Dataset Information

A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda.

ABSTRACT:

Background

The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SPAQ) for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eligible children in Karamoja region. Nonetheless, exploration of alternative regimens is warranted since parasite resistance threats persist.

Objective

The study aims to test the effectiveness of SMC with Dihydroartemisinin-piperaquine (DP) or SPAQ (DP-SMC & SPAQ-SMC), chemoprevention efficacy as well as the safety and tolerability of DP compared to that of SPAQ among 3-59 months old children in Karamoja region, an area of Uganda where malaria transmission is highly seasonal.

Methods

A Type II hybrid effectiveness-implementation study design consisting of four components: 1) a cluster randomized controlled trial (cRCT) using passive surveillance to establish confirmed malaria cases in children using both SPAQ and DP; 2a) a prospective cohort study to determine the chemoprevention efficacy of SPAQ and DP (if SPAQ or DP clears sub-patent infection and provides 28 days of protection from new infection) and whether drug concentrations and/or resistance influence the ability to clear and prevent infection; 2b) a sub study examining pharmacokinetics of DP in children between 3 to <6 months; 3) a resistance markers study in children 3-59 months in the research districts plus the standard intervention districts to measure changes in resistance marker prevalence over time and finally; 4) a process evaluation.

Discussion

This study evaluates the effects of SPAQ-SMC versus DP-SMC on clinical malaria in vulnerable children in the context of high parasite SP resistance, whilst informing on the best implementation strategies.

Conclusion

This study will inform malaria policy in high-burden countries, specifically on utility of SMC outside the sahel, and contribute to progress in malaria control.

SUBMITTER: Kajubi R

PROVIDER: S-EPMC10774186 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda.

Kajubi Richard R Ainsworth Jennifer J Baker Kevin K Richardson Sol S Bonnington Craig C Rassi Christian C Achan Jane J Magumba Godfrey G Rubahika Denis D Nabakooza Jane J Tibenderana James J Nuwa Anthony A Opigo Jimmy J

Gates open research 20231218

<h4>Background</h4>The World Health Organization (WHO) recommends seasonal malaria chemoprevention (SMC) with sulfadoxine-pyrimethamine and amodiaquine (SPAQ) for children aged 3 to 59 months, living in areas where malaria transmission is highly seasonal. However, due to widespread prevalence of resistance markers, SMC has not been implemented at scale in East and Southern Africa. An initial study in Uganda showed that SMC with SPAQ was feasible, acceptable, and protective against malaria in eli ...[more]

PMID: 38196920

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Project description:BackgroundMalnutrition and malaria are common co-morbidities in low-income countries, especially among under-fives children. But the malnutrition situation in Masasi and Nanyumbu districts, its interaction with malaria infection and the influence of socioeconomic factors are not well understood.MethodsChildren aged between 3-59 months in Masasi and Nanyumbu were screened for nutritional status and malaria infection in the community. Nutritional status was determined using age and anthropometric parameters. Z-scores (weight for age (WAZ), height for age (HAZ) and weight for height (WHZ)) were calculated based on the World Health Organisation (WHO) growth reference curves. Malaria infection was determined using malaria rapid diagnostic test and microscopy. Hemoglobin concentration was assessed using HemoCue spectrophotometer, and anemia was classified as hemoglobin concentration < 11.0g/dL. Structured questionnaire was used to collect socio- demographic information electronically.ResultsA total of 2242 children, 1539 (68.6%) from Masasi and 1169 (52.1%) females were involved in the study. The mean z-scores (WAZ = -0.60 and HAZ = -1.56) were lower than the WHO reference population. The overall prevalence of malnutrition was 49%, and it was significantly higher in Nanyumbu (52.5%) than in Masasi (47.3%), (x2 = 5.045, p = 0.025). Prevalence of malnutrition was higher in boys (53.0%) than in girls (45.0%) (x2 = 13.9, p < 0.001). Stunting was the most prevalent component of undernutrition; it was slightly prevalent in Nanyumbu (46.5%) compared to Masasi (42.0%), (x2 = 3.624, p = 0.057) and in boys (48.2%) than in girls (39.1%), x2 = 17.44, p<0.001. Only 15.8% of the undernourished children had malaria infection. Sex, age group and anaemia were significantly associated with undernourishment (p<0.05), while district and malaria infection were marginally (p≤0.06) associated with undernourishment. None of the undernutrition indices was associated with malaria infection.ConclusionUndernutrition was highly prevalent in the study population and was influenced sex, age, anaemia and malaria infection. More emphasis is needed to address the malnutrition problem especially stunting in Masasi and Nanyumbu districts.

Project description:BackgroundUtilization of malaria interventions is influenced by, among other things, the level of knowledge and attitude that the community has toward the infection as well as the available interventions. This study assessed malaria knowledge, attitudes, and practices on malaria infection and interventions in Masasi and Nanyumbu districts, Tanzania.MethodsA community-based cross-sectional survey was conducted between August and September 2020, among the heads of households having at least one under-five child. Information on knowledge, attitudes, and practices on malaria infection and interventions was gathered from the heads of the households using a structured questionnaire. The knowledge level was classified into low, moderate, and high. Attitudes were classified into positive and negative, whereas the practices were classified into good and poor. Children aged between 3 and 59 months were screened for malaria infection using a malaria rapid diagnostic test (mRDT). The proportion of the households' heads with high level of knowledge was the primary outcome. Proportions were compared using Chi-square or fisher's test, and logistic regression analysis was used as appropriate.ResultsA total of 1,556 household heads were interviewed, 1,167 (75.00%) were male, and according to marital status, 1,067 (68.57%) were couples. All the household heads had some knowledge of malaria, but 47.33% (736/1,555) and 13.83% (215/1,555) of them had moderate and high knowledge, respectively. The level of knowledge on malaria was significantly influenced by gender [adjusted odds ratio (aOR) = 0.72, 95.00% confidence interval (CI) = 0.56-0.94, p = 0.017], level of education (aOR = 1.50, 95.00% CI = 1.04-2.16, p = 0.03), and the occupation of the household head (aOR = 1.90, 95.00% CI = 1.22-2.96, p = 0.004). Majority of the households [83.87% (1,305/1,556)] had bed nets hanging on the sleeping spaces. Of the household heads possessing bed nets, 85.10% (514/604), 79.62% (586/736), and 95.35% (205/215) of them had a low, moderate, and high level of knowledge on malaria infection, respectively (trend x 2 = 31.53, p < 0.001). The majority [95.04% (1,474/1,551)] of the household heads perceived sleeping under the bed net to be beneficial. Furthermore, 15.56% (94/604), 14.67% (108/736), and 7.44% (16/215) of the household heads with low, moderate, and high knowledge, respectively, had children with malaria infection (trend x 2 = 9.172, p = 0.01).ConclusionThe study population had a good level of knowledge about malaria infection, and a good attitude toward malaria interventions, and the majority of them were using bed nets.

Project description:BackgroundMalaria and anemia remain major public health challenges in Tanzania. Household socioeconomic factors are known to influence these conditions. However, it is not clear how these factors influence malaria transmission and anemia in Masasi and Nanyumbu Districts. This study presents findings on malaria and anemia situation in under-five children and its influencing socioeconomic factors in Masasi and Nanyumbu Districts, surveyed as part of an ongoing seasonal malaria chemoprevention operational study.MethodsA community-based cross-sectional survey was conducted between August and September 2020. Finger-prick blood samples collected from children aged 3-59 months were used to test for malaria infection using malaria rapid diagnostic test (mRDT), thick smears for determination of asexual and sexual parasitemia, and thin smear for parasite speciation. Hemoglobin concentration was measured using a HemoCue spectrophotometer. A structured questionnaire was used to collect household socioeconomic information from parents/caregivers of screened children. The prevalence of malaria was the primary outcome. Chi-square tests, t-tests, and logistic regression models were used appropriately.ResultsOverall mRDT-based malaria prevalence was 15.9% (373/2340), and was significantly higher in Nanyumbu (23.7% (167/705) than Masasi District (12.6% (206/1635), p<0.001. Location (Nanyumbu), no formal education, household number of people, household number of under-fives, not having a bed net, thatched roof, open/partially open eave, sand/soil floor, and low socioeconomic status were major risks for malaria infection. Some 53.9% (1196/2218) children had anemia, and the majority were in Nanyumbu (63.5% (458/705), p<0.001. Location (Nanyumbu), mRDT positive, not owning a bed net, not sleeping under bed net, open/partially open eave, thatched window, sex of the child, and age of the child were major risk factors for anemia.ConclusionPrevalence of malaria and anemia was high and was strongly associated with household socioeconomic factors. Improving household socioeconomic status is expected to reduce the prevalence of the conditions in the area.

Project description:Seasonal malaria chemoprevention (SMC) for children under 5 years of age for up to four monthly cycles during malaria transmission season was recommended by the WHO in 2012 and has been implemented in 13 countries in the Sahel, reaching more than 30 million children annually. Malaria control programs implementing SMC have asked the WHO to consider expanding the age range or number of monthly cycles. We conducted a systematic review and meta-analysis of SMC among children up to 15 years of age and up to six monthly cycles. Twelve randomized studies were included, with outcomes stratified by age (< 5/≥ 5 years), by three or four versus five or six cycles, and by drug where possible. Drug regimens included sulfadoxine-pyrimethamine + amodiaquine, amodiaquine-artesunate, and sulfadoxine-pyrimethamine + artesunate. Included studies were all conducted in Sahelian countries in which high-grade resistance to sulfadoxine-pyrimethamine was rare and in zones with parasite prevalence ranging from 1% to 79%. Seasonal malaria chemoprevention resulted in substantial reductions in uncomplicated malaria incidence measured during that transmission season (rate ratio: 0.27, 95% CI: 0.25-0.29 among children < 5 years; rate ratio: 0.27, 95% CI: 0.25-0.30 among children ≥ 5 years) and in the prevalence of malaria parasitemia measured within 4-6 weeks from the final SMC cycle (risk ratio: 0.38, 95% CI: 0.34-0.43 among children < 5 years; risk ratio: 0.23, 95% CI: 0.11-0.48 among children ≥ 5 years). In high-transmission zones, SMC resulted in a moderately reduced risk of any anemia (risk ratio: 0.77, 95% CI: 0.72-0.83 among children < 5 years; risk ratio: 0.70, 95% CI: 0.52-0.95 among children ≥ 5 years [one study]). Children < 10 years of age had a moderate reduction in severe malaria (risk ratio: 0.53, 95% CI: 0.37-0.76) but no evidence of a mortality reduction. The evidence suggests that in areas in which sulfadoxine-pyrimethamine and amodiaquine remained efficacious, SMC effectively reduced malaria disease burden among children both < 5 and ≥ 5 years old and that the number of cycles should be commensurate with the length of the transmission season, up to six cycles.

Project description:BackgroundImplemented in 17 countries to date, seasonal malaria chemoprevention (SMC) is a recommended strategy to prevent childhood malaria in areas with seasonal transmission of P. falciparum through monthly administration of antimalarial medicines. Understanding the costs and resource requirements of SMC delivery is necessary for effective planning and resource allocation. This systematic literature review aims to assess the evidence on the cost and cost-effectiveness of SMC delivery.MethodsFollowing PRISMA guidelines, five databases were systematically reviewed to identify evidence on SMC costs and cost-effectiveness published between 2012 and 2023. Studies with defined costing methodologies and cost output measures were included, excluding those relying solely on mathematical modeling. Two reviewers assessed each study for eligibility and extracted cost data, which were adjusted for inflation. Quality assessment was completed using the CHEERS checklist.ResultsSix costing studies were identified spanning nine countries. Four studies examined costs during an SMC pilot or introduction, one during scale-up, and one costed newly established SMC campaigns through a multi-country project. Costs were examined at country level with the financial costs per child receiving a full course of SMC ranging from $1.71 to $12.46, while economic costs per child ranged from $2.11 to $29.06. Four studies included a cost effectiveness analysis with incremental cost-effectiveness ratios (ICERs) per clinical malaria case averted ranging from $5.41 to $138.03; ICER per disability-adjusted life year (DALY) averted from $24.51 to $182.88; and ICER per death averted from $688.86 to $18,418.81. Differences in cost estimates stemmed from different factors including variations in cost ingredients, scale of the intervention, and study perspectives.DiscussionThe level of detail for reporting SMC costs and cost categories varied greatly by study as did the scale of intervention, limiting comparability as well as an understanding of the complete costs and resource requirements for SMC implementation. Cost evidence is not from mature programs but from pilots or relatively new campaigns. Costs incurred by households and costs of the integrated delivery of SMC with other health interventions were often overlooked. Adopting a standardized costing approach for mature SMC programmes could provide a better understanding of resource requirements and costs while enhancing study comparability across settings, better informing future resource allocation and improving efficiency.

Dataset Information

A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda.

Background

Objective

Methods

Discussion

Conclusion

Publications

A hybrid effectiveness-implementation study protocol to assess the effectiveness and chemoprevention efficacy of implementing seasonal malaria chemoprevention in five districts in Karamoja region, Uganda.

Similar Datasets

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