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- ItemRestrictedThe effect of pulmonary rehabilitation on cardio-respiratory function of patients with chronic lung diseases identified during chest X-ray screening for pulmonary tuberculosis(Kamuzu University of Health Sciences, 11-03-22) Gwelama, PreciousType of Research Study This study will use an Experimental Study-it is a Randomized Controlled Trial (RCT) with 1:1 allocation to assess The Effect of Pulmonary Rehabilitation (PR) on Cardio-Respiratory Function of Patients with Pulmonary Tuberculosis in Blantyre. Problem to be studied The prevalence of Chronic Lung Diseases (CLDs) is high in patients undergoing Tuberculosis (TB) screening mostly due to previous pulmonary infections including pulmonary Tuberculosis (pTB). In order to prevent progressive loss of pulmonary function in these patients, interventions that prevent CLDs need to be employed. The National Tuberculosis Control Program (NTP) in Malawi does not have established guidelines in the management of pTB to prevent CLDs. Previous TB infection usually causes lung damage and post pTB survivors frequently present with persistent respiratory symptoms which clinically present as CLDs. Even though PR has shown to be effective in the management of CLDs by improving respiratory symptoms, physical function and health related quality of life (HRQoL), there is still limited evidence on the effect of PR during TB treatment. Furthermore the few studies performed so far with regard to PR in TB sequelae have confirmed the same positive results as those that are found with PR use in CLDs. Objectives Broad objective To compare the effect of PR (breathing exercises, strengthening and aerobic training PR techniques used in chronic lung diseases) at 6 weeks of treatment with no PR in the management of patients with TB. Specific objectives 1. To compare changes in spirometry Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) values in Litres (L) between participants receiving PR with those not receiving PR. 2. To assess the effect of PR on exercise tolerance in participants receiving PR in comparison to those not receiving PR. 3. To compare respiratory symptoms improvement of pTB between participants receiving PR with participants not receiving PR. Methodology This study will be conducted from 1st March to 31st May 2022 at the physiotherapy clinics based at Queen Elizabeth Central Hospital (QECH), Kamuzu University of Health Sciences (KUHES), and private practitioners in Blantyre. The study participants who will be selected will include a total of 240 participants. These participants will include pTB patients (≥18 years) who have initiated TB treatment with known HIV status from Blantyre District. Data on spirometry, physical function and HRQOL will be collected. Study Participants will then be randomly assigned to receive PR (the intervention) and no PR (control arm) using a sequence pre-generated by a statistician. The PR program will run for 6 weeks with a 90 min–120min supervised session at week one and week three. Continuous data will be analysed using a T test and Analysis of Variance (ANOVA) if normally distributed, and if skewed a Wilcoxon Rank Sum Test will be used. Furthermore, categorical variables will be analysed using a Fisher's exact test. Finally Logistic regression will be done to show differences between the intervention and control group. Expected findings and their dissemination It is expected that at the end of the study there will be evidence of clinically significant improvements in HRQoL, exercise tolerance, respiratory symptoms and lung function in patients receiving PR. These findings will be disseminated at District level, national conferences, the health facilities of the TB patients, College of Medicine Research and Ethics Committee (COMREC), Blantyre District Health Office (DHO), NTP and wider audiences through journal publications such as the Malawi Medical Journal.
- ItemRestrictedImpact of the COVID -19 pandemic on morbidity and mortality due to enteric infections in children < 5 years of age in Malawi(Malawi Liverpool Welcome Trust, 16-03-22) Jere, KhuzwayoStudy type: Observational study Problem: Since April 2020, Malawi has experienced three waves of Sars-Cov-2 rapid transmission and associated deaths. The spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has impacted health services globally. Consequent disruption of routine health services is expected to have long-term and far-reaching consequences. Significant reductions in the numbers of inpatients or attendance to primary/community health care clinics for illnesses other than COVID-19 have been described in many settings. Among other reasons, these changes could be due to movement restrictions preventing travel to health care facilities, lack of space at these facilities due to COVID-19, or avoidance of medical institutions due to concerns of exposure. Main objective: This protocol aims to assess the impact of COVID-19 on morbidity and mortality associated with enteric illness in Low -Middle-Income Countries (LMICs). Specific objectives: a. Evaluate the temporal diarrheal trends in relation to national and, where available, local COVID-19 activity, by examining routinely collected data on hospital admissions or attendance to the outpatient department (OPD) and community health clinics with a diagnosis of diarrhea. b. Assess the temporal trends in diarrheal disease severity and mortality among children under 5 years of age in relation to COVID-19 activity, by examining hospitalization data with a diagnosis of diarrheal illness. c. Estimate the impact of disruption to Extended Programme on Immunisation (EPI) on rotavirus diarrheal disease Methodology: Data on the monthly number of diarrheal disease cases, on monthly EPI vaccine and dose-specific administration, and on inpatient diarrheal cases’ associated mortality for children <5 for all 28 districts of Malawi will be obtained from the Ministry of Health’s Health Management Information System (HMIS). Data will be aggregated by the 5 health zones (Northern, Central East, Central West, Southeast, and Southwest regions of Malawi). Exploratory analysis will include data aggregation by urban-rural categories too. Where data gaps exist in the electronic database inspection of the physical records will be done in the districts. Expected Results and Dissemination: A negative impact on seeking care for diarrheal disease and on EPI is expected due to fear of contracting COVID19 at health facilities. Once the data is generated and analyzed for trends, the findings thereof will be shared with the College of Medicine Research Ethics Committee (COMREC), the Ministry of Health (MoH), published in peer reviewed journals and will be disseminated to the general public through the annual College of Medicine Research dissemination conference.
- ItemRestrictedKnowledge, attitude and practices towards risk factors of pulmonary tuberculosis among mine workers at Nathenje, Lilongwe(Kamuzu University of Health Sciences, 2020-10-08) Mwale, Portipher; Kamngoya, Rhoda; Gama, KetrinaPulmonary tuberculosis continues to be one of the health problem issue among mine workers worldwide. However, there is limited data on the knowledge, attitudes and practices on pulmonary tuberculosis among mine workers both here in Malawi and other sub-Saharan African countries. This could also be one of the contributing factors to the vast increase in PTB cases worldwide. This quantitative cross-sectional study has been designed to assess the knowledge, attitudes and practices towards pulmonary tuberculosis among quarry mine workers at Nathenje, Lilongwe, Malawi. The study will put much focus on assessing knowledge about PTB among quarry mine workers, exploring their attitude towards the use of protective measures against PTB and identifying measures put in place to prevent PTB among mine workers. The study will target quarry mine workers in Malawi and the study population will be the quarry mine workers at Nathenje aged 18 to 60 years. Convenience sampling method will be used in this study. The study will be conducted at Nathenje legal quarry mining sites in Lilongwe. Data will be collected from the quarry miners through self-administered questionnaires which will be printed both in Chichewa and English for the participants to choose based on their language preference. It is expected that our results will give a picture of the level of knowledge quarry miners have on pulmonary tuberculosis, their attitude towards the disease and practices towards the preventive measures put in place by their management. Results will be presented at the College of Medicine MBBS 4 research seminar, a copy will be sent to COMREC as well as to the College of Medicine library.
- ItemRestrictedAssessment of prevalence of pulmonary Tuberculosis among diabetic patients and Exploring Health Seeking Behaviors To Improve Early TB Diagnosis at Queen Elizabeth Central Hospital, Blantyre and Bwaila Hospital Lilongwe(Kamuzu university of Health Sciences, 2020-11-11) Rambiki, EthelThe study will aim to assess the relationship between prevalence of pulmonary tuberculosis and social determinants of health among Diabetic patients attending clinics at Queen Elizabeth Central Hospital and Bwaila Hospital. Globally, TB has been recognized as socially stratified disease that preys mostly on the disadvantaged countries, communities and sub populations. Unequal distribution of wealth, education, living and working conditions, nutrition has left some population more vulnerable to transitioning to active TB infection than others [12]. These factors, in addition to some disease states like diabetes as shown in other settings through studies has increased the risk greatly and increased the burden of disease. With Diabetes being regarded as a disease of the middle class, there is need for further research to establish the role that social determinants of health play in the event of diabetes to increase the risk of pulmonary tuberculosis and currently no such studies have been done in Malawi and diabetic and TB services are offered in parallel within our hospitals [6]. The study will therefore, bring out important issues on relationship between these key programmatic areas and explore some health seeking behaviors of patients that are have such co-morbidities. Study design The study will follow mixed methods designs where retrospective analytical observational study design will be used for secondary data and qualitative approach through in-depth interviews with key informants including diabetic patients. Study setting The study will be conducted in diabetic clinics at Queen Elizabeth Central Hospital in Blantyre and Bwaila Hospital in Lilongwe Study Participants 15 diabetic patients will be interviewed and secondary data of 685 diabetic patients screened for pulmonary TB will be extracted from facility TB registers. Sample size for in-depth interviews will be increased accordingly in case on theoretical non-saturation. Data collection A data extraction tool and an in-depth interview guide will be used to collect secondary and qualitative data respectively. Major variables to be collected include age, sex, type of diabetes, duration and type of treatment, HIV status, diagnostic test done, Test results, other comorbidities, previous TB infection, presence of TB in the family, history of smoking and alcohol intake, place of residence, average monthly income and occupation. 11-Nov
- ItemRestrictedGenetic diversity of drug resistant tuberculosis in Zambia(Kamuzu University of Health Sciences, 2021-03-04) Zimba, SharonType of study: A cross-sectional study Aim of the study: To establish the genetic diversity of drug resistant tuberculosis in Zambia Specific objectives: 1. To identify the circulating strains of Mtb in Zambia. 2. To classify the mycobacterium lineages associated with drug resistant TB in Zambia. 3. To determine the proportion of each mycobacterium lineage in drug resistant TB in Zambia. 4. To analyse the resistance trend among the circulating Mtb lineages in the past five (5) years in Zambia. Problem statement: Drug resistant tuberculosis has been reported to be an increasingly serious concern and a threat to public health due to its mode of spread and cost of treatment. In 2017, an estimated 3.5% of new cases and 18% of previously treated cases had MDR-TB globally with Africa reporting 2.7% in new cases and 14% in previously treated cases, and Zambia contributing about 1.1% in new cases and 18% in previously treated case although it is not classified as a high MDR-TB burden country (WHO, 2018). In 2018, about half a million new cases of rifampicin-resistant TB were reported, of which 78% had multidrug-resistant TB, worldwide. Of the new TB cases, 3.4% had drug resistant TB while 18% of previously treated cases had multidrug-resistant TB or rifampicin-resistant TB (WHO, 2019). In Zambia, there was an increase of drug resistant TB rate in new TB cases in 2018, from 1.1% reported in 2017 to 2.8% in 2018 while there was neither a decrease nor an increase in the MDR/RR rate in the previously treated TB cases as it remained unchanged at 18% (WHO, 2019). Despite the statistics and increase in the incidence and prevalence of MDR-TB in Zambia and Africa at large, there is inadequate documented literature on the association between the various strain and lineages in the Mycobacterium tuberculosis complex with drug resistant TB in Zambia, the proportion each lineage has contributed to the resistant strains and the trend of resistance patterns in each lineage over the past five (5) years. The study will be conducted in Zambia, on sputum samples with drug resistant TB archived at Chest Disease laboratory (CDL). The study units of 245 will be selected through Stratified sampling method. The samples will first be subdivided into strata based on the year of collection, and then the individual units will be collected from each stratum using simple random or systematic sampling. Data will be collected through the laboratory analysis of archived sputum samples. The analysis will include, liquid culture using the Mycobacteria Growth Indicator Tube (MGIT) system (to revive the mycobacterium) , Genotyping with a single nucleotide polymorphism (SNP) based PCR method using primers specific for each of regions of difference (L1), (L2) and (L3) and L4 according to Thermofisher Scientific Line probe assay and Single Nucleotide Pleomorphism (SNP) and Line probe assay will be performed using the Hain Life science technology. Data will be stored using MS excel database and analysed using SPSS version 21. Descriptive statistics will be presented in form of percentages, charts tables and graphs. Chi square test will be used to determine associations between categorical variables. Molecular data will be analysed using the taqMan Genotyper Software.
- ItemRestrictedRadio+ TB: Determining the optimal regimen for bacteriologically negative, radiographically apparent TB diagnosed using new tests(Kamuzu University of Health Sciences, 2021-05-12) Esmail, HanifThe type of research study: Prospective cohort study. The problem to be studied A proportion of patients presenting for assessment with pulmonary tuberculosis (TB) symptoms will have a negative sputum Xpert but will in fact have undiagnosed active TB or be at high risk of progression to active disease. This group is currently ineffectively managed. This study aims to evaluate novel field ready-diagnostic to assist in the diagnosis of Xpert negative TB. Broad objective: To determine a baseline screen strategy utilising novel diagnostics in patients presenting with symptoms to primary care that has a high predictive value for prevalent and incident culture positive TB and to establish patient and provider attitudes to treatment approaches on the basis of these novel tests. Specific objectives: 1. To determine the predictive value of chest x-ray computer-aided diagnostics (CXR CAD), TB host response blood test and face mask sampling for prevalent and incident culture positive TB, alone and in combination, in participants presenting to primary care with TB symptoms. 2. To use qualitative research methods to identify factors most relevant to patients in the diagnosis and management of bacteriologically-negative TB. 3. To measure patient and provider preferences for different diagnostic and treatment strategies for bacteriologically negative TB through a discrete choice experiment to inform a future randomised control trial design 4. To explore whether diagnostic and treatment preferences vary by individual or TB disease characteristics Methodology: A prospective cohort study for a diagnostic evaluation will be undertaken. Participants will be 200 adults with symptoms of TB presenting to Bangwe Health Centre for assessment of acute illness. Following consent, they will undergo investigation for TB using both routine (CXR, sputum Xpert) additional (Xpert Ultra and induced sputum culture) and research tests (Computer-aided X-ray diagnosis evaluation with 3 different software packages - Lunit, CAD4TB, Qure.ai; TB host response test; face mask sampling). Clinic staff will be provided with the results of routine and additional tests to inform patient management. Participants will return at 3 months for reassessment, with no further assessments planned. The primary outcome will be prevalence of microbiologically-confirmed TB at recruitment, and incidence of microbiologically-confirmed TB over 3 months of follow-up. We will also undertake a cross-sectional discrete choice experiment survey to investigate patient and provider preferences for treatment choices around insipient TB infection. A qualitative study will be undertaken to develop survey for the discrete choice experiments. Expected findings and their dissemination We expect high rates of CXR abnormalities and that these will be highly sensitive for prevalent/incident TB but not specific. We anticipate that adding a TB HR Blood tests or face mask sampling will increase positive predictive value for prevalent/incident TB. Results will be disseminated to patients and clinic staff through MLW Science Communication Department, to COMREC, to the Blantyre District Health Office, to the Malawi National TB Programme, and locally and internationally through presentations and peer-reviewed journal publications.
- ItemRestrictedClinical evaluation of the host gene signature for tuberculosis diagnosis and treatment response monitoring(Kamuzu University of Health Sciences, 2021-09-15) Nakiboneka, RitahThis study will be a cross-sectional case-control study, accompanied by a prospective longitudinal follow-up study of patients with Xpert MTB/RIF (Xpert) confirmed active pulmonary TB. Eligible participants will be adults aged 18 years, belonging to the following groups: i) Presumptive TB cases or confirmed TB patients, these will include: • Active TB patients with confirmed TB disease (Group 1-Xpert positive) • Clinically diagnosed patients being started on TB treatment (Group 2- Xpert MTB/RIF negative) • Individuals with cough or respiratory symptoms (Group 3 - XpertMTB/RIF negative, QuantiFERON negative and not started on TB treatment) ii) Apparently Healthy individuals, these will include: • LTBI (Group 4 - QuantiFERON positive, having no clinical signs of TB) • Healthy volunteers (Group 5 - QuantiFERON test negative and no underlying medical conditions) Participants with positive Xpert MTB/RIF test without rifampicin resistance, will be placed on therapy and followed in a longtudinal study for 9 months to monitor treatment response success. These patients will be assessed at 2 weeks, and months 4, 6, and 9. At each visit blood will be collected (host gene response test) and sputum (culture, TB MBLA assay). Drug resistant TB cases and those unable to come back for follow-up visits will be excluded. The problem [to be studied]: Tuberculosis (TB) is a global health problem with a quarter of the world’s population infected with Mycobacterium tuberculosis (MTB). The current diagnostic tests for ATB are focused on detection of MTB bacilli within sputum samples and are thus not useful for diagnosing LTBI. Similarly, the immunological tests- although approved for use by the USA Food and Drug Administration (FDA) as diagnostic tests for LTBI, are not approved for ATB, and cannot differentiate between ongoing or resolved disease from either LTBI or ATB. These challenges led the WHO to call for the development of new non-sputum triage tests for TB diagnosis. These tests should detect latently infected individuals before they progress to active disease and no sputum conversion has occurred. They should detect TB in children and immunocompromised individuals who cannot produce sputum, should detect disseminated/extrapulmonary TB, and lastly, should be usable in monitoring therapy response. TB infection elicits specific gene expression in the human host to suppress or eliminate the infection. These genes can be detected in blood with over 80% specificity and sensitivity to TB disease. However, none of the gene sets has been adopted as a simple point of care diagnostic test in a clinical setting. Designing a simple gene diagnostic test and using it to diagnose TB infection will improve both diagnosis and therapy monitoring in TB disease. The objective: To clinically evaluate the accuracy of the host gene signature for diagnosis of TB and monitoring response to anti-TB therapy over the course of treatment. Methodology: Both male and female consenting adults will be enrolled into this study. A total of 266 participants will be recruited to the case-control study. Participant recruitment and treatment follow-up will be done from Blantyre, Malawi. Individuals seeking care at Queen Elizabeth Central Hospital and three health centres in Blantyre (Bangwe, Limbe, Ndirande), will be informed about the study. Those who show interest to join the study will be consented. The study will also be advertised through word of mouth to apparently - healthy participants in the Blantyre community and in HIV testing centers. Those who express interest will be invited to come to the hospital to learn more, and consider signing informed consent forms. This will be the break down of participants in each group: 116 individuals with active PTB (Group 1 and 2), 50 TB negative cases having respiratory symptoms (Group 3), 50 individuals with latent TB (Group 4), and lastly 50 healthy controls (Group 5). After consenting to join the study, 9 mL of blood will be drawn from each participant. Presumptive TB cases will also be asked to offer a sputum sample. Blood and sputum samples will be processed from Blantyre laboratory for detection of the host signature and Mycobacteria tuberulosis bacilli respectively. Expected findings and their dissemination: Upon completion of the project, Sensitivity, Specificity, Positive predictive value, and Negative predictive value of the host gene signature at detecting TB in: culture confirmed actively infected TB cases, Xpert MTB/RIF confirmed ATB cases and in latently infected individuals will be described. Treatment response monitoring by the gene sets will also be described by change in Cq values from baseline signifying change in gene expression as patient bacterial burden reduces due to therapy. This change will be compared to TB-MBLA measured sputum bacterial load. Results from this study will be analysed and published in a PhD manuscript, and in a research publication in an anonymised form. Results and data from this study may also be shared on a database accessible by other researchers but only in an anonymised form. Results from this study will also be presented in scientific meetings in an anonymised form.
- ItemRestrictedExploring post-TB morbidity in urban Blantyre, Malawi (ExPo-TB)(Liverpool School of Tropical Medicine, 2021-10-18) Meghji, JamilahThis is a cross-sectional study The clinical problem Previous work completed in urban Blantyre, Malawi has demonstrated a high burden of ongoing respiratory morbidity amongst adults successfully completing pulmonary tuberculosis (PTB) treatment, including structural lung damage and abnormal spirometry in over a third of patients. These findings are consistent with data from other settings. We have since shown that this post-TB lung disease (PTLD) is associated with chronic symptoms, ongoing health seeking, and adverse socioeconomic outcomes in Malawi. However, there remain no guidelines for the clinical management of post-TB lung disease, and services for symptomatic former TB patients remain limited. In a recent NIHR funded programme of stakeholder engagement around post-TB care in East Africa, in which we interviewed 39 policy makers, funders, health care providers, and TB-survivors in Malawi and Kenya, a need was expressed for more local, programmatic data on the burden of post-TB morbidity, in order to inform decision making around investment in the prevention and management of post-TB morbidity. In addition, the management of TB survivors presenting to health services with chronic or recurrent respiratory symptoms (cough, chest pain, breathlessness, sputum) was identified as a key area of clinical concern for patients and providers. In the absence of standardised clinical care pathways, these patients are frequently managed with empirical antibiotics or TB retreatment, whilst underling PTLD remains undiagnosed and untreated. This cross-sectional study will leverage existing links between the Malawi-Liverpool-Wellcome Trust (MLW) and the Malawi National TB Programme (NTP) in urban-Blantyre to address these challenges, by systematically measuring the existing burden of post-TB morbidity, and describe the existing context of post-TB care. Aims and Broad objectives The aim of this study is to describe the burden, experiences and management of post-TB morbidity amongst TB survivors in urban Blantyre. Specific objectives 1. To systematically measure the burden of residual physical and psychosocial morbidity experienced by TBsurvivors within urban Blantyre, at TB treatment completion. 2. To understand produce a narrative analysis of TB-survivor beliefs about residual or recurrent respiratory symptoms after TB treatment completion, and how this informs health seeking practices experiences of health seeking, in Bangwe township. 3. To understand produce a narrative analysis of the beliefs and practices of health care providers in urban Blantyre, when managing TB survivors with residual or recurrent respiratory symptoms after TB treatment completion.
- ItemRestrictedPredictors of Isoniazid preventive Therapy uptake and completion in Under-5 contacts of Adult Tuberculosis patients in Blantyre(2021-11-11) Chiumia, SymonType of study: An Analytical Cross-sectional study in 14'7 high tuberculosis (TB) burden health facilities in Blantyre District. The Problem. The uptake oflsoniazid Preventive Therapy (IPT) among under-five children in contact with adult tuberculosis patients, has been suboptimal globally (27% versus global target of>90% annually) and Malav1,'i is no exception. Accord.ing to the United Nations High-Level Meeting, 4 million under-five children were targeted worldwide by 2022. Malawi was assigned a minimum cumulative target of 25,780 under-five children by the year 2022. Malawi, with its high IIIVrrB burden and high child mortality, has had a few studies on factors associated with child IPT uptake. Thus, there is an urgent need to identify independent predictors oflsoniazid Preventive Therapy Uptake and Completion to reduce the national child disease burden and mortality rates. Objectives: To detenuine individual predictors of isoniazid uptake and completion in µnder-five children in contact with adult pulmonary TB patients in high TB burden heallh facilities in Blantyre district. .fulecific: 1. To define the characteristics of under-five children registered for TB screening and IPT uptake and those who completed therapy. 2. To detem1ine predictors of IPT uptake and completion . Methodology: We will do the study in fill_? out of 14 FaHdomly selected high TB burden Blantyre district facilities, Y,hieh ·,vere indepeadently seleeteEI using routinely collected medical data of the contacts registered in 2019. Using sampling frames of facility TB contact registers, we will extract anonymized data of all4S4-registered contacts in the registers in order to get adequate sample size.ay s:,-slell'!atie raudom Saffijlling of eontaets. Contact medical factors and demographic information will be collected. Our primary outcomes will be the number of contacts initiated and completed IPT. Descriptive analysis in STATA 2015, followed by logic analyses will be done(bivariable and then multivariable). Expected Findings and Dissemination We hypothesize that there will be a significant association between contact factors and their chances of getting TB screening, Isoniazid initiation, and completion. Thes_e findings will inform key stakeholders on strategies to improve lsoniazid uptake and the planned shorter regimen Isoniazid and Rifapentine (3HP) rollout, thereby reducing child morbidity and mortality. Results will be disseminated through peer-reviewed publications and presentations at relevant scientific conferences and shared with key stakeholders. A project completion report will be submitted to the College of Medicine Research and Ethics Committee.
- ItemRestrictedThe prevalence of drug resistant tuberculosis in clinical isolates in Blantyre and Lilongwe, Malawi(Kamuzu University of Health Sciences, 2021-11-11) Sikwese, Tionge DastonThe type of research study: We will conduct a cross-sectional study on Mycobacterium Tuberculosis (MTB) Positive isolates from the EXACT study (Utility of the Xpert® MTB/RIF Ultra assay with the GeneXpert®Omni System and digital chest radiography for diagnosis of tuberculosis in high HIV prevalence settings) which was conducted at Kamuzu University of Health Sciences in 2020 to 2021 and Isolates from National Tuberculosis Reference Laboratory in Lilongwe. 1.2. The problem to be studied Patients infected with Multidrug Resistance Tuberculosis (MDR –TB) strains are difficult to cure and are more likely to remain sources of infection for a longer period of time than are patients with drug-susceptible strains, as a result it necessary to conduct a prevalence survey on MDR-TB in order to assess the emerging cases of MDR-TB. 1.3. The Research objectives 1.3.1. Broad objective To investigate the prevalence of drug resistant tuberculosis in clinical isolates existing framework for drug resistance in Blantyre and Lilongwe 1.3.2. Specific objectives • To determine the number of patients presenting with investigate the prevalence of drug resistance TB among patients registering for TB treatment in Blantyre and Lilongwe To find out the number of patients presenting with investigate the prevalence of Extremely Drug resistance (XDR) TB in Blantyre and Lilongwe using sample pooling method • To describe the association between MDR-TB and Age, Sex and HIV status characteristics of patients with MDR-TB using the following parameter (Age, Sex and HIV) To describe pathways of care for patients with MDR-TB in Blantyre and Lilongwe 1.4. Methodology We will conduct Line Probe Assay test using GenoType MTBDRplus (version 2.0) on 400 culture isolates for Mycobacterium Tuberculosis which were archived from January 2019 active in COM/MLW TB laboratory in Blantyre and Isolates from National TB reference Laboratory in Lilongwe. From the identified MDR-TB we are going to investigate the prevalence of XDR-TB using the pooling method. 1.5. Expected findings and their dissemination. We hypothesize that there is increasing prevalence of MDR-TB among TB patients registering for treatment in Blantyre and Lilongwe. The results of this trial will also be submitted to College of Medicine Research and Ethics Committee (COMREC) and for publication in open access and medical journals. The results of the trial will also be shared with policy makers at the Ministry of Health in Malawi and the World Health Organization (WHO
- ItemRestrictedClinical trial to evaluate intermittent screening and treatment with high sensitivity rapid diagnostic tests and intermittent preventive treatment of malaria in asymptomatic school children to decrease P. falciparum infection and transmission(2021-11-18) Cohee, LaurenType of research study: Randomized clinical trial Problem: How should school-based malaria preventive treatment programs be designed to improve the health and educational achievement of children and decrease malaria transmission? Objectives: Obj 1: Evaluate the efficacy of intermittent screening and treatment (IST) and intermittent preventive treatment (IPT) to improve student health and education. Obj 2: Assess the impact of IST and IPT on P. falciparum (Pf) transmission. Obj 3: Compare the sensitivity of currently used (conventional) and high sensitivity rapid diagnostic tests (hs-RDT) to detect Pf infections that impact health and transmission to evaluate their use as a screening test for IST. Methodology: All objectives will be addressed in the context of a randomized controlled clinical trial in one school in Machinga District comparing the efficacy of school-based hsRDT-IST and IPT to standard care (control). Outcomes include Pf infection, clinical malaria disease, anemia, school attendance, test scores, as well as predicted infectiousness and household infection prevalence in a subsample of participants’s households. Students in all grades in a single primary school in an area of moderate transmission of malaria will be offered enrollment (total target sample size 750 students). Students will be randomized to receive either hsRDT-IST, IPT, or standard care (control). Students in the IPT arm and students with positive hsRDT on screening in the IST arm will be treated. Girls less than 10 years old and all boys will be treated with dihydroartemisinin-piperaquine. Girls 10 years old and older will be treated with chloroquine. The intervention will be conducted three times total during school terms which coincide with peak malaria transmission (January-June). Outcomes will be measured at each intervention visit and 6-8 weeks after the final intervention. At each visit, students will be interviewed about symptoms and treatment history and a fingerprick blood sample will be obtained to detect and characterize infection. At baseline and final visits, hemoglobin will be measured. At the baseline visit for students in the IST arm and the final visit for students in the control arm will be tested for infection with both a conventional RDT and hsRDT. Treatment will be based on hsRDT results, but conventional RDT results will provide further comparisons of the need for the increased sensitivity of hsRDTs. Symptomatic malaria is defined as objective fever and a positive conventional RDT. Pf infection is defined as parasite DNA detected by qPCR amplification of the 18SrRNA gene. Detection, quantification, and assessment of gametocyte sex ratio will be conducted using RT-qPCR amplification of CCp4 (female gametocyte marker) and PfMGET (male gametocyte marker). A subsample of households of students in each arm will be visited and household members who chose to participate will be tested for Pf infection to determine if treatment of schoolchildren decreases transmission of infection to their household members. Expected findings and dissemination: We hypothesize that both approaches to preventive treatment (IST and IPT) will be effective in improving health and education outcomes when compared to control. However, IPT will be more effective in reducing transmission as measured by predicted infectiousness and household infection prevalence. We will discuss our findings with national and district-level leaders. Results will be disseminated in peer-reviewed journals, international conferences, KUHeS Research Day, as well as provided to community leaders. The findings will be useful for policymakers and program managers for both national and international malaria control programs. We anticipate that results will directly inform the design of programmatic implementation of school-based malaria chemoprevention programs.
- ItemRestrictedTB transmission prevention behaviors among women living with HIV and TB in Malawi: A hygiene-geo-temporal approach(Kamuzu University of Health Sciences, 2022-02-08) Lee, SangAHIV-related TB has emerged as the dominant health challenge in sub-Saharan Africa, including Malawi, and is the size of a pandemic calling for a rapid response. Malawi has the highest rate of HIV infection in the world, and more than 75% of cases of TB are HIVassociated, accounting for approximately 86% of all deaths from HIV- associated TB. The need for a coordinated approach for preventing and controlling TB among the HIV population and a public health education program addressing the prevention of TB transmission is essential at the highest level. However, there is limited information about this population’s health behaviors, and the social and cultural aspects of TB and HIV and its prevention in Malawians have been largely unexplored. Therefore, this proposed study seeks to describe HIV-positive women’s TB transmission prevention behaviors and to identify the multi-level factors influencing TB transmission prevention behaviors in order to develop a situation-specific, evidence-based health education and health policy that will effectively address the problem. The broad objective for the study is: To examine TB transmission prevention behaviors of women living with HIV/TB. The specific aims for the study include: To assess TB transmission prevention behaviors among women living with HIV/TB, with the focus on those women’s behaviors to prevent the spread of TB to other healthy people To identify factors influencing TB transmission prevention behaviors among women living with HIV/TB at the individual, relational, and societal levels. Findings from this study will provide scientifically and culturally relevant data on Malawians. It will help healthcare providers and stakeholders to understand the multi-level determinants of TB transmission prevention behaviors among Malawian women with HIV/TB and dynamic interaction of determinants and will provide the key to developing a culturally grounded and theory-based health program to prevent TB transmission among Malawians with HIV/TB.
- ItemRestrictedMolecular investigation of the aetiology of tuberculosis-like clinical syndromes in adults presenting for primary health care at Limbe and Ndirande health centres in Blantyre, Malawi.(Kamuzu University of Health Sciences, 2022-02-09) Mnyanga, Alice ChimwemweType of research study: A prospective cohort study Problem to be studied: Tuberculosis (TB) diagnosis is still a challenge worldwide, especially in low- and medium-income countries where resources are limited and most cases are missed in primary health care facilities in resource limited settings. Smear negative TB patients are usually prescribed antibiotics to rule out TB. This practice drives antimicrobial resistance and promotes inappropriate use of antibiotics. A holistic investigation for other respiratory pathogens is rarely considered and sometimes completely ignored. Broad Objective: The broad aim of this study is to determine the aetiology of respiratory symptoms in patients presenting with TB-like cough for tuberculosis screening at Limbe and Ndirande health centres. Specific objectives i. To establish the prevalence of viral pathogens among patients with a microbiologically negative sputum result whose symptoms did not improve after antibiotic treatment. ii. To compare burden of viral infections in the azithromycin, amoxycillin and standard of care treatment arms for patients whose symptoms did not resolve after 8 days iii. To identify bacterial-viral co-infection in all patients randomized in all the 3 treatment arms namely azithromycin, amoxycillin and standard of care Methodology: We will use molecular diagnostic tests to investigate other causes of cough that is TB-like in adults attending primary health care facilities in Blantyre district. We will isolate viral nucleic acid from stored nasopharyngeal swabs collected from 173 patients enrolled in the ACT-TB trial between 2019-2020. These patients will be drawn from the three treatment arms namely azithromycin, amoxycillin and standard of care. Using the Fast-Track Diagnostic 33 respiratory pathogen panel, we will perform multiplex PCR to detect 19 viruses, 12 bacteria and 1 fungal pathogens simultaneously. Specifically, we will analyse only those samples from patients who were prescribed antibiotics after a microbiologically negative TB test, but symptoms of cough did not resolve. Expected findings and dissemination: We expect to identify at least one or more viral and or bacterial respiratory pathogens from these patients who were prescribed antibiotics but whose symptoms did not resolve at day 8. We will use these findings to influence policy makers in introduction of portable viral diagnostic resources in primary health care facilities to ensure proper management of antibiotics , to promote holistic diagnostic investigation to ensure patients conditions are managed adequately and antimicrobial resistance will be managed in the long run. Findings from this study will be submitted to a peer reviewed journal, HNTI, KUHeS and COMREC.
- ItemRestrictedOptimising methodology for tongue swab testing for Mycobacterium tuberculosis complex (Mtbc) in an outpatient setting in Malawi, version 1.0(Kamuzu University of Health Sciences, 2022-05-30) Savage, Helen; MacPherson, PeterThe type of research study A diagnostic evaluation The problem to be studied Research undertaken to optimise using oral swabs to diagnose Mycobacterium tuberculosis complex (Mtbc) has not resulted in widely accepted, reliable and reproducible methods. We will use previously reported methods in the literature combined with commercially available swabs and media to produce a swabbing methodology that can be reproduced to test accuracy in a clinical setting. The study will aim to look at analytical validity of a swabbing methodology. Broad Objective To optimise the methodology of collecting and analysing tongue swabs to diagnose Mtbc and the acceptability and feasibility to individuals in a clinic setting in Malawi. Specific Objectives 1. Evaluate the limit of detection of PCR for Mtbc compared to Xpert Ultra in a series of spiked with Mtbc at different dilutions. 2. To evaluate the feasibility and acceptability of healthcare worker (HCW) and self-taken tongue swabs to diagnose Mtbc using the Xpert Ultra cartridge in a sample of adults with microbiologically confirmed PTB. 3. To compare detection of Mtbc from tongue swabs when analysed using Xpert Ultra versus manual PCR in a sample of adults with microbiologically confirmed PTB. Methodology Participants in the study will be adults at Queen Elizabeth Hospital, Blantyre with confirmed pulmonary TB. Individuals positive on Xpert Ultra sputum test for TB attending clinic to initiate treatment will be recruited. Participants will be consented then invited to complete a questionnaire to assess clinical history and symptoms. They will then be asked to have two tongue swabs taken (one by the participant and one by a healthcare worker). They will then be asked a short questionnaire on their experience of sampling (Figure 1: Study clinic workflow). Samples will be labelled and transported to the MLW/KUHeS TB Laboratory for processing by Xpert Ultra with remaining sample frozen for analysis by PCR (DNA extracted using PrimeXtract kit and stored until testing with Primestore qPCR). All DNA extraction and qPCR will be conducted at the MLW/KUHeS TB Laboratory, following the study SOP. Expected Findings and their dissemination We expect to identify a new methodology for collecting and processing tongue swabs that is likely to have lower sensitivity than Xpert Ultra on sputum, but sufficiently accuracy for screening rapid screening purposes. We do not expect there to be a difference between self-taken and healthcare worker taken swabs. Results will be presented at local meetings both in Liverpool and Malawi and shared with COMREC. They will be further presented at national and international conferences such as Union world conference on Lung Health. The final aim will be to publish in a peer reviewed journal. Results will be prepared in a visual format accessible to participants and presented either at community meetings or displayed in the clinic in the context of COVID-19.
- ItemRestrictedTuberculosis immunoreactivity surveillance in Malawi (Timasamala) version 1.0(Kamuzu University of Health Sciences, 2022-06-09) Rickman, HannahSummary This cross-sectional epidemiological study will evaluate a novel methodology of tuberculosis (TB) surveillance, determine the prevalence of TB immunoreactivity in young children, adolescents and young adults in Blantyre, Malawi, and determine the risk factors and spatial distribution of TB infection. We intend to recruit children aged 1-5 years old, adolescents 10-17 years, and adults 18-40 years and test them for immunoreactivity to M. tuberculosis using the QIAreach-QFT interferongamma release assay (IGRA). We will recruit from two places: community cross-sectional household testing, and convenience sampling within primary health clinics (PHCs). Results will be used to identify areas of high TB risk in Blantyre, inform targeted interventions, and provide recommendations for future TB surveillance methodologies. Type of study Cross-sectional epidemiological survey, with nested case-control and qualitative acceptability and feasibility studies. Problem to be studied Current methods of TB surveillance are resource-intensive, requiring many people to be tested to detect neighbourhood variation in TB epidemiology, and are unable to capture transmission dynamics as TB disease is often far removed from the causative transmission event. Using new, more accessible diagnostics for TB exposure (such as QIAreach-QFT), and pragmatic methodologies such as convenience sampling in health centres, may make it more feasible for cities in high-burden settings to “Know Their Epidemic”. However, these methodologies have not been previously evaluated. Objectives Aim: To evaluate the feasibility, acceptability, utility and potential impact of a TB surveillance methodology using immunoreactivity testing to understand spatial and population variation in TB infection risk Specific objectives To determine the annual risk of TB infection (ARTI) in Blantyre, and explore the individual- and area-level risk factors for infection 2. To compare the outputs of convenience sampling in PHCs with that obtained from conventional cross-sectional community sampling, with respect to the estimated ARTI and the characteristics of participants recruited 3. To test the hypothesis that urban areas with high TB case notifications have higher rates of TB infection amongst children aged 1-5 years 4. To evaluate the feasibility and acceptability of performing surveillance using blood tests for TB infection and other infectious diseases To identify high-risk spatial areas and groups within Blantyre, and model the potential population-level impact of targeted TB case-finding and prevention interventions Methodology Children aged 12-60 months (1-5 years) of age will be recruited from 1) consecutive children attending three primary health clinics: Bangwe, Limbe and Ndirande, and 2) cross-sectional population-weighted random household sampling across their catchment areas. 3181 children or 100 children with a positive IGRA will be recruited from each setting. Additionally, from the community household sampling, adolescents 10-17 years and adults 18-40 years present in recruited households (estimated approximately 3,000 in total) will be recruited through convenience sampling. Guardians and participants will be approached for informed consent, and will complete a baseline questionnaire which includes demographic and clinical information, as well as their home geolocation using the validated ePal app. Participants will then be tested for TB infection using the QIAreach-QFT IGRA blood test. Serum samples will also be taken and stored for future analysis. Children (1-5 years) testing positive will be assessed for any evidence of active TB disease, and depending on the outcome referred for either further investigations or TB preventive therapy. Their household contacts are also recommended to receive screening for TB disease. Those testing positive will be followed up at 3 and 9 months to ensure they have been entered into care. Participants testing positive and age- and sex-matched controls will also be included in a nested case-control study which investigates the role of novel diagnostics in this cohort. A subset will also be invited into a qualitative study on the acceptability and feasibility of this approach. Adolescents and adults testing positive will be notified of their results via phone. They will be reminded of information given during recruitment about implications of a positive test result. WHO does not recommend routine TB preventive therapy in adults and adolescents without HIV or other risk factors. In this group, the risk of developing active TB disease in the following 2 years after a positive test result is very low. In this study, all participants will be advised to seek care at a clinic if they develop TB symptoms, and to seek HIV testing if their HIV status is unknown. Expected findings 1. We expect to be able to measure the annual risk of TB infection (ARTI) in Blantyre, and identify and treat children at high risk of developing TB disease. We hypothesise that the ARTI will vary by age, sex and other risk factors. We expect to identify and characterise neighbourhoods in Blantyre where there is a high risk of TB infection 2. We expect that the more cost-effective methodology of recruiting from PHCs will give similar results to that from more intensive cross-sectional sampling, and may therefore be a useful sampling methodology for programmatic use in Blantyre and in other settings. 3. We anticipate that the areas with the highest risk of infection may differ from areas which have a high rate of case notifications, for example including areas with more men and people who are HIV-negative, which may reflect groups who are currently underdiagnosed. 4. We expect that this will be an acceptable, feasible methodology which may be used by TB programmes in other settings to perform cost-effective surveillance for TB. We plan to use these findings in the planning of future spatially-targeted interventions, and to inform further work to estimate the population-level impact of reducing the pool of TB infection on future TB transmission and burden. Findings from this study will be disseminated to Blantyre DHO, the Malawi
- ItemRestrictedTB and HIV knowledge and training outcomes among peer educators in Malawi prisons(Kamuzu University of Health Sciences, 2022-07-05) Mwalabu, GetrudeType of research study: This is a quasi-experimental, two group pretest-posttest educational intervention study. Problem under study: Prison inmates are a vulnerable population with higher rates of TB and HIV both at admission and throughout their incarceration. New evidence indicates higher rates of COVID-19 in prison populations, globally. The peer educator model has been shown to be an effective means of sharing health knowledge across a large prison population, but requires a proper initial training of the peer educators. There is a need for studies that measure the knowledge acquisition of peer educators following training on TB, HIV and COVID. Objectives: This stud intends to assess peer educators knoledge on TB, HIV and COVID at Maula Prison in Lilongwe, Malawi before and after a 2-day training session. The specific objectives include the following: 1. Determine current level of TB, HIV and COVID knowledge among inmates and peer educators in Lilongwe, Malawi 2. Provide an educational intervention on TB, HIV and COVID to prison peer educators 3. Determine level of TB, HIV and COVID knowledge one week after completion of 2-day training session for peer educators. Methodology: This study will take place in Maula Prison in Lilongwe, Malawi and intends to train 48 peer educators with a control group of inmates of equivalent size to strengthen the design of the study (n=96). The intervention group of prison peer educators and the control group of inmates will be asked the same questions during the pretest and the posttest. STATA 17 software will be used for data analysis. Expected findings and dissemination: The hypothesis is that the intervention group of peer educators will demonstrate improved posttest scores, significantly higher than the control group. Results will be disseminated via report to the prison medical staff, COMREC, and submitted for peer-reviewed presentations and a publication.
- ItemRestrictedSurvival rate and determinants of mortality during TB treatment among adult TB - HIV co-infected in-patients at central hospitals in Malawi: a case study of Zomba Central Hospital, version 1.0(2022-08-05) Kazembe, DicksonEXECUTIVE SUMMARY Research title: Survival rate and determinants of mortality during TB treatment among adult TB - HIV co-infected patients in central hospitals in Malawi: a case study of Zomba Central Hospital Study type: This is a hospital-based quantitative retrospective cohort study design. The study will use secondary data from patients admitted to the TB ward at Zomba Central Hospital from 2017 to 2021. Problem statement: There is limited knowledge on the survival rate and determinant of mortality during TB treatment among adult TB – HIV coinfected in-patients hospitalized in tertiary hospitals in Malawi. Literature shows that the survival rate and risk factors for mortality of TB - HIV co- infected patients differs from place to place even within Sub-Saharan African countries. Furthermore, the determinants of mortality among TB – HIV coinfected patients change with time. Management of TB - HIV co-infected patients present challenges resulting in a reduced survival rate. The response to treatment may be slow in TB – HIV coinfected patients, especially when the patients are severely immune-compromised. Central hospitals provide tertiary health care to patients referred from secondary or primary health care such as district hospitals, and they are in a critical health situation that needs specialized health care that affects their treatment outcomes. However, there are few reported studies on survival rate and determinant mortality among adult TB – HIV coinfected patients hospitalized in tertiary hospitals in Malawi. Objectives of the study Broad objective To assess survival rate and determinants of mortality among hospitalized adult TB - HIV co- infected patients at Zomba Central Hospital. Specific objectives To determine social demographic factors associated with reduced survival rate among hospitalized adult TB - HIV co-infected patients To determine clinical factors associated with reduced survival rate among hospitalized adult TB - HIV co-infected patients To evaluate the probability of surviving hospitalization among TB - HIV co-infected in- patients05-Aug-2022 ii Dickson Kazembe - P.06/22/3674: Expedited protocol version II.0 To assess the trend of survival rate among adult TB - HIV co-infected patients hospitalized at ZCH over 5 years period between 2017 and 2021 Methodology: The study will use a hospital-based quantitative retrospective cohort study design. The study will use secondary data from patients admitted to the TB ward at Zomba Central Hospital from 2017 to 2021. The data will be coded, entered, and cleaned in Microsoft excel 2016 then exported and analyzed using STATA version 16. Expected findings: the researcher expects to find the probability of surviving a duration of hospitalization among adult TB-HIV coinfected patients in central hospitals. The study findings will be helpful to understand the impact of the TB - HIV co-infection that will be used in developing policies in managing the TB - HIV cases in central hospitals as well as used as a basis for future research studies. Dissemination of the results: The final copies of the dissertation will be submitted and made available to KUHEs, ZCH, and TB or/and HIV program stakeholders. In addition, the report of the study will be presented and shared with ZCH management, health professionals, stakeholders, and patients through meetings at the health facility, research conferences, and peer-reviewed journals