Yogan Pillay IAS, Paris 23 July 2017 South Africa’s experience in brining PrEP to scale for a range of populations Yogan Pillay IAS, Paris 23 July 2017

WHO Guidance September 2015 10/31/2017 WHO Guidance September 2015 WHO GUIDANC E Universal Test and Treat (UTT) or Treat All: ART should be initiated in everyone living with HIV regardless of their CD4 cell count. Pre-Exposure Prophylaxis (PrEP): People with a substantial risk of HIV infection should be provided with daily PrEP as part of a combined HIV prevention strategy.

PrEP & T&T IMPLEMENTATION PROCESS 2015 – 2017 Consultation October 2015 (Pre- policy) January 2016 (Draft policy) March 2016 (Policy) September 2016 (Review findings) Policy 1st Draft December 2015 2nd Draft January 2016 Implementation guidelines PrEP & Test & Treat for sex worker March 2016 Implementation Truvada approved for PrEP 1 December 2015 National Health Council decision March 2016 Implement policy Audit of sites March 2016 Launch of the Sex Worker Plan 2016-19 April 2016 Preparation April – May 2016 Commenced 1 June 2016 11 sites MSM 1 April 2017

Objectives of the PrEP and Treat all Policy Expanded prevention options: Offer and promote PrEP as an additional option in the context of combination prevention Increase access to treatment: Provide treatment to those who test positive for HIV Integration: Integrate PrEP and Treat All into other HIV prevention programmes, policies, and services Quality of care: Provide PrEP and Treat All within the broader framework of quality health service provision Communication and community-based strategies: Implement evidence-informed communication and advocacy strategies

Implementation Process Comprehensive Package of HIV Prevention & Treatment Interventions Implementation Process

Implementation Process Audit of sites National level support for sites considered ready to implement PrEP Training Clinicians (NIMMART trained nurses) Lay Counsellors (Testing) Peer educators (Education & social mobilisation) M & E officers (Data management) Monitoring & evaluation IEC and promotional material PrEP drugs procured and distributed centrally

Package of Interventions Outreach Identification Peer lead Information & Education Support Prevention Information & education Counselling Testing Condom promotion PEP PREP STI screening TB screening Treatment Test & Treat ART Viral loads Opportunistic infections STI treatment Linkage to care (second line) Adherence Trauma counselling Creative spaces Support groups Human rights protection

Progress with implementation Comprehensive Package of HIV Prevention & Treatment Interventions Progress with implementation

SW implementation data MSM implementation data Oral PrEP: what we know June 2016 – June 2017 SW sites 30 783 26 848 (87%) 1 877 (7%) Total HIV tests Neg. HIV tests PrEP commencements April – June 2017 MSM sites 1 199 1 125 (94%) 209 (19%) Total HIV tests Neg. HIV tests PrEP commencements PrEP incorporated well into combination prevention delivered by NIMART trained nurses Since implementation, clients’ view of PrEP has evolved; increased levels of cycling due to risk profile changes Peer outreach, convenient operating hours, and mobile services drive higher service uptake Strong adherence support is critical, especially in the first few months of PrEP use Lessons Learned SW implementation data MSM implementation data Data sources Note: HIV testing numbers reflect new tests, not routine testing for current PrEP users

Oral PrEP: what we know

Early Review: Lessons and Action 11 SW ● MSM ● AGYW

Implementation Challenges + Lessons Responses Retaining clients through 1 & 4 month follow-up Counselling job aids (2) for health providers to support retention Training sessions dedicated to counselling, and social mobilisation lead by experts Examination of follow-up outcomes in ongoing operational research Best Practice identified at sites with higher retention rates Misinformation about PrEP (e.g. side effects) Training for all peer educators and outreach personnel IEC materials for quick reference with facts dispelling misinformation Dialogue session with peer educators to discuss outreach approaches Similar clinical Qs repeated across sites Training dedicated to PrEP clinical considerations, including FAQs Clinical support mechanisms for implementing sites for clinical guidance Clinical Job Aid for HTS, combination prevention, and treatment Timely & complete data reporting from sites for M&E M&E/reporting training; ongoing site-specific support Practical exercises included in trainings to enhance practical understanding Quick reference job aid, official guidance document, and M&E review checklist for M&E reporting forms, shared with all sites SW ● MSM ● AGYW

EARLY LESSONS Outreach key in reaching target population and important for follow-up Mobile sites attract more demand than the stand alone clinics initiating PrEP & ART in mobile units a challenge (lab results, frequency of visits) Peer-led programme: higher demand creation and uptake Peer educators taking PrEP & ART potentially very beneficial in supporting uptake Communication is important (through whatsapp groups, peer educators, creative spaces and focus groups)

EARLY LESSONS Basic staff required are nurse, counsellor and peer educator For roll out to public facilities will require special attention to staff attitudes and responsiveness Special attention to treatment adherence and consistent use of prevention interventions (Condoms & PrEP) is needed Operating hours need to suit the target population Providing services close to where the target population can access services easily

Status of research agenda on effective practices to target and deliver PrEP to AGYW Significant coverage in studies Some studies address topic Question Status Q1 How can PrEP be effectively targeted to higher-risk AGYW? Q2 What are the major barriers to PrEP uptake for AGYW and how can they be addressed? Q3 What legal or ethical considerations are relevant for PrEP provision to AGYW? Q4 What service delivery and civil society channels will most effectively reach AGYW? Q5 What types of investments are required to effectively deliver PrEP through these channels? Q6 How can negative health care worker attitudes be effectively mitigated? Q7 What are the most effective strategies to build awareness and generate demand for PrEP amongst AGYW? Q8 How are AGYW communicating about PrEP to partners or family members and/or involving them in decisions? Q9 How are “periods of risk” defined? What strategies / tools support AGYW decision-making around on/off decisions? Q10 To what extent are AGYW adhering to PrEP? What messages and strategies effectively support adherence? Q11 Are AGYW getting regular HIV/STI testing? What strategies effectively support retention in regular testing? Q12 What information do health care facilities need to collect and report to NDoH? What data are demonstration projects collecting?

Retention and adherence Side effects and other challenges AGYW working group – demo data Uptake Variation in uptake across studies and geographies observed, with 36% to 98% reported Retention and adherence Retention and adherence have been reported by various studies and, again, display variation across studies and geographies. 40% to 70% of study participants were either reporting continued PrEP use or displaying sufficient tenofovir blood levels at time of reporting Side effects and other challenges Study feedback to date on challenges with uptake and adherence mirrors much of what has been reported from PrEP implementation at SW sites – concerns around daily pill taking and side effects as well as discontinuation due to side effects such as headache, fatigue, and nausea.

PrEP uptake, adherence, retention Outreach and communication AGYW working group – additional lessons learned Across the demonstration projects, all have underscored the need for flexibility and adaptability in providing oral PrEP to young women in South Africa. The diversity of settings – urban, rural, formal, informal – in which young women live means that oral PrEP cannot be a one-size-fits-all prevention tool. What works well for secondary school students in Vulindlela may not be appealing for a university student in Johannesburg. The below notes some key themes from demonstration projects to date. PrEP uptake, adherence, retention Outreach and communication Most common reasons for opting out are pill-related (i.e. pill size, taste, remembering it every day) Side effects are a barrier to uptake and adherence SMS reminders and setting a regular phone alarm are commonly used/referenced adherence tactics Community education is critical to uptake and adherence; reduces stigma of AGYW sexual activity, legitimizes PrEP as prevention, dispels widespread misinformation, and informs parents/caregivers NDoH logo on IEC materials encourages trust Caregivers are influential in AGYW’s decision regarding PrEP use – especially HIV+ caregivers Peer mobilisers, particularly early adopters. are critical to link AGYWs to services Staff sensitisation Service delivery Training alone may not increase staff sensitisation and reduce stigmatisation; mentoring is critical It is valuable to have a Youth Champion on staff Making information and communication materials about PrEP widely available (through platforms such as BWise and She Conquers) can reduce the negative impact of insensitive healthcare workers Substantial clinical management is needed in the first few months after initiation Provision in schools will be complex, but tertiary institutions hold promise for reaching older AGYW Integration into ANC and family planning services is a great option, as it keeps PrEP from becoming a vertical intervention Mobile services have encouraged strong uptake of services; communities expressed openness to mobile SRH services in and around schools

Proposed/potential way forward for oral PrEP implementation To discuss with HEAIDS on Thursday AM – need confirm #s where possible Ongoing Ongoing Proposed start: Winter 2017 Proposed start: Early spring 2017 Continued SW site expansion Continued MSM site expansion University health centres Government clinics in 22 prioritised She Conquers sub-districts ~30 partner-supported sex worker sites currently undergoing readiness evaluations and receiving support to begin oral PrEP implementation Identification in progress of potential sites for integrated service delivery 12 campus clinics across 7 institutions serving more than 120 000 learners currently ART accredited and ready for further assessment; 5 additional campuses provide ART through down-referral Q1-3 schools, TVET colleges, and universities with close proximity to local clinics under assessment; propose at least 1 clinic per prioritised sub-district With the above expansion and operations research, NDoH will have significantly more robust data and learnings to inform broader national implementation by October 2017

Operations research update: aims Client factors Primary Aim: To examine factors affecting clients’ decision to initiate, continue, and/or stop PrEP use, including perception of risk, beliefs about PrEP safety and effectiveness, social support, experience and satisfaction with services, and side effects of oral PrEP. Secondary Aims: Assess provider knowledge, attitudes, and practiced behaviours around oral PrEP delivery Explore the effect of oral PrEP provision on condom use and use of other prevention methods and services (e.g. STI, family planning) Examine oral PrEP marketing and communication mechanisms by investigating: the primary source of knowledge of PrEP among current, past, and never-users and clients’ identification with and messaging for IEC materials and creative concepts Provider factors Sources of knowledge

PrEP in Pregnancy Noted the WHO guidance & convened a technical working group Technical report prepared & presented to larger group For implementation, prioritise: safer conception those in sero-discordant relationships (VL not suppressed/ unknown) “Can be done within an implementation research science context rather than as a clinical trial or through compassionate use of unlicensed drug” Seeking guidance from the medicines regulator (MCC) on use of ARV for prevention in pregnancy

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