There are about 340 clinical studies being (or have been) conducted in Malawi. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Vaccination is a potentially critical component of efforts to arrest development and dissemination of antimicrobial resistance (AMR), though little is known about vaccination impact within low-income and middle-income countries. This study will evaluate the impact of vaccination on reducing carriage prevalence of resistant Streptococcus pneumoniae and extended spectrum beta-lactamase-producing Escherichia coli and Klebsiella species. We will leverage two large ongoing cluster-randomised vaccine evaluations in Malawi assessing; first, adding a booster dose to the 13-valent pneumococcal conjugate vaccine (PCV13) schedule, and second, introduction of the RTS,S/AS01 malaria vaccine. Six cross-sectional surveys will be implemented within primary healthcare centres (n=3000 users of outpatient facilities per survey) and their local communities (n=700 healthy children per survey): three surveys in Blantyre district (PCV13 component) and three surveys in Mangochi district (RTS,S/AS01 component). We will evaluate antibiotic prescription practices and AMR carriage in children ≤3 years. For the PCV13 component, surveys will be conducted 9, 18 and 33 months following a 3+0 to 2+1 schedule change. For the RTS,S/AS01 component, surveys will be conducted 32, 44 and 56 months post-RTS,S/AS01 introduction. Six health centres in each study component will be randomly selected for study inclusion. Between intervention arms, the primary outcome will be the difference in penicillin non-susceptibility prevalence among S. pneumoniae nasopharyngeal carriage isolates in healthy children. The study is powered to detect an absolute change of 13 percentage points (ie, 35% vs 22% penicillin non-susceptibility). This study has been approved by the Kamuzu University of Health Sciences (Ref: P01-21-3249), University College London (Ref: 18331/002) and University of Liverpool (Ref: 9908) Research Ethics Committees. Parental/caregiver verbal or written informed consent will be obtained prior to inclusion or recruitment in the health centre-based and community-based activities, respectively. Results will be disseminated via the Malawi Ministry of Health, WHO, peer-reviewed publications and conference presentations.
This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.
The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings.
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about Pre-exposure prophylaxis (PrEP) use during pregnancy and breastfeeding. Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period. Investigators will recruit 50 women to participate in the feasibility pilot study. A subset of these participants will participate in qualitative interviews. Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews. Procedures (methods): Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, Long-acting injectable cabotegravir (CAB-LA), and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use during pregnancy and breastfeeding. Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. 100 HIV-negative pregnant women will be recruited to participate in the pilot study. A subset of these participants will participate in qualitative interviews. Up to 20 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews. Procedures (methods): 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. Investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in oral PrEP will be referred to government PrEP services.
With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.
The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi.
The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels.
Worldwide, the number of people living with long-term health conditions, including chronic kidney disease (CKD), is increasing. CKD is usually asymptomatic in early stages but can progress to advanced disease, including kidney failure, causing significant morbidity and mortality. In low-income countries of sub-Saharan Africa, including Malawi, treatments for kidney failure are not yet widely available and are prohibitively expensive . It is therefore vital to: (a) Prevent development of CKD in the first place (b) Detect CKD earlier so that more cost-effective treatments can be given to slow progression. There is little evidence on factors that drive CKD progression in Malawi, or on interventions that may be cost-effective for improving detection and slowing disease progression in this setting. This PhD will address these knowledge gaps, through the following aims: 1) Determine the mortality associated with CKD, and the risk factors driving its development and progression in Malawian adults 2) Investigate the impacts of different models for integrating screening and prevention strategies for CKD and its risk factors into health services for other long-term conditions in low- and middle-income countries 3) With patients, carers, healthcare workers and policy makers, evaluate the feasibility and acceptability of different potential models for integrating CKD screening and prevention strategies into health services for high-risk patient groups in Malawi
This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of >1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure. To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).