South Africa’s experience in brining PrEP to scale for a range of populations

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

2. 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.

3. PrEP & T&T IMPLEMENTATION PROCESS 2015 – 2017 MSM 1 April 2017

4. 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

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

6. 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

7. Package of Interventions

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

9. 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 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 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 Lessons Learned SW implementation data MSM implementation data Data sources Note: HIV testing numbers reflect new tests, not routine testing for current PrEP users

10. Oral PrEP: what we know

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

12. Implementation Challenges + Lessons Challenges Responses • 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 Retaining clients through 1 & 4 month follow-up • 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 Misinformation about PrEP (e.g. side effects) • 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 Similar clinical Qs repeated across sites 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

13. 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)

14. 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

15. Status of research agenda on effective practices to target and deliver PrEP to AGYW Significant coverage in studies Some studies address topic

16. 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.

17. 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 • Integrationinto 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

18. 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 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 Identification in progress of potential sites for integrated service delivery With the above expansion and operations research, NDoH will have significantly more robust data and learnings to inform broader national implementation by October 2017

19. Operations research update: aims 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. Client factors • 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 Sources of knowledge Provider factors

20. 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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