to adolescents who start and stop PrEP due to the seasonality of risk of HIV acquisition.

15. Considerations for Demand Creation. 1.Messaging PrEP as positive health choices. 2.Target communication strategies to different groups / networks of adolescents in need of PrEP. 3.Engage adolescents in the design of social marketing messages & communication materials on PrEP initiation, use and adherence. 4.Standardize context-appropriate tools to monitor PrEP readiness among adolescents. E.g. in Bangkok, PrEP Readiness Index† i.e. awareness, belief & willingness to use PrEP. †Donn Colby, Thai Red Cross, Thailand. PrEP Demand Creation and Monitoring: the perspective from SE Asia presented at PrEP and Adolescent Consultation, Vancouver, 2015

16. Considerations for Adherence Support & Monitoring. Adherence Adherence support groups – physical (e.g peer groups & case care workers) and virtual (e.g. chat room). Use of technology driven reminders like sms reminders. Bio-medical monitoring e.g. drug level measurement. Monitoring Self testing. Cost of testing HIV testing and creatinine monitoring. Integration of monitoring with routine care.

17. Clinical Considerations. 1.Monitor drug safety, acceptability and patterns of use in adolescents less than 18 years. 2.Evaluate long term impact of TDF-based regimens on adolescents who undergo multiple cycles of starting and stopping PrEP. 3.Document strategies for PrEP implementation in the different sub- populations of AGYW e.g. adolescent girls who sell sex and AGYW in different settings. 4.Address ethical / legal and regulatory barriers involvement of adolescents less than 18 years in research in some setting.

18. Next Steps. 1.Need for demonstration projects to address these considerations and inform global implementation. 2.WHO Guidelines on PrEP should incorporate these considerations with specific focus on adolescents. “PrEP provides an opportunity for empowering adolescents to take control of their sexual health”. ------ youth advocates.

19. United Nations Children’s Fund 3, UN Plaza, New York, NY 10017, USA www.unicef.org © United Nations Children’s Fund November, 2015 For more information, please contact Dr. Tajudeen Oyewale Programme Specialist, HIV (Adolescents) UNICEF New York, HQ. toyewale@unicef.org

20. Five major studies demonstrated PrEP’s preventive efficacy across risk groups including adolescents age 18 and 19 # Age 18-24 (Total) 579 (889) 1153 (2499) 533 (5758) 1107 (1219) 1033 (2413

21. OLE= Open Label Extension PrEP Adherence does not need to be 100% to be effective