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Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial.

ABSTRACT: BACKGROUND:Malaria-endemic countries in sub-Saharan Africa are shifting from the presumptive approach that is based on clinical judgement (CJ) to the test-based approach that is based on confirmation through test with rapid diagnostic tests (RDT). It has been suggested that the loss of the prophylactic effect of presumptive-administered ACT in children who do not have malaria will result in increase in their risk of malaria and anaemia. METHODS AND FINDINGS:We undertook a cluster-randomized controlled trial to compare the effects of the presumptive approach using clinical judgment (CJ-arm) and the test-based approach using RDTs (RDT-arm in a high-transmission setting in Ghana. A total of 3046 eligible children (1527 in the RDT arm and 1519 in the CJ- arm) living around 32 health centres were enrolled. Nearly half were female (48.7%) and 47.8% were below the age of 12 months as at enrolment. Over 24-months, the incidence of all episodes of malaria following the first febrile illness was 0.64 (95% CI 0.49-0.82) and 0.76 (0.63-0.93) per child per year in the RDT and CJ arms respectively (adjusted rate ratio 1.13 (0.82-1.55). After the first episode of febrile illness, the incidence of severe anaemia was the same in both arms (0.11 per child per year) and that of moderate anaemia was 0.16 (0.13-0.21) vs. 0.17 (0.14-0.21) per child year respectively. The incidence of severe febrile illness was 0.15 (0.09, 0.24) in the RDT arm compared to 0.17 (0.11, 0.28) per child per year respectively. The proportion of fever cases receiving ACT was lower in the RDT arm (72% vs 81%; p = 0.02). CONCLUSION:The test-based approach to the management of malaria did not increase the incidence of malaria or anaemia among under-five children in this setting. TRIAL REGISTRATION:ClinicalTrials.gov NCT00832754.

SUBMITTER: Baiden F

PROVIDER: S-EPMC4824463 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial.

Baiden Frank F Bruce Jane J Webster Jayne J Tivura Mathilda M Delmini Rupert R Amengo-Etego Seeba S Owusu-Agyei Seth S Chandramohan Daniel D

PloS one 20160407 4

<h4>Background</h4>Malaria-endemic countries in sub-Saharan Africa are shifting from the presumptive approach that is based on clinical judgement (CJ) to the test-based approach that is based on confirmation through test with rapid diagnostic tests (RDT). It has been suggested that the loss of the prophylactic effect of presumptive-administered ACT in children who do not have malaria will result in increase in their risk of malaria and anaemia.<h4>Methods and findings</h4>We undertook a cluster- ...[more]

PMID: 27055275

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Project description:The presumptive approach of confirming malaria in health facilities leads to over-diagnosis of malaria, over use of anti-malaria drugs and the risk of drug resistance development. WHO recommends parasitological confirmation before treatment with artemisinin-based combination therapy (ACT) in all suspected malaria patients. The use of malaria rapid diagnostic tests (mRDTs) would make it possible for prescribers to diagnose malaria at point-of-care and better target the use of antimalarials. Therefore, a cost-effectiveness analysis was performed on the introduction of mRDTs for management of malaria in under-five children in a high transmission area in Ghana where presumptive diagnosis was the norm in public health centres.A cluster-randomised controlled trial where thirty-two health centres were randomised into test-based diagnosis of malaria using mRDTs (intervention) or clinical judgement (control) was used to measure the effect of mRDTs on appropriate treatment: 'a child with a positive reference diagnosis prescribed a course of ACT or a child with a negative reference diagnosis not given an ACT'. Cost data was collected from five purposively selected health centres and used to estimate the health sector costs of performing an mRDT and treat children for malaria and other common febrile illnesses. Costs of training healthcare personnel and supervision in the study period were also collected. A sample of caregivers to children participating in the trial was interviewed about household cost incurred on transport, drugs, fees, and special food during a period of one week after the health centre visit as well as days unable to work. A decision model approach was used to calculate the incremental cost-effectiveness ratios (ICERs). Univariate and multivariate sensitivity analyses were applied to assess the robustness of ICERs.The availability of mRDTs for malaria diagnosis resulted in fewer ACT treatments compared to the clinical judgement approach (73% versus 81%) and more children appropriately treated (70% versus 57%). The introduction of mRDT-based diagnosis would cost the Ministry of Health US$18.6 per extra appropriately treated child under five compared to clinical judgement while the ICER from a societal perspective was lower at US$11.0 per appropriately treated child. ICERs were sensitive to a decrease in adherence to negative mRDTs, malaria positivity rate and specificity of the mRDT.The introduction of mRDTs is likely to be considered cost-effective in this high transmission setting as this intervention increased the number of appropriately treated children at low cost.ClinicalTrials.gov NCT00832754.

Project description:IntroductionWHO now recommends test-based management of malaria (TBMM) across all age-groups. This implies artemisinin-based combination treatment (ACT) should be restricted to rapid diagnostic test (RDT)-positive cases. This is a departure from what caregivers in rural communities have been used to for many years.MethodsWe conducted a survey among caregivers living close to 32 health centres in six districts in rural Ghana and used logistic regression to explore factors likely to influence caregiver acceptability of RDT based case management and concern about the denial of ACT on account of negative RDT results. Focus group discussions were conducted to explain the quantitative findings and to elicit further factors.ResultsA total of 3047 caregivers were interviewed. Nearly all (98%) reported a preference for TBMM over presumptive treatment. Caregivers who preferred TBMM were less likely to be concerned about the denial of ACT to their test-negative children (O.R. 0.57, 95%C.I. 0.33-0.98). Compared with caregivers who had never secured national health insurance cover, caregivers who had valid (adjusted O.R. 1.30, 95% CI 1.07-1.61) or expired (adjusted O.R. 1.38, 95% CI 1.12-1.73) insurance cover were more likely to be concerned about the denial of ACT to their RDT-negative children. Major factors that promote TBMM acceptability include the perception that a blood test at health centre level represents improvement in the quality of care, leads to improvement in treatment outcomes, and offers opportunity for better communication between health workers and caregivers. Acceptability is also enhanced by engaging caregivers in the procedures of the test. Apprehensions about negative health worker attitude could however undermine acceptance.ConclusionTest (RDT)-based management of malaria in under-five children is likely to be acceptable to caregivers in rural Ghana. The quality of caregiver-health worker interaction needs to be improved if acceptability is to be sustained.

Project description:BackgroundGhana is among the top 10 highest malaria burden countries, with about 20,000 children dying annually, 25% of which were under five years. This study aimed to produce interactive web-based disease spatial maps and identify the high-burden malaria districts in Ghana.MethodsThe study used 2016-2021 data extracted from the routine health service nationally representative and comprehensive District Health Information Management System II (DHIMS2) implemented by the Ghana Health Service. Bayesian geospatial modelling and interactive web-based spatial disease mapping methods were employed to quantify spatial variations and clustering in malaria risk across 260 districts. For each district, the study simultaneously mapped the observed malaria counts, district name, standardized incidence rate, and predicted relative risk and their associated standard errors using interactive web-based visualization methods.ResultsA total of 32,659,240 malaria cases were reported among children < 5 years from 2016 to 2021. For every 10% increase in the number of children, malaria risk increased by 0.039 (log-mean 0.95, 95% credible interval = - 13.82-15.73) and for every 10% increase in the number of males, malaria risk decreased by 0.075, albeit not statistically significant (log-mean - 1.82, 95% credible interval = - 16.59-12.95). The study found substantial spatial and temporal differences in malaria risk across the 260 districts. The predicted national relative risk was 1.25 (95% credible interval = 1.23, 1.27). The malaria risk is relatively the same over the entire year. However, a slightly higher relative risk was recorded in 2019 while in 2021, residing in Keta, Abuakwa South, Jomoro, Ahafo Ano South East, Tain, Nanumba North, and Tatale Sanguli districts was associated with the highest malaria risk ranging from a relative risk of 3.00 to 4.83. The district-level spatial patterns of malaria risks changed over time.ConclusionThis study identified high malaria risk districts in Ghana where urgent and targeted control efforts are required. Noticeable changes were also observed in malaria risk for certain districts over some periods in the study. The findings provide an effective, actionable tool to arm policymakers and programme managers in their efforts to reduce malaria risk and its associated morbidity and mortality in line with the Sustainable Development Goals (SDG) 3.2 for limited public health resource settings, where universal intervention across all districts is practically impossible.

Project description:BackgroundThe World Health Organization recommended the Test, Treat and Track (T3) strategy for malaria control that, every suspected malaria case should be tested prior to treatment with Artemisinin-based combination therapy (ACT) and tracked. We assessed the performance and challenges in the implementation of T3 strategy among children under-five years in Volta and Oti Regions of Ghana.MethodA descriptive cross-sectional study was carried in 69 health facilities. Exit interviews were conducted for caregivers of children with fever using a semi-structured questionnaire. Clinicians were interviewed at the out-patient department in each facility. Descriptive statistics was conducted, Chi-square test and logistic regression were used to determine the associations between completion of T3 and independent variables.ResultsMost children, 818/900 (90.9%) were tested for malaria and 600/818 (73.4%) were positive for malaria parasitaemia using rapid diagnostic test. Of those testing positive for malaria, 530/600 (88.3%) received treatment with ACTs. Half, (109/218) of the children testing negative for malaria also received ACTs. Also, 67/82 (81.7%) of children not tested for malaria received ACTs. Only 408/900 (45.3%) children completed T3 with Community Health-based Planning Services (CHPS) compound having the highest completion rate 202/314 (64.3%). CHPS Compounds were 6.55 times more likely to complete T3 compared to the hospitals [(95% CI: 3.77, 11.35), p<0.001]. Health facilities with laboratory services were 2.08 times more likely to complete T3 [(95% CI: 1.55, 2.79), p<0.001] The main challenge identified was clinicians' perception that RDTs do not give accurate results.ConclusionTesting fever cases for malaria before treatment and treating positive cases with ACTs was high. Treating negative cases and those not tested with ACTs was also high. Health facilities having laboratory services and facility being CHPS compounds were key predictors of completing T3. Clinician's not trusting RDT results can affect the T3 strategy in malaria control. Periodic training/monitoring is required to sustain adherence to the strategy.

Project description:BackgroundArtisanal mining creates enabling breeding ground for the vector of malaria parasites. There is paucity of data on the effects of artisanal mining on malaria. This study assessed burden of malaria and caregivers' health-seeking behaviour for children under five in artisanal mining communities in East Akim District in Ghana.MethodsA cross-sectional study involving caregivers and their children under five was conducted in three artisanal mining communities in the East Akim District in Ghana. Caregivers were interviewed using a structured questionnaire. Finger prick blood samples were collected and analysed for haemoglobin concentration using a rapid diagnostic test, and thick and thin blood smears were analysed to confirm the presence of malaria parasites.ResultsOf the 372 children under 5 years included in the study, 197 (53.1%) were male, with a mean age (± SD) of 23.0 ± 12.7 months. The proportion of children with malaria (Plasmodium falciparum and P. malariae) was 98.1% and 1.9%, respectively, whilst the proportion with anaemia (Hb < 11.0 g/dl) was 39.5% (n = 147). Almost all caregivers were female (98.9%), and 28.6% (n = 106) did not have access to any malaria control information. Caregivers associated malaria infection with mosquito bites (68.3%, n = 254) and poor sanitation (21.2%, n = 79). Malaria in children under five was significantly associated with anaemia (OR 11.07, 95% CI 6.59-18.68, n = 111/160, 69.4%; P < 0.0001), residing close to stagnant water (≤ 25 m) from an artisanal mining site (AOR 2.91, 95% CI 1.47-5.76, P = 0.002) and caregiver age younger than 30 years (OR 0.44, 95% CI 0.208-0.917, n = 162, 43.55%, P = 0.001).ConclusionsThere is a high burden of malaria and anaemia among children under five in artisanal mining communities of the East Akim District, and far higher than in non-artisanal mining sites. Interventions are needed to effectively regulate mining activities in these communities, and strengthen malaria control and health education campaigns to curtail the high malaria burden and improve health-seeking behaviour.

Project description:ObjectiveTo test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis.DesignRandomised, controlled, open label clinical trial.SettingFour clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria ("microscopy setting") and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms ("clinical setting").ParticipantsPatients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients.Main outcome measuresThe primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years.ResultsOf the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm.ConclusionWhere microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.

Project description:BackgroundEvery year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and cost-effectiveness of newborn home visits in a programme setting.MethodsWe prospectively collected detailed cost data alongside the Newhints trial, which tested the effect of a home-visits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI -12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the first week of life by community-based surveillance volunteers. We calculated incremental cost-effectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-effectiveness planes and cost-effectiveness acceptability curves. We then modelled the potential cost-effectiveness for baseline neonatal mortality rates of 20-60 deaths per 1000 livebirths with use of a meta-analysis of effectiveness estimates.FindingsIn the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) community-based surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or $0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95% CI 2963 to -7674) per newborn life saved, or $352 (95% CI 104 to -268) per discounted life-year saved, and had a 72% chance of being highly cost effective with respect to Ghana's 2009 gross domestic product per person. Key determinants of cost-effectiveness were the discount rate, protective effectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER increased from $127 per life-year saved at a neonatal mortality rate of 60 deaths per 1000 livebirths, to $379 per life-year saved at a rate of 20 deaths per 1000 livebirths. The strategy had at least a 99% probability of being highly cost effective for lower-middle-income countries in all neonatal mortality rate scenarios modelled, and at least a 95% probability of being highly cost effective for low-income countries at neonatal mortality rates of 30 or more deaths per 1000 livebirths.InterpretationOur findings show that the seemingly modest mortality reductions achieved by a newborn home-visit strategy might in fact be cost effective. In Ghana, such strategies are also likely to be affordable. Our findings support recommendations from WHO and UNICEF that low-income and middle-income countries implement newborn home visits.FundingThe Bill & Melinda Gates Foundation, UK Department for International Development, WHO.

Dataset Information

Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial.

Publications

Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial.

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