Assessing the implementation fidelity, feasibility, and sustainability of community-based house improvement for malaria control in southern Malawi: a mixed-methods study.

BACKGROUND: Despite significant success in the fight against malaria over the past two decades, malaria control programmes rely on only two insecticidal methods: indoor residual spraying and insecticidal-treated nets. House improvement (HI) can complement these interventions by reducing human-mosquito contact, thereby reinforcing the gains in disease reduction. This study assessed the implementation fidelity, which is the assessment of how closely an intervention aligns with its intended design, feasibility, and sustainability of community-led HI in southern Malawi. METHODS: The study, conducted in 22 villages (2730 households), employed a mixed-methods approach. Implementation fidelity was assessed using a modified framework, with longitudinal surveys collecting data on HI coverage indicators. Quantitative analysis, employing descriptive statistics, evaluated the adherence to HI implementation. Qualitative data came from in-depth interviews, key informant interviews, and focus groups involving project beneficiaries and implementers. Qualitative data were analysed using content analysis guided by the implementation fidelity model to explore facilitators, challenges, and factors affecting intervention feasibility. RESULTS: The results show that HI was implemented as planned. There was good adherence to the intended community-led HI design; however, the adherence could have been higher but gradually declined over time. In terms of intervention implementation, 74% of houses had attempted to have eaves closed in 2016-17 and 2017-18, compared to 70% in 2018-19. In 2016-17, 42% of houses had all four sides of the eaves closed, compared to 33% in 2018-19. Approximately 72% of houses were screened with gauze wire in 2016-17, compared to 57% in 2018-19. High costs, supply shortages, labour demands, volunteers' poor living conditions and adverse weather were reported to hinder the ideal HI implementation. Overall, the community described community-led HI as feasible and could be sustained by addressing these socioeconomic and contextual challenges. CONCLUSION: Our study found that although HI was initially implemented as planned, its fidelity declined over time. Using trained volunteers facilitated the fidelity and feasibility of implementing the intervention. A combination of rigorous community education, consistent training, information, education and communication, and intervention modifications may be necessary to address the challenges and enhance the intervention's fidelity, feasibility, and sustainability.

Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial.

BACKGROUND: Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women. METHODS: In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13-26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up. FINDINGS: Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group vs 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference -3·1 g [-75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34). INTERPRETATION: In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight. FUNDING: Bill & Melinda Gates Foundation (INV-010612).

Incidence of clinical malaria, acute respiratory illness, and diarrhoea in children in southern Malawi: a prospective cohort study.

BACKGROUND: Malaria, acute respiratory infections (ARIs) and diarrhoea are the leading causes of morbidity and mortality among children under 5 years old. Estimates of the malaria incidence are available from a previous study conducted in southern Malawi in the absence of community-led malaria control strategies; however, the incidence of the other diseases is lacking, owing to understudying and competing disease priorities. Extensive malaria control measures through a community participation strategy were implemented in Chikwawa, southern Malawi from May 2016 to reduce parasite prevalence and incidence. This study assessed the incidence of clinical malaria, ARIs and acute diarrhoea among under-five children in a rural community involved in malaria control through community participation. METHODS: A prospective cohort study was conducted from September 2017 to May 2019 in Chikwawa district, southern Malawi. Children aged 6-48 months were recruited from a series of repeated cross-sectional household surveys. Recruited children were followed up two-monthly for 1 year to record details of any clinic visits to designated health facilities. Incidence of clinical malaria, ARIs and diarrhoea per child-years at risk was estimated, compared between age groups, area of residence and time. RESULTS: A total of 274 out of 281 children recruited children had complete results and contributed 235.7 child-years. Malaria incidence was 0.5 (95% CI (0.4, 0.5)) cases per child-years at risk, (0.04 in 6.0-11.9 month-olds, 0.5 in 12.0-23.9 month-olds, 0.6 in 24.0-59.9 month-olds). Incidences of ARIs and diarrhoea were 0.3 (95% CI (0.2, 0.3)), (0.1 in 6.0-11.9 month-olds, 0.4 in 12.0-23.9 month-olds, 0.3 in 24.0-59.9 month-olds), and 0.2 (95% CI (0.2, 0.3)), (0.1 in 6.0-11.9 month-olds, 0.3 in 12.0-23.9 month-olds, 0.2 in 24.0-59.9 month-olds) cases per child-years at risk, respectively. There were temporal variations of malaria and ARI incidence and an overall decrease over time. CONCLUSION: In comparison to previous studies, there was a lower incidence of clinical malaria in Chikwawa. The incidence of ARIs and diarrhoea were also low and decreased over time. The results are promising because they highlight the importance of community participation and the integration of malaria prevention strategies in contributing to disease burden reduction.

The effect of community-driven larval source management and house improvement on malaria transmission when added to the standard malaria control strategies in Malawi: a cluster-randomized controlled trial.

BACKGROUND: Current standard interventions are not universally sufficient for malaria elimination. The effects of community-based house improvement (HI) and larval source management (LSM) as supplementary interventions to the Malawi National Malaria Control Programme (NMCP) interventions were assessed in the context of an intensive community engagement programme. METHODS: The study was a two-by-two factorial, cluster-randomized controlled trial in Malawi. Village clusters were randomly assigned to four arms: a control arm; HI; LSM; and HI + LSM. Malawi NMCP interventions and community engagement were used in all arms. Household-level, cross-sectional surveys were conducted on a rolling, 2-monthly basis to measure parasitological and entomological outcomes over 3 years, beginning with one baseline year. The primary outcome was the entomological inoculation rate (EIR). Secondary outcomes included mosquito density, Plasmodium falciparum prevalence, and haemoglobin levels. All outcomes were assessed based on intention to treat, and comparisons between trial arms were conducted at both cluster and household level. RESULTS: Eighteen clusters derived from 53 villages with 4558 households and 20,013 people were randomly assigned to the four trial arms. The mean nightly EIR fell from 0.010 infectious bites per person (95% CI 0.006-0.015) in the baseline year to 0.001 (0.000, 0.003) in the last year of the trial. Over the full trial period, the EIR did not differ between the four trial arms (p = 0.33). Similar results were observed for the other outcomes: mosquito density and P. falciparum prevalence decreased over 3 years of sampling, while haemoglobin levels increased; and there were minimal differences between the trial arms during the trial period. CONCLUSIONS: In the context of high insecticide-treated bed net use, neither community-based HI, LSM, nor HI + LSM contributed to further reductions in malaria transmission or prevalence beyond the reductions observed over two years across all four trial arms. This was the first trial, as far as the authors are aware, to test the potential complementary impact of LSM and/or HI beyond levels achieved by standard interventions. The unexpectedly low EIR values following intervention implementation indicated a promising reduction in malaria transmission for the area, but also limited the usefulness of this outcome for measuring differences in malaria transmission among the trial arms. Trial registration PACTR, PACTR201604001501493, Registered 3 March 2016, https://pactr.samrc.ac.za/ .

Leveraging phone-based mobile technology to improve data quality at health facilities in rural Malawi: a best practice project.

BACKGROUND: To further reduce malaria burden, identification of areas with highest burden for targeted interventions needs to occur. Routine health information has the potential to indicate where and when clinical malaria occurs the most. Developing countries mostly use paper-based data systems however they are error-prone as they require manual aggregation, tallying and transferring of data. Piloting was done using electronic data capture (EDC) with a cheap and user friendly software in rural Malawian primary healthcare setting to improve the quality of health records. METHODS: Audit and feedback tools from the Joanna Briggs Institute (Practical Application of Clinical Evidence System and Getting Research into Practice) were used in four primary healthcare facilities. Using this approach, the best available evidence for a malaria information system (MIS) was identified. Baseline audit of the existing MIS was conducted in the facilities based on available best practice for MIS; this included ensuring data consistency and completeness in MIS by sampling 25 random records of malaria positive cases. Implementation of an adapted evidence-based EDC system using tablets on an OpenDataKit platform was done. An end line audit following implementation was then conducted. Users had interviews on experiences and challenges concerning EDC at the beginning and end of the survey. RESULTS: The existing MIS was paper-based, occupied huge storage space, had some data losses due to torn out papers and were illegible in some facilities. The existing MIS did not have documentation of necessary parameters, such as malaria deaths and treatment within 14 days. Training manuals and modules were absent. One health centre solely had data completeness and consistency at 100% of the malaria-positive sampled records. Data completeness and consistency rose to 100% with readily available records containing information on recent malaria treatment. Interview findings at the end of the survey showed that EDC was acceptable among users and they agreed that the tablets and the OpenDataKit were easy to use, improved productivity and quality of care. CONCLUSIONS: Improvement of data quality and use in the Malawian rural facilities was achieved through the introduction of EDC using OpenDataKit. Health workers in the facilities showed satisfaction with the use of EDC.

A Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP): Statistical analysis plan.

Background: Anaemia affects more than half of Africa's pregnancies. Standard care, with oral iron tablets, often fails to achieve results, with compliance and gastrointestinal side-effects being a significant issue. In recent years, intravenous iron formulations have become safe, effective, and quick to administer, allowing the complete iron requirements of pregnancy to be provided in one 15-minute infusion. The Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) will evaluate whether a modern intravenous iron formulation, ferric carboxymaltose (FCM), given once during the second trimester is effective and safe in improving maternal and neonatal outcomes for treatment of moderate to severe anaemia in sub-Saharan Africa.   The objective was to publish the detailed statistical analysis plan for the REVAMP trial prior to unblinding the allocated treatments and performing the analysis.   Methods: REVAMP is a multicentre, two-arm, open-label, parallel-group randomized control trial (RCT) in 862 pregnant women in their second trimester. The trial statistician developed the statistical analysis plan in consultation with the trial management team based on the protocol, data collection forms, and study outcomes available in the blinded study database.   Results: The detailed statistical analysis plan will support the statistical analyses and reporting of the REVAMP trial after unblinding the treatment allocations.   Conclusions: A statistical analysis plan allows for transparency as well as reproducibility of reporting and statistical analyses.