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- 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
- 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.
- 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
- 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.
- 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.