UVRI is the National entity mandated by the MoH to carry out all HIV Reference Laboratory related activities at the National Level. Working with the MoH and the Central Public Health Laboratory (CPHL), UVRI will support the expansion of the National Quality Assurance Program to include all other HIV-related testing. This is aimed strengthening the MoH capacity to deliver Quality Assured (QA) HIV-related laboratory services. UVRI will assist the MoH to capture, analyze and use quality assurance data for quality improvement. With FY 2013 funding UVRI will conduct training in Good Clinical Laboratory Practice (GCLP) and Quality Assurance for HIV-related testing using the stepwise WHO approach to Strengthen Laboratory Management Towards Accreditation (SLMTA), participate in mentoring and monitoring lab performance, support the HIV drug resistance monitoring unit, the Early Infant Diagnosis (EID) program, surveillance and survey activities, conduct innovative implementation science, assist in developing and executing implementation science priorities and lay the foundation for a laboratory training center. The project conforms to PEPFAR principles of country ownership by supporting the MoH implement the National Health Laboratory Strategic Plan as a tool for the National Health Laboratory Policy 2010-2015 implementation. These activities include assisting to increase access to testing through the specimen referral and testing hub network, data collection, analysis and utilization to inform program implementation, health system strengthening for sustainability, increasing impact through strategic partnerships, linkages and coordination integration with other Implementing partners.

Vehicles for the movement of staff and supplies may be procured under this FOA.

The project has national coverage & will be conducted in collaboration with other MOH institutions, particularly the Central Public Health Laboratory (transitioning to the National Health Laboratories), District Health Offices & IPs, including WHO & NIH, funded under separate arrangements. Activities to be carried out include; assistance with the development & implementation of national safety & infrastructure standards; implementation of a customized LIMS with linkages to the MOH Resource Centre; support for training & strengthening regional medical equipment workshops; building the capacity of UVRI by hiring experienced technical & management staff; expansion & implementation of a national comprehensive QA plan for lab services including blood banks; lab support for implementation science; assistance in the implementation/coordination of a specimen/patient referral & reporting system; support for the National HIVDR Coordination Unit & the National EID Program; introduction of GCLP courses as a first step in developing a Center for Integrated Laboratory Training & support for the National Specimen Referral System. The project will be managed by MOH staff & monitored by CDC technical & finance staff. UVRI is now a parastatal organization & has the authority to manage its own finances & this should improve performance. CDC will work with UVRI to improve management and performance of all USG-supported labs on the UVRI campus strengthening the capacity of MOH to respond to epidemics and outbreaks. This will ensure that all USG programs are supported by the same high-quality lab performance. At the same time UVRI & CDC staff will be encouraged to rotate through any of the jointly-managed labs to broaden their exposure to quality lab work, both technical & managerial. CDC Uganda intends downsizing its lab staff as UVRI engages additional staff in a phased approach to ensure continuity of services. This strategy of merging CDC lab activities with those of MOH & the gradual replacement of CDC with UVRI staff is intended to promote Ugandan Government ownership. Uganda now has a NHLSP & a costed strategic plan for its implementation. An inventory of all lab activities in the country is near completion & will enable MOH to identify the gaps where donor support is needed. In this way, it is hoped that more donors will be encouraged to support the lab system strengthening activities in the country, reducing the burden on USG. Data will be collected routinely & measured against targets for project evaluation & cost-effectiveness. Other measures will include; sensitization of district health teams on the program & their role; building capacity in data collection, processing, analyzing & utilizing & the integration of data in the HMIS for planning & training managers in quality lab management.

The main activity here is to conduct an impact evaluation of combination prevention interventions ART for Prevention, male circumcision and PMTCT - in the RHSP cohort in collaboration with NIH and other partners. Other activities to be carried out include; support for HIV surveillance & surveys, including HIVDR; collection & analysis of data to inform the development and conduct of implementation science; assistance in building the national IT infrastructure to link all health facilities; development of information systems to support surveillance, QA, curative, preventive and promotive services; building capacity for conducting evaluations; assistance in defining the distribution of human resources for health and for HIV disease surveillance, support for informatics & epidemiological aspects of SI in order to improve data usage, through effective monitoring & evaluation activities particularly at the district level using the new DHIS software. Other measures will include; sensitization of district health teams on the program & their role; building capacity in data collection, processing, analyzing & utilizing & the integration of data in the HMIS for planning & training managers in quality lab management.

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With USG funding, the HIV Reference and Quality Assurance Laboratory at UVRI has established a national laboratory QA program focused specifically on HIV serological testing. This activity will continue and will be expanded to include all HIV-related testing at all testing sites in the country and will focus on ensuring that lay & community health workers, in addition to counselors and lab staff, who take samples for testing are providing quality services to the client, notably obtaining and providing quality samples following national SOPs. In FY 2012 training in QA/QC will be conducted for testing personnel in both government & non-government laboratories and those offering community based testing. SOPs for laboratory safety, sample processing, Rapid and ELISA HIV testing, rapid syphilis testing and proficiency panel preparations for HIV will be reviewed and updated. Adherence to SOPs and their availability will be assessed. The Rapid HIV test kit evaluation will be finalized and new national testing algorithm formulated. Sites will be further assessed for compliance with good clinical laboratory practice, waste disposal and the availability of requirements to conduct quality HIV testing. This information will be shared with partners and sites during support supervision visits, workshops and a regular newsletter. The training to be provided will include: conducting supervisory visits, preparation & characterization of HIV serologic PT panels & distribution & interpretation of results. UVRI will work with DFLPs and CPHL to ensure that their activities, especially support supervision visits, are incorporated in the annual district work-plan, & engage with the district leaders on the importance of high-quality lab results. While the existing M & E plan drawn from national and USG requirements and tools will guide implementation of activities, more partnerships will be established with government and non-government organizations, plus the new districts. UVRI will develop a quality assurance plan that takes advantage of joint supervisory visits and PT panel distribution with partners. Accredited labs using national/international standards will be documented and others registered for the accreditation process. The program will continue to provide apprenticeship to both counselors and lab trainees at the UVRI clinic (HC 2). For efficient and cost-effective management of the program, there will be a need to support organizational, financial and administrative structures and mechanisms with UVRI, 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 & maintaining and improving on linkages with key service providers and trainers. UVRI will support integrated training especially in the diagnostics of HIV, malaria, syphilis and tuberculosis thus maximizing the benefits out of the available resources. The training provided to this cadre of personnel will ensure provision of high quality support supervision of laboratories throughout the country.

The project will support HIV prevention efforts among MARPs in Uganda including fishing communities. These communities are among the HIV high-risk groups in Uganda characterized by engaging in high-risk sexual behaviors, in unprotected sex, sexual networking and high alcohol consumption resulting in high HIV prevalence compared to the general population. The project will provide; HIV testing and counseling services; linkage of HIV-infected persons to care; HIV treatment services to eligible persons; conduct STI diagnosis and treatment; provide male and female condoms; conduct intensive risk-reduction education to the target population to reduce new infections & provide services to improve the quality of life for those who are infected and affected. The program will collaborate with the leadership of health facilities in the catchment area to implement and monitor project activities. The program will design innovative approaches to improve uptake of services in the community, put in place strategies for improving adherence to care and treatment services and help communities to adopt less-risky sexual behaviors in an effort to control and prevent HIV transmission in these communities. The program will collaborate with other prevention service providers to implement other HIV prevention services like PMTCT, SMC and treatment for prevention and in other instances, link the clients to service providers. The program will also plan and conduct evaluations to assess the impact of the program in reducing the incidence of HIV among most-at-risk communities.