Delivering PrEP to Young women: Preliminary Findings WHO Satellite Session, IAS Paris 2017 Quarraisha Abdool Karim, PhD* on behalf of the CAPRISA PrEP Demo Project Team Associate Scientific Director: CAPRISA Member: UNAIDS Scientific Expert Panel Professor in Clinical Epidemiology, Columbia University Adjunct Professor in Public Health, University of KwaZulu-Natal

WHO policy on ARVs and Pre-exposure prophylaxis (PrEP): Daily Truvada PrEP recommended as global standard for all at high risk New WHO PrEP guidelines “..the use of daily oral pre-exposure prophylaxis is recommended as an additional prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches..”

Prevention Gap– Key Populations

HIV in adolescent girls and young women 1000 young women acquired HIV every day in 2015 90% of all new HIV infections in 15-19 year-olds are in girls in southern Africa, 74% and in eastern Africa; 60% of population <30 years Only 6% reduction in HIV among young women aged 15-24 years from 2010 to 2015.

Which of these are prevention tools for young women in Africa? Existing HIV prevention strategies- ABCCP: Abstinence Behaviour (Be faithful) Condoms (Male & Female) Circumcision PrEP Which of these are prevention tools for young women in Africa? HIV in pregnant women in rural South Africa (2001-2013) Age Group (Years) HIV Prevalence (N=4818) ≤16 11.5% 17-18 21.3% 19-20 30.4% 21-22 39.4% 23-24 49.5% >25 51.9% Source: Abdool Karim Q, 2014

Project Goal & Potential Outcomes To assess the feasibility, acceptability, uptake and patterns of use of daily, oral tenofovir diproxyl fumarate + emtricitabine provided as part of SRH services to young women (and men) at risk of acquiring HIV in urban and rural KwaZulu-Natal Potential Outcomes to inform PrEP scale-up: How will PrEP be used & what will patterns of PrEP use look like? Who wants to use PrEP? Who will be successful PrEP users? What factors influences adherence? What client and provider support is needed for PrEP use? Change Title to: Goal and outcomes of the CAP084 PrEP Demo Project

Approach Community and PHC level awareness raising of HIV, knowledge of HIV status; prevention and treatment options. Those interested in PrEP are referred to CAPRISA facility CAPRISA : General Information Session on PrEP and what PrEP use entails If interested in PrEP use - Screening and eligibility assessment If eligible – initiated on PrEP and dispensed with 14 days of drug Follow-up 7 days (telephonic/clinic) D14, M1, M2, M3, M6, M9, M12 HIV testing, safety, pregnancy, STIs, adherence

PrEP Uptake and Patterns of Use March 2016 - February 2017 Average age 23 years Range: 18-30 years # enrolled & offered PrEP 429 # initiated on PrEP 264 (61%) % still on PrEP after 6 months (n=154+25) 67.8%  Main reasons for not initiating PrEP Not interested / willing / ready to take PrEP / Forget pills Concerned about side effects & drug resistance No self-perceived HIV risk Concerned about objection from family Reasons for stopping PrEP (N = 110*) Clinician-initiated (n=31): vomiting, rash, PV bleeding Self-initiated (n=91): nausea, headaches, dizziness, abdominal pain, fatigue, rash 

Adherence to PrEP: Pill count 55% (147/264) of women who initiated PrEP reported interrupted PrEP usage 36% (53/147) reported interrupting PrEP more than once 81% (215/264) of women who initiated PrEP missed at least 1 pill Self-reported reasons for missing pills include: Forgot, missed clinic appointment, lost pills, travelling, pills stolen (n=1), does not recall, chose to stop PrEP Mean adherence based on pill count is 92% Quantitative drug level data expected in September 2017

Facilitators to PrEP Uptake: 14 FGDs Need for innovative interventions to build: Trust & Awareness of PrEP Motivation to use ARVs for prevention vs getting infected and going on ARV treatment Re-packaging: Current containers associated with HIV treatment (Stigmatization of HIV- people as AIDS patients/ confusion in homes with AIDS patients & limited space/privacy) Reduce product stigma: Segmented introduction (CSW/MSM) labelling and stigmatizing PrEP use Govender E, Personal Communication

Summary Adolescent girls and young women in eastern and southern Africa - a priority for PrEP 2/3 of young women initiate PrEP, when offered Adherence based on pill counts is >90% About 1/3 interrupt PrEP for concomitant ill- effects which are real or perceived effects of PrEP Substantial clinical management needed in the first few months after PrEP initiation Too early to inform PrEP roll-out

Acknowledgements This project is funded by: US Agency for International Development (USAID) (Washington DC and Pretoria) President’s Emergency fund for AIDS Relief (PEPFAR) FHI 360 (Pretoria) South African Department of Science and Technology (DST) MACAIDS Fund (via Tides Foundation) CAPRISA CAPRISA is the UNAIDS Collaborating Centre for HIV Research and Policy CAPRISA hosts a DST-NRF Centre of Excellence in HIV Prevention CAPRISA hosts a MRC HIV-TB Pathogenesis and Treatment Research Unit CAPRISA Partner Institutions: