. WOOLS-KALOUSTIAN M.D. M.S. ASSOCIATE PROFESSOR OF MEDICINE INDIANA UNIVERSITY SCHOOL OF MEDICINE Beyond the Primary Health Care Center

Successes: ART Roll-Out

Challenges: Human Resources and Resource Distribution Delays in rollout are in part due to the substantial human resources necessary to establish and maintain an HIV care delivery infrastructure. Sub-Saharan Africa home to only 3% of the world’s health care workers – Home of two thirds of persons living with HIV/AIDS – Increasing survival rates on ART – 2010 guidelines: increases the number of individuals in need of ART Commands less than 1% of the world’s health expenditures – External Brain Drain Delays in rollout may also be related to the geographic distribution of resources. Slightly less than 60% of the population resides in rural areas. – Health care workers are concentrated in urban areas » High rural Doctor: population ratios » Western Cape ratio 10X that of rural provinces in South Africa

Addressing the Challenges 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 constrained settings is limited. Experience with models of care beyond the clinical setting is particularly lacking

QUEUES at the Rural Clinic

Community Care Coordinator (CCC) Study: Objective To assess whether community-based care by Persons living with HIV/AIDS and with a secondary school education (Community Care Coordinators (CCCs) could replace clinic-based care for people living with HIV/AIDS. CCC Study

Setting Low Risk Express Care USAID-AMPATH Partnership Clinics

Setting Study conducted within the HIV Clinic and the community surrounding the Mosoriot Rural Health Center Serves Kosirai Division, a community of 60,000 in a province with an estimated HIV prevalence of 7.4%. The center cared for nearly 4,000 HIV infected adults, over half of whom were receiving ART. 24 geographic regions called sub-locations Unit of randomization CCC Study

Methods: Standard of Care Monthly clinic visits for patients on ART Seen by a nurse who triaged and obtained vital signs Seen by a clinical officer or physician (~10% of visits) interim history addressed acute concerns reviewed medications and adherence prescribed ART and OI prophylaxis. Seen by pharmacy tech or pharmacy nurse provided with a one month supply of all medications. Requires contact with a minimum of 3 health care providers.

Methods: Design and Randomization Prospective community cluster randomized controlled clinical trial. Community (sub-location) randomization stratified by distance from the road Adjacent to Road Non-Adjacent to Road 1 intervention group: 2 control groups (Standard of Care) CCC Study

Community Care Coordinators = Community Health Workers Chosen from HIV clinic population clinically stable 100% adherence to ART over the six months prior to recruitment considered by the clinic staff to be a good role model and mentor for other patients CCC Study

Intervention Monthly home assessments by CCCs using PDA to record ART adherence, vital signs and patient symptoms. – Responsible for 2/3 of the HIV care visits Routine clinic visit every 3 months. CCC Study

Methods: PDA pre-programmed with symptom/adherence questions. Alerts were triggered when responses fell outside of pre-established parameters. CCC Study

Inclusion and Exclusion Criteria Inclusion Criteria <18 years old Stable on ART X 3 months No adherence issues Household members were aware of the patients’ HIV- status Lived in Kosirai Division Willing to consent to participate Exclusion Criteria Active WHO stage 3 or 4 condition Pregnant Hospitalized in previous three months Unable to participate in the informed consent process CCC Study

Methods: Statistical Analysis Outcome Measures: Adherence, VL, New OIs, stability of ART, Pregnancies and number of clinic visits Analysis : intention to treat Comparison of continuous variables Two-sample Student’s t-test (normal distributions) Wilcoxon rank-sum test for skewed variables Comparisons of proportions for dichotomous variables Fisher’s exact test. Event-free survival Kaplan-Meier methods log-rank test : comparison of time to event Adjustment of the analyses for unbalance covariates – Cox proportional hazard regression model CCC Study

Enrollment: Figure 1

CCC Study

CCC Conclusions CCCs with secondary school education and mobile computer-based decision support can provide safe and effective HIV care. These results support WHO’s recommendation that people living with HIV/AIDS be used as part of an HIV-care model that shifts specified care tasks away from health care providers to lay individuals. Similar Study: Rates of virologic failure in patients treated in a home-based care program versus a facility-based HIV-care model in Jinja, southeast Uganda: A cluster-randomized equivalence trial (Jaffar 2009) – Lay worker versus facility based care – Findings similar: no differences in virologic, immunologic, or clinical outcomes CCC Study

Future Research Combined Co-op and CCC model Pre-ART community based care Linkage of home-based testing with community based care

Acknowledgements Doris Duke Charitable Foundation Indiana University School of Medicine Moi University School of Medicine Moi Teaching and Referral Hospital United States Agency for International Development-Academic Model for Providing Access to Healthcare ( USAID-AMPATH) Sylvester Kimaiyo Joe Mamlin Robert Einterz William Tierney Hank Selke Raj Vedanthan Emmanuel Kemboi The staff and patients of USAID-AMPATH Moi Teaching and Referral Hospital