Do you think Universal Test and Treat should be implemented in all clinics and hospitals in South Africa?

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1 UTT SDI and other TLA s Dr Julia Turner Right to Care NGO Acknowledgements to Dr Francois Venter, Dr Giordano, Dr Leon Levin, Dr Louise Gilbert, Dr Rachel Wake, Dr Mhairi Maskew and many others

2 Do you think Universal Test and Treat should be implemented in all clinics and hospitals in South Africa? 1. Yes 2. No

3 A very quick history! 1995 Adverse events Poorly tolerated Defaulting Resistance Ho DD. Time to hit HIV, early and hard. N Engl J Med 1995;333:

4 International AIDS Society 2002 Start ART when CD4 < CD4 < CD4 <500 JAMA 2002:288(2)222

5 2008 CHER study shows 76% decrease in Infants mortality Violari et al. NEJM 2008

6 2015 TEMPRANO trial 2056 patients from Ivory Coast followed for 2 ½ yrs. All with CD4<800 Randomly assigned into 4 arms Death Tuberculosis Cancer Invasive bacterial infections

7 2015 START trial: Randomized study immediate ART or deferred < patients f/u for 3 years VL suppression CD4 count

8 Cardiovascular disease Kaposi s Sarcoma Tuberculosis Malignant lymphoma Bacterial infectious disorder Cancer not related to AIDS Bone or joint injury Depressed mood Infection with unspecified pathogen Injury not elsewhere classified Suicidal or selfinjurious behaviour

9 2016 Universal Test and Treat Regardless of CD4 count UNAIDS:

10 2016 Partners study Suppressed VL means no transmission to sexual partners U=U Undetectable = Untransmissible TasP Treatment as Prevention

11 Is TasP working? South Africa HSRC survey shows reduction in HIV incidence in only 5 years! Age Total Male Female UTT, PrEP and other prevention interventions seem to be working

12 So how is South Africa doing? : (HST SA Compendium 2015) UTT started September : (HSRC survey 2017)

13 Abstracts from IAS PHC clinics in JHB, 258 adults (Dorina Onoya) Pre-UTT UTT Initiation < 30 days 58.8% 98.7% Median time to initiation 25 days 8 days 10 clinics in Mpumalanga (Noah Haber) Pre-UTT UTT Initiation < 90 days 31% 58% Large differences between clinics

14 Is your clinic or hospital starting everyone on ART regardless of CD4 count? 1. Yes 2. No

15 Challenges to Implementation Overburdened Health Care System Only a few clinicians who initiate ART Time consuming to initiate Tracing the Pre-ART list Linkage to care Community based testing > clinic initiation Clinic HCT > clinic initiation Hospital > clinic initiation

16 Challenges to Implementation Overburdened Health Care System Community delivery models Differentiated Models of Care Central Chronic Medicine Dispensing and Distribution (CCMDD) Adherence Clubs

17 Challenges to Implementation Only a few clinicians who initiate ART NIMART Ongoing training in conjunction with mentoring and logbook support Working with onsite or roaming doctors Improve health worker management Change attitudes Starter pack: Helpline numbers, Support staff contacts, Useful resources

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19 Challenges to Implementation Tracing the Pre-ART list Download Pre-ART List from TIER.net Allocate staff member to trace and monitor Contact via phone or address Work with community workers

20 PreART Waiting Lists in JHB Clinics Clinic Name Apr-18 Sep-18% left Clinic A % Clinic B % Clinic C % Clinic D % Clinic E % Clinic F % Clinic G % Clinic H % Clinic I % Clinic J % Clinic K % Clinic L % Clinic M % Clinic N % Many patients were written off as untraceable The lists haven t increased again= testament to UTT

21 Challenges to Implementation Linkage to care Community based testing > clinic initiation Checking accuracy of data collection and looking for duplicates Mapping out organisations Ensure record keeping with correct contact information Functional referral forms Systems for conversations between organisations and facilities Linkage to care officers, peer navigators, Jabu project

22 Challenges to Implementation Linkage to care Community based testing > clinic initiation Clinic HCT > clinic initiation Hospital > clinic initiation SDI Same Day Initiation

23 Do you think same day initiation on ART should be implemented in all clinics and hospitals in South Africa? 1. Yes 2. No

24 Systematic review and meta-analysis of LTFU before initiation studies in sub-saharan Africa (Catrina Mugglin) 29 studies, > patients 72% had a CD4 count done 40% were eligible for ART 25% started ART ART initiation is typically very tedious Therefore 37.5% attrition before ART initiation

25 Same DayART Study in Haiti (Serena Koenig) T. P. Giordano Slide: Koenig S, WEAE0202, AIDS 2016, Durban,SA

26 Same DayART T. P. Giordano Slide: Koenig S, WEAE0202, AIDS 2016, Durban,SA

27 RapIT study: SDI of ART in a clinic and hospital in JHB (Sydney Rosen) 377 adults SDI vs. control (POC CD4, bloods, TB screen +/- sputum, intense counselling) vs. (5-6 visits before initiation) SDI control 25%

28 Number of adults ART initiation in <90 days VL suppression at 10 months Retention in care % LTFU before initiation SDI Control Difference 97% 72% + 25% 64% (78% of 51% (79% of those Cost! initiated) those initiated) 81% (84% of 64% (88% of those initiated) those initiated) 14% 78% % LTFU after initiation 86% 22% + 13% + 17%

29 SLATE Trial 600 adults randomized Peri-Urban clinics in JHB and Kenya Control: Standard initiation procedures Intervention: Symptom report Medical history Clinical exam Readiness assessment If all satisfactory -> SDI Primary outcomes: Initiation <28 days Retention at 8 months Intervention Control Initiated <7 days 68% 40% Initiated <28 days 82% 72% Initiated and retained at 6/12 53% 50% 50% screened out + TB screen SLATE II GeneXpert +/- ulam

30 July 2017 WHO Guideline World Health Organization. (2017). Guidelines for the management of advanced HIV and rapid initiation of antiretroviral therapy.

31 How are we doing in SA? Johannesburg Cape Town

32 Is the facility where you work starting people on ART on the same day that they first test HIV positive? 1. Yes 2. No

33 Challenges in clinics Resistance from nurses and doctors Many anxieties or disbelief about SDI No one likes change Change takes time, effort and resources No blood results Fear of IRIS Increased defaulting? Lead to resistance? Counselling? Don t have staff available everyday to initiate Roaming doctors Workload - overburdened Certain clinics run on certain days and nurses do not want to be interrupted

34 Challenges in Hospitals Resistance from doctors Many anxieties or disbelief about SDI No one likes change Change takes time, effort and resources Supposed to decentralise and refer stable patients Only keep complicated patients Drs like to have blood results Fear of IRIS Increased defaulting? Lead to resistance? Counselling? Don t have staff available everyday to initiate Roaming doctors Workload - overburdened Certain clinics run on certain days and nurses do not want to be interrupted

35 Challenges in clinics Resistance from nurses and doctors Many concerns about SDI No one likes change Change takes time, effort, money and other resources

36 Tell Clinicians the Benefits Better clinical outcomes due to less time off ART Less LTFU (especially before initiation) More people initiated Treatment as prevention Shorter time to treatment means less anxiety Create a norm that people with HIV require treatment

37 Address Clinicians Concerns Lack of blood results: Might treat with the wrong ARVs (Hepatitis B, renal insufficiency) Fear of IRIS: Don t want to miss TB or Cryptococcus

38 What to do about blood results? Hep B Cr Hb-AZT CD4 TB CrAg Tenofovir in 1 st line Urinalysis, hpt, DM Examination/ Fingerprick Hb Universal test and treat Symptom screen Cryptococcal meningitis?

39 Dr Rachel Wake s CrAg study findings and d/w ID consultant in Johannesburg Check CD4 & Call back Very small risk to very few people The Gauteng algorithm screens out all WHO stage 3 or 4 Therefore -> SDI does greater good for more people

40 WHO Guideline Lack of blood tests should not stop SDI as long as the patients are asymptomatic

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43 Do you think it s ok to start ART in a patient who passes the screening algorithm instead of blood results? 1. Yes 2. No

44 Discuss their other concerns Less time for adequate counselling? Increased LTFU after initiation? Increased resistance? Most studies showed similar retention in care, If a decrease, always outweighed by more people being initiated Resistance is about the quality of counselling Psychosocial readiness is included in the algorithm SDI is only offered, never forced

45 Challenges in clinics Don t have staff available everyday to initiate Drs come on certain days Different clinics on different days Initiations are time consuming Train, mentor nurses Clear and practical algorithm Allocate and alternate: must be fair Monitor and acknowledge

46 Accountability Monitoring and Reporting Initiated 1, 1% 1, 1% 3, 3% 5, 6% 4, 5% Initiated the following month Untraceble Relocated to Malawi 74, 84% Not Ready TR/out not I

47 Competing messages Challenges in clinics Need a plan, and algorithm and memorandum to be agreed on by all stakeholders If one clinician is negative then everyone is too scared to do SDI

48 Linkage to Initiation Challenges in clinics Counsellors physically bring the patient to the clinician who is initiating Clinician counsel, assess and if they pass the algorithm - offer SDI, never force. Take baseline bloods Adherence counselling and information on side effects Return <7days for counselling and blood results Ideally clinician should check blood results on labtrak the next day and call back if need be.

49 Challenges in Hospitals Change is even more difficult in a complex system Testing: Which departments? every entry point. ELISA vs rapid test Cost Registers Confirmatory tests Not followed up Need a structured system Every patient should have a known status in file, Cost for 1 ELISA test: R52.02 On ward round alert ward sister of those needing tests so that when the counsellor comes to the ward she can say which beds

50 Challenges in Hospitals Linkage to initiation Initiated in the ward or in ARV Clinic? Who s accountable? Separate files? d/c via ART clinic? Initiated at hospital or clinic? Criteria Time before transfer out?

51 ANC: SDI

52 Birth PCRs Mortality peaks at 2-3 months Birth PCR register RTHB f/u results NB: f/u birth PCR registers and NHLS PCR Results for Action NHLS PCR Results for reports Action Allocate staff to trace POC birth PCR Registers for testing schedule Monitoring and reporting Bourne et al. AIDS 2009

53 Clinicians concerns systematic and structural challenges

54 What do the patients think? Qualitative study: in-depth interviews with 80 HIV + adults from 10 clinics in Mozambique (Amilcar Magaco) 60 initiated, 20 not initiated Barriers to initiation Don t believe the test results Don t understand why they should start treatment right away Concerns about ART side effects Fear of inadvertent disclosure and discrimination Limited privacy at health facilities Facilitators to initiation Being healthy and wanting to remain healthy Wanting to maintain responsibilities Wanting to care for their families Avoiding unwanted disclosure Long waiting times

55 Address patient s concerns You can live a completely normal life if you take your ART everyday No AIDS No opportunistic infections No transmission to baby No transmission to partner You will look healthy and normal You will live a normal lifespan Medicines are much better now. Fewer side effects, many options. Try to improve privacy in the clinic Adherence don t have to take your tablets at exactly the same time every night, but you have to take them every night otherwise - resistance

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58 Mutant virus

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60 Conclusion Whirlwind through History and evidence behind UTT and SDI Challenges with implementation Solutions and strategies

61 Is UTT good? 1. Yes 2. No

62 Is SDI good? 1. Yes 2. No

63 It s about how it s done Thank you

64 Acknowledgements Francois Venter Leon Levin Louise Gilbert Mhairi Maskew Lawrence Long Rachel Wake Jeremy Nel Kamban Hirasen