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. Wools-Kaloustian M.D. M.S. Associate Professor of Medicine Indiana University School of Medicine

Beyond the Primary Health Care Center. . Wools-Kaloustian M.D. M.S. Associate Professor of Medicine Indiana University School of Medicine. Successes: ART Roll-Out. Challenges: Human Resources and Resource Distribution.

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. Wools-Kaloustian M.D. M.S. Associate Professor of Medicine Indiana University School of Medicine

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  1. Beyond the Primary Health Care Center .Wools-Kaloustian M.D. M.S.Associate Professor of Medicine Indiana University School of Medicine

  2. Successes: ART Roll-Out

  3. 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

  4. 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

  5. QUEUES at the Rural Clinic

  6. CCC Study 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.

  7. Setting USAID-AMPATH Partnership Clinics Low Risk Express Care

  8. CCC Study 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

  9. 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.

  10. CCC Study 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)

  11. 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

  12. 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.

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

  14. CCC Study Inclusion and Exclusion Criteria Inclusion Criteria Exclusion Criteria Active WHO stage 3 or 4 condition Pregnant Hospitalized in previous three months Unable to participate in the informed consent process • <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

  15. 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

  16. Enrollment: Figure 1

  17. CCC Study

  18. CCC Study

  19. 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

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

  21. 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

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