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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
• 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 nonphysician 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
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.
Low Risk Express Care
Setting
USAID-AMPATH Partnership Clinics
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
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)
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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.
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)
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.
Have you vomited within the last 48hrs?
Yes
No
Blood in Emesis
Move to next question
Unable to keep food down for 24 hrs
Unable to keep water down for 24 hrs
Unable to keep medications down for 48 hrs
Yes to Any
Call outreach vehicle for
immediate transport
No to All
Return the next day and ask
questions about vomiting
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’ HIVstatus
• 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
Enrollment: Figure 1
CCC Study
CCC Study
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
Future Research
• Combined Co-op and CCC model
• Pre-ART community based care
• Linkage of home-based testing with
community based care
Acknowledgements
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Moi Teaching and
Referral Hospital
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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