1. 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

2. 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.

3. 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 April 2016
Preparation April – May 2016
Commenced 1 June sites
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. Implementation Process
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
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

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

9. SW implementation data MSM implementation data
Oral PrEP: what we know
June 2016 – June 2017
SW sites
30 783
(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

10. Oral PrEP: what we know

11. Early Review: Lessons and Action11
SW ● MSM ● AGYW

12. 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

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
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?

16. 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.

17. 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

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
Identification in progress of potential sites for integrated service delivery
12 campus clinics across 7 institutions serving more than 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

19. 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

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

21. THANK YOU FOR YOUR ATTENTION!