1University of Maryland; 2Futures Group International; 3CDC; 4USAID Sustained improvement in antiretroviral treatment outcomes in a large cohort in sub-Saharan Africa: bucking the trend Authors: Ojoo SA1, Nganga L2, Odhiambo FA1, Wandina D1, Ooko H2, Ngethe R2, Nganga LW3, Odek J4, Burrows L2, Redfield R1 1University of Maryland; 2Futures Group International; 3CDC; 4USAID

Baggaley, 2012; Boulle, 2010; Nglazi, 2011; Introduction Kenya has successfully expanded access to ART, with over 600,000 patients on ART by December 2012. Scale-up has occurred within an acute care health system, with suboptimal capacity for chronic care Published reports demonstrate increased rates of loss to follow-up (LTFU) with each calendar year of patient enrolment Attrition may minimize gains anticipated with expanded treatment coverage. Globally 9.7 m patients were on ART by Dec 2012; Kenya contributed over 600k to this figure. Remarkably this expansion of services has occurred within a HC system designed to support acute episodic care, with suboptimal capacity for chronic care services. Published reports from SSA indicate that with HIV service expansion, patient retention in care may be a growing challenge, with increased rates of loss to follow-up (LTFU) with each calendar year of patient enrolment observed. Baggaley et al. 2012; World Health Organization 2012; Granich et al. 2009; Lancet 373, 48–57; Boulle et al. 2010; AIDS 24, 563–572. Nglazi et al. 2011 Journal of Acquired Immune Deficiency Syndromes 56, e1–e8. Baggaley, 2012; Boulle, 2010; Nglazi, 2011;

Background: AIDSRelief Program A robust chronic care model developed Community-facility linkage Prioritized patient case-management Standardized patient encounter tools Electronic HMIS (IQCare) Capacity for data-driven process & patient care improvement AIDSRelief Kenya Sites: This presentation is based on data from the AR program, PEPFAR funded program implemented in 10 countries including Kenya, where 29 facilities were supported to provide HIV prevention, care and treatment services. From the outset a robust chronic care model was defined for implementation and comprised CBTS, patient case management recognizing that patient vulnerability is dynamic, standardized patient encounter tools, EMR, DDIU/QI. The degree to which the model was implemented was fairly uniform across sites. CRS was the prime with the University of Maryland responsible for the the technical strategy.

Objective To describe the yearly trends in retention and attrition rates of patients on ART in the AIDSRelief Kenya program.

Methods Retrospective analysis of de-identified data of adults age >15 years, enrolled on ART from 2004-2012 Patients missing DOB, transferred-out were excluded. Year of ART start was main explanatory variable, and 12-month retention the main end-point Rates were derived from K-M survival probability estimates Cox proportional hazards used to determine effect of year of ART start, adjusted for baseline characteristics Wald confidence limits used for all time-event analyses Retrospective analysis of de-identified data of adult patients enrolled on ART in this program. Rates were derived from Kaplan-Meier (K-M) survival probability estimates with 95% confidence limits calculated around the survival probabilities. Patients in the AR program did not have access to routine VL testing, thus as part of program quality reviews patient level outcomes were assessed periodically based on viral load measurement in a sample of patients. Cox proportional hazards models were used to determine effect of year of ART initiation adjusted for relevant baseline characteristics. Wald confidence limits were used for all time-to-event (K-M and multivariate) analyses. Jan-Mar 2011, HIV RNA measurements (Cavidi ExaVir®Load) carried out in a random sample of 1,114 patients on ART for >12m [median (IQR) duration on ART 52 (34.5-64) months] On-treatment suppression (HIV RNA<200 copies/ml) rate calculated

Results Data was analyzed for 64,259 adults, followed up on ART, for a median duration of 31 (IQR 11-53) months. 68% of patients female; median baseline age 37 (IQR 30-44) years 68% of patients were from rural facilities Median baseline CD4 count was 204 (IQR 101-303) cells/mm3 On-treatment viral RNA suppression rate in 1,114 patients was 93.7% Viral suppression rate based on the cavidi platform and a cut off of 200 c/ml

Location of Point of Service Baseline characteristics by year of ART start Location of Point of Service WHO clinical stage at ART start Baseline median CD4 count % with CD4 < 50 stable at 8-10% This is predominantly rural program. cohort entering care became healthier over time as shown in this slide. There was improvement in documentation with significant decline in undocumented bWHO Stage, indicated in red, from 45% in 2004/05 to 2% in 2012. Median baseline CD4 count increase from 150 (IQR 73-255) cells/mm3 in 2004/05 to 254 (IQR 130-341) cells/mm3 in 2012. Documentation of the CD4 count at baseline also increased from 56% in 2004 to 78% in 2012. % of patients with CD4 < 50 remained stable at 8-10%. Documented opportunistic infections at ART Initiation declined significantly over time, from 44% in 2004/05 to 15% in 2012.

12-month cohort retention and attrition rates ART Start Cohort Year Number of Patients Starting ART Retention (%) 95% CI Mortality (%) LTFU (%) 2004/05 4,081 83.8 82.6-84.9 11.6 10.6-12.6 7.1 6.3-8.0 2006 5,710 87.0 86.1-87.9 8.5 7.8-9.3 5.8 2007 7,259 84.8 83.9-85.6 8.3 7.6-8.9 7.3 6.6-7.9 2008 8,880 83.5 82.7-85.1 7.6 7.0-8.2 9.3 8.7-10.0 2009 10,213 84.4 83.7-85.1 7.7 7.2-8.2 8.0 7.4-8.5 2010 10,616 86.4 85.7-87.0 6.7-7.6 6.5 6.0-7.0 2011 8,804 88.8 88.1-89.0 6.1 5.7-6.7 4.1 3.7-4.5 2012 9,696 93.0 92.1-93.8 4.5 3.8-5.3 2.2 1.8-2.6

Loss to follow up over time by year of ART start 2008 – poor rates as a result of an election gone bad. Duration (in months) on ART

Mortality over time by year of ART start Mortality fell from 11.6(10.6,12.6) to 4.5(3.8,5.3)% Duration (in months) on ART

Retention over time by year of ART start Duration (in months) on ART

CQI/DDIU Guided Interventions (THPE077) 12m probability of retention, mortality & LTFU by ART initiation cohort CQI/DDIU Guided Interventions (THPE077) Looking at the cohorts of patients starting ART in each calendar year, the overall retention rate increased from 83.8% (95% CI 82.6-84.9) to 93% (95% CI 92.1-93.8) Mortality rate decreased from 11.6% (95% CI 10.6-12.6) to 4.5% (95% CI 3.8-5.3) LTFU rate declined from 7.1% (95% CI 6.3-8.0) to 2.2% (95% CI 1.8-2.6)

Conclusion 12-month probability of retention improved significantly during 8 years of patient follow-up in this large cohort (185,512 patient years of follow up) A significant and sustained reduction in LTFU rates in successive calendar years was observed; inconsistent with several publications As would be expected, there was a significant reduction in mortality rates over the 8-year period Degree of reduction in mortality - published

Conclusion These outcomes, increasing retention, as a result of declining mortality & LTFU rates, as well as high viral suppression, suggest that programmatic conditions for optimal population impact of expanded ART coverage can be achieved in resource-limited settings. Degree of reduction in mortality - published

Acknowledgement PEPFAR-CDC/HRSA Facilities, staff and patients University of Maryland Futures Group International Catholic Relief Services Catholic Medical Missions Board Robert Redfield Lucy Nganga Francesca Odhiambo Hesbon Ooko Daniel Wandina Lucy Wanjiku Nganga James Odek