East Africa Regional CD4 Workshop: The Role of CD4 Testing During Viral Load Scale-Up

Transcription

1 East Africa Regional Workshop: The Role of Testing During Viral Load Scale-Up May 2017 Nairobi, Kenya 1

2 Background... 3 Strengthening the Interface between Diagnostics and Care... 3 Country Needs and Gaps Analysis... 5 Burundi:... 5 Kenya:... 8 Rwanda: Tanzania: Uganda: Clinical Continuum of Care Quality Assurance Connectivity Country Presentations: Clinical Continuum of Care Country Presentations: Laboratory Systems Strengthening Discussion Appendix 1 - Agenda Appendix 2 - List of Participants Appendix 3 Summary of Country Needs and Gaps Acknowledgements

3 Background In 2014 UNAIDS launched their ambitious target to help end the AIDS epidemic. The goal, by 2020, is for 90% of all people living with HIV to know their HIV status, 90% of all people knowing their HIV status to be on antiretroviral therapy, and 90% of all people receiving antiretroviral therapy to be virally suppressed. The 2016 WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection recommended that all patients who tested positive for HIV initiate antiretroviral therapy regardless of count and emphasized that viral load monitoring should be used to determine treatment failure. The introduction of the 2016 WHO Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection resulted in some confusion for country programs on the future role of testing in light of countries scaling up viral load testing. As a result, the International Diagnostics Centre (IDC) organized a workshop during ASLM2016 to try and clarify some of the critical issues related to the use of testing in the management of HIV infection. The report from the ASLM2016 workshop can be found here. One recommendation from the ASLM2016 workshop was for the IDC to organize regional workshops to better understand the role of testing in country programs as they are scaling up viral load testing. As a result, the IDC organized the first regional workshop in Nairobi on May 2017 and invited the five countries from the East African Community (Burundi, Kenya, Rwanda, Tanzania and Uganda) to participate. This report is a summary of the country situational analyses on country preparedness for VL scale up, demand forecasts, and funding needs to sustain testing for patient management. Strengthening the Interface between Diagnostics and Care Lara Vojnov from the WHO presented on the role of and viral load testing and the rationale for the recommendation from the WHO to treat all people living with HIV regardless of cell counts. Several studies have shown a strong correlation between increasing viral load with increased risk of HIV transmission. Scale up of viral load testing has been slower than anticipated, especially in Sub-Saharan Africa (SSA). Currently routine viral load is fully implemented in 47% of low and middle-income countries and partially implemented in 26%. In SSA, only four countries (Botswana, Kenya, Namibia, and South Africa) have wellestablished viral load programs that have been scaled up and has increased access for people living with HIV. All other countries in SSA are either piloting, recently rolling out their viral load program, or still in the planning phase. 3

4 The WHO treatment guidelines recommend routine viral load monitoring should be carried out at 6 months and at 12 months after initiating antiretroviral therapy (ART) and then every 12 months thereafter if the patient is stable on ART. The guidelines further state that monitoring can be stopped for individuals who are stable on ART and virally suppressed, and receive routine yearly viral load monitoring. The WHO treatment guidelines still recommend the use of testing for clinical management. count is the best predictor for disease status and immediate risk of death and thus should be used to identify those who have advanced HIV disease. Patients who are unstable or have advanced HIV disease should receive a test every six months until stable. The new Advanced Disease Guidelines (to be published July 2017) will define a package of care for people with advanced disease. Performing a test at baseline is important because even though many countries have adopted test and treat, the percentage of patients starting ART with advanced disease has not changed and new data suggest that up to 50% of patients with advanced disease are asymptomatic. Data from the IeDEA cohort suggests that 25-50% of people are starting ART with advanced HIV disease. There are different thresholds for potential interventions for people with advanced HIV disease: What Threshold Why Identification of patients with advanced HIV disease 200 Increased risk of death Clinical stage has poor sensitivity LF-LAM for TB 100 Poor diagnostic accuracy at higher cell counts CrAg for cryptococcal meningitis 100 (200?) Limited cost-effectiveness at higher cell counts Threshold to be reviewed CTX prophylaxis 350 Clinical benefit Pre-emptive therapy for cryptococcal meningitis 100 (200?) Clinical benefit Threshold to be reviewed Tailored adherence counseling 200 Clinical benefit Strengthening the Interface between Diagnostics and Care Countries need a clearer understanding, as well as support and planning, for the scale up of viral load testing and the role for testing, as well as thresholds Scale up of viral load testing has been slow, leaving a gap in patient management WHO treatment guidelines still recommend the use of testing for clinical management Patients should receive a test at baseline for risk assessment and testing should be continued for patients who remain unstable or with advanced HIV disease New Advanced Disease Guidelines will define a package of care for people with advanced disease Up to 50% of people with advanced disease may be asymptomatic 25-50% of people are starting ART with advanced HIV disease 4

5 Country Needs and Gaps Analysis A questionnaire was sent to the country programs in advance of the workshop to gain a better understating on the status of their viral load scale up as well as to provide some demand forecast for both viral load and testing. Burundi: HIV Status Treatment Monitoring Treatment Patient Manage ment HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 57,233 61,538 Yes 500 9,621 42,169 5,443 Demand Forecasts - Testing Volumes 2016 Coverage Total tests 36,977 8,600 4,806 4,305 ART Eligibility 0 8,600 4,806 4,305 Treatment Monitoring Patient Management (<200 ) 36,977 46% Demand Forecasts - Viral Load Testing Volumes Total Viral Load Tests 11,086 20% 41,950 53,196 72,355 Testing Volumes by Instrument (Number of Tests) Lab 23,813 5,710 1,615 2,859 POC 13,164 2,890 3,191 1,446 Viral Load Lab 11,086 Viral Load POC 0 5

6 Utilization Rates Lab 66% POC 34% Viral Load Lab 100% Viral Load POC 0% Testing Volumes Number of Tests Total Tests ART Eligibility Demand Forecast - and Viral Load Number of Tests Viral Load

7 30000 Testing Volumes by Instrument Number of Tests Lab POC % 2016 Current Lab vs. POC Testing 100% 75% 50% Viral Load 25% 0% Lab POC Lab POC 7

8 Kenya: HIV Status Treatment Monitoring Treatment Patient Manage ment HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,419, ,182 Yes 41,383 1,135, ,673 Demand Forecasts - Testing Volumes 2016 Coverage Total Tests 864,000 N/A 32,592 N/A ART Eligibility 800, Treatment Monitoring Patient Management (<200 ) , ,000 5% 0 32,592 0 Demand Forecasts - Viral Load Testing Total Viral Load Tests 857,530 80% 325,915 32,592 0 Testing Volumes by Instrument (Number of Tests) Lab ,814 0 POC 0 0 9,778 0 Viral Load Lab 857,530 Viral Load POC 0 8

9 1,200,000 Testing Volumes Number of Tests 900, , ,000 Total Tests ART Eligibility Treatment Monitoring Patient Management Demand Forecast - and Viral Load Number of Tests Viral Load

10 30000 Testing Volumes by Instrument Number of Tests Lab POC Rwanda: HIV Status Treatment Monitoring Treatment Patient Manage ment HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 215, ,462 Yes 22, ,471 59,460 Demand Forecasts - Testing Volumes 2016 Coverage Total Tests 26, % Treatment Monitoring Patient Monitoring (<200 ) Demand Forecasts - Viral Load Testing Volumes Total Viral Load Tests 154,322 86% 196, ,453 10

11 Testing Volumes by Instrument (Number of Tests) Lab 18,720 25,814 15,049 POC 7,280 10,039 5,852 Viral Load Lab 154,322 Viral Load POC 0 Utilization Rates lab 72% POC 28% Viral Load Lab 100% Viral Load POC 0% Demand Forecast - and Viral Load Number of Tests Viral Load

12 25000 Testing Volumes by Instrument Number of Tests Lab POC % 2016 Current Lab vs. POC Testing 100% 75% 50% Viral Load 25% 0% Lab POC Lab 12

13 Tanzania: HIV Status Treatment Monitoring Treatment Patient Manage ment HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,385,779 1,325,271 Yes 740, , ,466 Demand Forecasts - Testing Volumes 2016 Coverage Total Tests 2,534,272 1,336, , ,733 ART Eligibility 1,291,562 70% Treatment Monitoring Patient Management (<200 ) 1,171,014 70% 1,336, , ,733 71, Demand Forecasts - Viral Load Testing Volumes Total Viral Load Tests 183,549 16% 1,336,254 1,519,694 1,881,681 Testing Volumes by Instrument (Number of Tests) Lab 935, POC 400, , ,733 Viral Load Lab 183,549 Viral Load POC Utilization Rates Lab 70% POC 40% Viral Load Lab 100% Viral Load POC 0% 13

14 3,000,000 Testing Volumes 2,250,000 Number of Tests 1,500,000 Total Tests ART Eligibility Treatment Monitoring Patient Managment 750, ,000,000 Demand Forecast - and Viral Load 2,250,000 Number of Tests 1,500, ,000 Viral Load

15 1,000,000 Testing Volumes by Instrument 750,000 Number of Tests 500,000 Lab POC 250, ,000,000 Testing Volumes by Instrument Number of Tests 750, , ,000 Lab POC

16 125% 2016 Current Lab vs. POC Testing 100% 75% 50% Viral Load 25% 0% Lab POC Lab Uganda: HIV Status Treatment Monitoring Treatment Patient Manage ment HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,507,475 1,079,059 Yes 75, , ,214 Demand Forecasts - Testing Volumes 2016 Coverage Total Tests 582, , , ,673 ART Eligibility 69,297 12% 296, , ,307 Treatment Monitoring Patient Management (<200 ) 513,646 56% 34,208 36,118 40, ,055 94, ,707 Demand Forecasts - Viral Load Testing Volumes 16

17 Demand Forecasts - Testing Volumes Total Viral Load Tests 673, % 1,200,000 1,493,654 1,786,278 Testing Volumes by Instrument (Number of Tests) Lab 448, ,171 97,895 74,668 POC 134, , , ,004 Viral Load Lab 665,904 Viral Load POC 7,260 Utilization Rates lab 23% POC 77% Viral Load Lab 99% Viral Load POC 1% 17

18 700,000 Testing Volumes 525,000 Number of Tests 350,000 Total Tests ART Eligibility Treatment Monitoring Patient Management 175, ,250,000 Demand Forecast - and Viral Load 1,800,000 Number of Tests 1,350, ,000 Viral Load 450,

19 500,000 Testing Volumes by Instrument Number of Tests 375, , ,000 lab POC The country is in the process of rolling out EID POC by August 2017 (GeneXpert, Alere Q, Samba) 125% 2016 Current Lab vs. POC Testing 100% 75% 50% Viral Load 25% 0% Lab POC Lab POC 19

20 Clinical Continuum of Care Dr. Mfinanga from the National Institute of Medical Research Muhimbili Medical Research Centre was unable to attend and Dr. Frank Angira from KEMRI graciously presented on the clinical continuum of care for Dr. Mfinanga. The continuum of HIV services refers to a comprehensive package of care including HIV prevention, diagnostics, treatment and care and support for people at risk for HIV or living with HIV and their families. For people who test positive for HIV, the continuum of care would look like this: Link Many countries have now started programs for differentiated care. In some countries, patients who are adherent and stable on ART are monitored less frequently and receive 3 or 6 months of ART so that they do not have to return to the clinic monthly. However, people with advanced disease require additional specialized care such as screening for tuberculosis and a cryptococcal antigen test. In order to reach the final 90 of the UNAIDS target, retention of patients on treatment is critical. Community interventions such as community ART groups (CAGs) can play a crucial role in engaging patients to be adherent and remain on ART. CAG members check on each other to make sure that medications are taken on time and monitor for side effects and other illnesses. One representative from the group goes to the health clinic and collects all the ART for the members of the CAG, so there are fewer individual clinic visits. Other strategies to improve adherence include sending SMS reminders to patients to take their medications. There are many barriers and hurdles along the continuum of care. Testing for HIV (the first 90) often does not reach key populations such as sex workers, men who have sex with men, injection drug users, and young people (especially adolescents). Self-testing programs, which are being rolled out in some SSA countries, may help improve testing rates among key populations. 20

21 Once an individual has tested positive for HIV, they need to be linked to care. This is oftentimes the most difficult step in the continuum of care. One major reason why people are not linked to care is because of stigma. Many clinics are often known as HIV clinics and people do not want to be seen attending that clinic so that their neighbors and friends know the individual is HIV positive. Oftentimes, the individual may go to a more distant clinic but it becomes burdensome because of taking additional time off from work, increased cost of transportation, long wait times at the clinic, and clinic hours usually require arriving very early in the morning. Access to testing has become more difficult since Tanzania implemented test and treat. Stock outs for reagents or cartridges for devices are now more frequent and some of the devices are no longer functioning. This is especially true for rural facilities compared to urban facilities. As noted earlier, people with advanced HIV disease require an enhanced package of care. Advanced disease is defined as an adult with fewer than 200 cell counts or who are at WHO clinical stage 3 or 4. The leading causes of death among people with advanced disease include tuberculosis. cryptococcal meningitis, pneumocystis pneumonia, diarrheal diseases, toxoplasmosis, and severe bacterial infections. In the past five years, the percentage of people with advanced disease has not changed even though the guidelines have changed to start ART earlier. There is considerable risk of death for people before and just after initiating ART if they have low cell counts. The risk after initiating ART is primarily due to immune reconstitution inflammatory syndrome (IRIS), therefore close monitoring is required for 3-6 months after starting treatment. The WHO guidelines recommend that a package of screening, prophylaxis, rapid ART initiation (within 7 days) and intensified adherence support should be offered to all people presenting with advanced disease. From a patient s perspective, a baseline test prior to starting ART and a test after virological failure on ART is important to determine if s/he has fewer than 200 cell counts. A semi-quantitative that can cheaply, rapidly and accurately provide a yes/no answer at the 200 cut-off could be very useful. If a patient s count is found to be below 200, this should trigger additional tests for serum cryptococcal antigen (scrag) and possibly LF-LAM for TB. If the count is below 100, then further tests may be necessary. The WHO's Advanced Disease Guidelines, which will be issued in July 2017 will have more details regarding testing and types of tests at different thresholds. Simple and cheap point-of-care tests are needed to accurately diagnose TB, cryptococcal disease, pneumocystis pneumonia, toxoplasmosis and severe bacterial infections. These tests are urgently needed to improve patient care and for countries to meet their targets. In addition to the new diagnostic tests that are required to improve patient care, treatment interventions will also be needed such as pre-emptive treatment for cryptococcal meningitis and possibly fluconazole as prophylaxis for cryptococcal meningitis. 21

22 Results from the REALITY trial, which included over 1800 adults and children over the age of 5 with fewer than 100 cells, showed that an enhanced prophylaxis package of co-trimoxazole plus 12 weeks of 100mg fluconazole, 12 weeks of isoniazid and pyridoxine, 5 days of 500mg azithromycin and a single dose of 400mg albendazole reduced mortality by 27% compared to standard-of-care. Furthermore, the incidence of TB was reduced by 28%, cryptococcal disease by 62% and hospitalizations by 17%. The diagnosis and screening package for patients with advanced disease includes: Interventions level Target Group Xpert MTB/RIF as first test for TB diagnosis in symptomatic (pulmonary, meningitis and extra pulmonary) patients LF-LAM for TB diagnosis in patients with signs and symptoms of TB Any level <100 cells or any count if seriously sick Adult, adolescent, children Adult, adolescent, children Cryptococcal antigen (CrAg) screening <100 cells Adult The prophylaxis and treatment package for patients with advanced disease includes: Interventions level Target Group Rapid ART initiation as recommended by WHO Any Adult, adolescent, children Tailored counseling to ensure optimal adherence to advanced disease package, including home visits <200 cells Adult, adolescent, children Co-trimoxazole/dapsone prophylaxis <350 or WHO Stage 3 or 4. In high malaria or bacterial infections settings, any Adult, adolescent, children TB preventive treatment Any Adult, adolescent, children Fluconazole pre-emptive therapy <100 cells Adult Clinical Continuum of Care is an important tool for differentiated care and to identify and treat advanced disease by providing an enhanced package of care leading causes of death among people with advanced disease include tuberculosis, cryptococcal meningitis, pneumocystis pneumonia, diarrheal diseases, toxoplasmosis, and severe bacterial infections a baseline test prior to starting ART and a test after virological failure on ART is important to determine if s/he has fewer than 200 cell counts, triggering additional tests Access to testing has become more difficult since implemented test and treat 22

23 Quality Assurance Paul Sandstrom from the Public Health Agency of Canada spoke about the QASI (Quality Assessment and Standardization on Immunology) program. The QASI laboratory network in Africa includes 25 countries, however, most of the sites are in nine countries. The QASI external quality assurance program involves sending out cold chain panels three times a year. Each panel has two specimens, which are stabilized whole blood product with low and mid counts. The panel material allows for point-of-care instruments, including PIMA and FACSPresto to participate in the EQA program. Currently, about 1500 sites participate in the EQA program. The program is funded by the Canadian government and there is no cost for countries or labs to participate. The largest cost for the program is the manufacturing of the stabilized whole blood product and the largest human resource cost is time dealing with remedial action. Connectivity Jackson Hungu from CHAI presented on the importance of connectivity and developing a user-friendly dashboard so that Ministries of Health can monitor country programs. He shared the NASCOP dashboard, which can provide the Ministry with detailed information on viral load and EID testing. Manufacturers need to provide this level of service for their point-of-care devices, otherwise they will be severely disadvantaged. Country Presentations: Clinical Continuum of Care Burundi: There are 46 health districts in Burundi and 36 PIMAs and 20 FACSCounts, so there are sufficient devices to support management of OI prophylaxis. Baseline is provided for individuals initiating ART, as per the WHO guidelines. Burundi does not have separate algorithms for differentiated care or pregnant women. The Burundi team at the workshop would like their guidelines to include testing at virological failure as well as differentiated models of care for pregnant women to prevent transmission of HIV during breastfeeding. Kenya: There are sufficient numbers of conventional platforms placed in district/county level health facilities, however there are insufficient numbers of instruments in the lower level health facilities, which handle the greatest volume of people living with HIV. Kenya would like to include messaging based on the Advanced Disease Guidelines, which would include, CrAg, TB LAM, hemoglobin, creatinine, HBV and STI testing. Kenya s viral load algorithm specifies that pregnant women should receive a viral load test at first contact. Kenya also has differentiated models of care for people with viral loads >1000 copies/ml with repeat viral load testing after adherence counseling. 23

24 Rwanda: FACSCaliburs and FACSCounts are placed at the National Reference Laboratory and at referral and district hospitals. There are PIMAs placed at a few high-volume health centers. The current guidelines recommend a baseline test for all newly identified patients and viral load at month 6 then every 12 months after initiating ART. The guidelines also recommend an enhanced viral load algorithm for pregnant and breastfeeding women. People with advanced disease or showing signs of disease progression should also receive a test, as cryptococcus screening is recommended for individuals with fewer than 200 cells. Tanzania: High volume facilities have conventional platforms whereas point-of-care devices are available at low volume or remote sites. A baseline test is performed prior to initiating ART and then every six months thereafter. tests are also performed for people who are suspected of having treatment failure. Additionally, tests are performed every six months for people with fewer than 350 cell counts. The current guidelines calls for a viral load test every three months after starting ART for the first year and then annually. Uganda: Conventional platforms are placed at secondary and tertiary levels and point of care devices are placed at primary health care facilities. Sites were selected based on patient load and samples are transported to testing sites using the lab transport network if testing is not available at a particular facility. Uganda does have an algorithm for viral load but not for testing. The guidelines for differentiated services delivery models is currently being developed and it is likely that will be included in the new guidelines. Country Situations - Clinical Continuum of Care There are sufficient devices in most countries to support patient management with baseline provided for individuals initiating ART, as per the WHO guidelines, except for Kenya where there is a need for more devices in lower level health facilities Most countries are developing or planning for separate algorithms for differentiated care/differentiated services delivery models, including targeted populations Countries would like to include messaging based on the Advanced Disease Guidelines Country Presentations: Laboratory Systems Strengthening Burundi: There are three viral load instruments in the country, two are located in Bujumbura and the third is located in the northern part of the country, which is used to provide viral load coverage for five provinces. There is a third party agent in charge of sample transport and distribution of results. The other 13 provinces in 24

25 the country, sample transport and distribution of results is handled by health districts. Some of the challenges identified by the Burundi team include: stockout ( and viral load), maintenance issues ( and viral load instruments), insufficient human resources, insufficient number of viral load devices to adequately scale up viral load testing, no connectivity solutions for and viral load instruments, and lack of quality control system (sites do not participate in EQA programs). Burundi has issues with procurement because they do not have accurate forecasting data. In order to get accurate forecasting data, they would use the following indicators: the number of people who know their HIV status (1st 90), the number of new HIV infections per year, the number of patients who get a viral load test, and the number of people with advanced disease. Kenya: The team from Kenya identified a number of issues with their laboratory system and they include: insufficient staffing, basic infrastructure issues (cold chain, electricity, sample transport logistics, connectivity, instruments), supply chain, instrument failures and maintenance issues, and a weak laboratory/clinical interface (viral load result utilization). In Kenya, the vendors for the devices and reagents have a monopoly and this has caused some problems with distribution of kits that are soon to expire. Another issue identified is the Government of Kenya drives and has ownership of the point-of-care agenda. In order to get accurate forecasting data, they would use the following indicators: the number of people who know their HIV status (1st 90), the number of new HIV infections per year, the number of patients on ART (2nd 90), the number of patients who are virally suppressed (3rd 90), and the number of people with advanced disease. Rwanda: Linkage to care is still an issue in Rwanda. Access to ART is health facility based, whereas HIV testing services are provided at facilities, mobile services and community based facilities. Some of the challenges the team from Rwanda identified include: problems with supply chain, healthcare workers are not skilled or trained sufficiently to manage patients with advanced HIV disease, increasing number of instrument failures (there are no engineers based in country to provide rapid support), high maintenance cost for instruments, especially in light of low utilization rates, and no connectivity solutions for and viral load instruments. In order to get accurate forecasting data, they would use the following indicators: the number of people who know their HIV status (1st 90), the number of new HIV infections per year, the number of patients on ART (2nd 90), the number of patients who are virally suppressed (3rd 90), and the number of people with advanced disease. Tanzania: The team from Tanzania identified a number of challenges including: a shortage of skilled healthcare personnel for patient management, issues with supply chain, difficulties with sample transport, lack of funding for diagnostic services, especially for the rapid scale up of viral load testing, and poor data management systems. In order to get accurate forecasting data, they would use the following indicators: the number of people who know their HIV status (1st 90), the number of new HIV infections per year, the number of patients on ART (2nd 90), the number of patients who get a viral load test, the number of patients who are virally suppressed (3rd 90), and the number of people with advanced disease. 25

26 Uganda: Turn-around times for results take longer in remote areas compared to urban settings. Some of the challenges identified by the team from Uganda include: problems with supply chain and poor inventory management, breakdown of instruments, knowledge gap for both health workers (especially rural) and patients, breakdown in the viral load sample transport system, poor forecasting data for, and limited funding for. The team from Uganda felt that the future role of testing is not clear given the shift in funding to scale up viral load testing. The team would like to see very clear guidelines from WHO on the role of moving forward. In order to get accurate forecasting data, they would use the following indicators: the number of new HIV infections per year, the number of patients who get a viral load test, the number of patients who are virally suppressed (3rd 90), and the number of people with advanced disease. Summary of Country Challenges Laboratory Systems Clear guidelines from WHO on the role of moving forward to better plan and budget for and viral load testing Continuous intermittent stock outs and weak procurement systems Lack of forecasting data to determine accurate demand forecasts Discussion There was agreement among the workshop participants that testing should remain a key measure for people living with HIV. There were discussions regarding the frequency of testing with agreement that it should be performed at baseline (prior to ART initiation), at virological failure and possibly more often if someone presents with advanced disease. Participants would like the WHO to provide clarity on this issue with the release of the Advanced Disease Guidelines in July The participants also urged the WHO to provide clarity on other diagnostic tests and medications necessary to manage patients with advanced disease. The clinicians felt it was particularly important to reflex to other necessary diagnostic tests when a patient reaches certain thresholds. This will be particularly important for supply chain management as many clinics, especially more rural health centers, often do not have the necessary diagnostic tests and medications. 26

27 Appendix 1 - Agenda 27

28 28

29 Appendix 2 - List of Participants 29

30 30

31 31

32 Appendix 3 Summary of Country Needs and Gaps Burundi HIV Status Treatment Monitoring Treatment Patient Manageme nt HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 57,233 61,538 Yes 500 9,621 42,169 5,443 Demand Forecasts - Testing Volumes 2016 Coverage Utilization Rates Total tests 36,977 8,600 4,806 4,305 ART Eligibility 0 8,600 4,806 4,305 Treatment Monitoring 36,977 46% Patient Management (<200 ) Demand Forecasts Viral Load Testing Volumes Total Viral Load Tests 11,086 20% 41,950 53,196 72,355 Testing Volumes by Instrument (Number of Tests) and Utilization Rates Lab 23,813 66% 5,710 1,615 2,859 POC 13,164 34% 2,890 3,191 1,446 Viral Load Lab 11, % Viral Load POC 0 0% 32

33 Kenya HIV Status Treatment Monitoring Treatment Patient Management HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,419, ,182 Yes 41,383 1,135, ,673 Demand Forecasts - Testing Volumes 2016 Coverage Utilization Rates Total tests 864,000 N/A 32,592 N/A ART Eligibility 800, Treatment Monitoring ,592 0 Patient Management (<200 ) 64,000 5% 0 32,592 0 Demand Forecasts Viral Load Testing Volumes Total Viral Load Tests 857,530 80% 325,915 32,592 0 Testing Volumes by Instrument (Number of Tests) and Utilization Rates Lab ,814 0 POC 0 0 9,778 0 Viral Load Lab 857,530 Viral Load POC 0 Rwanda 33

34 HIV Status Treatment Monitoring Treatment Patient Management HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 215, ,462 Yes 22, ,471 59,460 Demand Forecasts - Testing Volumes 2016 Coverage Utilization Rates Total tests 26, % 35,853 20,901 ART Eligibility Treatment Monitoring Patient Management (<200 ) Demand Forecasts Viral Load Testing Volumes Total Viral Load Tests 154,322 86% 196, ,453 Testing Volumes by Instrument (Number of Tests) and Utilization Rates Lab 18,720 72% 25,814 15,049 POC 7,280 28% 10,039 5,852 Viral Load Lab 154, % Viral Load POC 0 0% Tanzania 34

35 HIV Status Treatment Monitoring Treatment Patient Management HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,385,779 1,325,271 Yes 740, , ,466 Demand Forecasts - Testing Volumes 2016 Coverage Utilization Rates Total tests 2,534,272 1,336, , ,733 ART Eligibility 1,291,562 70% Treatment Monitoring 1,171,014 70% 1,336, , ,733 Patient Management (<200 ) 71, Demand Forecasts Viral Load Testing Volumes Total Viral Load Tests 183,549 16% 1,336,254 1,519,694 1,881,681 Testing Volumes by Instrument (Number of Tests) and Utilization Rates Lab 70% 935, POC 40% 400, , ,733 Viral Load Lab 183, % Viral Load POC 0% 35

36 Uganda HIV Status Treatment Monitoring Treatment Patient Management HIV Positive Status Known Treat All Threshold Pre-ART On ART Not on ART Viral Load 1,507,475 1,079,059 Yes 75, , ,214 Demand Forecasts - Testing Volumes 2016 Coverage Utilization Rates Total tests 582, , , ,673 ART Eligibility 69,297 12% 296, , ,307 Treatment Monitoring 513,646 56% 34,208 36,118 40,220 Patient Management (<200 ) ,055 94, ,707 Demand Forecasts Viral Load Testing Volumes Total Viral Load Tests 673, % 1,200,000 1,493,654 1,786,278 Testing Volumes by Instrument (Number of Tests) and Utilization Rates Lab 448,866 23% 153,171 97,895 74,668 POC 134,077 77% 459, , ,004 Viral Load Lab 665,904 99% Viral Load POC 7,260 1% 36

37 Acknowledgements The workshop was organized by the International Diagnostics Centre (Debi Boeras, Ben Cheng, Imelda Mahaka and Rosanna Peeling), housed at the London School of Hygiene and Tropical Medicine, and co-hosted by Kenya Medical Research Institute s Center for Global Health Research (KEMRI-CGHR). Financial support for the workshop was received from Alere, Beckman Coulter, and Omega Diagnostics. 37