1. Outcomes of Antiretroviral Treatment Programs in Rural Lesotho: Health Centers and Hospitals Compared Niklaus Labhardt, Motlalepula Sello, Mamokone A. Mohlaba, Olivia Keiser, Karolin Pfeiffer, Matthias Egger, Jochen Ehmer, Gilles Wandeler

2. Background Scarce human resources limit the scale up of antiretroviral therapy (ART) in rural southern Africa Early losses to follow-up are highest in settings with lowest numbers of health-care workers Task shifting and decentralization of care are recommended strategies to address chronic health care worker shortages Previous reports on ART delivery in decentralized settings are limited to short-term outcomes Van Damme et al. AIDS 2006 Wandeler et al. JAIDS 2012 Harries et al. Trop Med Int Health 2010 Shumbusho et al. PLoS Med 2009

3. Objectives 1.To d escribe programmatic factors and baseline characteristics of patients starting first-line ART in Hospitals and Health centers (HCs) in rural Lesotho 2.To compare short and long-term clinical outcomes between patients who started ART in the two types of facilities accross two different regions

4. SolidarMed ART Program (SMART) Swiss NGO (www.solidarmed.ch) 9 hospitals, 40 health centers in 4 countries 13,100 patients on ART by 2011 International epidemiologic Databases to Evaluate AIDS in Southern Africa (IeDEA-SA) network (www.iedea-sa.org)

5. SMART Lesotho Seboche 1 hospital, 5 health centers Population: ~ 55‘000 Adult HIV prevalence*: ~16% Paray 1 hospital, 7 health centers Population: ~ 77‘000 Adult HIV prevalence*: ~20% 2005: ART at hospitals 2007/08: Decentralization *Demographic Health Survey of Lesotho 2009

6. SMART Lesotho

7. Inclusion criteria / definitions Patients Over 16 years at start of ART No previous ART exposure Started first-line ART including 2 NRTI and 1 NNRTI Definitions No follow up: no visit after the start of ART LTFU: not returning to the clinic ≥ 6 months Retained in care: alive and on ART Chi et al. PLoS Med 2011

8. Statistical analyses All analyses compared patients treated in the two facility types (Hospitals and HCs) and were stratified by region (Paray and Seboche) Baseline characteristics compared with chi-squared and Mann-Whitney tests Kaplan-Meier curves for crude retention Multivariable logistic regression models for no follow-up Competing risk regression models for mortality and LTFU and results shown in a Forest plot

9. Flow chart ART start Jan 2008 - April 2011 N=3,969 ART start outside study area N=222 ART start at hospital N=1,705 ART start at health center N=2,042 Paray N=832Seboche N=873Paray N=1,247Seboche N=795

10. Resources for ART delivery Hospitals Health Centers 4Median number of physicians0 3Median number of nurse-clinicians1 2Median number of nurse-assistants1 6Median number of lay-counselors2 YesCD4 count on siteNo YesHemoglobin measurement on siteInconsistent NoViral Load measurement on siteNo

11. Baseline characteristics of patients Seboche (1,668) Paray (2,079) HospitalsHealth CentersP-valueHospitalsHealth CentersP-value Number of patients873795 8321,247 Number of women (%)569 (65.2)515 (64.8)0.87 517 (62.1)795 (63.8)0.478 Median age in years (IQR) 37 (31-47)39 (31-50)0.028 37 (30-47)39 (32-48)0.007 Median absolute CD4 count in cells/µl (IQR) 169 (86-278)208 (119-287)<0.001 157 (66-258)215 (133-290)<0.001 Median hemoglobin level in g/dl (IQR) 11.4 (10-12.7)12 (10.8-13.3)<0.001 12.1 (10.5-13.6)12.5 (11.5-13.7)0.002 WHO stage (%) I/II411 (47.1)546 (68.7)<0.001 438 (52.6)839 (67.4)<0.001 III/IV462 (52.9)249 (31.3) 394 (47.4)405 (32.6)

12. Overall retention in care: hospitals vs. HCs 50 100 60 70 80 90 17051009583245Hospitals 20421284677128 HCs Number at risk 0123 Health Centers Hospitals Years after ART start Proportion of patients retained (%)

13. Retention in care: hospitals vs. HCs by region 50 100 60 70 80 90 Proportion of patients retained (%) 832501289114Hosp. Paray 873508294131Hosp. Seboche 124779439556HCs Paray 79549028272HCs Seboche Number at risk 0123 Years after ART start HCs SebocheHCs Paray Hospital SebocheHospital Paray

14. Clinical outcomes, by region All analyses are adjusted for gender, age, baseline CD4 cell count, WHO stage, ART regimen and region

15. Limitations Heterogeneity between two regions Tracing of patients LTFU not consistent across sites Limited death ascertainment

16. Conclusion In rural Lesotho, patients who started ART in health centers had less advanced HIV disease than those in hospitals Health centers: overall retention slightly better and early losses less likely compared to hospitals. However, the determinants of retention in care (mortality, LTFU) differed across regions, underlining the importance of tracing patients LTFU

17. All patients and staff of the participating sites Collaborators from: SolidarMed Lesotho (N. Labhardt, M. Sello, M. A. Mohlaba) SolidarMed, Lucerne, Switzerland (J. Ehmer, K. Pfeiffer) University of Bern, Switzerland (M. Egger, O. Keiser) Financial support: NIH (NIAID, Grant U01AI069924) Acknowledgments