BackgroundMost malaria rapid diagnostic tests (RDTs) use HRP2 detection, including Paracheck-Pf®, but their utility is limited by persistent false positivity after treatment. PLDH-based tests become negative more quickly, but sensitivity has been reported below the recommended standard of 90%. A new pLDH test, CareStart™ three-line P.f/PAN-pLDH, claims better sensitivity with continued rapid conversion to negative. The study aims were to 1) compare sensitivity and specificity of CareStart™ to Paracheck-Pf® to diagnose falciparum malaria in children under five years of age, 2) assess how quickly false-positive CareStart™ tests become negative and 3) evaluate ease of use and inter-reader agreement of both tests.MethodsParticipants were included if they were aged between two and 59 months, presenting to a Médecins Sans Frontières community health centre in eastern Sierra Leone with suspected malaria defined as fever (axillary temperature > 37.5°C) and/or history of fever in the previous 72 hours and no signs of severe disease. The same capillary blood was used for the RDTs and the blood slide, the latter used as the gold standard reference. All positive participants were treated with supervised artesunate and amodiaquine treatment for three days. Participants with a persistent false-positive CareStart™, but a negative blood slide on Day 2, were followed with repeated CareStart™ and blood slide tests every seven days until CareStart™ became negative or a maximum of 28 days.ResultsSensitivity of CareStart™ was 99.4% (CI 96.8-100.0, 168/169) and of Paracheck-Pf®, 98.8% (95% CI 95.8-99.8, 167/169). Specificity of CareStart™ was 96.0% (CI 91.9-98.4, 167/174) and of Paracheck-Pf®, 74.7% (CI 67.6-81.0, 130/174) (p < 0.001). Neither test showed any change in sensitivity with decreasing parasitaemia. Of the 155 eligible follow-up CareStart™ participants, 63.9% (99/155) had a false-positive test on day 2, 21.3% (33/155) on day 7, 5.8% (9/155) on day 14, 1.9% (3/155) on day 21 and 0.6% (1/155) on day 28. The median time for test negativity was seven days. CareStart™ was as easy to use and interpret as Paracheck-Pf® with excellent inter-reader agreement.ConclusionsBoth RDTs were highly sensitive, met WHO standards for the detection of falciparum malaria monoinfections where parasitaemia was >100 parasites/μl and were easy to use. CareStart™ persistent false positivity decreased quickly after successful anti-malarial treatment, making it a good choice for a RDT for a hyperendemic falciparum malaria area.

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BackgroundMalaria is hyper-endemic and a major public health problem in Sierra Leone. To provide malaria treatment closer to the community, Médecins Sans Frontières (MSF) launched a community-based project where Community Malaria Volunteers (CMVs) tested and treated febrile children and pregnant women for malaria using rapid diagnostic tests (RDTs). RDT-negative patients and severely ill patients were referred to health facilities. This study sought to determine the referral rate and compliance of patients referred by the CMVs.MethodsIn MSF's operational area in Bo and Pujehun districts, Sierra Leone, a retrospective analysis of referral records was carried out for a period of three months. All referral records from CMVs and referral health structures were reviewed, compared and matched for personal data. The eligible study population included febrile children between three and 59 months and pregnant women in their second or third trimester with fever who were noted as having received a referral advice in the CMV recording form.ResultsThe study results showed a total referral rate of almost 15%. During the study period 36 out of 2,459 (1.5%) referred patients completed their referral. There was a significant difference in referral compliance between patients with fever but a negative RDT and patients with signs of severe malaria. Less than 1% (21/2,442) of the RDT-negative patients with fever completed their referral compared to 88.2% (15/17) of the patients with severe malaria (RR = 0.010 95% CI 0.006 - 0.015).ConclusionsIn this community-based malaria programme, RDT-negative patients with fever were referred to a health structure for further diagnosis and care with a disappointingly low rate of referral completion. This raises concerns whether use of CMVs, with referral as backup in RDT-negative cases, provides adequate care for febrile children and pregnant women. To improve the referral completion in MSF's community-based malaria programme in Sierra Leone, and in similar community-based programmes, a suitable strategy needs to be defined.

Summaryobjective Médecins Sans Frontières (MSF) runs a malaria control project in Bo and Pujehun districts (population 158 000) that includes the mass distribution, routine delivery and demonstration of correct use of free, long-lasting insecticide-treated nets (LLINs). In 2006 ⁄ 2007, around 65 000 LLINs were distributed. The aim of this follow-up study was to measure LLIN usage and ownership in the project area.methods Heads of 900 randomly selected households in 30 clusters were interviewed, using a standardized questionnaire, about household use of LLINs. The condition of any LLIN was physically assessed.results Of the 900 households reported, 83.4% owning at least one LLIN. Of the 16.6% without an LLIN, 91.9% had not participated in the MSF mass distribution. In 94.1% of the households reporting LLINs, the nets were observed hanging correctly over the beds. Of the 1135 hanging LLINs, 75.2% had no holes or 10 or fewer finger-size holes. The most common source of LLINs was MSF (75.2%). Of the 4997 household members, 67.2% reported sleeping under an LLIN the night before the study, including 76.8% of children under 5 years and 73.0% of pregnant women.conclusion Our results show that MSF achieved good usage with freely distributed LLINs. It is one of the few areas where results almost achieve the new targets set in 2005 by Roll Back Malaria to have at least 80% of pregnant women and children under 5 years using LLINs by 2010.

Background The Joint United Nations Programme on HIV/AIDS 90–90-90 goal envisions 90% of all people receiving antiretroviral therapy to be virally suppressed by 2020. Implied in that goal is that viral load be quantified for all patients receiving treatment, which is a challenging undertaking given the complexity and high cost of standard-of-care viral load testing methods. Recently developed point-of-care viral load testing devices offer new promise to improve access to viral load testing by bringing the test closer to the patient and also returning results faster, often same-day. While manufactures have evaluated point-of-care assays using reference panels, empiric data examining the impact of the new technology against standard-of-care monitoring in low- and middle-income settings are lacking. Our goal in this trial is to compare a point-of-care to standard-of-care viral load test on impact on various clinical outcomes as well to assess the acceptability and feasibility of using the assay in a resource-limited setting. Methods Using a two-arm randomized control trial design, we will enroll 794 patients from two different HIV treatment sites in Nigeria. Patients will be randomized 1:1 for point-of-care or standard-of-care viral load monitoring (397 patients per arm). Following initiation of treatment, viral load will be monitored at patients’ 6- and 12-month follow-up visits using either point-of-care or standard-of-care testing methods, based on trial assignment. The monitoring schedule will follow national treatment guidelines. The primary outcome measure in this trial is proportion of patients with viral suppression at month 12 post-initiation of treatment. The secondary outcome measures encompass acceptability, feasibility, and virologic impact variables. Discussion This clinical trial will provide information on the impact of using point-of-care versus standard-of-care viral load testing on patient clinical outcomes; the study will also supply data on the acceptability and feasibility of point-of-care viral load monitoring in a resource-limited setting. If this method of testing is acceptable and feasible, and also superior to standard of care, the results of the trial and the information gathered will inform future scaled implementation and further optimization of the clinic-laboratory network that is critical for monitoring achievement of the 90–90-90 goals. Trial registration US National Institutes of Health Clinical Trials.gov: NCT03533868 . Date of Registration: 23 May 2018. Protocol Version: 10. Protocol Date: 30 March 2018.