Impact of the Implementation of Laboratory Information System (WWDISA) on Timely Provision of HIV-1 Viral Load Results in a Rural Area, Inhambane, Mozambique.

WWDISA is an optional module of the DISA Laboratory Information system (LIS) that offers a web portal that allows access to test results over the internet for patient clinical management. This study aims to assess the applicability of using the WWDISA web application, and the lessons learned from its implementation in six health facilities in Mabote district, Inhambane province. Data from 2463 and 665 samples for HIV-viral load (HIVVL) tests, extracted from paper-based and WWDISA systems, respectively, were included, from January to December 2020. Data were simultaneously collected on a quarterly basis from both systems to allow comparison. The WWDISA turnaround time (TAT) from sample collection to results becoming available was found to be 10 (IQR: 8−12) days and significantly lower than the health unit manual logbook (p value < 0.001). Regarding the system efficiency, it was found that among 1978 search results, only 642 (32.5%) were found, and the main challenges according to the users were lack of connectivity (77%) and the website going down (62%). The WWDISA module has been shown to be effective in reducing the TAT, although a stable internet connection and accurate data entry are essential to make the system functional.

Quality assurance for point-of-care testing in Mozambique's National Health Service

Medical care in Mozambique is mostly provided through the national health service of the Ministry of Health. All primary healthcare and HIV-related services are provided free of charge. There are over 1500 public sector health facilities in Mozambique and most of these are primary healthcare centres. Although all hospitals have a laboratory, only a quarter of the health centres have a formal laboratory. In this context, point-of-care (POC) testing and syndromic management of diseases play an important role in the health system. Both communicable and non-communicable diseases are prevalent in the Mozambican population. Mozambique has a population of 28 million and is among the nine countries with the highest HIV prevalence in the world.1 HIV prevalence in the country among people aged 15­49 years is 11.5%, ranging from 3.7% in the Niassa province in the north to 25.1% in the Gaza province in the south.2,3 HIV prevalence is higher among women (13.1%) than among men (9.2%), and higher in urban areas (15.9%) compared with rural areas (9.2%).2,3 Among children aged between 0 and 11 years, HIV prevalence is 1.4%, and 2.3% in those younger than one year.2,3 It is estimated that 102 new infections in children occur daily in Mozambique (Ministry of Health, unpublished data). Demographic impact studies show that an estimated 1.6 million Mozambicans were living with HIV in 2009.

Guião para a auto-testagem de hiv em moçambique / Self-testing guide hiv in mozambique

O conhecimento do próprio estado serológico relativamente ao HIV é essencial para o sucesso da resposta global contra o HIV. Na última década, registou-se um aumento substancial dos serviços de testagem de HIV em todo o mundo, e estimase que em 2017, 75% das pessoas com HIV em todo o mundo conheciam seu estado (ONUSIDA, 2018), em grande parte devido ao aumento da disponibilidade de Testes de Diagnóstico Rápido (TDRs) de baixo custo, fornecidos por trabalhadores de saúde capacitados e implementado tanto nas unidades sanitárias como nas comunidades. Recentemente a ONUSIDA (Programa Conjunto das Nações Unidas Contra o VIH/ SIDA) definiu a meta 90-90-90, que visa contribuir para o fim da epidemia do SIDA, a qual preconiza que até 2020, 90% das pessoas que vivem com o HIV terão conhecimento de estarem infectadas com o vírus, 90% das pessoas diagnosticadas com infecção pelo HIV estarão a receber terapia antirretroviral ininterruptamente e 90% das pessoas que recebem terapia antirretroviral estarão em supressão viral. Apesar da grande expansão dos serviços de diagnóstico, 25% das pessoas que vivem com o HIV, continuam sem diagnóstico (ONUSIDA, 2018). E em muitos casos, as pessoas em maior risco de infecção pelo HIV (populações chave e vulneráveis) enfrentam outras barreiras no acesso aos serviços de testagem. É essencial que estes grupos tenham acesso ao diagnóstico, como uma estratégia, para alcance da meta global de diagnosticar 90% de todas as pessoas com HIV até 2020…

External Quality Assessment Programme for Early Infant Diagnosis of HIV-1, Mozambique, 2011-2014.

This study evaluated a National External Quality Scheme Program for early infant diagnosis of HIV. Fourteen laboratory technicians participated and nine testing panel cycles were sent between 2011 and 2014. The response rate was 100% for the first eight panels, and the number of technicians with a test score of 100% increased during the first three panels. Based on the evaluations of the technicians, the quality of testing for early infant diagnosis of HIV improved over time in the laboratories.

Mozambique's journey toward accreditation of the National Tuberculosis Reference Laboratory.

BACKGROUND: Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. METHODS: The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL's process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. RESULTS: Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. CONCLUSIONS: From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

Mozambique's journey toward accreditation of the National Tuberculosis Reference Laboratory

Background: Internationally-accredited laboratories are recognised for their superior test reliability, operational performance, quality management and competence. In a bid to meet international quality standards, the Mozambique National Institute of Health enrolled the National Tuberculosis Reference Laboratory (NTRL) in a continuous quality improvement process towards ISO 15189 accreditation. Here, we describe the road map taken by the NTRL to achieve international accreditation. Methods: The NTRL adopted the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme as a strategy to implement a quality management system. After SLMTA, the Mozambique National Institute of Health committed to accelerate the NTRL's process toward accreditation. An action plan was designed to streamline the process. Quality indicators were defined to benchmark progress. Staff were trained to improve performance. Mentorship from an experienced assessor was provided. Fulfilment of accreditation standards was assessed by the Portuguese Accreditation Board. Results: Of the eight laboratories participating in SLMTA, the NTRL was the best-performing laboratory, achieving a 53.6% improvement over the SLMTA baseline conducted in February 2011 to the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) assessment in June 2013. During the accreditation assessment in September 2014, 25 minor nonconformities were identified and addressed. In March 2015, the NTRL received Portuguese Accreditation Board recognition of technical competency for fluorescence smear microscopy, and solid and liquid culture. The NTRL is the first laboratory in Mozambique to achieve ISO 15189 accreditation. Conclusions: From our experience, accreditation was made possible by institutional commitment, strong laboratory leadership, staff motivation, adequate infrastructure and a comprehensive action plan.

Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics.

INTRODUCTION: Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers. METHODS: Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19). RESULTS: After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; p<0.0001). A generally good acceptability for point-of-care testing was seen among health workers. CONCLUSIONS: Point-of-care CD4+ T-cell enumeration resulted in a decreased time to initiation of antiretroviral therapy among treatment eligible women, without significant increase in testing coverage. Overall hemoglobin and syphilis screening increased. Despite the perception that point-of-care technologies increase access to health services, the variability in results indicate the potential for detrimental effects in some settings. Local context needs to be considered and services restructured to accommodate innovative technologies in order to improve service delivery to expectant mothers.

Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics / Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics

A anemia, a sífilis e o VIH são doenças de grande impacto entre as mulheres grávidas na África Subsariana. Foi realizado um estudo quase experimental em quatro unidades de saúde no sul de Moçambique para avaliar o efeito das tecnologias no local de atendimento para quantificação de hemoglobina, testes de sífilis e enumeração de células T CD4+ realizadas nos serviços de saúde materno-infantil na cobertura de testes e tratamento. e avaliar a aceitabilidade pelos profissionais de saúde. Os dados demográficos e de testagem das mulheres que frequentaram os primeiros serviços de cuidados pré-natais foram extraídos dos registos existentes, antes (2011; n = 865) e depois (2012; n = 808) da introdução dos testes no local de prestação de cuidados. Os resultados do estudo por unidade de saúde foram comparados usando testes z (variáveis ​​categóricas) e teste de soma de postos de Wilcoxon (variáveis ​​contínuas), enquanto pesos de variância inversa foram usados ​​para ajustar possíveis efeitos de agrupamento na análise agrupada. Uma entrevista estruturada de avaliação de aceitabilidade foi realizada com profissionais de saúde antes (n = 22). Após a implementação dos testes no local de atendimento, não houve mudança significativa na adesão ao rastreamento geral de hemoglobina (67,9% para 83,0%; p = 0,229), rastreamento de sífilis (80,8% para 87,0%; p = 0,282) e CD4+ T- teste celular (84,9% a 83,5%; p = 0,930). O início da terapia antirretroviral para mulheres elegíveis para tratamento foi semelhante na análise ponderada antes e depois, com variabilidade entre os locais. O tempo desde o diagnóstico do VIH até ao início do tratamento diminuiu (mediana de 44 dias para 17 dias; p<0,0001). Foi observada uma aceitabilidade geralmente boa para testes no local de atendimento entre os profissionais de saúde. A enumeração de células T CD4+ no local de atendimento resultou numa diminuição do tempo até ao início da terapêutica antirretroviral entre as mulheres elegíveis para tratamento, sem aumento significativo na cobertura de testes. O rastreio geral de hemoglobina e sífilis aumentou. Apesar da percepção de que as tecnologias no local de prestação de cuidados aumentam o acesso aos serviços de saúde, a variabilidade nos resultados indica o potencial para efeitos prejudiciais em alguns contextos. O contexto local precisa de ser considerado e os serviços reestruturados para acomodar tecnologias inovadoras, a fim de melhorar a prestação de serviços às mulheres grávidas.

Implementation of Point-of-Care Diagnostics Leads to Variable Uptake of Syphilis, Anemia and CD4+ T-Cell Count Testing in Rural Maternal and Child Health Clinics

Introduction: Anemia, syphilis and HIV are high burden diseases among pregnant women in sub-Saharan Africa. A quasi-experimental study was conducted in four health facilities in Southern Mozambique to evaluate the effect of point-of-care technologies for hemoglobin quantification, syphilis testing and CD4+ T-cell enumeration performed within maternal and child health services on testing and treatment coverage, and assessing acceptability by health workers. Methods: Demographic and testing data on women attending first antenatal care services were extracted from existing records, before (2011; n = 865) and after (2012; n = 808) introduction of point-of-care testing. Study outcomes per health facility were compared using z-tests (categorical variables) and Wilcoxon rank-sum test (continuous variables), while inverse variance weights were used to adjust for possible cluster effects in the pooled analysis. A structured acceptability-assessment interview was conducted with health workers before (n = 22) and after (n = 19). Results: After implementation of point-of-care testing, there was no significant change in uptake of overall hemoglobin screening (67.9% to 83.0%; p = 0.229), syphilis screening (80.8% to 87.0%; p = 0.282) and CD4+ T-cell testing (84.9% to 83.5%; p = 0.930). Initiation of antiretroviral therapy for treatment eligible women was similar in the weighted analysis before and after, with variability among the sites. Time from HIV diagnosis to treatment initiation decreased (median of 44 days to 17 days; p<0.0001). A generally good acceptability for point-of-care testing was seen among health workers. Conclusions: Point-of-care CD4+ T-cell enumeration resulted in a decreased time to initiation of antiretroviral therapy among treatment eligible women, without significant increase in testing coverage. Overall hemoglobin and syphilis screening increased. Despite the perception that point-of-care technologies increase access to health services, the variability in results indicate the potential for detrimental effects in some settings. Local context needs to be considered and services restructured to accommodate innovative technologies in order to improve service delivery to expectant mothers.

Working toward a sustainable laboratory quality improvement programme through country ownership: Mozambique's SLMTA story.

BACKGROUND: Launched in 2009, the Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has emerged as an innovative approach for the improvement of laboratory quality. In order to ensure sustainability, Mozambique embedded the SLMTA programme within the existing Ministry of Health (MOH) laboratory structure. OBJECTIVE: This article outlines the steps followed to establish a national framework for quality improvement and embedding the SLMTA programme within existing MOH laboratory systems. METHODS: The MOH adopted SLMTA as the national laboratory quality improvement strategy, hired a dedicated coordinator and established a national laboratory quality technical working group comprising mostly personnel from key MOH departments. The working group developed an implementation framework for advocacy, training, mentorship, supervision and audits. Emphasis was placed on building local capacity for programme activities. After receiving training, a team of 25 implementers (18 from the MOH and seven from partner organisations) conducted baseline audits (using the Stepwise Laboratory Quality Improvement Process Towards Accreditation [SLIPTA] checklist), workshops and site visits in six reference and two central hospital laboratories. Exit audits were conducted in six of the eight laboratories and their results are presented. RESULTS: The six laboratories demonstrated substantial improvement in audit scores; median scores increased from 35% at baseline to 57% at exit. It has been recommended that the National Tuberculosis Reference Laboratory apply for international accreditation. CONCLUSION: Successful implementation of SLMTA requires partnership between programme implementers, whilst effectiveness and long-term viability depend on country leadership, ownership and commitment. Integration of SLMTA into the existing MOH laboratory system will ensure durability beyond initial investments. The Mozambican model holds great promise that country leadership, ownership and institutionalisation can set the stage for programme success and sustainability.

Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study

Background: Loss to follow-up of HIV-positive patients before initiation of antiretroviral therapy can exceed 50% in low-income settings and is a challenge to the scale-up of treatment. We implemented point-of-care counting of CD4 cells in Mozambique and assessed the effect on loss to follow-up before immunological staging and treatment initiation. Methods: In this observational cohort study, data for enrolment into HIV management and initiation of antiretroviral therapy were extracted retrospectively from patients' records at four primary health clinics providing HIV treatment and point-of-care CD4 services. Loss to follow-up and the duration of each preparatory step before treatment initiation were measured and compared with baseline data from before the introduction of point-of-care CD4 testing. Findings: After the introduction of point-of-care CD4 the proportion of patients lost to follow-up before completion of CD4 staging dropped from 57% (278 of 492) to 21% (92 of 437) (adjusted odds ratio [OR] 0•2, 95% CI 0•15-0•27). Total loss to follow-up before initiation of antiretroviral treatment fell from 64% (314 of 492) to 33% (142 of 437) (OR 0•27, 95% CI 0•21-0•36) and the proportion of enrolled patients initiating antiretroviral therapy increased from 12% (57 of 492) to 22% (94 of 437) (OR 2•05, 95% CI 1•42-2•96). The median time from enrolment to antiretroviral therapy initiation reduced from 48 days to 20 days (p<0•0001), primarily because of a reduction in the median time taken to complete CD4 staging, which decreased from 32 days to 3 days (p<0•0001). Loss to follow-up between staging and antiretroviral therapy initiation did not change significantly (OR 0•84, 95% CI 0•49-1•45). Interpretation: Point-of-care CD4 testing enabled clinics to stage patients rapidly on-site after enrolment, which reduced opportunities for pretreatment loss to follow-up. As a result, more patients were identified as eligible for and initiated antiretroviral treatment. Point-of-care testing might therefore be an effective intervention to reduce pretreatment loss to follow-up.

Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study.

BACKGROUND: Loss to follow-up of HIV-positive patients before initiation of antiretroviral therapy can exceed 50% in low-income settings and is a challenge to the scale-up of treatment. We implemented point-of-care counting of CD4 cells in Mozambique and assessed the effect on loss to follow-up before immunological staging and treatment initiation. METHODS: In this observational cohort study, data for enrolment into HIV management and initiation of antiretroviral therapy were extracted retrospectively from patients' records at four primary health clinics providing HIV treatment and point-of-care CD4 services. Loss to follow-up and the duration of each preparatory step before treatment initiation were measured and compared with baseline data from before the introduction of point-of-care CD4 testing. FINDINGS: After the introduction of point-of-care CD4 the proportion of patients lost to follow-up before completion of CD4 staging dropped from 57% (278 of 492) to 21% (92 of 437) (adjusted odds ratio [OR] 0·2, 95% CI 0·15-0·27). Total loss to follow-up before initiation of antiretroviral treatment fell from 64% (314 of 492) to 33% (142 of 437) (OR 0·27, 95% CI 0·21-0·36) and the proportion of enrolled patients initiating antiretroviral therapy increased from 12% (57 of 492) to 22% (94 of 437) (OR 2·05, 95% CI 1·42-2·96). The median time from enrolment to antiretroviral therapy initiation reduced from 48 days to 20 days (p<0·0001), primarily because of a reduction in the median time taken to complete CD4 staging, which decreased from 32 days to 3 days (p<0·0001). Loss to follow-up between staging and antiretroviral therapy initiation did not change significantly (OR 0·84, 95% CI 0·49-1·45). INTERPRETATION: Point-of-care CD4 testing enabled clinics to stage patients rapidly on-site after enrolment, which reduced opportunities for pretreatment loss to follow-up. As a result, more patients were identified as eligible for and initiated antiretroviral treatment. Point-of-care testing might therefore be an effective intervention to reduce pretreatment loss to follow-up. FUNDING: Absolute Return for Kids and UNITAID.

Accurate CD4 T-cell enumeration and antiretroviral drug toxicity monitoring in primary healthcare clinics using point-of-care testing.

OBJECTIVE: To evaluate the accuracy of point-of-care tests (POCTs) for CD4 cell, clinical chemistry and hemoglobin in primary healthcare clinics in Mozambique. DESIGN AND METHODS: POCT and laboratory-based assays were conducted on adult HIV-positive patients enrolled consecutively at primary healthcare clinics in Mozambique. Patients were tested on-site with POCT CD4 (Pima), clinical chemistry (Reflotron) and hemoglobin (HemoCue) devices using finger prick blood. Results obtained on paired blood samples were used for agreement analysis (bias and limits of agreement). Repeatability analysis was also performed for POCT CD4 cell counting. RESULTS: Primary health nurses operating the Pima, Reflotron and HemoCue POCT devices produced results with low levels of bias for CD4(+) T-cell counts (-52.8 cells/µl), alanine aminotransferase (-0.2 U/l), aspartate aminotransferase (-4.0 U/l) and hemoglobin (0.95 g/dl). CD4(+) T-cell counts in paired specimens of finger prick and venous blood tested on the POCT CD4 device were in close agreement (bias -9 cells/µl, coefficient of variation 10.6%). The repeatability of POCT CD4 cell counting was similar to that observed with laboratory instruments (bias -6.2 cells/µl, coefficient of variation 10.7% vs. bias -5.7 cells/µl, coefficient of variation 7.5%). CONCLUSION: Primary health clinic nurses generated accurate results for CD4(+) T-cell counts, liver enzymes and hemoglobin using simple POC devices on finger prick samples at decentralized antiretroviral therapy (ART) clinics. POC diagnostics to monitor ART at primary healthcare level is technically feasible and should be utilized in efforts to decentralize HIV care and treatment.