1. Strengthening specimen referral and transport networks in resource-limited settings: a Nigerian pilot to improve diagnosis The 46 th UNION world conference on Lung health Cape Town, South Africa 2 nd – 6 th December 2015 S. Useni, S. Massaut, M. Gidado, J. Onazi, S. Gande, P. Nwadike, S. Kik

2. Outline  TB situation in Nigeria  Background  Why this pilot  Pilot model  Findings  Successful interventions  Challenges  Conclusion

3. TB Situation - Nigeria Population: 180,677,058 (projected for 2015) Population: 180,677,058 (projected for 2015) DOTS centers: 5,398 DOTS centers: 5,398 AFB microscopy centers: 1,515 AFB microscopy centers: 1,515 Culture DST laboratories: 8 Culture DST laboratories: 8 Incidence Rate: 338/100,000 Incidence Rate: 338/100,000 Total notified cases 2013 all forms: 100,401 (17.5%) Total notified cases 2013 all forms: 100,401 (17.5%) CNR all forms for TB 2013 (per 100,000): 57.3% CNR all forms for TB 2013 (per 100,000): 57.3% HIV prevalence : 4.1 % HIV prevalence : 4.1 % ART centers : 491 (85% TB/HIV co-located) ART centers : 491 (85% TB/HIV co-located) MDR among new TB cases: 2.9% MDR among new TB cases: 2.9% MDR among previously treated TB cases: 14.3% MDR among previously treated TB cases: 14.3%

4. Background In 2011 Xpert MTB/RIF was adopted to improve access for presumptive DR-TB patients In 2011 Xpert MTB/RIF was adopted to improve access for presumptive DR-TB patients In 2013 Xpert diagnostic algorithm was reviewed to include PLHIV as priority group for TB diagnosis In 2013 Xpert diagnostic algorithm was reviewed to include PLHIV as priority group for TB diagnosis In 2015 functional GeneXpert laboratories are 176 sites In 2015 functional GeneXpert laboratories are 176 sites National TB/HIV co-infection - 23% (23,104 cases) National TB/HIV co-infection - 23% (23,104 cases)

5. Why this pilot? Develop a practical model for specimen referral and transportation Develop a practical model for specimen referral and transportation Increase the number of PLHIV screened, tested for TB and put on treatment Increase the number of PLHIV screened, tested for TB and put on treatment Inform policy and public health practices Inform policy and public health practices

6. The Pilot Model TB/HIV Services Intensified Case Finding Increase TB mindedness Strengthen R&R and Supervision Increase Access to Diagnostic Services Simplify care and treatment

7. Geographical HIV prevalence by state National HIV prevalence - 4.1% National TB/HIV co-infection - 23% (23,104 cases) Nasarawa state Population 2,202,906 HIV Prevalence: 7.5% TB CNR: 128.2/100,000 Pilot Sites: Niger state Population 4,670,286 HIV Prevalence: 4.0% TB CNR: 35.9/100,000

8. Hub & Spoke Implementation XPERT Pilot Site 12 34 56 7 89 10 Nasarawa State Lafia (Dalhatu Araf Specialist Hospital) Niger State Minna General Hospital Existing XpertNew Xpert Referral SiteKm 1PHC New Market5 2GH Obi26 3PHC Doma Road, Lafia10 4PHC Kwandere (DOTS)12 5Family Health Clinic (FAHCI)5 6MCH Care Centre, Shabu11 7GH, Akwanga30 8GH Nassarawa Eggon22 9Ola Hospital, Akwanga32 10ERCC Alushi34 Referral SiteKm 1General Hospital Kuta80 2Rural Hospital Sarkin Pawa84 3MMM Fuka60 4Devine Mercy Hospital25 5Sabon Titi PHC Tunga Minna25 6Town Clinic Bosso25 7General Hospital Kagara120 8General Hospital Wushishi128 9IBB Hospital15 10FMC Gawu130

9. Xpert Diagnostic Algorithm

10. Specimen Transportation: Set-up Nonexistent at the start of operations Required implementation Reinforced on proper specimen collection procedures Trained on triple packaging (cold box) Transportation (dispatch) Registry Sputa only with Lab request forms Variable means of transit (fuel provided) Transportation twice per week from 10 peripheral sites Included RETURN of test results (TAT= 3-5 days)

11. Building Linkages Strengthening TB/HIV services Screening by HCW for PLHIV presumptive for TB & ALL new PLHIV - Using 4 symptoms checklist - According to National Guidelines - Sputa tested for ALL NEW and existing symptomatic PLHIV Bacteriologically confirmed diagnosis by Xpert Linkage to treatment (spokes to hubs) Registration of clients in National TB record (using existing tools) Establishing monthly meetings between HIV and TB programs (program coordinators, site supervisors, pilot coordinators, and staff)

12. Building Coordination Coordination strategy Hired 1 local consultant per State Biweekly mentoring/supervision visits - ensures availability materials (sputum cups, R & R tools, cartridges…) - ensuring data quality - troubleshooting - reviewing protocols - assessing progress - reinforcing pilot concepts Collaborating with all parties and partners Driving progress and integration

13. Pilot project indicators 1. 1.New presumptive TB cases by HIV status & test type 2. 2.New notified TB cases by HIV & bacteriological status 3. 3.MTB positive rate among PLHIV 4. 4.New Xpert MTB+ve cases with Rif-resistance 5. 5.RIF resistant rate 6. 6.Number of samples received on site and periphery. 7. 7.Treatment outcomes

14. Project monitoring   Data extracted from routine NTP & NAP registers  but training given and regular monitoring  No additional tools introduced, but training given and regular monitoring   Sources used to assess outcomes of indicators; Presumptive TB registers (Baseline vs Pilot) Laboratory Xpert register (Pilot period) Facility TB registers (Baseline vs Pilot) Monthly Xpert reports from laboratories Quarterly district notification summaries & treatment outcome reports monthly meetings Monitoring spot checks during monthly meetings  March  Baseline period (March – Dec 2013)   Pilot project period (March – Dec 2014)

15. Number of samples received from peripheral sites - based on presumptive TB register - 60% 41% 82% 40% 59%18%

16. Presumptive TB cases registered & tested (Baseline vs Pilot) Total tested baseline period: 1691 BaselinePilot Baseline: 84% of registered pres. TB cases tested 2842 presumptive TB cases tested 418 PLHIV tested Pilot: 86% of registered pres. TB cases tested 3689 presumptive TB cases tested 1534 PLHIV tested

17. Increase in PLHIVs tested for TB (Baseline vs Pilot) BaselinePilot Baseline: 15% of pres. TB cases were known PLHIV 418 PLHIV tested Pilot: 42% of pres. TB cases were known PLHIV 1534 PLHIV tested

18. Number of PLHIV tested remarkably increased 3-fold increase in HIV positives tested for TB 1,534 HIV positives tested in pilot period (84% of those registered) 418 HIV positives tested in baseline period (78% or those registered)

19. Type of TB tests used among presumptive TB cases

20. Bacteriologically confirmed TB cases among tested presumptive TB cases - based on presumptive TB register - Small increase in number of bacteriologically confirmed TB cases: 818 in baseline vs 962 in pilot

21. Bacteriologically confirmed TB cases by HIV status - based on presumptive TB register - Increase in bacteriologically confirmed TB cases among PLHIV Among PLHIV there were 180 Mtb positives in baseline vs 347 in pilot period Positivity rate among PLHIV 43% in baseline, 23% in pilot

22. Bacteriologically confirmed HIV+ TB cases - based on TB treatment register - Total number of PLHIVs with TB higher according to treatment registers, and no increase seen in pilot period. Number of TB cases diagnosed: 479 baseline, 497 pilot Number of bacteriologically confirmed TB cases: 361 baseline, 354 pilot Proportion bacteriologically confirmed TB cases: 75% baseline, 71% pilot

23. Number of new MTB+ RIF resistant cases RIF resistance rate for all and PLHIV No. Rif resistant TB cases All Baseline All Pilot PLHIV Baseline PLHIV Pilot Presumptive TB register0404 Lab register0403 TB treatment register5625 RIF resistance rate All Baseline All Pilot PLHIV Baseline PLHIV Pilot Presumptive TB register0%0.1%0%0.2% Lab register0%0.2%0%0.2% TB treatment register0.5% 0.4%1.0%

24. Successful Interventions Strengthened sputum transportation/referrals by reducing physical movement of clients. 60% (1,066 out of 2,665) of all sputum specimens that were tested with Xpert were from referral sites through hub and spoke model Improved access to diagnosis by geographic coverage for TB screening among PLHIV due to implementation of effective specimen referral system (at baseline, only 9 PLHIVs were tested with Xpert and in pilot period 782) Intensified case finding of 1.9 fold increase for notified bacteriological confirmed TB cases (at baseline 180 cases compared to pilot of 347 cases)

25. Successful Interventions cont’d. Increase access to TB treatment of co-infection through improved TB/HIV collaboration.   In the pilot period 1,232 TB cases (including 497 PLHIV), were registered for treatment; 824 of these (including 354 PLHIV) were bacteriologically confirmed TB cases Integrated routine supportive supervision by local consultant and LGA supervisors ensured progress, continued momentum, and assisted with developing collaborations between HIV/TB systems.

26. Overall Challenges Changing current testing paradigm (ALL asymptomatic new PLHIV) Maintaining overall understanding and motivation Coordination/communication - onsite/remotely - staff of separate programs and different interests Unpredictable interruptions - Industrial strike action by HCW from Jun. – Aug. 2014 and Nov. – Dec. 2014 (end pilot activities) - Political/civil unrest in Nasarawa state - Fire at Laboratory building in Niger state Potential (or perceived): increased Xpert related workload Insufficient tools and commodities - - No approval by NTP to print revised National tools - - Improvised existing tools to capture indicators - - Periodic stock out of cups, R&R tools, and cartridges Minor infrastructural upgrades in laboratories

27. Future impact Integration is Key for… Existing scale up plans of national program structures (NTP and HIV) including the 185 machines for NACA with GF support Joint Training modules Joint TB and HIV supervisory system Improved reporting and recording for both TB and HIV Connecting transportation systems which have been implemented by HIV partners for Xpert testing

28. A well-coordinated sputum transportation system to Xpert testing sites minimizes the movement of patients and increases access to diagnostic and care services; not only for TB but also HIV. Conclusion

29. Acknowledgments KNCV TB Foundation FMoH – NTBLCP & NASCP MoH Niger state - TBCLP & SASCP MoH Nasarawa state - TBCLP & SASCP