1. www.ias2011.org Decentralization of Laboratory Testing Capacity in Resource- Limited Settings: 7 Years of Experience in six African Countries F Marinucci, PhD 1, S Medina-Moreno 1, AD Paterniti 1, M Wattleworth 1,RR Redfield, MD 1 1 Institute of Human Virology, University of Maryland School of Medicine, Baltimore, 21201 US Abstract no. WEAD0101

2. www.ias2011.org AIDSRelief Consortium: PEPFAR Track 1.0 IP Catholic Relief Services (CRS) University of Maryland School of Medicine – Institute of Human Virology (IHV) Futures Group (FG) Catholic Medical Mission Board (CMMB) IMA World Health (IMA) Who We Are?

3. www.ias2011.org 98 22 44 18 19 28 3 6 Where Do We Work? 246 Local Partner Treatment Facilities (LPTF)+ 184 satellite sites 8

4. www.ias2011.org Who Do We Work With? 229 sites with laboratory mostly in underserved areas –Urban 58/229 (25%), Peri-urban 20/229 (9%), Rural 151/229 (66%) A majority of non-public sites and mission facilities –27% public and 73% non-public. The proportion between public and non-public sites differs by country Breakdown by level –17% primary 80% secondary 3% tertiary

5. www.ias2011.org Laboratory Level * General DescriptionLocation General Description Level I Primary - Health post and health center laboratories that primarily serve outpatients RuralVillages Level II Secondary - Laboratories in intermediate referral facilities for health centers (e.g. district hospitals) Peri- urban Towns outside city or regional towns Level III Tertiary - Laboratories in a regional/provincial referral hospital that may be part of a regional or provincial health administration Urban Regional towns or city * In some countries additional tiers may exist Laboratory levels classification based on Maputo Harmonization (2008) www.who.int/entity/diagnostics_laboratory/Maputo-Declaration_2008.pdf

6. www.ias2011.org UMSOM-IHV Model of Care Delivery Cornerstone: decentralization of care and treatment Care and Tx integrated into existing health care system Multidisciplinary approach with different areas of intervention Adherence as a vital therapeutic intervention Defined catchment area Highly supported community based adherence follow up Medically driven CQI Point-of-care laboratory capacity

7. www.ias2011.org  Centralized System Laboratory Approaches  Point-of-Care System Key Advantages –Quality is maintained though less complicated means –High-throughput, low reagent cost instrumentation is utilized Key Disadvantages –Limits for growth –Specimen or patient transport –Ineffective information systems Key Advantages –Patients’ timely access to diagnostics and results –No limits for growth Key Disadvantages –Complexity of quality systems –Higher staff turnover –Complexity of instrument service and support –Infrastructure Challenges

8. www.ias2011.org On-Site Laboratory Capacity  HIV diagnosis: rapid testing  Immunological staging: CD4 absolute/percentage  Safety monitoring: Hct or Hb, ALT, Creat  Major OI diagnosis: AFB, BF malaria, gram staining, CrAg  Monitoring of treatment response/treatment failure

9. www.ias2011.org Three-phase model implemented in collaboration with local partners in Nigeria, Tanzania, Kenya, Uganda, Rwanda, and Zambia Implementation strategy 1.site assessment and improvement (Y1-Y3) 2.appropriate technology selection with capacity building through training and laboratory mentoring (Y1-Y5) 3.quality management system strengthening and continuous quality improvement (Y6-Y7)

10. www.ias2011.org Phase I o Assessment of site by multidisciplinary teams o Overall laboratory capacity evaluation o Development of site-specific work plan for laboratory strengthening o Laboratory infrastructure refitting

11. www.ias2011.org Phase II o Appropriate technology selection and advocacy 1.national guidelines on equipment/testing algorithm 2.in-country suppliers able to provide reagents and technical assistance 3.population size of the catchment area of each site o Capacity building through practical training and laboratory mentoring 1.Onsite: specific needs, integrated into existing work plans 2.Centralized: aimed to develop in-country laboratory network 3.HQ training: comprehensive clinical lab training for field staff

12. www.ias2011.org Phase III  Quality management system strengthening  Introduction of new Laboratory Quality Improvement Tools  Improved coordination with MoH, CDC and other stakeholders

13. www.ias2011.org Results Number of Local Partner Treatment Facilities with HIV-LTC by Level and Location

14. www.ias2011.org Results cont’d Lab workers (N=1152) trained by topic (EA) Increase over time of quality of Malaria and AFB microscopy

15. www.ias2011.org Quality of CD4 Testing Capacity (CD4TC) Graded with LQIT by Level and Location UrbanPeri-urbanRural LQIT grade Level 1Level 2Level 3Level 1Level 2Level 3Level 1Level 2Level 3 Total (N=92) Excellent 2/28 (7%)5/28 (18%)2/28 (7%)0/12 (0%)2/12 (17%)0/12 (0%)0/52 (0%)12/52 (23%)0/52 (0%)23/92 (25%) Good 3/28 (11%)7/28 (25%)0/28 (0%)0/12 (0%)2/12 (17%)0/12 (0%)2/52(4%)17/52 (33%)0/0 (0%)31/92 (34%) Satisfactory 0/28 (0%)6/28 (21%)1/28 (4%)3/12 (25%)4/12 (33%)0/12 (0%)4/52 (8%)12/52 (23%)0/0 (0%)30/92 (33%) Unsatisfactory 0/28 (0%)2/28 (7%)0/28 (0%)0/12 (0%)1/12 (8%)0/12 (0%)0/52 (0%)5/52 (9%)0/0 (0%)8/92 (8%) Results cont’d

16. www.ias2011.org AIDSRelief Patients Over Time 201,697 335,561

17. www.ias2011.org Major achievements Low overall LTFU rate 4.2% Viral suppression average across 6 countries 88.7% Low general mortality rate 8.4% Decentralization of comprehensive care and treatment

18. www.ias2011.org Conclusions Balancing country-specific and site-specific factors was crucial in adapting this flexible model for decentralizing sustainable HIV-LTC Integrated and comprehensive approach Harmonization and standardization Continuous mentoring of laboratory workers was KEY to support decentralization efforts

19. www.ias2011.org Thank you www.ihv.org