There are about 23 clinical studies being (or have been) conducted in Swaziland. 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 will evaluate the clinical efficacy of different dosing regimens of the Moderna COVID-19 mRNA vaccine (100 mcg) in preventing COVID-19 disease in people who are living with HIV or have comorbidities associated with elevated risk of severe COVID-19, with the different vaccine regimens assessed determined by whether the participant had evidence of prior SARS-CoV-2 infection at enrollment.
Stool4TB aims to evaluate an innovative stool-based qPCR diagnostic platform (with the capacity to become a POC diagnostic tool) in the high TB and HIV burden settings of Mozambique, Eswatini and Uganda, under the hypothesis that it will narrow the extremely large TB case detection gap by improving TB confirmation rates in children and people living with HIV (PLHIV).
This is a multi-site, open-label non-inferiority study of the 9vHPV vaccine among a population of children, adolescents and young women living with HIV in Eswatini. This protocol seeks to assess immunogenicity of a two-dose 9vHPV vaccine regimen among girls and boys (9-14 years) and young women (15-26 years) living with HIV on antiretroviral therapy versus a three-dose 9vHPV vaccine regimen among HIV uninfected young women (15-26 years) in Eswatini. The secondary objectives include examining the safety profiles of the two-dose 9vHPV regimen in those living with HIV and the three-dose 9vHPV regimen in HIV-uninfected young women, as well as measuring the completion of the vaccination series among those living with HIV and those who are not infected with HIV.
Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials. Coronaviruses (CoVs) are spherical, enveloped viruses with positive-sense single-stranded RNA genomes. One fourth of their genome is responsible for coding structural proteins, such as the Spike (S) glycoprotein, envelope, membrane, and nucleocapsid proteins. Envelope, membrane, and nucleocapsid proteins are mainly responsible for virion assembly whilst the S protein is involved in receptor binding, mediating virus entry into host cells during CoVs infection via different receptors. SARS-CoV-2 belongs to the phylogenetic lineage B of the genus Betacoronavirus and it recognizes the ACE2 as the entry receptor. It is the seventh CoV known to cause human infections and the third known to cause severe disease after SARS-CoV and MERS-CoV. AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. Development of AZD1222, previously referred to as ChAdOx1 nCoV-19, was initiated by the University of Oxford, UK, with subsequent transfer of development activities to AstraZeneca. The ChAdOx1 platform has been used in 14 clinical studies sponsored by the University of Oxford with immunogens from multiple pathogens such as influenza, tuberculosis, malaria, chikungunya, Zika, MERS-CoV, and Meningitis B. Over 360 healthy adult participants have received ChAdOx1-vectored vaccines in these studies. These vaccines demonstrated robust immunogenicity after a single dose and favourable safety profiles, with no vaccine-related serious adverse events (SAEs).
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
The objectives of this data collection activity are to: 1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on DRV and/or ETR; 2. Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR every 6 months from the first data collection point through 2021; 3. Describe dynamics in HIV drug resistance mutations among patients who fail treatment on new regimens including DRV and/or ETR; 4. Describe demographics, clinical and laboratory profile of young adults who transition out of the donation program after the age of 25 years at 12 months after their transition.
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. This is a two-stage cluster sampled cross-sectional survey of 6,417 randomly selected households in Swaziland. Approximately 20,292 eligible persons will be approached (4,664 participants 0-14 years; 12,563 participants 15-49 years; 3,065 participants 50 years and older). Of the sample approached, 15,403 are expected to agree to a blood draw for home-based HIV rapid testing including 3,361 participants 0-14 years; 9,680 participants 15-49 years; and 2,362 participants 50 years and older. SHIMS 2, 2016 will characterize HIV incidence, prevalence, viral load suppression, cluster of differentiation 4 (CD4) T-cell distribution, and risk behaviors in a household-based, nationally-representative sample of the Swazi population and will describe uptake of key HIV prevention, care, and treatment services.
The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program (where all HIV-positive family members are seen together as a unit and receive care together) on viral suppression and retention in HIV-positive children <15 years through enrollment of a prospective cohort of 660 HIV-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).
This stepped-wedge cluster-randomized trial is embedded in an 18-month observational cohort study that has the aim to assess the operationalization of oral Pre-Exposure Prophylaxis (PrEP) in Swaziland as an additional HIV combination prevention method among individuals at high risk of HIV infection. The trial aims to determine the effect of a healthcare facility-based PrEP promotion package on the number of clients who take up PrEP.