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.
Beside the home, the school is often the second important setting for the development and education of children and adolescents. Students spend a large part of their life at school. However, there is recurrent occurrence of violence against children and of harsh discipline measures used in home and school settings. These may result into negative consequences. Hence, prevention strategies against the use of harsh discipline use in schools become a priority. In the baseline of this study the investigators will therefore examine the prevalence and consequences of violence against children in Southwestern Uganda. The study will be conducted in schools and common disciplinary measures used by teachers, and the perceptions of teachers' and students' in relation to commonly used and experienced disciplinary measures we will be investigated. In the second phase, the investigators then will implement and assess the effectiveness of an intervention aimed at reducing the use of harsh and violent disciplinary measures in schools. ICC-T training in the long-term aims at fostering better relations amongst students and teachers. Based on feasibility studies, ICC-T intervention is expected to result into better teacher-student relationships, change in teachers' attitudes and behaviors concerning the use of violent disciplinary measures in the school setting.
The investigators propose to evaluate a novel diagnostic approach for Kaposi's sarcoma (KS) that may be eventually deployed with portable, point-of-care techniques. This approach features confocal microscopy. The investigators will compare this new approach with the gold standard of histology from a traditional skin punch biopsy (which is standard of care) to determine the sensitivity and specificity of portable confocal microscopy in diagnosing KS.
The purpose of this study was to compare the virologic efficacy and safety of three antiretroviral (ARV) regimens, dolutegravir plus emtricitabine/tenofovir alafenamide, dolutegravir plus emtricitabine/tenofovir disoproxil fumarate, and efavirenz/emtricitabine/tenofovir disoproxil fumarate in pregnant women living with HIV-1 and to compare the safety of these regimens for their infants.
STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.
In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through the African continent and even to Asia, was larger than the available supply. In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever vaccine as a dose-sparing strategy. These recommendations were based on limited number of clinical trials and additional studies should assess the applicability of the fractional dose to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance of the fractional dose in young children and populations in Africa including those with HIV. This study aims to respond to some of the research questions that would allow broadening the recommendations on the use of fractional doses of yellow fever vaccine in emergency situations. The study will be conducted in Uganda and Kenya and the main objective is to assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to full dose for each WHO-prequalified manufacturer. As secondary objectives the study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of protective antibody levels; describe the geometric mean titre and the change in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after administration of fractional and full doses. The study consists of a randomized non-inferiority trial. The study aims to start in April 2017 in the two sites and aims to recruit 960 adults. Results for the main outcome will be reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for the studies in children and HIV positive adults.
This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based, temperature indicator in estimating the body temperature of Nigerian babies exposed to ambient temperature conditions. The particpants will be recruited among babies receiving Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and other babies in the nursery at Bowen University Teaching Hospital. There will also be an educational session to teach health workers and mothers about the signs for hypothermia and hyperthermia on the indicator. Then, the investigators will collect observational cross-sectional data on random days to see how many of the trained health workers and mothers were able to accurately recognize and provide appropriate response to warning signs on the indicator.
Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's health through family planning choices, regular health reviews, and support. A cohort study that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women having no desire for a (another) child during the 4 years since ART initiation, 51% had a serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of contraceptive use were family planning goals within the DYAD. One of the key predictors of effective contraceptive use was male partner involvement and CD4 count. The WHO recommends dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at providing information on whether continuous family planning accessibility and support has a measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV positive mothers delivering at MRRH, SW Uganda.
Current estimates point towards a huge increase in the number of people that are eligible to start ART in Uganda and globally. As many of the newly eligible patients are largely asymptomatic, there are concerns about adherence and retention of these individuals and especially those starting ART with a higher CD4 counts. Urgent information is required to plan for implementation of most recent WHO and National guidelines in the most cost effective manner as well as maximizing retention of HIV positive individuals in care and achieving virological suppression. The investigators plan to undertake research designed to see if investigators can optimize adherence, virological outcomes and HIV knowledge, in order to give an overall increased quality of life in vulnerable populations starting or established on ART in Kampala, Uganda. The investigators will test implementation of an open source software-based tool to send text messages and to give access to an interactive voice response system using patients' mobile phones. The investigators' aim to undertake an open labelled randomised trial at two sites: the IDI which is an urban centre of excellence in HIV care, and Kasangati Health Centre, which is a peri-urban public health care facility. The project aims to enrol HIV positive patients starting ART, already established on first line ART or switching to second line ART, including special populations (pregnant women, discordant couples and young people). The estimated length of the project is 30 months. The technology to be evaluated in this study is based on CONNECT FOR LIFETM m-health technology (CFL2015.01 or higher), which provides text messages or Interactive Voice Response (IVR) functionalities, and allows a computer to interact with humans through the use of voice and tones input via keypad and offers pill reminders, clinic visit reminders, health tips and support symptom reporting. Primary Objective is to determine the effect of the CFL2015.01 tool on quality of life of HIV patients receiving care at IDI and Kasangati HCIV. At the start of the intervention, all patients will undergo quality of life assessment, which will be repeated at months 6, 12, 18 and 24 months. The scores will be compared to assess the effect of the tool on quality of life. The Secondary Objectives are virological outcomes baseline, 6, 12,18 and 24 months, retention in care, aversion of early treatment failure, disease knowledge, clinic attendance and cost analysis.
The investigators propose the Delivery Optimization for Antiretroviral Therapy Study - The DO ART Study - a prospective randomized study of strategies to optimize community-based ART initiation, monitoring and resupply among HIV-positive persons in South Africa and Uganda. The investigators will work closely with community members, stakeholders, local providers, and the local Department of Health (DoH) to integrate the community-based ART delivery with HIV clinics, pharmacies and labs. Following community sensitization, participants will be recruited through community-based HTC and HIV clinics. HIV-positive persons not engaged in care will receive point-of-care CD4 testing to determine ART eligibility. HIV-positive persons who are eligible for ART by national guidelines will be randomized to one of three ART delivery arms: (i) Home ART initiation and mobile van ART monitoring and resupply, (ii) Hybrid model with clinic ART initiation and mobile van ART monitoring and resupply, and (iii) Clinic ART initiation, monitoring and resupply - the current standard of care (SOC)