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Browsing Protocols by Author "Phiri S, Kamija"

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    Assessing the effectiveness of extending Malaria Community Case Management (MCCM) to all ages in Malawi: a mixed methods study
    (Kamuzu University of Health Sciences, 2021-11-19) Phiri S, Kamija
    5.1 Background and rationale The burden of malaria is high in Malawi, where access to care remains a challenge. Integrated community case management (iCCM) has been shown to be effective in reducing morbidity and mortality among children less than five years of age for pneumonia, diarrhea, and malaria. Some countries, including Malawi, have expressed an interest in extending malaria community case management (mCCM). Rigorous studies to scale up mCCM for all ages are necessary prior to introducing and scaling up this strategy in high-transmission settings.5.2 Objectives 5.2.1 Broad Objective To analyse the effectiveness of extending community case management of malaria to all age groups over a 12-month period in the districts of Neno, Ntchisi and Salima, MalawiSpecific Objectives1.2.To assess analyze the effectiveness of extending mCCM to all ages on the proportion of children aged 2 months to <5 years, 5 to <15 years, and those aged 15+ years with febrile illness in the previous 2 weeks who: 1) sought care for that illness; 2) sought care within 24 hours; 3) were tested for malaria; and 4) were treated with an appropriate antimalarial if they tested positive for malaria 3.To describe the effectiveness of extending mCCM to all ages on the prevalence of malaria parasitaemia among children aged 2 months to <5 years, and among children 5 to <15 years 4.To evaluate the effectiveness of extending mCCM to all ages on the proportion of illchildren aged 2 months to <5 years seeking care for pneumonia and diarrhea. 5.To assess the acceptability, feasibility, perceptions and experiences of extending mCCM to all ages, according to community members, HSAs, and health facility in charges. 6.To estimate the implementation costs of extending mCCM to all ages from provider perspective. 7.To describe the incremental cost-effectiveness of extending mCCM to all ages for 12 months compared with standard CCM from societal perspective (provider and household). 5.3 Study Design Cluster-randomized trial with two arms (intervention and control) taking place in the catchment areas of a minimum of 24 health facilities (12 per arm) over a period of 12 months. ā— Control arm: Case management of malaria by health facilities and HSAs in line with current national recommendations (iCCM for children <5 years) ā— Intervention arm: Case management of malaria by health facilities and HSAs in line with current national recommendations (iCCM for children <5 years), with an extension of community case management of malaria to all ages To achieve the objectives of the study, three types of data collection will take place: 1. Cross-sectional household surveys, pre- and post-intervention (0 and 12 months, respectively) 2. Qualitative in-depth interviews and focus groups 3. Data abstraction of routine service use from HSAs and health facilities and periodic costs from project documents and reports 5.3.1 Study Interventions Screening with malaria rapid diagnostic test and treatment of malaria positive cases with firstfist line antimalarial therapy Artemether-Lumefantrine (AL). 5.3.2 Primary outcome The primary outcome is the proportion of individuals two months of age or older, reporting a fever in the previous 2 weeks who were tested with a malaria RDT by an HSA or at a health facility by a health worker. This outcome will be measured by cross-sectional household surveys. 5.3.3 Sample size 1. Enrollment in each cross-sectional household survey will be offered to 66 households in each health facility cluster (2 EAs per health facility with 33 households each EA), giving a total of 794 per arm (12 health facilities), or 1,588 households in total (24 health facilities). 2. The qualitative component will include in-depth interviews with 30-40 individuals in the intervention and control arms (HSAs + beneficiaries/care-seekers/community members + Facility in-charges) and 6 focus group discussions with care-seekers, HSA in the intervention and control arms. 3. Routine data abstraction will include the 24 study facilities and all HSAs in their catchment areas. 4. The cost data abstraction will include 2 district coordinators visited quarterly from the three study districts. 5.3.4 Data Analysis 1. Household Survey Data: A mixed effects logistic regression model will be fitted to the data to estimate the difference in odds of the outcome between the intervention and the control. Odds ratios and corresponding 95% confidence intervals will be reported. Tests of significance will be performed at a level of š›‚ = 0.05 with corrections for multiple comparisons when needed. 2. Qualitative data: Translation from Chichewa to English will occur during transcription into Word and will be kept secure until the analysis is complete. Translation and transcription will be verified by the research assistant and the scientific lead (social science) for quality assurance. Data will be coded and entered into NVivo 12 for the extraction themes will be identified using a content analysis approach. The analysis will be carried out according to the thematic analysis method, which consists of dividing the text into basic units for assessment. Each interview and focus group participant will be assigned a code or participant ID number, which will be used in presenting quotes. 3. Cost-effectiveness data: Cost and cost-effectiveness analyses will be undertaken to assess the financial and economic impacts of mCCM for all ages compared to the standard iCCM strategy (without extension of malaria treatment). The budget impact analysis will help determine if the expanded strategy is feasible given existing amounts in the national budget for malaria. 5.4 Expected findings and dissemination of results 5.4.1 Expected findings We hypothesize that the expansion of mCCM to all ages will lead to an increase in a) care seeking by patients with fever, b) the proportion of subjects with fever who received a malaria RDT, and c) the proportion of cases of malaria confirmed by RDT who received adequate antimalarial treatment. More specifically, we hypothesize that the proportion of individuals with recent fever for whom a malaria RDT was performed (main indicator) at the beginning of the study will be 40% in both arms, and will increase to 62% in the intervention arm by the end of the study. We assume that this proportion will remain constant at 40% in the control arm (see sample size section). 5.4.2 Dissemination of results A mid-term report will be submitted to the MoH NMCP and other study partners (WHO, PMI, USAID) in 2022. The report will include results of the baseline survey, and details on challenges and successes during study implementation. The mid-term report will also highlight key elements for planning the extension of mCCM to all ages for the country.