An investigation of fingerstick blood collection for point-of-care HIV-1 viral load monitoring in South Africa

Background. Viral load (VL) quantification is an important tool in determining newly developed drug resistance or problems with adherence to antiretroviral therapy (ART) in HIV-positive patients. VL monitoring is becoming the standard of care in many resource-limited settings. Testing in resource-limited settings may require sampling by fingerstick because of general shortages of skilled phlebotomists and the expense of venepuncture supplies and problems with their distribution.Objective. To assess the feasibility and ease of collecting 150 µL capillary blood needed for the use of a novel collection device following a classic fingerstick puncture.Methods. Patients were recruited by the study nurse upon arrival for routine ART monitoring at the Themba Lethu Clinic in Johannesburg, South Africa. Each step of the fingerstick and blood collection protocol was observed, and their completion or omission was recorded.Results. One hundred and three patients consented to the study, of whom three were excluded owing to the presence of callouses. From a total of 100 patients who consented and were enrolled, 98% of collection attempts were successful and 86% of participants required only one fingerstick to successfully collect 150 µL capillary blood. Study nurse adherence to the fingerstick protocol revealed omissions in several steps that may lower the success rate of capillary blood collection and reduce the performance of a subsequent VL assay.Conclusion. The findings of this study support the feasibility of collecting 150 µL of capillary blood via fingerstick for point-of-care HIV-1 VL testing in a resource-limited setting

Comparison of Xpert MTB/RIF with Other Nucleic Acid Technologies for Diagnosing Pulmonary Tuberculosis in a High HIV Prevalence Setting: A Prospective Study

In this prospective, real-world cohort study nested within a national screening program for tuberculosis, Lesley Scott and colleagues compare the performance of Xpert MTB/RIF on a single sputum sample with different TB sputum detection technologies

Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.

BACKGROUND: Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe. METHODS: We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940. FINDINGS: Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported. INTERPRETATION: Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone. FUNDING: Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.The SHINE trial is funded by the Bill & Melinda Gates Foundation (OPP1021542 and OPP113707); UK Department for International Development; Wellcome Trust, UK (093768/Z/10/Z, 108065/Z/15/Z and 203905/Z/16/Z); Swiss Agency for Development and Cooperation; US National Institutes of Health (2R01HD060338-06); and UNICEF (PCA-2017-0002)

Demographics, clinical characteristics, and results of TB diagnostics in 311 adults with suspected pulmonary TB.

a<p>Values are number (percent) unless otherwise indicated.</p>b<p>One case was smear-positive, culture-negative, and two cases were smear-positive, culture contaminated.</p>c<p>No indeterminate smear results; for MGIT culture, indeterminate = contaminated; for Xpert MTB/RIF, indeterminate = error or other result.</p>d<p>MGIT susceptibility testing done on selected isolates including all cultures where NAAT tests detected resistance.</p>e<p>Two cases were culture-positive with phenotypic-confirmed MDR; a third case was culture-negative.</p><p>NA, not applicable.</p

Heat map showing drug susceptibility profiles from 23 samples based on Xpert MTB/RIF, MTBDRplus on sputum, MTBDRplus on cultured isolates, and phenotypic culture (MGIT DST).

<p>The 23 samples were from a cohort of 311 participants. The heat map shows samples represented in rows and assigned numerical patient identifiers and testing methodologies in columns. Three colors are used to indicate the results: red, resistant; green, sensitive; yellow, not done, negative for <i>M.tb</i>, contaminated, or inconclusive. The samples are sorted into AFB-negative or -positive, with RIF and INH profiles in blocks side by side. Two columns are shown for the RIF results generated from the Xpert MTB/RIF using the amplification cycle threshold maximums 3.5 and 5.0. MDR TB was identified in two patients.</p

Test performance (including comparison to clinical case definitions) for smear microscopy, MGIT culture, MTBDRplus directly on sputum, LCTB, and Xpert MTB/RIF assays stratified by smear microscopy and HIV status.

<p>All tests performed on the same 177 sputum specimens. Confidence intervals 95%.</p>a<p>All values are percent (95% CI) unless otherwise indicated.</p><p>HIV status distribution was as follows: HIV-positive, 124; HIV-negative 26; HIV status unknown, 27.</p>b<p>Amongst 177 cases where all tests were done, 49 were smear-positive, culture-positive; 18 were smear-negative, culture-positive; 107 were smear-negative, culture-negative; in three cases NTM was isolated.</p>c<p>Where any of the three smears taken during the study period were positive.</p>d<p>Where all of the three smears taken during the study period were negative.</p