The CQUIN Learning Network Lighthouse ALUP and POC VL: Innovations and Experience

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The CQUIN Learning Network Lighthouse ALUP and POC VL: Innovations and Experience Eric Auben Mtemang ombe Lighthouse Trust - Malawi July 17-19, 2017 Harare, Zimbabwe

THE LIGHTHOUSE WHO recognized Centre of Excellence, works in close coordina9on with the Ministry of Health First specialist centre in Malawi for the care and support of people living with HIV and AIDS Registered as a public Trust in 2001 2

The Lighthouse Differen9ated Care Based on the principle that not one size fits all but that pa9ents have differing needs and requirements. Examples: v ALUP Package of Care v Point of Care (POC) Viral Load Tes:ng 3

The Lighthouse ALUP Package of Care Lighthouse uses a threshold of CD4 < 100 cells/ml Interven9ons: v Diagnos(c: Screen for disseminated TB (urine- LAM) and disseminated Cryptococcal infec9on (serum CrAg) v Prophylac(c: In pa9ents with CD4 counts < 100 the REALITY trial showed that a bundle of prophylac9c measures can significantly reduce early mortality 4

ALUP Package of Care 5 Lighthouse*+ ALUP+Flow+Chart+2.0+ CD4+count+done+for+!any%ART%ini*a*on%!failing%ART%pa*ent%with%high%VL%!sick%looking%pa*ent%on%ART% % Ask+and+look+for:+ + *Weight+loss+(LOW)+ (>10%+or+BMI+<18.5)+ *Night+sweats+(NS)+ *Chronic+cough++ *Shortness+of+breath+(SOB)+ *headache,+new+seizures+ *oral+candidiasis+ *KS+on+legs+or+palate+ *frequent+hospital+admission++ (>1+admission+in+3+months)+ *general+weakness+ +(needs+assistance+to+walk)+ ++ CD4% ++ <100+++++OR++ 100*200+and+paXent+ sick ++ ART+ Urine++ LAM+ CrAg+ (Serum)+ Albendazol+400mg+od+1/7+ Azithromycin+500mg+od+3/7+ CPT+ neg+ pos+ STOP!% LP+and++ CrAg+(CSF)+ neg+ pos+ Fluco+800+mg+od+2/52+then+ Fluco+400+mg+od+8/52+ hold+art,+admit+to+kch,++ provide+ampho+for+1/52+ Cough/LOW/NS+absent+ LOW/NS+pos+ Cough/SOB+pos+ FASH+ INH+300+/Vit+B6+25+mg+3/12+ TB+treatment+ TB+treatment+ TB+treatment+ INH+300+/Vit+B6+ 25+mg+3/12+ KS+on+legs,+mouth,+ + pos+ neg+ pos+ neg+ STOP!% pos+ neg+ INH+300+/Vit+B6+25+mg+3/12+ Date:+ + Pat.+Name: ++ Pat+ID: + Clinician: + Do+as+appropriate:++ 1) Sputum+Xpert++ 2) Treatment+with+amoxyl+500+ mg+tds+5/7+++azithromycin+ 500+mg+3/7+and+review+ 3) CXR+ TB+proven+or+ probable+ TB+ improbable+ Weight:+ + Height:+ + BMI: + TF+ >17+ <17+ STOP!% Refer+for+chemotherapy+ Refer+for+ Fundoscopy+CMV+reXniXs+screen + STOP!% CMV+pos+ CMV+neg+ Gancyclovir++i.o.+

How immunosuppressed are our pa9ents? v Results from Lighthouse 1.1.2017-15.4.2017 (approx. 100 new ini9a9ons/month, and 4,000 visits/month) v Total CD4 counts done 424 (= approx. 120/month) v For new ini9a9ons: 236 pa9ents (55%) v 1-6 month on ART: 7 pa9ents (2%) v 6-12 month on ART: 15 pa9ents (4%) v >12 month on ART: 119 pa9ents (32%) v New ini9a9ons: 236 => CD4>100: 181 (77%) / CD4<100: 55 (23%) WHO Stage >100 <=100 I or II 122 27 III or IV 30 19 Total 152 46

Lighthouse ALUP In depth analysis of 66 patients with CD4 count <100: No O.Is (CPT, Albendazole, Azithromycin, IPT) 37 (56%) TB diagnosed 14 (21%) Cryptococcemia 8 (12%) Cryptococcal meningitis 6 (9%) KS 1 (1%)

Viral load monitoring Malawi s Na9onal HIV program relies on monitoring of Viral Load (VL) to monitor treatment success This is rou9ne VL monitoring, targeted VL Current VL turn around 9me is ~ 3 months Poses a substan9al problem when dealing with targeted sample results, which may en9ce an immediate clinical ac9on 8

Point of Care Viral Load Monitoring Support from from the Bill & Melinda Gates Founda9on (BMGF) enabled Lighthouse to procure plalorms and cartridges for POC VL tests (GeneXpert HIVquant) The POC-VL machine allows Lighthouse to process 10-20 VL samples per day This has changed the approach to failing pa9ents 9

Lighthouse POC VL The POC-VL test is requested using a dedicated request form ( blue forms ) On this form the clinician specifies amongst other data the reason for the test as well the 9me interval to receiving the result and the ac9on that he or she takes in response to the result. 10

Lighthouse POC VL report for Jan - May, Current results: General POC tests done 2017 Lighthouse Total test machine status 581 Successful 537 (92%) Error or aborted 44 (8%) Of those successfully, Sample type 537 POC-VL 529 (99%) POC-EID 8 (1%) 11

Lighthouse POC VL POC-VL tests with requests documented Pa9ents with available POC-VL request informa9on 359 (62%) ( blue form ) Clinics sending POC-VL samples Lighthouse Clinic 259 (72%) KCH ward 29 (8%) N-CAP 71 (20%) Comment: The propor9on of pa9ents with available data on the reasons and ac9ons is lower than the total number of tests run. This is expected in a rou9ne opera9ons as forms have mul9ple possibili9es to go missing. The propor9on of 62% at Lighthouse lies in the range we may have expected. 12

Lighthouse POC VL VL status for all blue forms which were returned for data entry. VL Status Low (< 1,000 copies) High (>1,000 copies) Total VL results 100 144 244 13

Lighthouse POC VL Ac9on taken on high result LH (n=144) Referral for adherence 15 (10%) Switch to 2 nd line 87 (60%) No ac9on 3 (2%) Other 3 (2%) 14

POC VL: Time from ordering VL to Ac:on taken @ Lighthouse Ac9on taken Low VL result High VL result All Same day 43 (66%) 70 (69%) 113 Next day 13 (20%) 16 (16%) 29 Later 9 (13%) 15 (14%) 24 Total 65 101 166 Comment: Out of 359 with blue forms, 166 had 9me and date of ac:on taken documented 13

Lighthouse POC VL Problems and way forward The biggest opera9onal problem lies in the supply chain management of cartridges. As LH is the only clinic in the country doing the test on a larger scale, the supplier onen has no stock available in the country Ini9ally the expected number of tests to purchase was unclear, so it was difficult to es9mate the demand. Internal slow procurement process also added to these obstacles. Now in a beper posi9on to predict the expected demand, we expect this problem to be less relevant in the future; currently a 6months supply has been received. 16

Lighthouse POC VL The main problem from an inves9ga9onal side is the low return of forms. Solu9on: The data manager will generate a list of pa9ents who had a test done and the files of the pa9ents will be assessed as it is assumed that a substan9al number of forms were filed away without recording. 17

Thank you!