Last data update: Jun 24, 2024. (Total: 47078 publications since 2009)
Records 1-22 (of 22 Records) |
Query Trace: Alemnji G [original query] |
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Assessing sex differences in viral load suppression and reported deaths using routinely collected program data from PEPFAR-supported countries in sub-Saharan Africa
Fernandez D , Ali H , Pals S , Alemnji G , Vasireddy V , Siberry GK , Oboho I , Godfrey C . BMC Public Health 2023 23 (1) 1941 BACKGROUND: In sub-Saharan Africa, more women than men access HIV testing and treatment and may have better viral load suppression (VLS). We utilized routinely reported aggregated HIV program data from 21 sub-Saharan African countries to examine sex differences in VLS and death rates within antiretroviral therapy (ART) programs supported by the United States President's Emergency Plan for AIDS Relief (PEPFAR). METHODS: We included VLS and reported death data for persons aged 15 + years on ART from October-December 2020 disaggregated by sex and age for each subnational unit (SNU). We used linear mixed-model regression to estimate VLS proportion and negative binomial mixed-model regression to estimate the rates of death and death plus interruptions in treatment (IIT). All models were weighted for SNU-level ART population size and adjusted for sex, age, HIV/tuberculosis coinfection, country, and SNU; models for reported deaths and deaths plus IIT were also adjusted for SNU-level VLS. RESULTS: Mean VLS proportion was higher among women than men (93.0% vs. 92.0%, p-value < 0.0001) and 50 + than 15-49 age group (93.7% vs. 91.2%, p-value < 0.0001). The mean rate of reported deaths was higher among men than women (2.37 vs. 1.51 per 1000 persons, p-value < 0.0001) and 50 + than 15-49 age group (2.39 vs. 1.50 per 1000, p-value < 0.0001); the mean rate of reported deaths plus IIT was higher among men (30.1 in men vs. 26.0 in women per 1000, p-value < 0.0001) and higher among 15-49 than 50 + age group (34.7 vs. 22.6 per 1000, p-value < 0.0001). CONCLUSIONS: The mean rate of reported deaths was higher among men in most models despite adjusting for VLS. Further exploration into differences in care-seeking behaviors; coverage of screening, prophylaxis, and/or treatment of opportunistic infections; and more extensive testing options for men to include CD4 is recommended. |
Building integrated testing programs for infectious diseases
Alemnji G , Mosha F , Maggiore P , Alexander H , Ndlovu N , Kebede Y , Tiam A , Albert H , Edgil D , de Lussigny S , Peter T . J Infect Dis 2023 228 (10) 1314-1317 In the past two decades, testing services for diseases such as HIV, TB and malaria have expanded dramatically. Investments in testing capacity and supportive health systems have often been disease specific, resulting in siloed testing programs with suboptimal capacity, reduced efficiency, and limited ability to introduce additional tests or respond to new outbreaks. Emergency demand for SARS-CoV2 testing overcame these silos and demonstrated the feasibility of integrated testing. Moving forward, an integrated public laboratory infrastructure that services multiple diseases, including SARS-CoV-2, influenza, HIV, TB, hepatitis, malaria, sexually transmitted diseases, and other infections will help improve universal healthcare delivery and pandemic preparedness. However, integrated testing faces many barriers including poorly aligned health systems, funding and policies. Strategies to overcome these include greater implementation of policies that support multi-disease testing and treatment systems, diagnostic network optimization, bundled test procurement, and more rapid spread of innovation and best practices across disease programs. |
Progress in scale up of HIV viral load testing in select sub-Saharan African countries 2016-2018
Fonjungo PN , Lecher S , Zeh C , Rottinghaus E , Chun H , Adje-Toure C , Lloyd S , Mwangi JW , Mwasekaga M , Eshete YM , Pati R , Mots'oane T , Mitruka K , Beukes A , Mwangi C , Bowen N , Hamunime N , Beard RS , Kabuje A , Nabadda S , Auld AF , Balachandra S , Zungu I , Kandulu J , Alemnji G , Ehui E , Alexander H , Ellenberger D . PLoS One 2023 18 (3) e0282652 INTRODUCTION: We assessed progress in HIV viral load (VL) scale up across seven sub-Saharan African (SSA) countries and discussed challenges and strategies for improving VL coverage among patients on anti-retroviral therapy (ART). METHODS: A retrospective review of VL testing was conducted in Côte d'Ivoire, Kenya, Lesotho, Malawi, Namibia, Tanzania, and Uganda from January 2016 through June 2018. Data were collected and included the cumulative number of ART patients, number of patients with ≥ 1 VL test result (within the preceding 12 months), the percent of VL test results indicating viral suppression, and the mean turnaround time for VL testing. RESULTS: Between 2016 and 2018, the proportion of PLHIV on ART in all 7 countries increased (range 5.7%-50.2%). During the same time period, the cumulative number of patients with one or more VL test increased from 22,996 to 917,980. Overall, viral suppression rates exceeded 85% for all countries except for Côte d'Ivoire at 78% by June 2018. Reported turnaround times for VL testing results improved in 5 out of 7 countries by between 5.4 days and 27.5 days. CONCLUSIONS: These data demonstrate that remarkable progress has been made in the scale-up of HIV VL testing in the seven SSA countries. |
Contribution of PEPFAR-supported HIV and TB molecular diagnostic networks to COVID-19 testing preparedness in 16 countries
Romano ER , Sleeman K , Hall-Eidson P , Zeh C , Bhairavabhotla R , Zhang G , Adhikari A , Alemnji G , Cardo YR , Pinheiro A , Pocongo B , Eno LT , Shang JD , Ndongmo CB , Rosario H , Moreno O , DeLen LAC , Fonjungo P , Kabwe C , Ahuke-Mundeke S , Gama D , Dlamini S , Maphalala G , Abreha T , Purfield A , Gebrehiwot YT , Desalegn DM , Basiye F , Mwangi J , Bowen N , Mengistu Y , Lecher S , Kampira E , Kaba M , Bitilinyu-Bangoh J , Masamha G , Viegas SO , Beard RS , vanRooyen G , Shiningavamwe AN , I JM , Iriemenam NC , Mba N , Okoi C , Katoro J , Kenyi DL , Bior BK , Mwangi C , Nabadda S , Kaleebu P , Yingst SL , Chikwanda P , Veri L , Simbi R , Alexander H . Emerg Infect Dis 2022 28 (13) S59-s68 The US President's Emergency Plan for AIDS Relief (PEPFAR) supports molecular HIV and tuberculosis diagnostic networks and information management systems in low- and middle-income countries. We describe how national programs leveraged these PEPFAR-supported laboratory resources for SARS-CoV-2 testing during the COVID-19 pandemic. We sent a spreadsheet template consisting of 46 indicators for assessing the use of PEPFAR-supported diagnostic networks for COVID-19 pandemic response activities during April 1, 2020, to March 31, 2021, to 27 PEPFAR-supported countries or regions. A total of 109 PEPFAR-supported centralized HIV viral load and early infant diagnosis laboratories and 138 decentralized HIV and TB sites reported performing SARS-CoV-2 testing in 16 countries. Together, these sites contributed to >3.4 million SARS-CoV-2 tests during the 1-year period. Our findings illustrate that PEPFAR-supported diagnostic networks provided a wide range of resources to respond to emergency COVID-19 diagnostic testing in 16 low- and middle-income countries. |
HIV Viral Load Monitoring Among Patients Receiving Antiretroviral Therapy - Eight Sub-Saharan Africa Countries, 2013-2018
Lecher SL , Fonjungo P , Ellenberger D , Toure CA , Alemnji G , Bowen N , Basiye F , Beukes A , Carmona S , de Klerk M , Diallo K , Dziuban E , Kiyaga C , Mbah H , Mengistu J , Mots'oane T , Mwangi C , Mwangi JW , Mwasekaga M , N'Tale J , Naluguza M , Ssewanyana I , Stevens W , Zungu I , Bhairavabhotla R , Chun H , Gaffga N , Jadczak S , Lloyd S , Nguyen S , Pati R , Sleeman K , Zeh C , Zhang G , Alexander H . MMWR Morb Mortal Wkly Rep 2021 70 (21) 775-778 One component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) goal to end the HIV/AIDS epidemic by 2030, is that 95% of all persons receiving antiretroviral therapy (ART) achieve viral suppression.(†) Thus, testing all HIV-positive persons for viral load (number of copies of viral RNA per mL) is a global health priority (1). CDC and other U.S. government agencies, as part of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), together with other stakeholders, have provided technical assistance and supported the cost for multiple countries in sub-Saharan Africa to expand viral load testing as the preferred monitoring strategy for clinical response to ART. The individual and population-level benefits of ART are well understood (2). Persons receiving ART who achieve and sustain an undetectable viral load do not transmit HIV to their sex partners, thereby disrupting onward transmission (2,3). Viral load testing is a cost-effective and sustainable programmatic approach for monitoring treatment success, allowing reduced frequency of health care visits for patients who are virally suppressed (4). Viral load monitoring enables early and accurate detection of treatment failure before immunologic decline. This report describes progress on the scale-up of viral load testing in eight sub-Saharan African countries from 2013 to 2018 and examines the trajectory of improvement with viral load testing scale-up that has paralleled government commitments, sustained technical assistance, and financial resources from international donors. Viral load testing in low- and middle-income countries enables monitoring of viral load suppression at the individual and population level, which is necessary to achieve global epidemic control. Although there has been substantial achievement in improving viral load coverage for all patients receiving ART, continued engagement is needed to reach global targets. |
Notes from the Field: Impact of the COVID-19 Response on Scale-Up of HIV Viral Load Testing - PEPFAR-Supported Countries, January-June 2020.
Lecher SL , Naluguza M , Mwangi C , N'Tale J , Edgil D , Alemnji G , Alexander H . MMWR Morb Mortal Wkly Rep 2021 70 (21) 794-795 CDC and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) are committed to maintaining an international response to the HIV epidemic even as countries face the challenge of controlling the COVID-19 pandemic (1). The Joint United Nations Programme on HIV/AIDS has set the following 95-95-95 targets for HIV infection control by 2030: 1) ensure that 95% of HIV-positive persons are aware of their HIV status, 2) ensure that 95% of these persons receive antiretroviral treatment (ART) and 3) facilitate viral load testing and suppression (viral load ≤1,000 HIV RNA copies per mL of blood) among 95% of persons with HIV infection (2). PEPFAR and international donors support 50 countries by investing in diagnostic testing, ART, and viral load testing to monitor treatment outcomes. Recent COVID-19–related stay-at-home orders and travel restrictions have affected essential HIV services worldwide. In the face of these challenges, CDC and PEPFAR are committed to sustaining the momentum necessary to achieve the target goal of facilitating testing and viral suppression among 95% of persons with HIV. |
Building and sustaining optimized diagnostic networks to scale-up HIV viral load and early infant diagnosis
Alemnji G , Peter T , Vojnov L , Alexander H , Zeh C , Cohn J , Watts DH , de Lussigny S . J Acquir Immune Defic Syndr 2020 84 Suppl 1 S56-s62 BACKGROUND: Progress toward meeting the UNAIDS 2014 HIV treatment (90-90-90) targets has been slow in some countries because of gaps in access to HIV diagnostic tests. Emerging point-of-care (POC) molecular diagnostic technologies for HIV viral load (VL) and early infant diagnosis (EID) may help reduce diagnostic gaps. However, these technologies need to be implemented in a complementary and strategic manner with laboratory-based instruments to ensure optimization. METHOD: Between May 2019 and February 2020, a systemic literature search was conducted in PubMed, the Cochrane Library, MEDLINE, conference abstracts, and other sources such as Unitaid, UNAIDS, WHO, and UNICEF websites to determine factors that would affect VL and EID scale-up. Data relevant to the search themes were reviewed for accuracy and were included. RESULTS: Collaborations among countries, implementing partners, and donors have identified a set of framework for the effective use of both POC-based and laboratory-based technologies in large-scale VL and EID testing programs. These frameworks include (1) updated testing policies on the operational utility of POC and laboratory-based technologies, (2) expanded integrated testing using multidisease diagnostic platforms, (3) laboratory network mapping, (4) use of more efficient procurement and supply chain approaches such as all-inclusive pricing and reagent rental, and (5) addressing systemic issues such as test turnaround time, sample referral, data management, and quality systems. CONCLUSIONS: Achieving and sustaining optimal VL and EID scale-up within tiered diagnostic networks would require better coordination among the ministries of health of countries, donors, implementing partners, diagnostic manufacturers, and strong national laboratory and clinical technical working groups. |
Clinical-laboratory interface interventions to improve impact of viral load and early infant diagnosis testing scale-up
Alemnji GA , Pati R , Chun H , Zeh C , Mosha F , Siberry G , Ondoa P . AIDS Res Hum Retroviruses 2020 36 (7) 550-555 Despite tremendous improvements in viral load (VL) monitoring and early infant diagnosis (EID) in many countries, low VL and EID testing rates and low VL suppression rates persist in specific regions and among certain subpopulations. The VL/EID cascade includes patient and provider demand creation, sample collection and transportation, laboratory testing, results transmission back to the clinic, and patient management. Gaps in communication and coordination between clinical and laboratory counterparts can lead to suboptimal outcomes, such as delay or inability to collect and transport samples to the laboratory for testing and failure of test results to reach providers and patients in an efficient, timely, and effective manner. To bridge these gaps and optimize the impact of VL/EID scale-up, we reviewed the components of the cascade and their inter-relationships to identify barriers and facilitators. As part of this process, people living with HIV must be engaged in creating demand for VL/EID testing. In addition, there should be strong communication and collaboration between the clinical and laboratory teams throughout the cascade, along with joint performance review, site visits, and continuous quality improvement activities. Strengthening the clinical-laboratory interface requires innovative solutions and implementation of best practices, including the use of point-of-care diagnostics, simplified data systems, and an efficient supply chain system to minimize interface gaps. |
Trends and gaps in national blood transfusion services - 14 sub-Saharan African countries, 2014-2016
Kanagasabai U , Chevalier MS , Drammeh B , Mili FD , Qualls ML , Bock N , Benech I , Nelson LJ , Alemnji G , Watts DH , Kimani D , Selenic D . MMWR Morb Mortal Wkly Rep 2018 67 (50) 1392-1396 Ensuring availability of safe blood products through recruitment of voluntary, nonremunerated, blood donors (VNRDs) and prevention of transfusion-transmissible infections (TTIs), including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis, is important for public health (1,2). During 2004-2016, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) provided approximately $468 million in financial support and technical assistance* to 14 sub-Saharan African countries(dagger) with high HIV prevalence to strengthen national blood transfusion services (NBTSs)( section sign) and improve blood safety and availability. CDC analyzed these countries' 2014-2016 blood safety surveillance data to update previous reports (1,2) and summarize achievements and programmatic gaps as some NBTSs begin to transition funding and technical support from PEPFAR to local ministries of health (MOHs) (2,3). Despite a 60% increase in blood supply since 2004 and steady declines in HIV prevalence (to <1% among blood donors in seven of the 14 countries), HIV prevalence among blood donors still remains higher than that recommended by the World Health Organization (WHO) (4). PEPFAR support has contributed to significant reductions in HIV prevalence among blood donors in the majority of PEPFAR-supported countries, and linking donors who screen HIV-positive to confirmatory testing and indicated treatment, as well as further reducing TTIs, remains a public health priority (5). |
Improving laboratory efficiency in the Caribbean to attain the World Health Organization HIV Treat All recommendations
Alemnji GA , Chase M , Branch S , Guevara G , Nkengasong JN , Albalak R . AIDS Res Hum Retroviruses 2017 34 (2) 132-139 Scientific evidence showing the benefits of early initiation of antiretroviral therapy (ART) prompted World Health organization (WHO) to recommend that all persons diagnosed HIV-positive should commence ART irrespective of CD4 count and disease progression. Based on this recommendation, countries should adopt and implement the HIV "Treat All" policy to achieve the UNAIDS 90-90-90 targets and ultimately reach epidemic control. Attaining this goal along the HIV treatment cascade depends on the laboratory to monitor progress and measure impact. The laboratory plays an important role in HIV diagnosis to attain the first 90 and in viral load (VL) and HIV drug resistance testing to reinforce adherence, improve viral suppression, and measure the third 90. Countries in the Caribbean region have endorsed the WHO HIV "Treat all" recommendation; however, they are faced with diminishing financial resources to support laboratory testing, seen as a rate-limiting factor to achieving this goal. To improve laboratory coverage with fewer resources in the Caribbean there is the need to optimise laboratory operations to ensure the implementation of high quality, less expensive, evidence-based approaches that will result in more efficient and effective service delivery. Suggested practical and innovative approaches to achieve this include: 1) targeted testing within HIV hotspots; 2) strengthening sample referral systems for VL; 3) better laboratory data collection systems; and 4) use of treatment cascade data for programmatic decision making. Furthermore, strengthening quality improvement and procurement systems will minimize diagnostic errors and guarantee a continuum of uninterrupted testing which is critical for routine monitoring of patients to meet the stated goal. |
Development and implementation of the Caribbean Laboratory Quality Management Systems Stepwise Improvement Process (LQMS-SIP) towards accreditation
Alemnji G , Edghill L , Guevara G , Wallace-Sankarsingh S , Albalak R , Cognat S , Nkengasong J , Gabastou JM . Afr J Lab Med 2017 6 (1) 496 Background: Implementing quality management systems and accrediting laboratories in the Caribbean has been a challenge. Objectives: We report the development of a stepwise process for quality systems improvement in the Caribbean Region. Methods: The Caribbean Laboratory Stakeholders met under a joint Pan American Health Organization/US Centers for Disease Control and Prevention initiative and developed a userfriendly framework called 'Laboratory Quality Management System - Stepwise Improvement Process (LQMS-SIP) Towards Accreditation' to support countries in strengthening laboratory services through a stepwise approach toward fulfilling the ISO 15189: 2012 requirements. Results: This approach consists of a three-tiered framework. Tier 1 represents the minimum requirements corresponding to the mandatory criteria for obtaining a licence from the Ministry of Health of the participating country. The next two tiers are quality improvement milestones that are achieved through the implementation of specific quality management system requirements. Laboratories that meet the requirements of the three tiers will be encouraged to apply for accreditation. The Caribbean Regional Organisation for Standards and Quality hosts the LQMS-SIP Secretariat and will work with countries, including the Ministry of Health and stakeholders, including laboratory staff, to coordinate and implement LQMS-SIP activities. The Caribbean Public Health Agency will coordinate and advocate for the LQMS-SIP implementation. Conclusion: This article presents the Caribbean LQMS-SIP framework and describes how it will be implemented among various countries in the region to achieve quality improvement. |
Combatting global infectious diseases: A network effect of specimen referral systems
Fonjungo PN , Alemnji GA , Kebede Y , Opio A , Mwangi C , Spira TJ , Beard RS , Nkengasong JN . Clin Infect Dis 2017 64 (6) 796-803 The recent Ebola virus outbreak in West Africa clearly demonstrated the critical role of laboratory systems and networks in responding to epidemics. Because of the huge challenges in establishing functional laboratories at all tiers of health systems in developing countries, strengthening specimen referral networks is critical. In this review article, we propose a platform strategy for developing specimen referral networks based on 2 models: centralized and decentralized laboratory specimen referral networks. These models have been shown to be effective in patient management in programs in resource-limited settings. Both models lead to reduced turnaround time and retain flexibility for integrating different specimen types. In Haiti, decentralized specimen referral systems resulted in a 182% increase in patients enrolling in human immunodeficiency virus treatment programs within 6 months. In Uganda, cost savings of up to 62% were observed with a centralized model. A platform strategy will create a network effect that will benefit multiple disease programs. |
Improving laboratory efficiencies to scale-up HIV viral load testing
Alemnji G , Onyebujoh P , Nkengasong JN . Curr Opin HIV AIDS 2017 12 (2) 165-170 PURPOSE OF REVIEW: Viral load measurement is a key indicator that determines patients' response to treatment and risk for disease progression. Efforts are ongoing in different countries to scale-up access to viral load testing to meet the Joint United Nations Programme on HIV and AIDS target of achieving 90% viral suppression among HIV-infected patients receiving antiretroviral therapy. However, the impact of these initiatives may be challenged by increased inefficiencies along the viral load testing spectrum. This will translate to increased costs and ineffectiveness of scale-up approaches. This review describes different parameters that could be addressed across the viral load testing spectrum aimed at improving efficiencies and utilizing test results for patient management. RECENT FINDINGS: Though progress is being made in some countries to scale-up viral load, many others still face numerous challenges that may affect scale-up efficiencies: weak demand creation, ineffective supply chain management systems; poor specimen referral systems; inadequate data and quality management systems; and weak laboratory-clinical interface leading to diminished uptake of test results. SUMMARY: In scaling up access to viral load testing, there should be a renewed focus to address efficiencies across the entire spectrum, including factors related to access, uptake, and impact of test results. |
Improving the quality of and access to HIV rapid testing in the Caribbean region: Program implementation, outcomes, and recommendations
Alemnji GA , Guevara G , Parris K , Kalou M , Behel SK , Parekh B , Nkengasong JN , Albalak R . AIDS Res Hum Retroviruses 2016 32 (9) 879-84 In 2008 HIV rapid testing (HIV RT) was only minimally used in the Caribbean region. Collaboration with countries and international partners since then has resulted in greater availability and use of HIV RT services. Surveys were conducted in 2012 and 2014 among 11 selected Caribbean countries to inform stakeholders of progress made since 2008 and to identify strategies to further improve access and uptake of high-quality HIV RT in community- and facility-based settings in support of the UNAIDS 90-90-90 targets. Key accomplishments during this period include: 1) presence of in-country national HIV RT algorithms; 2) use of the dried tube specimen (DTS) as an external quality assessment (EQA) program; 3) use of standardized logbooks for data collection and monitoring; and, 4) use of oral fluid for HIV RT, particularly for key population surveys. Although progress has been made since 2008 to increase access and improve the quality of HIV RT among countries in the Caribbean some work remains to be done. This includes the development of new policies and implementation of existing ones, task shifting, quality and access to testing, testing strategies, and integration of HIV RT into HIV Testing Services (HTS). |
Evaluation of locally established reference intervals for hematology and biochemistry parameters in Western Kenya
Odhiambo C , Oyaro B , Odipo R , Otieno F , Alemnji G , Williamson J , Zeh C . PLoS One 2015 10 (4) e0123140 BACKGROUND: Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities. METHODS: An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial. RESULTS: About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals. CONCLUSION: Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa. |
The impact of SLMTA in improving laboratory quality systems in the Caribbean region
Guevara G , Gordon F , Irving Y , Whyms I , Parris K , Beckles S , Maruta T , Ndlovu N , Albalak R , Alemnji G . Afr J Lab Med 2014 3 (2) 199 BACKGROUND: Past efforts to improve laboratory quality systems and to achieve accreditation for better patient care in the Caribbean Region have been slow. OBJECTIVE: To describe the impact of the Strengthening of Laboratory Management Toward Accreditation (SLMTA) training programme and mentorship amongst five clinical laboratories in the Caribbean after 18 months. METHOD: Five national reference laboratories from four countries participated in the SLMTA programme that incorporated classroom teaching and implementation of improvement projects. Mentors were assigned to the laboratories to guide trainees on their improvement projects and to assist in the development of Quality Management Systems (QMS). Audits were conducted at baseline, six months, exit (at 12 months) and post-SLMTA (at 18 months) using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist to measure changes in implementation of the QMS during the period. At the end of each audit, a comprehensive implementation plan was developed in order to address gaps. RESULTS: Baseline audit scores ranged from 19% to 52%, corresponding to 0 stars on the SLIPTA five-star scale. After 18 months, one laboratory reached four stars, two reached three stars and two reached two stars. There was a corresponding decrease in nonconformities and development of over 100 management and technical standard operating procedures in each of the five laboratories. CONCLUSION: The tremendous improvement in these five Caribbean laboratories shows that SLMTA coupled with mentorship is an effective, user-friendly, flexible and customisable approach to the implementation of laboratory QMS. It is recommended that other laboratories in the region consider using the SLMTA training programme as they engage in quality systems improvement and preparation for accreditation. |
The centrality of laboratory services in the HIV treatment and prevention cascade: the need for effective linkages and referrals in resource-limited settings
Alemnji G , Fonjungo P , Van Der Pol B , Peter T , Kantor R , Nkengasong J . AIDS Patient Care STDS 2014 28 (5) 268-73 Strong laboratory services and systems are critical for delivering timely and quality health services that are vital to reduce patient attrition in the HIV treatment and prevention cascade. However, challenges exist in ensuring effective laboratory health systems strengthening and linkages. In particular, linkages and referrals between laboratory testing and other services need to be considered in the context of an integrated health system that includes prevention, treatment, and strategic information. Key components of laboratory health systems that are essential for effective linkages include an adequate workforce, appropriate point-of-care (POC) technology, available financing, supply chain management systems, and quality systems improvement, including accreditation. In this review, we highlight weaknesses of and gaps between laboratory testing and other program services. We propose a model for strengthening these systems to ensure effective linkages of laboratory services for improved access and retention in care of HIV/AIDS patients, particularly in low- and middle-income countries. |
Strengthening national health laboratories in sub-Saharan Africa: a decade of remarkable progress
Alemnji GA , Zeh C , Yao K , Fonjungo PN . Trop Med Int Health 2014 19 (4) 450-8 OBJECTIVES: Efforts to combat the HIV/AIDS pandemic have underscored the fragile and neglected nature of some national health laboratories in Africa. In response, national and international partners and various governments have worked collaboratively over the last several years to build sustainable laboratory capacities within the continent. Key accomplishments reflecting this successful partnership include the establishment of the African-based World Health Organization Regional Office for Africa (WHO-AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA); development of the Strengthening Laboratory Management Toward Accreditation (SLMTA) training programme; and launching of a Pan African-based institution, the African Society for Laboratory Medicine (ASLM). These platforms continue to serve as the foundations for national health laboratory infrastructure enhancement, capacity development and overall quality system improvement. Further targeted interventions should encourage countries to aim at integrated tiered referral networks, promote quality system improvement and accreditation, develop laboratory policies and strategic plans, enhance training and laboratory workforce development and a retention strategy, create career paths for laboratory professionals and establish public-private partnerships. Maintaining the gains and ensuring sustainability will require concerted action by all stakeholders with strong leadership and funding from African governments and from the African Union. |
Strengthening national laboratory health systems in the Caribbean region
Alemnji GA , Branch S , Best A , Kalou M , Parekh B , Waruiru W , Milstrey E , Conn W , Nkengasong JN , Lecher S . Glob Public Health 2012 7 (6) 648-60 The President's Emergency Plan for AIDS Relief (PEPFAR) programme for the Caribbean Region was established in 2008 to address health system challenges, including fragile laboratory services and systems. The laboratory component of this programme consisted of several phases: assessment of laboratory needs of all 12 countries engaged in the programme; addressing gaps identified during the assessment; and monitoring and evaluation of the progress achieved. After one year of PEPFAR collaboration with national governments and other partners, laboratory services and systems greatly improved. Some of the milestones include: (1) the accreditation of a public laboratory; (2) improved access to HIV diagnosis with faster turnaround time; (3) establishment of capacity for platforms for DNA PCR, viral load and HIV drug resistance; (4) development of the laboratory workforce; and (5) establishment of a framework for implementation of sustainable quality management systems for laboratory accreditation. The progress recorded in strengthening laboratory health systems after one year of initiating this collaboration shows that with a rigorous initial assessment, programme design and intervention and strategic partnership, national laboratory health systems can be greatly enhanced to support programme implementation. Continued collaboration and country leadership is critical to create an integrated and sustainable laboratory network in the Caribbean. |
HIV testing in developing countries: what is required?
Alemnji G , Nkengasong JN , Parekh BS . Indian J Med Res 2011 134 (6) 779-86 HIV diagnostic and follow up testing are usually done in laboratory settings. However, in developing countries there is a need to decentralize testing as the majority of the population lives in rural settings. In developing countries stringent quality assurance (QA) practices, which include appropriate training, development of standard operating procedures, maintenance of operator proficiency, routine use of quality control (QC) specimens, standardized data management, equipment calibration and maintenance, and biohazard safety with proper disinfection/disposal procedures are not routinely followed to ensure reliability of results and a safe work environment. The introduction of point-of-care testing technologies involving the use of non-laboratorians in routine testing has further increased the complexity of QA. Therefore, a careful approach towards improvement of laboratories that encourages best practices, coupled with incentives, and review of government policies in point-of-care testing is needed to improve quality of testing as decentralization takes place. Development of a functional laboratory tiered network that facilitates communication, referral, training and problem solving could further enhance confidence in laboratory testing. There is also a need for special considerations in implementing a step-wise approach towards quality improvement, strengthening of the supply chain management, human capacity development, infrastructure upgrade, and strong public private partnerships to ensure long term sustainability of these efforts. |
Prevalence of drug resistance-related polymorphisms in treatment-naive individuals infected with nonsubtype B HIV type 1 in Cameroon.
Fonjungo PN , Youngpairoj AS , Alemnji GA , Eno LT , Lyonga EJ , Eloundou MA , Shanmugam V , Mpoudi-Ngole E , Kalish ML , Folks TM , Pieniazek D . AIDS Res Hum Retroviruses 2011 28 (7) 675-84 Mutations associated with the use of protease (PR) and reverse transcriptase (RT) inhibitors have been mostly mapped for HIV-1 subtype B. The prevalence of these mutations in drug-naive HIV-1 subtype B infected individuals is low but occurs at high frequencies in treated individuals. To determine the prevalence of treatment-associated mutations in non-B viruses, we analyzed a 1613bp pol region of specimens collected from 57 HIV-1 infected treatment-naive individuals from Cameroon. Of the 57 HIV-1 sequences, 43 belonged to CRF02-AG, two to CRF11-cpx, six to subtype A, one to subtype D and five were unclassifiable. Of the 57 PR sequences, 100% contained at least one codon change giving substitutions at positions 10, 11, 16, 20, 33, 36, 60, 62, 64, 69, 77, and 89. These substitutions gave the following prevalence pattern, 36I/L (100%, 57/57) > 89M/I (98%, 56/57) > 69K/R (93%, 53/57) > 20I/R (89%, 51/57) > 16E (16%, 9/57) > 64M (12%, 7/57) > 10I (11%, 6/57) > 11V (5%, 3/57) = 62V (5%, 3/57) = 77I (5%, 3/57) > 233F/V (4%, 2/57) = 60E (4%), which differed significantly from subtype B at positions 20, 36, 69 and 89. All but one (98%) of the 57 RT sequences (438 amino acid residues) carried substitutions located at codons 39A (7%), 43E (7%), 122E (7%), 312Q (2%), 333E (2%), 335C/D (89%), 356K (89%), 358K (14%), 365I (2%), 371V (81%), 376S (11%) or 399D (4%); the frequency of these substitutions ranged from <0.5% to 4% in RT of subtype B. The high prevalence of minor mutations associated with protease inhibitors (PI) and reverse transcriptase inhibitors (RTI) represent natural polymorphisms. HIV-1 PR and RT sequences from ARV-naive HIV-infected persons in Cameroon are important for monitoring the development of resistance to PIs and RTIs as such mutations could lead to treatment failures in individuals undergoing ARV therapy. |
Scaling up HIV rapid testing in developing countries: comprehensive approach for implementing quality assurance
Parekh BS , Kalou MB , Alemnji G , Ou CY , Gershy-Damet GM , Nkengasong JN . Am J Clin Pathol 2010 134 (4) 573-84 In the last few years, the use of HIV rapid testing has expanded worldwide in response to the call for universal access to prevention, care, and treatment by UNAIDS and the World Health Organization. HIV rapid testing is performed by people with varied skills in laboratory and nonlaboratory settings. Accurate HIV diagnostic testing is the first step to identifying infected persons for follow-up referral and care. However, there are several challenges related to test kit quality, test selection, testing algorithms, training, quality assurance (QA), quality of new lots, and postmarket performance. We highlight various issues that impact the quality of HIV rapid testing and provide solutions to monitor and improve test accuracy, especially in resource-limited settings. These include the use of validated kits, training with emphasis on QA, use of a standardized log book, dried-tube specimen-based proficiency testing, new kit lot verification, and postmarket surveillance. Systematic implementation of these tools should greatly enhance the quality of HIV rapid testing. |
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