Strengthening the Diagnosis and Treatment of Malnutrition Through Increased Nurse Involvement: A Quality Improvement Project From Pediatric Wards in Mozambique.

BACKGROUND: Childhood acute malnutrition continues to be a serious health problem in many low-resource settings in Africa. On pediatric wards in Mozambique, missed opportunities for timely diagnosis and treatment of malnutrition may lead to poor health outcomes. To improve inpatient nutritional care, a quality improvement (QI) project was implemented that aimed to engage pediatric nurses in inpatient malnutrition diagnosis and treatment. METHODS: In 2 Mozambican referral hospitals, for 6 months, the Plan-Do-Study-Act framework for QI was implemented to identify key drivers of the following measures: having complete anthropometric evaluation documented at admission, 3 or more weight measurements per hospitalization week, documentation of nutritional therapy for eligible patients, and documentation of referral for outpatient nutritional rehabilitation after discharge. Clinical data were abstracted from hospital charts and entered into an EpiInfo database, including a 3-month observation period after the project, and analyzed retrospectively. RESULTS: A total of 2,208 children from wards other than malnutrition were included in the analysis. Complete anthropometric evaluation at admission improved from 24.4% 2 months before the QI project to 80.1% during and 75.2% in the 3 months after the project (P<.001). The percentage of patients with 3 or more weight measurements per hospitalization week rose from 22.3% to 82.8% during and 75.0% after the project (P<.001). Documentation of nutritional therapy increased from 58.8% before to 67.1% during and 70.6% after the project (P=.54), and documentation of referral for outpatient nutritional rehabilitation after discharge decreased from 55.9% to 54.9% during and increased to 70.6% after the project, (P<.001). CONCLUSION: Nurse engagement may lead to important advancements in the diagnosis and treatment of acute malnutrition in pediatric wards other than malnutrition in Mozambique. Task-sharing, particularly nurse engagement, in combination with QI methodology, may be considered for wards in similar settings with a high burden of malnutrition.

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.

Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings.

Background: In resource-poor countries, antigen-based rapid tests (Ag-RDTs) performed at primary healthcare and community settings improved access to SARS-CoV-2 diagnostics. However, the technical skills and biosafety requirements inherent to nasopharyngeal and oropharyngeal (OP) specimens limit the scale-up of SARS-CoV-2 testing. The collection of nasal-swabs is programmatically viable, but its performance has not been evaluated in resource-poor settings. Methods: We first evaluated the performance of SteriPack self-collected nasal swabs for the detection of SARS-CoV-2 by real-time PCR in 1498 consecutively enrolled patients with suspected infection. Next, we evaluated the clinical performance of three nasal swab-based Ag-RDTs against real-time PCR on OP specimens. Results: The sensitivity of nasal swabs was 80.6% [95% CI: 75.3−85.2%] compared to OP specimens. There was a good correlation (r = 0.58; p < 0.0001) between Ct values of 213 positive cases obtained using nasal and OP swabs. Our findings show sensitivities of 79.7% [95% CI: 73.3−85.1%] for Panbio COVID-19 Ag-RDT, 59.6% [95% CI: 55.2−63.8%] for COVIOS Ag-RDT, and 78.0% [95% CI: 73.5−82.0%] for the LumiraDx SARS-CoV-2 Ag-RDT. Conclusions: In our setting, the COVIOS Ag-RDT did not meet WHO requirements. Nasal swab-based Ag-RDTs for SARS-CoV-2 detection constitute a viable and accurate diagnostic option in resource-poor settings.

Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings

Background: In resource-poor countries, antigen-based rapid tests (Ag-RDTs) performed at primary healthcare and community settings improved access to SARS-CoV-2 diagnostics. However, the technical skills and biosafety requirements inherent to nasopharyngeal and oropharyngeal (OP) specimens limit the scale-up of SARS-CoV-2 testing. The collection of nasal-swabs is programmatically viable, but its performance has not been evaluated in resource-poor settings. Methods: We first evaluated the performance of SteriPack self-collected nasal swabs for the detection of SARS-CoV-2 by real-time PCR in 1498 consecutively enrolled patients with suspected infection. Next, we evaluated the clinical performance of three nasal swab-based Ag-RDTs against real-time PCR on OP specimens. Results: The sensitivity of nasal swabs was 80.6% [95% CI: 75.3−85.2%] compared to OP specimens. There was a good correlation (r = 0.58; p < 0.0001) between Ct values of 213 positive cases obtained using nasal and OP swabs. Our findings show sensitivities of 79.7% [95% CI: 73.3−85.1%] for Panbio COVID-19 Ag-RDT, 59.6% [95% CI: 55.2−63.8%] for COVIOS Ag-RDT, and 78.0% [95% CI: 73.5−82.0%] for the LumiraDx SARS-CoV-2 Ag-RDT. Conclusions: In our setting, the COVIOS Ag-RDT did not meet WHO requirements. Nasal swab-based Ag-RDTs for SARS-CoV-2 detection constitute a viable and accurate diagnostic option in resource-poor settings

HIV risk factors among adolescent and young adults: A geospatial-temporal analysis of Mozambique AIDS indicator survey data.

In a developing country, it is very crucial to know where the HIV/AIDS epidemic is much more prevalent and where direct interventions are needed, especially when managing limited and scarce resources. We therefore examine the spatial distribution of HIV in Mozambique, and also assess how the epidemic evolved over a six-year period (2009-2015), with respect to potential risk factors among adolescents and young adults. We used data from the 2009 and 2015 Mozambique AIDS indicator surveys. The data were analysed jointly, by extending the work of Muleia et al. (2020) to allow for different bivariate spatial smoothing functions for both surveys. The results showed considerable spatial variation. From 2009 to 2015, the probability to be HIV positive reduced by 43.6% for young women. The results also showed dependence of the probability for HIV infection on sociodemographic factors. The findings herein will help health officials design efficient target interventions.

Nevirapine hair and plasma concentrations and HIV-1 viral suppression among HIV infected ante-partum and post-partum women attended in a mother and child prevention program in Maputo city, Mozambique.

INTRODUCTION: Prevention of mother to child transmission of HIV (PMTCT) is frequently challenged by irregular access to more effective anti-retroviral therapy. Nevirapine single dose (sdNVP), sdNVP+AZT+3TC for MTCT prophylaxis and NVP+ AZT+3TC for treatment and PMTCT were withdrawn due to low genetic resistance barrier and low efficacy. However current PMTCT lines in Mozambique include DTG+3TC+TDF, TDF+3TC+EFV, DTG +ABC+3TC, and AZT + NVP syrup prophylaxis for exposed babies. We assessed NVP hair and plasma concentrations and association with HIV-1RNA suppression among HIV+ ante-partum and post-partum women under PMTCT in Maputo, Mozambique. METHODS: From December 2013 to November 2014, prospectively were enrolled 200 HIV+ ante-partum women on 200mg nevirapine and zidovudine 300 plus lamivudine 150mg twice daily at least with 3 months treatment and seen again at 24 weeks post-partum. Self-reported pill-taking adherence, NVP concentrations in hair, plasma, hemoglobin, CD4 cell count, HIV-1 RNA load was evaluated. NVP concentration in hair and plasma was analyzed as categorical quartile variable based on better data fit. NVP concentration was set between ≤3.77 ng/ml in plasma and ≤17,20 ng/mg in hair in quartile one to ≥5.36 ng/ml in plasma and ≥53.21 ng/mg in hair in quartile four. Logistic regression models for repeated measures were calculated. Following the World Health Organization (WHO) guidelines we set viral suppression at HIV-1RNA < 1000 c/mL. Outcome was HIV-1 RNA<1000 copies/ml. Predictor was NVP concentration in hair categorized in quartiles. RESULTS: In total 369 person-visits (median of 1.85) were recorded. Self-reported adherence was 98% (IQR 97-100%) at ante-partum. In 25% person visits, NVP concentrations were within therapeutic levels (3.77 ng/ml to 5.35 ng/ml) in plasma and (17.20 ng/mg to 53.20 ng/mg) in hair. In 50% person visits NVP concentrations were above 5.36 ng/ml in plasm and 53.21 ng/mg in hair. HIV-1 RNA suppression was found in 34.7% of women with two viral loads, one at enrollment and another in post-partum. Odds of HIV-1 RNA suppression in quartile 4, was about 6 times higher than in quartile 1 (p-value = 0.006) for NVP hair concentration and 7 times for NVP plasma concentration (p-value = 0.012). CONCLUSIONS: The study results alert for potential low efficacy of current PMTCT drug regimens in use in Mozambique. Affordable means for individual monitoring adherence, ART plasma and hair levels, drug resistant and HIV-1 RNA levels monitoring are recommended for prompt identification of inadequate drug regimens exposure patterns and adjust accordingly.

Performance Evaluation of the STANDARDTM Q COVID-19 and PanbioTM COVID-19 Antigen Tests in Detecting SARS-CoV-2 during High Transmission Period in Mozambique.

(1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate the clinical performance of two SARS-CoV-2 rapid antigen tests during a high transmission period. (2) Methods: A total of 1277 patients seeking SARS-CoV-2 diagnosis were enrolled at four health facilities. Nasopharyngeal swabs for rapid antigen and real time PCR testing were collected for each patient. Sensitivity, specificity, positive and negative predictive values, misclassification rate, and agreement were determined. (3) Results: The overall sensitivity of Panbio COVID-19 was 41.3% (95% CI: 34.6-48.4%) and the specificity was 98.2% (95% CI: 96.2-99.3%). The Standard Q had an overall sensitivity and specificity of 45.0% (95% CI: 39.9-50.2%) and 97.6% (95% CI: 95.3-99.0%), respectively. The positive predictive value of a positive test was 93.3% and 95.4% for the Panbio and Standard Q Ag-RDTs, respectively. A higher sensitivity of 43.2% and 49.4% was observed in symptomatic cases for the Panbio and Standard Q Ag-RDTs, respectively. (4) Conclusions: Despite the overall low sensitivity, the two evaluated rapid tests are useful to improve the diagnosis of symptomatic SARS-CoV-2 infections during high transmission periods.

Inpatient Point-of-Care HIV Early Infant Diagnosis in Mozambique to Improve Case Identification and Linkage to Antiretroviral Therapy.

INTRODUCTION: Novel approaches to case identification and linkage to antiretroviral therapy (ART) are needed to close gaps in early infant diagnosis (EID) of HIV. Point-of-care (POC) EID is a recent innovation that eliminates the long turnaround times of conventional EID that limit patient management in the inpatient setting. The initial deployment of POC EID in Mozambique focused primarily on outpatient clinics; however, 2 high-volume tier-4 pediatric referral hospitals were also included. METHODS: To assess the impact of inpatient POC EID, a retrospective review of testing and care data from Hospital Central de Beira (HCB) and Hospital Central de Maputo (HCM) was performed for the period September 2017 to July 2018, with comparison to the 8-month pre-POC period when dried blood spots were used for conventional EID. RESULTS: Monthly testing volume increased from 8.5 tests pre-POC to 17.6 tests with POC (P<.001). Among 511 children with POC testing, the median age was 5 months, there was ongoing breastfeeding in 326 (63.8%), and 136 (26.6%) of mothers and 146 (28.6%) of infants had not received ART or antiretroviral prophylaxis, respectively. POC tests were positive in 152 (29.7%) infants, and 52 (37.5%) had a previous negative DNA polymerase chain reaction through the conventional outpatient EID program. Linkage to ART for infants with HIV-positive tests improved 64% during the POC period (P=.002). Inpatient mortality for infected infants during the POC period was 28.2%. Excluding these deaths, 61.2% of eligible infants initiated ART as inpatients, but only 29.8% of those discharged without ART were confirmed to have initiated as outpatients. CONCLUSIONS: Inpatient wards are a high-yield site for EID and ART initiation that have historically been overlooked in programming for prevention of mother-to-child transmission. POC platforms represent a transformative opportunity to increase inpatient testing, make definitive diagnoses, and improve timely linkage to ART. Scale-up plans should prioritize pediatric wards.

Performance of a True Point-of-Care Assay for HIV-1/2 Viral Load Measurement at Antenatal and Postpartum Services.

BACKGROUND: Timely viral load (VL) results during pregnancy and the postpartum period are crucial for HIV disease management and for preventing mother-to-child transmission. Point-of-care (POC) VL testing could reduce turnaround times and streamline patient management. We evaluated the diagnostic performance of the novel m-PIMA HIV-1/2 VL assay (Abbott, Chicago, IL) in Mozambique. SETTING: The study was conducted in prenatal and postpartum consultation rooms in 2 primary health care clinics. Sample collection and testing on m-PIMA were performed by trained nurses. METHODS: HIV-infected pregnant and postpartum women on antiretroviral treatment (ART) or ART naive were tested using both on-site m-PIMA POC and referral laboratory-based real-time VL assays. Linear regression analysis and Bland-Altman plots were used to calculate the agreement between both. FINDINGS: Correlation between venous blood plasma POC and plasma laboratory-based VL was strong (r2 = 0.850, P < 0.01), with good agreement between the methods [overall bias 0.202 log copies/mL (95% CI: 0.366 to 0.772 log copies/mL)]. Using the threshold of 1000 copies/mL, which is used to determine ART failure, the sensitivity and specificity of the POC VL assay were 95.0% (95% CI: 91.6% to 97.3%) and 96.5% (95% CI: 94.2% to 98.0%), respectively. The correlation coefficient between the venous and capillary sample types was 0.983 (r2 = 0.966). CONCLUSIONS: On-site, nurse-performed POC VL testing is feasible and accurate in resource-limited primary health care settings. The operational challenge of plasma separation within clinics for POC testing was successfully overcome using minicentrifuges. The use of capillary blood could simplify the execution of the assay in a clinical environment.

Accurate HIV viral load measurement in primary health care settings using the cobas® plasma separation card.

INTRODUCTION: Plasma is considered the gold standard for HIV viral load (VL) testing, however its use is challenging due to the need for phlebotomy and centrifugation services, as well as cold chain for transporting to laboratories for testing. The use of Dried Blood Spot (DBS) specimen has allowed a rapid expansion of antiretroviral therapy (ART) monitoring in remote areas in many African countries, however, the VL in DBS may overestimate the copies of viral RNA result at the clinically relevant range of 1000 copies/ml, due to proviral DNA and intracellular RNA. The characteristics of the cobas® Plasma Separation Card (PSC) specimen are similar to fresh plasma (gold standard), so a better performance of HIV VL is expetected in PSC specimen and can be an alternative to DBS. This study aims to evaluate the performance of cobas® PSC for VL testing at primary health care facilities in Mozambique. METHODOLOGY: HIV-1 infected adults on ART were enrolled consecutively in two health facilities in Mozambique, between August 2018 and October 2018. Capillary and venous cobas® PSC, DBS and fresh plasma specimens were collected from each patient. All specimens were tested for VL using CAP/CTM v2.0. Sensitivity and specificity of viral load using DBS, capillary and venous PSC specimens were estimated. Viral load obtained in fresh plasma specimen was used as reference and a threshold of 1000 copies/ml was considered for the analyses. RESULTS: From the total 613 patients included for the study, 2444 specimens including DBS (613), plasma (613), venous cobas® PSC (609) and capillary cobas® PSC (609) were collected and 2407 results were obtained. Sensitivity and specificity of the VL using venous cobas®PSC specimen at 1000 copies/ml threshold were 99.8% and 98.1% respectively, whereas for capillary cobas® PSC sensitivity was 99.6% and specificity was 97.2%. For DBS VL, sensitivity was 96.9% and specificity was 81.8%. Misclassification rate was more prominent in DBS specimens (5.9%), but lower in venous and capillary cobas®PSC with a rate of 0.3% and 0.7% respectively. CONCLUSION: The cobas® PSC specimen has improved performance over DBS for more accurate VL testing aligned with plasma testing. The use of this specimen type can increase the rates of reliable VL results and this will improve the quality of VL monitoring of HIV-positive patients in low-income settings.

Spatial Distribution of HIV Prevalence among Young People in Mozambique.

Mozambique has a high burden of HIV and is currently ranked sixth worldwide for adult prevalence. In Mozambique, HIV prevalence is not uniformly distributed geographically and throughout the population. We investigated the spatial distribution of HIV infection among adolescents and young people in Mozambique using the 2009 AIDS Indicator Survey (AIS). Generalized geoadditive modeling, combining kriging and additive modeling, was used to study the geographical variability of HIV risk among young people. The nonlinear spatial effect was assessed through radial basis splines. The estimation process was done using two-stage iterative penalized quasi-likelihood within the framework of a mixed-effects model. Our estimation procedure is an extension of the approach by Vandendijck et al., estimating the range (spatial decay) parameter in a binary context. The results revealed the presence of spatial patterns of HIV infection. After controlling for important covariates, the results showed a greater burden of HIV/AIDS in the central and northern regions of the country. Several socio-demographic, biological, and behavioral factors were found to be significantly associated with HIV infection among young people. The findings are important, as they can help health officials and policy makers to design targeted interventions for responding to the HIV epidemic.

Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study

Introduction: Viral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis (EID) is performed using nucleic-acid testing in children under 18 months. Resource-limited health systems face severe challenges to scale-up both viral load and EID to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an EID assay in children younger than 18 months. Methods: This study was an observational, prospective study, including children between one and 18 months of age who were born to HIV-positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and viral load testing using the Roche CAP/CTM HIV-1 Qualitative v2 and Roche CAP/ CTM HIV-1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard. Results: A total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994. Conclusions: The comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional EID testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.

Viral load assay performs comparably to early infant diagnosis assay to diagnose infants with HIV in Mozambique: a prospective observational study.

INTRODUCTION: Viral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis is performed using nucleic-acid testing in children under 18 months. Resource-limited health systems face severe challenges to scale-up both viral load and early infant diagnosis to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an early infant diagnosis assay in children younger than 18 months. METHODS: This study was an observational, prospective study, including children between one and 18 months of age who were born to HIV-positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and VL testing using the Roche CAP/CTM HIV-1 Qualitative v2 and Roche CAP/CTM HIV-1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard. RESULTS: A total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994. CONCLUSIONS: The comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional early infant diagnosis testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.

Spatial Distribution of HIV Prevalence among Young People in Mozambique

Abstract: Mozambique has a high burden of HIV and is currently ranked sixth worldwide for adult prevalence. In Mozambique, HIV prevalence is not uniformly distributed geographically and throughout the population. We investigated the spatial distribution of HIV infection among adolescents and young people in Mozambique using the 2009 AIDS Indicator Survey (AIS). Generalized geoadditive modeling, combining kriging and additive modeling, was used to study the geographical variability of HIV risk among young people. The nonlinear spatial effect was assessed through radial basis splines. The estimation process was done using two-stage iterative penalized quasi-likelihood within the framework of a mixed-effects model. Our estimation procedure is an extension of the approach by Vandendijck et al., estimating the range (spatial decay) parameter in a binarycontext. The results revealed the presence of spatial patterns of HIV infection. After controlling for important covariates, the results showed a greater burden of HIV/AIDS in the central and northern regions of the country. Several socio-demographic, biological, and behavioral factors were found to be significantly associated with HIV infection among young people. The findings are important, as they can help health officials and policy makers to design targeted interventions for responding to the HIV epidemic.

Mapping maternal mortality rate via spatial zero-inflated models for count data: A case study of facility-based maternal deaths from Mozambique.

Maternal mortality remains very high in Mozambique, with estimates from 2015 showing a maternal mortality ratio of 489 deaths per 100,000 live births, even though the rates tend to decrease since 1990. Pregnancy related hemorrhage, gestational hypertension and diseases such as malaria and HIV/AIDS are amongst the leading causes of maternal death in Mozambique, and a significant number of these deaths occur within health facilities. Often, the analysis of data on maternal mortality involves the use of counts of maternal deaths as outcome variable. Previously we showed that a class of hierarchical zero-inflated models were very successful in dealing with overdispersion and clustered counts when analyzing data on maternal deaths and related risk factors within health facilities in Mozambique. This paper aims at providing additional insights over previous analyses and presents an extension of such models to account for spatial variation in a disease mapping framework of facility-based maternal mortality in Mozambique.

Performance of point-of-care birth HIV testing in primary health care clinics: An observational cohort study.

BACKGROUND: Failure to timely diagnose HIV in infants is a major barrier for scaling-up paediatric antiretroviral treatment (ART). WHO recommends birth testing for earlier diagnosis and to improve test coverage, but current diagnosis takes 2-3 weeks to complete, thereby limiting the ability of care givers to provide follow-on care, especially in low-resource settings. We evaluated the benefit of implementing rapid diagnosis of HIV at birth in primary health care maternity wards in Mozambique. METHODS AND FINDINGS: Infants born to HIV-infected mothers delivering consecutively at eight primary health care clinics were tested within 24 hours of delivery using on-site POC (Alere q HIV1/2 Detect) and standard laboratory (Roche COBAS AmpliPrep/TaqMan HIV-1 qualitative assay v2.0) testing. Infants were also tested at 4-6 weeks of age with both assays. Of 2,350 HIV-exposed infants enrolled in this implementation research study, 33 tested HIV-positive at birth on both assays. Sensitivity and specificity of POC testing compared with laboratory testing at birth were 100% (95% CI 89·4-100·0) and 100% (95% CI 99·8-100·0), respectively. At 4-6 weeks of age, 61 infants were identified as HIV-positive; of these 29 (47·5%) had a positive test at birth. Testing at both birth and 4-6 weeks identified 71 HIV-positive infants compared with 61 infants by testing at 4-6 weeks alone, a 16% increase. Two infants tested positive at birth but tested HIV-negative during follow-up. CONCLUSIONS: Adding POC birth testing to the 4-6 week screen may increase access to HIV diagnosis and expedite ART initiation in primary health care settings within low resource settings. Guidance on appropriate confirmatory HIV testing algorithms for birth testing is needed.

Effect of point-of-care early infant diagnosis on antiretroviral therapy initiation and retention of patients.

OBJECTIVE: We measured the effect of point-of-care (POC) early infant HIV testing on antiretroviral therapy initiation rates and retention in care among infants in Mozambique. DESIGN: A cluster-randomized trial was conducted in 16 primary healthcare centres providing either on-site POC arm (n = 8) or referred laboratory [standard-of-care (SOC) arm; n = 8] infant HIV testing. METHODS: The primary outcomes were the proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection, and the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. RESULTS: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection was 89.7% (157 of 175) for the POC arm and 12.8% (13 of 102) for the SOC arm [relative risk (RR)(adj) 7.34; P < 0.001]. The proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up was 61.6% (101 of 164) for the POC arm and 42.9% (21 of 49) for the SOC arm [RR(adj) 1.40; P < 0.027]. The median time from sample collection to antiretroviral therapy initiation was less than 1 day (interquartile range: 0-1) for the POC arm and 127 days (44-154; P < 0.001) for the SOC arm. CONCLUSION: POC infant HIV testing enabled clinics to more rapidly diagnose and provide treatment to HIV-infected infants. This reduced opportunities for pretreatment loss to follow-up and enabled a larger proportion of infants to receive test results and initiate antiretroviral therapy. The benefits of faster HIV diagnosis and antiretroviral treatment may also improve early retention in care.

Maternal death and delays in accessing emergency obstetric care in Mozambique.

BACKGROUND: Despite declining trends maternal mortality remains an important public health issue in Mozambique. The delays to reach an appropriate health facility and receive care faced by woman with pregnancy related complications play an important role in the occurrence of these deaths. This study aims to examine the contribution of the delays in relation to the causes of maternal death in facilities in Mozambique. METHODS: Secondary analysis was performed on data from a national assessment on maternal and neonatal health that included in-depth maternal death reviews, using patient files and facility records with the most comprehensive information available. Statistical models were used to assess the association between delay to reach the health facility that provides emergency obstetric care (delay type II) and delay in receiving appropriate care once reaching the health facility providing emergency obstetric care (delay type III) and the cause of maternal death within the health facility. RESULTS: Data were available for 712 of 2,198 maternal deaths. Delay type II was observed in 40.4% of maternal deaths and delay type III in 14.2%.and 13.9% had both delays. Women who died of a direct obstetric complication were more likely to have experienced a delay type III than women who died due to indirect causes. Women who experienced delay type II were less likely to have also delay type III and vice versa. CONCLUSIONS: The delays in reaching and receiving appropriate facility-based care for women facing pregnancy related complications in Mozambique contribute significantly to maternal mortality. Securing referral linkages and health facility readiness for rapid and correct patient management are needed to reduce the impact of these delays within the health system.

Early diagnosis of preeclampsia using placental growth factor: An operational pilot study in Maputo, Mozambique.

In well-resourced settings, reduced circulating maternal free placental growth factor (PlGF) aids in either predicting or confirming the diagnosis of preeclampsia, fetal growth restriction, stillbirth, preterm birth, and delivery within 14 days of testing when pre-eclampsia is suspected. This operational pilot implementation of maternal plasma PlGF in women with suspected preeclampsia was conducted in six antenatal clinics in Maputo, Mozambique (six control clinics for comparison). The primary outcome was transfer to higher levels of care, following the informative PlGF assay. Of antenatal visits, 133/31,993 (0.42%) and 20/33,841 (0.06%) resulted in pre-eclampsia-related transfers of care for women attending intervention and control clinics, respectively (p < .0001). The clinic-to-delivery for women with low PlGF (<100 pg/ml) interval was shorter, (vs normal PlGF (median 10 days [IQR 1-25] vs 36 [11-83], p < .0001)). Low PlGF was associated with younger maternal age, higher blood pressure, earlier delivery, more therapeutic interventions, preterm birth, lower birth weight, and perinatal loss. In addition, one-third of hypertensive women with PlGF < 50 pg/ml suffered a stillbirth. In urban Mozambican women with symptoms and/or signs suggestive of preeclampsia, low maternal plasma PlGF concentrations are associated with increased risks of adverse pregnancy outcomes, especially early delivery and stillbirth. Therefore, introducing PlGF into the clinical care of women with suspected preeclampsia was associated with increased transfers to higher levels of care; low PlGF (<100 pg/ml) was associated with increased maternal and perinatal risks. PlGF < 50 pg/ml is particularly associated with stillbirth in women with suspected preeclampsia.

Early diagnosis of preeclampsia using placental growth factor: An operational pilot study in Maputo, Mozambique

n well-resourced settings, reduced circulating maternal free placental growth factor (PlGF) aids in either predicting or confirming the diagnosis of preeclampsia, fetal growth restriction, stillbirth, preterm birth, and delivery within 14 days of testing when pre-eclampsia is suspected. This operational pilot implementation of maternal plasma PlGF in women with suspected preeclampsia was conducted in six antenatal clinics in Maputo, Mozambique (six control clinics for comparison). The primary outcome was transfer to higher levels of care, following the informative PlGF assay. Of antenatal visits, 133/31,993 (0.42%) and 20/33,841 (0.06%) resulted in pre-eclampsia-related transfers of care for women attending intervention and control clinics, respectively (p < .0001). The clinic-to-delivery for women with low PlGF (<100 pg/ml) interval was shorter, (vs normal PlGF (median 10 days [IQR 1-25] vs 36 [11-83], p < .0001)). Low PlGF was associated with younger maternal age, higher blood pressure, earlier delivery, more therapeutic interventions, preterm birth, lower birth weight, and perinatal loss. In addition, one-third of hypertensive women with PlGF < 50 pg/ml suffered a stillbirth. In urban Mozambican women with symptoms and/or signs suggestive of preeclampsia, low maternal plasma PlGF concentrations are associated with increased risks of adverse pregnancy outcomes, especially early delivery and stillbirth. Therefore, introducing PlGF into the clinical care of women with suspected preeclampsia was associated with increased transfers to higher levels of care; low PlGF (<100 pg/ml) was associated with increased maternal and perinatal risks. PlGF < 50 pg/ml is particularly associated with stillbirth in women with suspected preeclampsia.