Eswatini NTCP and Baylor Global TB Pilot Project on DR-TB Contact Management. WHO Child and Adolescent Working Group October 2018 Dr Debrah Vambe

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Eswatini NTCP and Baylor Global TB Pilot Project on DR-TB Contact Management WHO Child and Adolescent Working Group October 2018 Dr Debrah Vambe

Objectives Review current status of DR and DS-TB care and treatment in Eswatini Describe pathway toward project initiation Overview of Pilot Project Goal: improve comprehensive contact management for children exposed to DR-TB Early enrollment and observations

Overview of TB Situation 1600 1400 1200 1,227 1,257 1,287 1,317 1,349 1,382 1000 1,069 1,058 800 948 870 867 907 945 773 600 400 200 749 757 751 720 610 605 440 565 403 351 403 295 398 0 2009 2010 2011 2012 2013 2014 2015 2016 2017 Prevalence rate Incidence rate Notification rate

Drug resistance survey preliminary results Variable New Retreatment All 2009/2010 MDR-TB prevalence 2017 MDR Prevalence 7.7 33.9 19.3 3.7 (2.6; 5.2) 10.9 (6.2; 17.3) 4.7 (3.5; 6.2)

Eswatini: TB Notifications 2011-2017 TB/HIV > 70% of cases DR-TB 2015 2016 2017 584 384 318

Eswatini: Proportion of Child TB GeneXpert Introduced Proportion of DR-TB Cases = 3%

National Efforts to Increase Child TB Case Finding Re-focus attention on clinical diagnosis with GXP and MTB Culture as complementary tools Contact tracing and IPT registers developed and rolled out. Main emphasis has been DS-TB contact management Began planning a DR-TB Contact Management Pilot

Project Development Review of existing evidence Consultation with international experts Discussion among NTCP and Baylor Presentation of existing data and plan at the tuberculosis TWG NHRRB Approval for Pilot

DR-TB Contact Management Pilot Sites 3 2 4 1 1. Good Shepherd = Urban referral hospital 2. Mankanyane = Rural referral hospital 3. Baylor Clinic = Urban outpatient clinic 4. Emkhuzweni Health Center = Rural Health Center

DR-TB Contact Management Strategy 1. Register confirmed index case with DR-TB 2. Home assessment performed to discuss 1. Infection control 2. Document all household contacts 3. Contact screening and collection of sputum for symptomatic individuals 4. Schedule clinic evaluation for children and adolescent contacts (0-18 years)

Clinical Documentation Developed Clinical Tools for implementation Self contained clinical folder for longitudinal follow-up Card for families with scheduled visits and medication information Adapted patient information into local language

Household Contact Assessment 0 14 Years Old Current cough?* Fever for > 2 weeks? 15+ Years old Current cough?* Fever/Night sweats for > 2 weeks? Positive TB Confirmed Evaluation for TB Poor weight gain/ftt? Loss of weight? Clinical TB History of a TB contact? History of a TB contact? * Cough for > 2 weeks; or of any duration + another symptom/contact. Treat Alt. Condition (PNA) vs. Monitor Repeat Clinical Assessment

Household Contact Assessment:Negative 0 14 Years Old Current cough?* Fever for > 2 weeks? Poor weight gain/ftt? History of a TB contact? 15+ Years old Current cough?* Fever/Night sweats for > 2 weeks? Loss of weight? History of a TB contact? * Cough for > 2 weeks; or of any duration + another symptom/contact. symptom screen Negative Or Disease Excluded Assess CXR 1) If Abnl Evaluate TB 2) If Normal Proceed 1) Child < 5 or HIV + 2) Intense Exposure No to Either = Monitor Yes to Both= Prevent

Quantifying Exposure Score of 6 or higher with clinician judgment = Intense Exposure Mandalakas et al, IJTLD, 2012

No Measurement of Infection TST and IGRA not currently available in the public sector Also rarely used Limiting treatment to high risk individuals Age < 5 PLHIV TST/IGRA sensitivity reduced in these high-risk populations Children in this group often also have co-morbidities helminth infection and malnutrition

Treatment Regimen and Monitoring Mono H Or PDR Levofloxacin 15-20 mg/kg 6 months Suggested Follow-Up Preventative therapy (Months) Baseline 1 Clinical Monitoring (Months) Baseline MDR Levofloxacin 15-20 mg/kg INH 15-20 mg/kg 6 months 2 3 3 6 6 12 12 18 18 Active screening for TB symptoms at each visit Active drug side effect monitoring with tools for grading and reporting

Contact Characteristics(N=23) Variable HIV Status Contact Characteristics N (%) Positive 2 (9%) Negative 18 (78%) Unknown/Exposed 3 (13%) Age < 5 17 (74%) 5-18 6 (26%) Gender Female 16 (69%) Prior TB Treatment Yes 1 (4%) Prior TB Exposure Yes 12 (52%)

Patient-Clinic Distribution 1 5 3 14 Emkhuzweni Mankanyane Good Shepherd Baylor

Navigation through contact management algorithm Patients still being evaluated for TB disease Two caregivers discontinued (taste) 25 20 15 5 9 11 13 10 5 23 18 14 12 10 0 Total Evaluated Pathway to Preventive Rx Monitoring or Disease Evaluation Eligible by Age/HIV Eligible by Exposure Disease Excluded + Initiated Persisted on Treatment Caregivers are generally bringing their youngest children

TB Disease Evaluation Positive TB Symptom Screen: 5/23 (26%) 4/5 negative by Xpert, 1/5 symptom resolution(likely viral) and normal CXR None of the 23 child contacts have been diagnosed with DR-TB Several with ongoing disease work-up

Potential Adverse Events Active assessment of all potential medication side effects from clinical booklet Guidance to include severe adverse events in adsm reporting Only 2 have reported mild, transient headache CNS Headache Headache (mild/intermittant) self resolved (mild/intermittant) self resolved LFX+INH LFX

Barriers 1. Transport 2. CXR quality and interpretation 3. Bitter taste of medication if crushed Facilitators 1. Strong clinicians and care teams at selected sites 2. Differentiated models provide clinical care (facilitated transport vs. home visits vs. financial support) 3. Caregiver motivation 4. New guidance

Conclusion New program but we hope to build on these 4 sites to improve contact management nationally Although more WHO guidance is still needed on treatment regimens Hope to share more results in the next meeting

Acknowledgements Clinical Team Cedric Wawa Jean Claude Kilola Didier Diayezu Alex Kay Eswatini NTCP Leadership Themba Dlamini Sisi Dube Welile Sikhondze Baylor College of Medicine: Global TB Program Alex Kay Anna Mandalakas Caitlyn Jasumback Sentinel Project Jennifer Furin Patients and Families