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1 Harvard School of Public Health PEPFAR Nigeria Tanzania Botswana April 17, 2005 Phyllis Kanki, PI
2 Population 130 Million Nigeria Million Tanzania Million Botswana 0.24 HIV Infectio AIDS Cases
3 Botswana National ARV Program Monitoring Statistics Indicator Result Female:male 63:37(%) Median baseline CD4 count 84 (range 1-849) Median CD4 increase after 12 months 166 cells/mm Patient follow-up 90% 5000 Adherence (zero tolerance) 85% 0 Jan-06 Apr-06 Jul-06 Oct-06 Jan-07 Apr-07 Jul-07 Time Oct-07 Jan-08 Apr-08 Toxicity requiring medication switch VL<400 copies at 6 months < 7% 86%* Enrolled On ARV Deaths Survival Probability (12 mo) 0.83
4 BOTSWANA - proposed program Expanded outpatient ARV at IDCC Princess Marina Hospital,Gabarone Establish second ARV clinic - Botsogo - Gabarone Roll-out KITSO training program to MDs, nurses, counselors
5 BOTSWANA - in-country modification Master Trainer Corps of local HIV/AIDS Care Trainers at ARV roll-out sites - coordinated with existing AIDS care training efforts Expand Monitoring and Evaluation/ Data Management capabilities of the National MASA ARV Therapy Program
6 KITSO - Setswana for knowledge the Botswana MOH national training program for AIDS care and ARV Classroom: 1394 AIDS Clinical Care Fundamentals 377 Laboratory Fundamentals 437 Intro to HIV, Biosafety, & MASA 52 Introduction to AIDS Clinical Care 30 Medication Adherence Counseling 2290 Total Trainees Practical 4 week training in all aspects of AIDS clinical diagnosis, management and treatment.
7 Botswana National ARV Program 32,000 patients on ART Paper Computer record system Need to track screening and care efforts Evaluate efficacy and toxicity outcomes Analyze drug resistance data with clinical outcomes Pharmaco-vigilance
8 Lessons Learned: Botswana human resource shortage - issue for hiring of personnel Training and long-term training needs are usually underestimated in ARV roll-out programs Optimal training involves at least three formats (classroom, practical, and continuing) M & E should be part of overall ARV Scale-up, not an add-on
9 Tanzania Treatment Centers - 3 Districts of Dar es Salaam Temeke Hospital - Temeke District Mwananyamala Hospital - Kinondoni District Amana Hospital - Ilala District Infectious Disease Center Muhimbili Research Clinic Target: ART to 3000
10 Tanzania - Training Includes training for ART and care Training plan for counseling, laboratory and pharmacy. Developed counseling reference Training synchronized with National AIDS Control Program
11 Tanzania -Infrastructure MUCHS-Harvard lab is fully equipped for all lab investigations (CBC, Chemistries CD4 cell counts and Viral Load) Quality Assurance program - proficiency testing, maintenance of equipment and training. Internet connectivity and computerized data entry
12 Tanzania - ARV Protocol ARV Treatment Planned visit schedule Visits Week Patient assessments Testing consent Visit ARV treatment consent MapCue review HIV test (if needed) Syphillis test Physician exam Counseling and patient education Medication dispensed Laboratory assessments Diag/Stage Pre-ARV Initiation ARV 2 wk Initiation follow-up Monthly follow-up visit q4wks q16wks after wee after wee CD4 Chemistries (SGPT/ALT min) NVP PRN Hematology (Hb minimum) AZT PRN Lipids
13 Tanzania Government of Tanzania ordered generic drugs ($2 million) - first line drugs available (Dec 2004) January 2005 adequate for 450 patients available to HSPH PEPFAR HIV+ patients - assess ART eligibility and provided prevention, care, and support. 715 patients on ARV on palliative care
14 Lessons Learned: Negotiations with Government of Tanzania for provision of first-line generic ARVs difficult to harmonize with PEPFAR program and goals All PEPFAR grantees will provide second line, alternative and salvage drugs (branded) Difficulties anticipated in coordinating first line drug supply
15 NIGERIA Target states Under Borno Oyo Plateau 10+ Lagos million HIV infected
16 Nigerian National ARV program ,000 adults and 5,000 children. Generic based 3 month stock-out - Nov January Despite significant international funding- no drugs bought Currently 16,000 on ARV treatment
17 350,000 patients to treat ARV sites - >100 patients a day. Infrastructure and capacity for scale-up and sustainability Target annually
18 Training and Capacity Building Clinical ARV management for physicians Ethical Issues in Research and Care Data management Universal Protection for healthcare workers Training modules and manuals for physicians on ART CD4/CD8 enumeration and viral load assays
19 HIV/STD Laboratory Capacity Building HIV: ELISA, rapid tests, Western blot Syphilis (TPHA/RPR) STIs N. gonorrhoeae Candida spp. C. trachomatis T. vaginalis Bacterial vaginosis OI and TB diagnosis CD4/CD8 counts Viral load and PCR Dx Drug resistance
20 Prevention of Mother to Child Transmission 4 sites developed through Gates funded APIN program Training of health care workers Development of labs Scale-up to cover major cities (50,000 pregnant women) PEPFAR provides ART to eligible mothers and infected infants Year 2 - PEPFAR will expand to 2 tertiary sites and 19 satellite clinics
21 APIN Plus/PEPFAR Enrollment ( ) National Institute of Medical Lagos University Teaching 68 Military Hospital University of Maiduguri Teaching University College Hospital Jos Univerisity Teaching Active Patients on ART Target Patients Total
22 Government Program % Viral Suppresion (<400 copies) % Viral Load Below Detection 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% All Sites JUTH 68 Military NIMR 6-12mo. >12mo.
23 Nigeria -Monitoring & Evaluation Toxicity and Efficacy reporting in real time to country coordinator Expedited Adverse Event Reporting (NIH 11.04) Weekly submission of all electronic records and week summary to country coordinator Regular site assessments: clinical care, pharmacy, laboratory QA/QC, financial/administrative
24 Community Support & Prevention Persons Living With AIDS (PLWA) Support groups - at each PEPFAR site VCT advocacy Patient ARV education Patient adherence support HIV Prevention and education Serve on Indigent Fund Committee
25 Lessons Learned: Government relations are key National ARV committee endorsement 1000Naira - no parallel tracks Regular communication on progress Build capacity - country ownership Successful implementation, scale-up and sustainability built on collaboration
26 HSPH PEPFAR Botswana R. Marlink Tanzania W. Fawzie Nigeria R. Murphy P. Kanki G. Tendani N. Ndwapi J. Mukhema I. Thior M. Mine C. Bussmann M. O Brien P. Cardiello G. Msamanga D. Mtasiwa G. Chalimilla E. Ekong W. Odutolu J. Idoko O. Idigbe I. Adewole C. Okany S. Akanmu W. Gashau C. Idehen D. Owujekwe
Phyllis Kanki Principal Investigator Harvard PEPFAR. Institute of Medicine Washington DC January 7, 2010
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