There are about 292 clinical studies being (or have been) conducted in Zambia. 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.
The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.
The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.
"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl - implemented in schools as part of a 10-week program culminating in a tournament event; (2) SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are HIV-positive. The programs work together to build a continued support system which encourages uptake of Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for HV-positive participants) and continued engagement with health services over the long-term (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV treatment and care). The study team has developed an enhanced SKILLZ-Girl offering, which will include a comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the implementation of sessions and the additional offering of HIVST and contraceptive services at the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The central hypothesis is that this enhanced curriculum will increase HIV testing and contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm). The investigators further hypothesize that the intervention in the enhanced arm will positively and directly affect a number of mediating factors including attendance at soccer events where community-based SRH services are offered, SRH knowledge, empowerment, self-confidence, and perceptions of gender balance, and (reduced) stigma. For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase disclosure to family and partners, increase feelings of social support, empowerment, self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention in HIV care and treatment. This study will be conducted in up to 32 secondary schools that GRS currently serves in the Lusaka Urban District.
The purpose of the study is to find out if individuals who received first and second dose of Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed protection against future attacks to cholera. The investigators also want to investigate whether vitamin A deficiency and being HIV positive increases the chances of suffering from cholera.
The purpose of this study is to learn more about infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.
The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe repurposed interventions, with complementary mechanisms of action.
This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso. Given the limited feasibility of the current complex diagnostic methods used to detect Shigella in endemic and developing countries due to the costs, the none availability of reagents and a requirement of expensive and complex machinery, we suggest to use a rapide, easy-to-use, cost-effective, and robust Polymerase Chain Reaction (PCR) based rapid tool, the Loop-mediated isothermal amplification (LAMP) based diagnostic assay (ES-RLDT). This baseline study will enable us to generate an accurate estimate of Shigella incidence so as to inform future trials' designs of an oral vaccine development (ShigOraVax) in Burkina Faso and Zambia. This project is part of the EDCTP2 programme supported by the European Union under grant agreement "No RIA2018V-2308
The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period. This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.
TB remains the foremost infectious disease killer globally. A startling statistic is that two out of every five TB cases globally (40%) remain undiagnosed and untreated. These 'missed' or undiagnosed cases are disproportionately concentrated in large peri-urban 'slums' and informal settlements of large cities in Africa and Asia (they are frequently minimally symptomatic but remain infectious). The lack of a sensitive low cost same-day test represented a major challenge to active community-based case finding (ACF) compared to the current model where patients 'self-seek' care (passive case finding). More recently, sensitive TB DNA-detection tests called Gene Xpert (Xpert) have become available. This is a nucleic acid amplification test-based technology which can rule-in a diagnosis of TB in two thirds of smear negative pulmonary TB cases. GeneXpert® has now been rolled out in many African countries and is the frontline TB test in primary care clinics in South Africa. The investigators recently showed that GeneXpert® significantly reduced the time to treatment initiation in the setting of passive case finding (elaborated in next section). The investigators further showed that GeneXpert® can be performed by a minimally trained healthcare worker. However, historically technical and logistical demands meant that the GeneXpert® MTB-RIF assay was not ideally suited to use at point of care and in South Africa it is still centrally located. Small portable battery-operated versions of these tests are now available (EDGE, GeneXpert two-module mobile platform). The investigators conducted a large study in South Africa and Zimbabwe (published in 2016) that showed that using the old non-portable version of Xpert on a mini-truck equipped with a generator was feasible and highly effective for ACF. A subsequent study funded by the American government (XACT II), showed that using the portable version of Xpert on the back of a small low-cost scalable panel van (in effect a mobile mini-clinic) was feasible and had a very high pick-up rate of TB in peri-urban communities (~10% of those undergoing targeted screening). In this study, the investigators will test the hypothesis that community-based active case finding (ACF) using Gene Xpert Edge (in a low cost scalable mini-mobile clinic) performed at point-of-care (POC) is feasible and more effective (lower proportion of TB cases failing to initiate treatment especially if they are 'super-spreaders' i.e. highly infectious) than Xpert performed in a centralised laboratory.
Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)