Clinical mentoring a new approach for African VL Margriet den Boer 1, Merce Herrero 2, Mounir Lado 3, Atia Atiaby 4, Duncan Ochol 3, Cherinet Adera 5, Jorge Alvar 6, Betgel Mekonen 5, Koert Ritmeijer 7 1 Médecins Sans Frontières UK/KalaCORE; World Health Organisation Switzerland; 3 IMA World Health South Sudan; 4 World Health Organisation Sudan; 5 Amigos Da Silva/KalaCORE Ethiopia; 6 Drugs for Neglected Diseases Switzerland; 6 Médecins Sans Frontières Netherlands
Diagnostic Algorithm for Primary VL in South Asia Kala-azar suspect : fever > 2 wks + splenomegaly and/or wasting rk39 RDT - + Non kala-azar search other diagnosis + treat kala-azar treatment
Diagnostic Algorithm for Primary VL in East Africa Kala-azar suspect : fever > 2 wks + splenomegaly and/or wasting Laboratory rk39 RDT + - Direct Agglutination Test (DAT) Negative < 1/400 Borderline 1/800 1/3200 Positive > 1/3200 Non kala-azar search other diagnosis + treat spleen or lymphnode aspiration - + kala-azar treatment
Sensitivity and Specificity of RDTs in the Indian subcontinent WHO/TDR, Visceral Leishmaniasis Rapid Diagnostic Test Performance, 2011 Product Manufacturer Sensitivity Specificity IT-Leish Kalazar Detect Bio-Rad Laboratories InBios International Inc. 98.8% (96.5 99.6%) 99.6% (97.8 99.9%) 97.6% (94.8 98.9%) 96.0% (92.8 97.8%) Excellent perfect performance of different rk39 RDTs for diagnostic confirmation of VL in Indian subcontinent
Sensitivity and Specificity of RDTs in East Africa WHO/TDR, Visceral Leishmaniasis Rapid Diagnostic Test Performance, 2011 Product Manufacturer Sensitivity Specificity IT-Leish Kalazar Detect Bio-Rad Laboratories InBios International Inc. 87.2% (82.5 90.8%) 67.6% (61.6 73.1%) 96.4% (93.3 98.1%) 90.8% (86.6 93.8%) Poor adherence to the clinical case definition (15% prior probability) will result in a positive predictive value of: Kalazar Detect 56% IT-Leish 81%
Parasitology Lymph node Bone marrow Spleen Lacks sensitivity ~50-80% 65% compared to DAT 1:6400 in 7880 Sudanese patients Babiker et al. AmJTrop Med Hyg 2007; 76:689-93 Lacks sensitivity ~70-80% Painful Sterilisation Medical procedure Sensitivity ~95% Needs expertise Procedure Reading Medical procedure Risk of bleeding Not suitable for remote field use
Treatment Effective, safe, cheap, acceptable (patient friendly) South Asia: Liposomal amphotericin B: single intravenous dose Effective and safe No or limited hospitalisation High cost of drug Cold chain requirement East Africa: SSG + paromomycin 17 days injections Effective but significant toxicity High cost of long hospitalisation High dose L-AmB for vulnerable groups
Pentavalent antimonials Antimonials are contra-indicated in: HIV/KA coinfection Age > 45 years Pregnancy Renal failure Jaundice Cardiac arrhythmias Severely impaired general condition
Pentavalent antimonials Sodium stibogluconate (SSG ) IM slowly injected - 20 mg/kg/day Side effects: Pancreatitis, cardiac, liver and renal toxicity Sudden death has occurred
VL endemic areas in East Africa Ethiopia: epidemic during 2005-2007 caused 2,364 new cases and 87 deaths (CFR: 4%) South Sudan: epidemic during 2009 2012 caused more than 28,000 new cases and 850 deaths (CFR: 3.8%)
Clinical mentoring South Sudan and Ethiopia Teams with a MD, nurse and labtech regularly visit VL treatment facilities Activities: Clinical case and mortality reviews Ward rounds Quality control of diagnostic tests Bedside teaching and ad hoc training Stop-gap of shortages of drugs, diagnostics and HR Collecting reporting data Use standardized checklists
Intensive monitoring Ethiopia: 3 teams conducted over 85 mentoring visits to 18 health facilities in 5 endemic regions between June and April 2017 South Sudan: In over 125 mentoring visits in 31 facilities between February 2015 and April 2017
Conflict in South Sudan Since December 2013 the context deteriorated with extreme violence affecting the VL endemic regions. Health structures were destroyed and looted, health staff and patients killed leading to collapse of general basic health care. Civil populations hide in the bush (high infection risk and exposure to sandflies + poor food security), most health NGOs evacuated and no capacity in MoH. Very poor access to affected areas due to insecurity Setting of absent infrastructure
Observations in practice Ethiopia South Sudan
Findings Large variety of shortcomings in all aspects of care; clinical and laboratory practices, nursing, reporting, VL supply gaps and absence of guidelines, SOP's and diagnostic and clinical algorithms. What indicators to use for scoring and documenting progress?
A hospital in Ethiopia First visit: Lack of rk39 RDT and DAT; patients receive no nutritional support; only 65% of patients met the case definition; many patients were diagnosed clinically, 40% of patients received SSG alone; spleen aspirates on outpatient basis; poor monitoring of vital signs and poor nursing care; lack of HIV testing After 6 th visit: HIV testing 100%; nutritional support for severe malnutrition 90%; case definition followed 90%; no more SSG monotherapy; clinical algorithm followed
Gaps remaining HR turn over and lack of nurse care; untrained MD treating patients; diagnostic algorithm not followed; clinical diagnosis still used; patient and lab documentation poor; trained VL focal person not actively participating; poor reporting; no nutritonal support for moderately malnourished Action: on the job training; seminar session on VL management; feedback to medical director and matron
Cost-effectiveness and sustainability? We have difficulty finding a hand over strategy for this essential intervention: VL focal person in each hospital? MoH mobile teams? Distant monitoring? Lessons learnt from HIV mentoring?
Thank you! DFID, KalaCORE and implementing organisations: IMA in South Sudan Amigos da Silva in Ethiopia The tireless mentoring teams