K. Wools-Kaloustian , R. Kosgei, S. Kimaiyo, P. Braitstein, E. Sang,

1. Low risk express care: A nurse-centered model for the management of stable patients on combination antiretroviral therapy (cART) K. Wools-Kaloustian, R. Kosgei, S. Kimaiyo, P. Braitstein, E. Sang, B. Musick, C. Yiannoutsos, A. Siika

2. Low Risk Express Care Background • ART rollout in resource-constrained settings has been slow. • More than 5 million of the 9.5 million people living in low- and middle-income countries in need of ART are still without access to treatment. • Delays in rollout are in part due to the substantial financial and human resources necessary to establish and maintain an HIV care delivery infrastructure. • Sub-Saharan Africa is the home of two thirds of persons living with HIV/AIDS but only 3% of the world’s health care workers and commands less than 1% of the world’s health expenditures.

3. Low Risk Express Care Background • To maximize access to ART in resource-constrained settings, leaders in international health have advocated: • The decentralization of HIV care • Use of existing infrastructure • A shift from physician-centered care models to those utilizing non-physician health workers trained in simplified and standardized approaches to care • Experience with feasible models of task shifting in HIV care programs in resource poor areas is limited

4. Low Risk Express Care Methods: Objective • To evaluated the impact of “Low Risk Express Care” (LREC), a program in line with WHO's recommendation to shift much of the responsibility of HIV-care from physicians and mid-level practitioners (clinicians) to nurses.

5. Low Risk Express Care Methods: Setting USAID-AMPATH Partnership Clinics

6. Low Risk Express Care Methods: Eligibility • LREC eligibility criteria: • >18 years • Stable on cART > 6 mo • CD4 count > 200 cells/µl • No active opportunistic infection • No history of adherence issues

7. Low Risk Express Care Methods: Model ▪▪▪ Responsible during all visits ▪▪ Responsible during two thirds of visits ▪ Responsible during one third of visits P= Physician; CO= Clinical Officer; N = Nurse

8. Low Risk Express Care Methods: Analysis Patient 1 • A retrospective analysis including data from the 12-month period both pre and post introduction of LREC Patient 2 Patient 3 Patient 4 Introduction of LREC – 12 mo. Introduction of LREC Introduction of LREC + 12 mo

9. Low Risk Express Care Methods: Analysis • Outcomes of interest between groups and time dependent • Adherence • CD4 Response ( square root of CD4) • Death/LTFU (LTFU define as no visit for 6 months) • Data were analyzed using: • Descriptive statistics • Longitudinal analyses • Proportional hazards regression models addressing time until loss-to-follow-up or death • Analyses were weighted by propensity scores to adjust for differential LREC enrollment

10. Low Risk Express Care Results: Univariate Analysis • 17,922 patients were eligible for LREC with 38.2% enrolling • Enrolled and non-enrolled groups were equivalent with regard to: • Gender : 70% female • Median age: 36 years • The LREC-enrolled group had a significantly: • Higher median CD4 count at: • cART initiation: 143 versus 135 cells/µl (p = 0.015) • LREC eligibility: 326 versus 301 cells/µl (p< 0.0001) • Lower WHO stage at: • cART initiation: Stage I/II 49.7 versus 46.6% (p = 0.0002) • LREC eligibility: Stage I/II 52.0% versus 47.4% (p< 0.0001) • Less likely to be cared for at the Referral Hospital • 20.6% versus 34.1% (p< 0.0001)

11. Low Risk Express Care Results: Logistic-Regression Model for Enrollment

12. Low Risk Express Care Results: Adherence Longitudinal Model

13. Low Risk Express Care Results: Adherence Average probability of being perfectly adherent by weeks from eligibility for EC

14. Low Risk Express Care Results: Factors associated with square root CD4 counts after EC eligibility

15. Low Risk Express Care Results: CD4 Trajectory Adjusted analysis of CD4 trajectory for enrollees in EC and those patients not enrolled

16. Low Risk Express Care Results: Risk of LTFU/Death

17. Low Risk Express Care Limitations • Biases Related to: • Referral versus non-referral clinic site • Make-up of cohort and duration of cohort involved in each of these sites • Frequency of CD4 count testing (variability between Referral Hospital and other sites) • Frequency of Adherence assessment

18. Low Risk Express Care Conclusions • Patients with higher CD4 counts and less advanced HIV disease, treated at rural health centers, were preferentially enrolled into LREC. • After adjusting for this finding, LREC appears to have no adverse impact on patient outcomes and may decrease the rate of loss to program (LTFU or Death). • More rigorous assessments of task shifting are necessary in order to unequivocally conclude that these models are equivalent or better than the current standard of care. • Randomized Controlled Trials

19. Acknowledgements • Indiana University School of Medicine • Moi University School of Medicine • Moi Teaching and Referral Hospital • This research was supported in part by a grant to the USAID-AMPATH Partnership from the United States Agency for International Development as part of the President’s Emergency Plan for AIDS Relief (PEPFAR). Moi Teaching and Referral Hospital