The Uganda Virus Research Institute (UVRI) is a department of Government of Uganda (GOU), dedicated to conduct research on viral diseases since 1936. UVRI has continued to conduct research in isolation and characterization of HIV strains, understanding better the epidemiology and molecular epidemiology of HIV before and after the introduction of ART, comparing modalities of delivering ART, HIV vaccine and microbicide evaluation, PMTCT, HIV sero-behavioural survey, and provided the Ministry of Health (MOH) with HIV surveillance data from ANC and STI clinics. UVRI is mandated by MOH to provide Quality Assurance/Quality Control (QA/QC) to all HIV serological testing sites both public and private. Building on the experience over the past five years with USG funding, the HIV Reference and Quality Assurance Laboratory at the Uganda Virus Research Institute established a national laboratory quality assurance (QA) program focused specifically on HIV-related testing. This activity focuses on ensuring that the lay and the community health workers in addition to counselors and lab staff that obtain samples and test provide quality service. The goal is provision of quality assurance for HIV in the republic of Uganda.Objective1.Strengthen capacity at UVRI to assure the quality of HIV testing nationwide.2.Scale up rapid HIV testing services accross the country according to national and international standards3.In collaboration with other stakeholders provide support supervision to sites providing HIV, TB and malaria diagnostics.4.Proper management of cooperative agreement funds 5. Preparation of the sustainability of HIV QA/QC services accross the country. 6. Evaluation of the project.UVRI works with other partners in the implimentation of its activities.

The development of HIV drug-resistance (HIVDR) is recognized as a serious threat to the efficacy of current ART, & will compromise PEPFAR efforts to provide long-term treatment in sub-Saharan countries. Drug resistance (DR) is likely to have a greater influence on the long term success of ART programs than any other single factor. Emergence of resistance to one or more ARV drugs is a reason for therapeutic failure in the treatment of HIV. In addition, resistance to one ARV drug sometimes confers a reduction in or a loss of susceptibility to other or all drugs of the same class. Patients with HIVDR must switch treatment regimens, reducing treatment options & significantly raising medication costs. Resistance is usually the result of sub-optimal regimens, or inconsistent use resulting from poor adherence &/or interrupted drug supply. The optimum time for minimizing the emergence & transmission of resistance is when treatment initiatives are still in the early stages & first-line regimens are widely used. Prevention, surveillance & monitoring of drug resistance are critical to the success of clinical & public health HIV/AIDS programs. WHO has developed standardized strategies, protocols, & guidelines for the prevention of HIVDR in resource-limited settings that are designed to be implemented alongside treatment programs? As part of this strategy, many African countries including Uganda have set up National HIVDR prevention, surveillance & monitoring programs in collaboration with WHO-AFRO. Among others the WHO plan includes periodic evaluations of early warning indicators (EWI) which have been shown to correlate with early emergence of DR. EWIs include poor drug supply continuity, inappropriate prescribing practices, & poor adherence among clients among others.

Objective 1: To continue to support the coordination for HIVDR Prevention, Monitoring and Surveillance at both national and Institutional level.1a) Support the coordinating center for the HIVDR Prevention, Surveillance and Monitoring Programme at UVRI in close collaboration with STD/ACP. 1b) Support the National HIVDR working group. Objective 2: To support and coordinate surveillance of HIVDR transmission in different geographical settings using Threshold Surveys. 2a) Conduct one Threshold transmission surveillance possibly in Mbarara. Objective 3: To Monitor Emerging HIVDR in treatment cohorts in selected sites. 3a) Conduct an HIV DR surveillance in 5 treatment sites (sites will be selected by geographical region, size and service provider). Objective 4: Support in country genotypic laboratories with adequate capacity to support HIVDR surveillance and monitoring activities in the country. 4a) Support UVRI in performing genotyping. 4b) Support the HIVDR resistance specimen collection repository at UVRI and other laboratories. 4c)Support UVRI and other laboratories in provision of internal and external quality control measures for procedures and reagents. 4d) Provide training and other forms of technical assistance to laboratories handling specimens to be genotyped for the HIVDR monitoring and surveillance

With USG funding, the HIV Reference and Quality Assurance Laboratory at UVRI has established a national laboratory QA program focused specifically on HIV-related testing. This activity focuses on ensuring that the lay and the community health workers in addition to counselors and lab staff that obtain samples for testing are providing quality service to the client, obtain and provide quality samples following bio-safety guidelines.

During FY 2009, in-service training in QA/QC was provided to 70 lab and non-lab staff from the South West region in addition to staff from 323 other sites. Five SOPs for laboratory safety, sample processing, rapid and Elisa HIV testing, rapid syphilis testing and proficiency panel preparations for HIV were reviewed, updated and distributed to 1085 sites. We prepared and distributed 2835 proficiency testing panels to 476 testing sites PT results and provided corrective action when required. first response HIV test kit for plasma and whole blood was evaluated and disclosed a sensitivity of 97.6% and specificity of 95.6 for plasma and the respective values for whole blood are 97.6% and 98.3%.We compiled an HIV testing inventory, held sensitization meetings with the staff at the sites regarding quality assurance, provided support supervision in collaboration with National and Regional Lab Coordinators and District Lab Focal Persons, distributed SOPs and other information tools, provided formal reports disseminating the findings of support supervision to 476 testing sites both public and private. 222 testing sites employed non lab staff majority of whom were nurses and counselors (only 21 sites had these working without lab trained staff); 53 and 22 testing sites conducted CD4 counts and Viral Loads respectively, while 336 performed TB diagnostics, 396 performed malaria slides, 339 performed syphilis serology, 42 performed renal and liver function tests and 139 performed heamatology including lymphocytes. Adherence to SOPs was assessed; availability of SOPs was at 59.3% accessibility to SOPs was at 69.5%.About half of the sites displayed the SOPs, 67.2% understood them, while 69.7% implemented them. More than 95% of the testing sites implemented the National Testing Algorithms. Sites were further assessed for compliance with good clinical laboratory practice, waste disposal and availability of requirements to conduct HIV testing. This information was shared with partners and sites during support supervision, workshop and the newsletter.

In FY 2010, UVRI shall ensure quality HIV testing is offered to individuals through training, support supervision and continuous assessment of QA/QC in all laboratories testing for HIV, TB, STI. There is need to scale up HCT services through training of service providers. 723 testing cadres will be trained in different courses- 225 lay and community health care workers trained for 5 days in HIV counseling and quality HIV rapid testing; 93 District Laboratory Focal Persons and Regional Laboratory Coordinators to receive TOT in use and handling of DST and DBS for 5 days; 225 clusters comprising of counselors, phlebotomists and laboratory personnel to be trained for 5 days in the quality assurance in pre analytical, analytical and post analytical aspects of HIV testing;150 staff identified by poor performance in proficiency panels to be given a refresher course in rapid HIV testing for 5 days; 30 Regional Laboratory Coordinators and the In-Charges of National and Regional Referral Hospitals to be trained for 5 days in preparation and characterisation of PTPS.

The training provided to RLCs and DLFPs will include: conducting supervisory visits, preparation and characterization of PT panels, distribution and interpretation of the results. We will work with DFLPs to ensure that their activities especially support supervision visits are incorporated in the annual district plan, and engage with the district leaders on the importance of high quality lab results. While the existing M&E plan drawn on national and USG requirements and tools will guide implementation of activities, more partnerships will be established with government and non government organizations, and, the virtual districts of the army, police and prisons. Support supervision visits, provision of Dried Tube Serum as PT panels and continuous assessment of QA/QC services in laboratories testing for HIV, TB, STI and malaria will continue. HIV serology testing QA/QC project will expand services to all HIV testing sites in the country. Working with MOH, particularly the Quality Assurance Unit, the HIV rapid test training coordination unit at CPHL and regional and district-level laboratory supervisors, we shall identify laboratories currently conducting HIV rapid testing and the tests/algorithm. New kits and algorithms will be evaluated. 1000 labs will be visited, 500 new labs and 500 old labs with poor performance in HIV quality assurance. Emphasis will be placed on the hard-to-reach areas, sites handling small volumes of specimens, private labs and labs where testing is mainly performed by nonlab personnel. We shall develop a quality assurance plan that takes advantage of joint supervisory visits and panel distribution with partners. Accredited labs using national/international standards will be documented and others assisted to get accredited. LIMS shall be linked to databases at CPHL and MOH to facilitate sharing of information including reports, logistics management and training needs. Discordant results will be resolved and external quality assurance done. The SOP for counseling and testing will be integrated for the benefit of the counselors, phlebotomists, and laboratory staff. With help from the Ministry of Education and Sports quality assurance of HIV testing will be taught in all lab training institutions. We shall continue to provide apprenticeship to both counselors and lab trainees at the UVRI clinic. Regular communication will be provided to labs in Uganda to highlight the role of the National HIV QA Lab, share lessons learned, identify problems/issues for which assistance is required, and allow for dialogue about recent news and innovations in HIV lab services. For efficient and cost-effective management of the program, we shall establish organizational, financial and administrative structures and mechanisms necessary to carry out the program activities. A semi-annual report that disseminates the findings of the support supervision visits, resolution of discordant results, PT and evaluations of performance characteristics will be provided to MOH, implementing partners and testing sites. To achieve this, there is need to task shift by training lay and community health workers in quality HIV testing throughout the country. By maintaining and developing strong linkages with key service providers and trainers, UVRI shall support integrated training especially in the diagnostics of HIV, malaria, syphilis and tuberculosis thus maximizing benefits out of the available resources. The training provided to this cadre of personnel will ensure provision of high quality support supervision.

The development of HIV drug-resistance (HIVDR) has been recognized as a serious threat to the efficacy of current antiretroviral therapy (ART), and will compromise the efforts of PEPFAR to provide long term treatment, not only in Uganda but also in other sub-Saharan countries. Drug resistance is likely to have a greater influence on the long term success of ART programs than any other single factor. The emergence of resistance to one or more antiretroviral drugs is one of the more common reasons for therapeutic failure in the treatment of HIV. In addition, the emergence of resistance to one antiretroviral drug sometimes confers a reduction in or a loss of susceptibility to other or all drugs of the same class. Patients with drug resistance must switch treatment regimens, reducing treatment options and significantly raising medication costs, assuming appropriate 2nd line drugs are available at all. Resistance is most often the result of sub-optimal regimens, or inconsistent use due to poor adherence and/or interrupted drug supply. The optimum time for minimizing the emergence and transmission of resistance is when treatment initiatives are still in the early stages and first-line regimens are widely used (WHO,2003). Therefore, prevention, surveillance and monitoring of drug resistance are critical to the success of clinical and public health HIV/AIDS programs. WHO has developed a standardized strategy and protocols for the prevention of HIVDR in resource limited settings, designed to be implemented alongside treatment programs. As part of this strategy and in accordance with WHO guidelines, many African countries including Uganda have set up National HIVDR prevention, surveillance and monitoring programs in collaboration with WHO-AFRO. The major principles of containment of HIVDR include: appropriate ARV drug access, proper prescribing and usage, drug adherence, reduction of HIV transmission, and appropriate programmatic response based on the results of monitoring and surveillance. The WHO and Uganda HIV DR Monitoring Plan includes periodic evaluations of early warning indicators (EWI) which have been shown to correlate with early emergence of drug resistance. EWI include poor drug supply continuity, inappropriate prescribing practices, poor adherence among clients, among others.

A consensus workshop on prevention of DR was held in Kampala in January 2007. A National HIVDR Monitoring Plan was developed with support from WHO, and has been endorsed by the MOH and Uganda AIDS Commission. Under the plan, the Uganda Virus Research Institute (UVRI), working closely with the MOH-ACP and other partners, was identified to coordinate these activities including: 1) the creation of a National HIV drug resistance Data Center in collaboration with the MOH Resource Center; 2) the establishment of a national drug resistance reference laboratory; 3) the coordination of all activities (program management, data coordination, and administration); 4) the establishment of a National HIVDR working group (HIVDR WG) within the MOH and as part of the National ART Committee. The plan addresses key areas of care and treatment within the National Strategic Plan for HIV/AIDS, 2007/8-2011/12, and is relevant to PEPFAR goals. The national HIVDR WG is comprised of individuals with different expertise and from different organizations including the MOH, CDC, Medical Research Council, WHO, UVRI and PEPFAR-supported treatment partners including JCRC, IDI, Catholic Relief Services, TASO and MJAP. With some funding from WHO, the HIVDR WG conducted a pilot survey in 2007 at 41 treatment sites to collect EWI. The sites were selected from different geographical regions, represented different levels and modes of ART service delivery, and were supported by a range of funders. The indicators included prescribing practices, percentage of patients lost to follow up, patients on first line ART, appointment keeping, adherence, and drug supply continuity. The preliminary findings of this study indicated that 71% of sites started all patients on appropriate first line drugs, 85% of sites had less than 20% loss to follow up during the first year, and 71% retained more than 70% clients on first line ART during the first year. Most worrying, however, was the observation that only 19 sites reported no drug stock outs in any quarter in the previous year. The results of this pilot were presented at the Uganda AIDS Conference (UAC), the WHO-AFRO HIV DR meeting in Namibia, to various key partners, and to the PEPFAR country team. Some funds were also obtained from the UNAIDS to contribute to the dissemination of the EWI surveys. Other funds for dissemination will come from PEPFAR through CDC. More work on EWI was done in 2008 this has allowed us to compare the performance of these facilities after one year which I will describe here. Trained field workers abstracted data from patients' paper-based and electronic medical records in 41 facilities in 2007 and 76 in 2008 where ART had been established for at least one year. Data was obtained for a subset of patients recruited during July-September of 2006 and 2007 respectively. HIVDR-EWI were assessed separately for each facility, with national level analysis comprising of proportion of facilities meeting predetermined targets. About 71% of facilities in 2007 and 74% in 2008 prescribed appropriate standard first-line ARV-regimen to all (100%) their newly enrolled clients at ART-start. The target of < 20% of patients lost-to-follow-up during the first 12-months was met by 85% of facilities in 2007, and 75% in 2008. In 71% of facilities, over 70% of patients started on first-line ART were still on first-line treatment after 12 months in 2007, while all facilities met this target in 2008. Few facilities had at least 80% of patients attending all clinical appointments during a 12-month period in 2007 and 2008. About 17% of facilities reported no ARV drug stock outs over a 12-months period in 2007, but this increased to 26% in 2008. The "ART adherence" indicator i.e. proportion of individuals with =90% adherence by pill count over a 12-month period (target: 80%) was not obtained. Five facilities in 2008 and eight in 2007 didn't meet the minimum targets for at least three HIVDR EWI. In conclusion therefore ART programme practices in several facilities pose a risk for HIVDR. Weaknesses in record keeping, drug supply and client retention require urgent redress. Facilities with weak performance should have focused attention for prevention of HIVDR. We plan to hold workshops to disseminate this information. This work was funded by WHO. UVRI, through support from WHO and MRC, conducted a study in Entebbe to determine whether resistant viruses were transmitted to recently infected individuals. No resistant viruses were identified. The HIVDR WG recommended that this activity be repeated in 2008. In 2008 we initiated a new study funded by PharmaAccess to look at transmitted drug resistance in newly diagnosed individuals in Kampala, at Naguru teenage clinic and at a VCT center at the AIDS Information Center. This is a cross-sectional survey of n=85 consecutively enrolled participants of individuals likely to be recently infected using the PharmAccess African Studies to Evaluate Resistance (PASER). So far 31 individuals have been enrolled and sequencing is underway, a few resistance mutations have been noted. With funding from MRC, the Global Fund and EDCTP, UVRI established the National HIV drug resistance reference laboratory and was accredited by WHO. In 2009, we applied to obtain WHO regional accreditation, and the accrediting team visited UVRI on 10th September 2009. The UVRI laboratory has been expanded and a new wing will be commissioned shortly to allow process more samples. Meanwhile we have been approached to sequence samples from Tanzania and Zimbabwe. In 2009 we developed proposals to look for funds to introduce DBS for resistance testing

Another protocol briefly described below has been developed to be submitted to the IRB to conduct another round of EWI. 150 individuals will be trained for 5 days in HIV drug resistance early warning indicators needed to monitor programme performance. In addition, 15 laboratory staff will be trained for 5 days in processing of samples for HIV drug resistance testing; of these 4 will be trained for 10 days in HIV drug resistance testing and analysis.

Data on EWI will be collected from a sample of 100 facilities, by 10 teams each of 2 trained field workers. Data will again be collected from electronic and paper-based systems. We plan to annually abstract data from selected ART service sites to obtain information on ART programmatic factors and client behavior that may be associated with an increased risk of HIV drug resistance. A purposive sample of facilities that have provided ART for at least one year will be selected each year. Standardized data abstraction forms will be used to collect information on HIVDR EWI from facility level client data from a minimum of 30 patient medical records per site. Centrally constituted and trained field data collection teams with experience in ART data management will visit sites to abstract routinely collected data from client files, patient registries and/or electronic data bases. The variables of interest include ART regimens prescribed at treatment initiation and at 12 months, loss to follow-up, appointment keeping and ART adherence and facility level drug supply continuity. Abstracted data will be entered into a database centrally at the MOH and cleaned. Descriptive statistics of the variables of interest will be produced separately for each facility. National level analysis will comprise of the proportion of facilities meeting the required standards. The results of the assessment will be provided to the MOH, bilateral and other agencies providing support to ART facilities and to the facilities themselves. This will enable programs and facilities to develop methods to address specific problems identified. Data will also be used to support national decision-making on ART programme planning for HIVDR prevention activities and ART programme performance in the country. Annual reports will be produced and disseminated and results may also be published in medical journals.

UVRI is mandated by MOH to provide Quality Assurance/Quality Control (QA/QC) to all HIV serological testing sites both public and private. Building on the experience over the past five years with USG funding, the HIV Reference and QA Laboratory at the UVRI established a national laboratory QA program focused specifically on HIV-related testing to provide quality service to the client, obtain and provide quality samples following bio-safety guidelines. As we role out ARV treatment, we need to ensure that we also prevent development of HIV drug resistance (HIVDR). The development of HIVDR is recognized as a serious threat to the efficacy of current ART, & will compromise PEPFAR efforts to provide long-term treatment in sub-Saharan countries. DR is likely to have a greater influence on the long term success of ART programs than any other single factor. Emergence of resistance to one or more ARV drugs is a reason for therapeutic failure in the treatment of HIV. In addition, resistance to one ARV drug sometimes confers a reduction in or a loss of susceptibility to other or all drugs of the same class. Patients with HIVDR must switch treatment regimens, reducing treatment options & significantly raising medication costs. Resistance is usually the result of sub-optimal regimens, or inconsistent use resulting from poor adherence &/or interrupted drug supply. The optimum time for minimizing the emergence & transmission of resistance is when treatment initiatives are still in the early stages & first-line regimens are widely used. Prevention, surveillance & monitoring of drug resistance are critical to the success of clinical & public health HIV/AIDS programs. WHO has developed standardized strategies, protocols, & guidelines for the prevention of HIVDR in resource-limited settings that are designed to be implemented alongside treatment programs. As part of this strategy, Uganda has set up National HIVDR prevention, surveillance & monitoring programs in collaboration with WHO-AFRO.

During FY 2009, in-service training was in QA/QC was provided to 70 lab and non-lab staff from the South West region in addition to staff from 323 other sites. Five SOPs for laboratory safety, sample processing, rapid and Elisa HIV testing, rapid syphilis testing and proficiency panel preparations for HIV were reviewed, updated and distributed to 323 sites. We prepared and distributed 2835 proficiency testing panels to 476 testing sites PT results and provided corrective action when required. first response HIV test kit for plasma and whole blood was evaluated and disclosed a sensitivity of 97.6% and specificity of 95.6 for plasma and the respective values for whole blood are 97.6% and 98.3%.We compiled an HIV testing inventory, held sensitization meetings with the staff at the sites regarding quality assurance, provided support supervision in collaboration with National and Regional Lab Coordinators and District Lab Focal Persons, distributed SOPs and other information tools, provided formal reports disseminating the findings of support supervision to 476 testing sites both public and private. 222 testing sites employed non lab staff majority of whom were nurses and counselors (only 21 sites had these working without lab trained staff); 53 and 22 testing sites conducted CD4 counts and Viral Loads respectively, while 336 performed TB diagnostics, 396 performed malaria slides, 339 performed syphilis serology, 42 performed renal and liver function tests and 139 performed heamatology including lymphocytes. Adherence to SOPs was assessed; availability of SOPs was at 59.3% accessibility to SOPs was at 69.5%.About half of the sites displayed the SOPs, 67.2% understood them, while 69.7% implemented them. More than 95% of the testing sites implemented the National Testing Algorithms. Sites were further assessed for compliance with good clinical laboratory practice, waste disposal and availability of requirements to conduct HIV testing. This information was shared with partners and sites during support supervision, workshop and the newsletter.

With funding from WHO, the HIVDR WG conducted a pilot survey in 2007 to collect EWI at 41 treatment sites and in 2008, extended this to cover 76 sites including those surveyed in 2008. The sites were selected from different geographical regions, represented different levels & modes of ART service delivery, & were supported by a range of funders. In 2009, we applied to obtain WHO regional accreditation, and the accrediting team visited UVRI on 10th September 2009. The UVRI lab has been expanded and a new wing will be commissioned shortly to allow us process more samples. In 2009 we developed proposals to look for funds to introduce dried blood spots (DBS) for resistance testing. This proposal to evaluate DBS for HIV-1 drug resistance testing and to prepare for WHO accreditation in using DBS for HIVDR at UVRI is important if we are to scale up our monitoring activities. The advantages of DBS card used (filter paper) is they are easy to obtain and store, although the procedures for preparing DBS must be followed precisely, the training required is less intensive. The DR WG continues to meet regularly and to make efforts to secure funding from other sources to support HIVDR activities. Some members of this committee have presented updates to the National ART committee and we are pleased to say that the HIVDR WG is the most active subcommittee.

There is need to scale up HCT services through training of service providers. In FY 2010, 723 testing cadres will be trained in different courses- 225 lay and community health care workers trained for 5 days in HIV counseling and quality HIV rapid testing; 93 District Laboratory Focal Persons and Regional Laboratory Coordinators to receive TOT in use and handling of DST and DBS for 5 days; 225 clusters comprising of counselors, phlebotomists and laboratory personnel to be trained for 5 days in the quality assurance in pre analytical, analytical and post analytical aspects of HIV testing;150 staff identified by poor performance in proficiency panels to be given a refresher course in rapid HIV testing for 5 days; 30 Regional Laboratory Coordinators and the In-Charges of National and Regional Referral Hospitals to be trained for 5 days in preparation and characterisation of PTPS.

The training provided to RLCs and DLFPs will include: conducting supervisory visits, preparation and characterization of PT panels, distribution and interpretation of the results. We shall conduct trainings in collaboration with CPHL, MJAPand AMREF to avoid duplication. We will work with DFLPs to ensure that their activities especially support supervision visits are incorporated in the annual district plan, and engage with the district leaders on the importance of high quality lab results. While the existing M&E plan drawn on national and USG requirements and tools will guide implementation of activities, more partnerships will be established with government and non government organizations, and, the virtual districts of the army, police and prisons. Support supervision visits, provision of Dried Tube Serum as PT panels and continuous assessment of QA/QC services in laboratories testing for HIV, TB, STI and malaria will continue. HIV serology testing QA/QC project will expand services to all HIV testing sites in the country. Working with MOH, particularly the Quality Assurance Unit, the HIV rapid test training coordination unit at CPHL and regional and district-level laboratory supervisors, we shall identify laboratories currently conducting HIV rapid testing and the tests/algorithm. New kits and algorithms will be evaluated. 1000 labs will be visited, 500 new labs and 500 old labs with poor performance in HIV quality assurance. Emphasis will be placed on the hard-to-reach areas, sites handling small volumes of specimens, private labs and labs where testing is mainly performed by nonlab personnel. We shall develop a quality assurance plan that takes advantage of joint supervisory visits and panel distribution with partners. Accredited labs using national/international standards will be documented and others assisted to get accredited. LIMS shall be linked to databases at CPHL and MOH to facilitate sharing of information including reports, logistics management and training needs. Discordant results will be resolved and external quality assurance done. With help from the Ministry of Education and Sports quality assurance of HIV testing will be taught in all lab training institutions. We shall continue to provide apprenticeship to both counselors and lab trainees at the UVRI clinic. Regular communication will be provided to labs in Uganda to highlight the role of the National HIV QA Lab, share lessons learned, identify problems/issues for which assistance is required, and allow for dialogue about recent news and innovations in HIV lab services. For efficient and cost-effective management of the program, we shall establish organizational, financial and administrative structures and mechanisms necessary to carry out the program activities. A semi-annual report that disseminates the findings of the support supervision visits, resolution of discordant results, PT and evaluations of performance characteristics will be provided to MOH, implementing partners and testing sites. We are aiming at having two laboratories accredited by WHO; these are the National HIV Reference Laboratory and the National Drug Resistance Laboratory, both housed at UVRI.

We shall follow the WHO guidelines to have our laboratory accredited in use of DBS for drug resistance genotyping. WHO recommends the shipping of DBS on dry ice to avoid freeze thaw as humidity is a big problem for DBS. However since there is no strong data to support this recommendation, in 2009/10 we plan to conduct a study to further look at the effect of shipping DBS at two different conditions (room temperature versus dry ice) on genotypic results. We plan to collaborate with CDC and WHO to investigate the effect of shipment of DBS on dry ice versus shipment at ambient temperatures

We are working towards operationalizing the HIVDR coordinating center in FY 2010, with PEPFAR funding. A protocol has been developed following the WHO template to be submitted soon to the ethics committee to conduct a monitoring study of emerging ART resistance in 3 pilot facilities. The activity will involve abstraction of baseline data from client medical records and an aliquot of residual plasma from ART naïve clients initiating treatment at these facilities for viral load and genotyping at UVRI laboratories. Non-biological data will also be abstracted from the clinical records of these individuals quarterly using standardized forms. At the end of 12 months, another plasma sample and demographic and treatment related data will also be abstracted for viral load testing and genotyping for individuals that fail to suppress their viral load at 12-months end point.

During 2009, 34,606 infants were tested at 550 facilities. Main challenges are shipping of spxs, results reporting and follow-up of exposed, breast-feeding infants. EID currently uses 8 labs (Mildmay and 7 JCRC labs). All commodities are donated by UNITAID. EID has no secure funding past September 2010, other than UNITAID that will continue through 2011. PEPFAR awards for both JCRC and Mildmay end in September 2010 and follow-on RFAs do not include funds for EID this is confounded by the ongoing scale-up. By 2014, MOH plans to conduct 100,000 PCR tests pa. If testing continues as is, the cost of the program will increase from $2.0M per year in 2010/2011 to $3.6M in 2013/2014. In total, the EID program will require $11.4M over the next 4 years (if overhead costs remain at $22.20 per spx at JCRC and foc at Mildmay).

Given increasing costs and no secure funding, PCR testing must be made as cost-effective as possible. An analysis conducted by MOH suggests costs can be dramatically reduced by consolidating PCR testing in 2 labs using automated, high-throughput platforms. Overhead costs should reduce to $6-9 per spx, the international benchmark - this will save $3.6M over the next 4 years. Consolidating testing in 2 labs will also improve overall efficiencies, sharing the burden of testing and avoiding delayed reporting. With 2 labs working 10 hours per day in a 5-day week, Uganda has ample capacity for the next 4 years.

Cost implications: Both Mildmay and UVRI/CDC would need to hire additional staff; a back-up AmpliPrep-Taqman 96 platform will be provided foc by Roche; SMS-printers will be needed for results reporting. Regardless of where the automated labs are located, MOH will need to establish a transport network to bring samples to these labs using a simple courier service to transport samples daily from the existing hubs to the testing labs - this is the subject of a 2nd proposal.