There are about 849 clinical studies being (or have been) conducted in Uganda. 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.
This study aims to evaluate clinical outcomes and antibiotic prescription patterns following the use of diagnostic algorithms, point of care (PoC) rapid diagnostic tests, and behaviour change interventions in cases of acute febrile illnesses in children, adolescents and adults presenting at out patient clinics in lower and middle income countries. The study is to be implemented in 2 phases- the first run from 2020 to 2021 and the 2nd phase from 2021 to 2022 to include COVID-19 PoCTs.
This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD. We hope to better understand how effective TLD will be in sub-Saharan Africa. If treatment failure occurs, we seek to understand the possible reasons, including drug resistance and adherence challenges.
Management of menstruation can present substantial challenges to girls in low-income settings. The aim of this study is to pilot an intervention package to improve menstrual health (MH) management among school girls in 2 secondary schools in Entebbe sub-District, Uganda, and to prepare for a future cluster randomised trial to evaluate the impact of the intervention on school attendance, school performance and bacterial vaginosis. The recently completed study (MENstrual hygiene and Safe male Circumcision in Ugandan Schools (MENISCUS-1) showed that menstruation is a key reason for school absenteeism in this setting. The qualitative research showed substantial embarrassment and fear of teasing regarding menstruation, and suggested that this, together with pain and lack of effective materials for menstrual hygiene management, led to school absenteeism. In a small quantitative sub-study of daily diaries, 40 girls reported school absence on 28% of period-days, compared with 7% of non-period days (adjusted odds ratio=5.99, 95%CI 4.4-8.2, p<0.001). Evaluation of menstrual management interventions, which address both the psycho social aspects of menstruation (knowledge, self-confidence, attitudes), and the physical aspects (management of pain, use of appropriate materials to eliminate leakage of menstrual blood, improved WASH facilities) are needed. In the current study (MENISCUs-2), the investigators will pilot the MH interventions developed in MENISCUS-1 as a package delivered to all girls in one school year in two schools in Wakiso District. The intervention consists of: - Training teachers to improve current delivery of the Government guidelines for puberty education delivered by teachers (usually female). - A drama skit to address issues around menstruation, engaging girls, boys, parents and teachers. - Provision of a menstrual management kit, including re-usable pads and training teachers and peers to teach girls how to use these menstrual management methods - Supplying analgesics (paracetamol) for menstrual cramps using a voucher scheme - Basic improvements to school sanitation facilities, including ensuring girls' privacy The primary outcome is to review whether criteria for progression to a future trial are met. The criteria are that i) the education session and drama skit are delivered, the majority of girls use the pads, and that soap is available for >50% of observation visits; and ii) the retention rate in school over 9 months is >60%. The investigators will compare the relative risk of absenteeism on period-days and non-period-days from diaries, within MENISCUS-2 (the new pilot study in which the intervention will take place) and within MENISCUS-1 (the previous feasibility study where no intervention had taken place when the diaries were collected) schools. They will estimate the number of girls who are retained at school in order to estimate the likely loss to follow-up within a future trial. They plan to submit a proposal for a full trial in 2019.
In the recent past there has been a number of large urban Yellow Fever outbreaks in sub-Saharan Africa, tropical South Americas, The demand for Yellow Fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through Africa and to Asia was larger than the available global supply. In this situation, the World Health Organisation (WHO) developed recommendations for the use of fractional doses of Yellow Fever vaccine as a dose-sparing strategy. These recommendations were based on data from a limited number of clinical trials, none of which had been conducted in Africa. This was due to the uncertainties on the minimum dose requirement. Our study complements a study which is comparing full standard dose to 1/5th of standard dose of all four WHO-prequalified YF vaccines in adults (ClinicalTrials.gov number: NCT02991495), and is currently ongoing at KEMRI CGMRC and Epicentre, Mbarara which is designed to answer questions on the use of current stock of YF vaccines with a potency as close as possible to each manufacturers' minimum release. Data from this trial will inform a WHO recommendation on using 1/5th of the current standard dose of vaccine for outbreak control. However, since many vials will contain excess YF vaccine such that 1/5th of a vial is likely to be substantially above the current minimum potency requirements, these data may not be scientifically explanatory regarding the minimum dose required for preventive use. The new complementary study, aims to determine the lowest YF vaccine dose that is non-inferior to the current standard full dose among populations in sub-Saharan Africa. The study will be conducted in Kenya (KEMRI Center for Geographical Medicine Research-Coast (CGMR-C), Kilifi) and Uganda (Epicentre, Mbarara) with trial participants recruited at both sites, using vaccine from one WHO-prequalified manufacturer (Institut Pasteur de Dakar, Senegal (IPD)).
Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people: - People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1). - People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2). - People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study. - People starting TLD who have not taken anti-HIV medication before (Group 4). Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.
RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults. VRC-EBOADC086-00-VP, a chimpanzee adenovirus serotype 3 vector-based Ebola vaccine, encodes wild type (WT) glycoprotein (GP) from the Sudan strain of Ebolavirus and is administered intramuscularly (IM).
Currently, 16 African countries include the use of pre-referral rectal artesunate (RAS) in their treatment policies. However, guidelines for RAS use vary widely across countries and inappropriate use of RAS as a monotherapy and consequential development of resistances against artemisinin based treatments is of particular concern. In the frame of the Unitaid-funded "Community Access to Rectal Artesunate for Malaria" (CARAMAL) Project, quality-assured RAS will be rolled in selected areas of the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Approximately 3,000 treatments of RAS will be dispensed by trained community health workers to children <5 years of age in each project country per year. Linked to the tracking of (severe) malaria patients in the frame of the CARAMAL project, this study will assess the frequency of artemisinin resistance markers in the study settings and tentatively assess whether the introduction of RAS could increase the selection of resistant P. falciparum strains. The study will be conducted in close collaboration with the Global Malaria Programme of the WHO. Finger-prick blood samples will be collected from children < 5 years of age with signs of severe febrile illness and a positive mRDT presenting to community-based providers and referral facilities before and after the pilot roll-out of pre-referral RAS at community level.
This study is designed as two sequential trials. The first is a phase I open label trial to evaluate the safety and tolerability of MAT2203. The maximal tolerated and non-toxic daily dose,will then be moved forward into a multi-day safety trial. The Phase II trial will investigate toxicity and early fungicidal activity (EFA) of MAT2203 with flucytosine.
The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.
An open-label, single arm phase II study of the candidate Ebola Vaccine Ad26.ZEBOV/MVA-BN®-Filo