1	Decentralizing ARV Therapy through Faith-Based Health Care Networks Anthony Amoroso, MD Assistant Professor of Medicine University of Maryland School of Medicine Institute of Human Virology Director HIV Services, VA Maryland Health Care System Medical Advisor, AIDSRelief-PEPFAR
2	AIDSRelief Consortium Catholic Relief Services Catholic Medical Missions Board Interchurch Medical Assistance Institute of Human Virology/University of Maryland School of Medicine Futures Group
3	In Dec 2000 only 50,000 pts estimated to be on ART in all of sub Saharan Africa. The Global AIDS fund, WHO’s 3 by 5 Program and the PEPFAR each are poised to accelerate access to antiretroviral therapy particularly in resource constrained countries confronting HIV/AIDS.
4	Total USG global expenditure in HIV/AIDS in 2004 was $2.217 billion $317 million spent on research $547 million to global aids fund $845 million to PEPFAR countries
5	Magnitude of the Challenge Providing durable ART therapy in terms of decades Providing treatment that is scalable in terms of 100,000s of patients The urgent need to begin expanding treatment programs in the setting of few local experienced ART providers and few continuity clinics Limited evidence based data, in the different targeted populations, to guide clinical decision making process
6	45% of Eligible US Patients Not On HAART
7	Decentralizing HIV Care to the Community Clinic Level Will Be Essential to Meet Treatment Needs and Goals (WHO “Public Health Approach”)
8	2004 WHO “3 by 5” report: Estimated 700,000 patients on ARV worldwide PEPFAR 67,000 directly supported by 300 USG supported health facilities Only 40,000 “new” patients directly supported MSF 12,058 patients on ARV AIDSRelief supports a reported 15,500 patients directly “supported” over 12,000 “new” patients 54 sites
9	AIDSRelief Contribution to PEPFAR 2004 Country AIDS AIDSRelief % Total ART* Releif** of ART PTs Guyana 400 49 12.25% Haiti 2800 156 5.57% Kenya 8000 4403 55.04% Nigeria 5700 831 14.58% Rwanda 4200 0 0.00% So.Africa 4900 2537 51.78% Tanzania 1500 756 50.40% Uganda 26400 5847 22.15% Zambia 3400 977 28.74% Total 57,300 15,556 27% * From PEPFAR Annual Report to Congress ** From AIDSRelief Dec 04-Feb 05 Quarterly Reports to CDC
10	The Challenge of Decentralization Decentralized faith based healthcare infrastructure: very few tertiary referral hospitals working with mostly small rural mission hospitals, rural dispensaries run by nursing staff, home based care projects with community nurse support only Different treatment populations: from pregnant women, infants, children, very advanced AIDS, previous treatment experienced patients, significant SD NVP exposure, to asymptomatic ambulatory patients Markedly different socioeconomic factors: from working urban residents, to displaced refugees with enormous food insecurities.
11	Challenge/Struggle/Dilemma Ensuring equal access to quality care in a decentralized health care infrastructure The need to not forfeit quality clinical care in the process
12	"“The reason for high..." “The reason for high mortality rates at some sites is simple but depressing: Patients become ill because of TB or some other OI; they think they may have HIV; they attend VCT; they present to an ART program faced with targets and bereft of basic diagnostic capabilities; they are placed on ART; they die of the OI or of immune reconstitution syndrome.” J. Fielder, Kijabe Hospital Kenya
13	Only $12 million spent directly on the purchase of ARV drugs within PEPFAR ARV drug related costs are estimated to be less than 30% of total care package to support ART. “Drug costs are no longer the fundamental obstacle for treatment” PEPFAR congressional report
14	Lack of human resources without a doubt are the critical limiting element for scale up Little experience exists in the treatment of HIV outside of developed world This is particularly severe for treatment of children building clinical capacity/ experience in medical, lab, and basic sciences was not adequately addressed prior to availability for ARV drugs Real mentored medical education of MD, RN, lab, other health care professional Lab diagnostic systems, evaluation systems, information systems, drug procurement/distribution, logistic systems, are costly and were non existent in many cases simple medical records do not exist at many treatment facilities
15	Challenge/Struggle/Dilemma Efforts to date are using the experienced providers to maximal degree and utilized the “best” sites to have treated the current patients Ability to reach beyond established programs, beyond tertiary govt. referral hospitals and into rural settings, small mission hospitals, small govt. hospitals will take an enormous amount of experienced human resources, concerted and reasoned planning and monetary resources.
16	Keys to Efficient Scale-UP Rapid and lasting improvement in clinical capacity Breaking paradigm that physicians have to complete initial patient encounter and prescribe ARV Strong emphasis on patient preparation and family directed care
17	Improving Clinical Capacity Four major working premises Improving what we have Initiate process to foster existing provider expertise. 2. Building new sustainable capacity Increase treatment expertise throughout the decentralized network 3. Increase utilization of all medical personnel 4. Support after training Maintaining continuous communication and QA/QI process
18	Developing Clinical Centers of Excellence Already there exists outstanding HIV care programs and experienced providers within AIDSRelief. Some sites have different strengths, being large volume management, adherence treatment support programs, clinically strong medical director, well organized nurse based home based care programs Developing these sites into “centers of excellence” to support scale up of new sites in the surrounding area. Allows for a modeling approach for development of a treatment plan for initiating AVR and provides a training center for new/novice providers to gain clinical experience in a supportive setting
19	Optimizing non-physician staff to support HIV care and treatment Equip existing community nursing /community health workers with: Clear identification/ establishment of expectations of what different levels of providers should be accomplishing. Integrate staff to improve overall efficiency of continuity of care Build fund of knowledge and improve clinical judgment What is critical, what should be addressed immediately, what should be referred, etc….
20	Treatment preparation Acceptance of HIV status Spousal and guardian disclosure/notification Willing to be visited at home Referral by community health worker/patients Compliance with multiple clinic visits Septrin pill counts Pill box Attendance at treatment preparation seminar
21	Utilization of current health care strengths: Community Nursing and Health Workers Prior to ARVs, Counseling is done Home visits performed Pill counts are performed Family support assessed Frequent home visits emphasized for first few weeks following ARV initiation DOT for 2-4 weeks Home visits 3X week until improvement
22	Treatment preparation Most patients well-prepared to start ARVs Better acceptance of HIV status Higher compliance compared with previously treated patients Patient and family understanding of HIV and ART greatly increased after treatment preparation seminar Follow-up is facilitated through home visits and support groups
23	FBO Keys to Success Strong community referral networks with trained community health workers Pre-existing Home visits by nurse and adherence staff, now including HIV-positive persons A network of support groups Standardized treatment preparation Team cohesion with frequent meetings (community and clinical) Emphasis on diagnosis and treatment of opportunistic infections, particularly CNS infections and TB Pre-existing hospital infrastructure has been vital in this regard Clinicians dedicated to providing comprehensive care
24	"“Tuesday we reviewed the..." “Tuesday we reviewed the files of 34 patients from a rural and impoverished area who are currently on ARVs. There had not been one missed appointment among this cohort (we did have one default and one death from this region). We just started our first mobile clinic to this region; the project vehicle is key to reaching patients and providing access to care.”
25	Negatives to current approach Slower enrollment Process sometimes must be compromised to reach patient targets A few patients feel stigmatized More expensive initially (staffing) In the long run, will be less expensive by preventing resistance, need for second line regimens, and hospitalizations
26	Comprehensive “delivery” of care Kijabe Hospital-Kenya Individual counseling is done by the nurse, social worker, or clinician Guardian required Disclosure required Treatment preparation seminar is mandatory Barriers to adherence questionnaire and treatment contract emphasize important points prior to initiation Home visits, especially early in the course of therapy, and support groups are crucial Post-pharmacy counseling done for all patients until stable Pill box and medication chart filled Pills counted prior to departure from hospital Regimen explained Nutrition assistance (now under private funding) distributed to needy patients
27	"“I" “I should state that not all patients…do well. Some just never understand, or are never able to understand, because of cognitive dysfunction induced by HIV and/or an OI. Others have such weak social supports that the burden of the disease and ART is just too great. But these are the uncommon exceptions in our program. Community efforts can have a tremendous transformative effect when it comes to stigma and compliance. ” Fielder
28	Future directions Devolving care of stable patients to sites closer to patients’ homes through mobile clinics, dispensaries, and community health workers Besides stigma, the biggest obstacle we face is transport. Utilization of best available antiretroviral agents over emphasis on immediate cost to access ARVs driving unfavorable regimen selection Identifying HIV and beginning treatment earlier in the disease process Guidelines for ARV initiation for only symptomatic patients severely complicating and increasing costs of medical care
29	"The pathway to achieve long..." The pathway to achieve long term durable benefits of antiretroviral therapy in different settings remains to be defined Durability of ARV induced viral control in the end will determine ultimate access, scalability and sustainability of current and future ARV programs.