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NCT ID: NCT04826094 Recruiting - HIV Infections Clinical Trials

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

Start date: March 16, 2021
Phase: Phase 1
Study type: Interventional

This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS). The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.

NCT ID: NCT04825782 Recruiting - Pregnancy Related Clinical Trials

MiMBa Pregnancy Registry

Start date: February 22, 2021
Phase:
Study type: Observational

The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence on the safety of a range of antimalarials when used in pregnancy, particularly in the first trimester. This will be a multi-country observational study and will be deployed in several field sites in Africa.

NCT ID: NCT04814927 Recruiting - Clinical trials for Mucosal Inflammation

Impact of Contraceptives on Cervico-Vaginal Mucosa

UMPALA
Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.

NCT ID: NCT04814680 Not yet recruiting - Clinical trials for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images

Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate

Start date: June 15, 2021
Phase:
Study type: Observational

This is a non-interventional pilot study with the following objectives: - Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments - Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures - Determine the required sample size needed to support a future study to fully validate the machine-learning algorithm

NCT ID: NCT04813159 Not yet recruiting - STEMI Clinical Trials

Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA

RIC-AFRICA
Start date: May 2021
Phase: N/A
Study type: Interventional

The RIC-AFRICA study is a sub-Saharan African prospective, multi-centre, randomised, sham-controlled, clinical trial of 1200 ST-segment elevation myocardial infarction (STEMI) patients undergoing predominantly thrombolytic therapy in 18 sites across South Africa, Kenya, Sudan and Uganda. The purpose of the study is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated predominantly with thrombolytic therapy.

NCT ID: NCT04810650 Not yet recruiting - Hypertension Clinical Trials

A Multisectoral Strategy to Address Persistent Drivers of the HIV Epidemic in East Africa

SAPPHIRE
Start date: April 2021
Phase: N/A
Study type: Interventional

The overall objective is to determine to reduce HIV incidence and to improve community health with multi-sector, scalable interventions. This study will consist of two phases: Phase A, in which randomized trials will assess effectiveness, fidelity and cost and improve context-specific "fit" of prevention and treatment interventions. Combining effectiveness with implementation, costing and modelling outcomes, Phase A will optimize intervention packages with context specific adaptations in structured consultation with stakeholders. Phase B, which will evaluate the effects of these optimized dynamic prevention and treatment packages, alone and in combination, on prevention coverage, population-level suppression, and HIV incidence, as well as other health outcomes, in a balanced, community randomized 2x2 factorial design. This clinicaltrial.gov registration is for Phase A.

NCT ID: NCT04805112 Recruiting - Clinical trials for Human Immunodeficiency Virus

Acceptability, Feasibility and Impact of Oral HIV Self-testing for Partner Testing Among Kenyan Adolescent Girls Aged 15-19 Years: A Randomized Controlled Trial

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial will assess the feasibility, acceptability and impact of the provision of multiple oral-fluid based HIV self-test kits to HIV-negative adolescents aged 15-19 years to promote HIV testing among their sexual partners and couples testing.

NCT ID: NCT04801602 Recruiting - Typhoid Fever Clinical Trials

Commercial Typhoid Tests Validation Trial

Start date: October 25, 2020
Phase:
Study type: Observational

Typhoid fever (typhoid) is an enteric bacterial infection caused by Salmonella enterica serovar Typhi (Salmonella Typhi; S. Typhi). It is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases worldwide and 116.8 thousand deaths in 2017. Like many febrile illnesses, typhoid presents with non-specific symptoms and signs, especially in its early stages. In routine healthcare settings in low- and middle-income countries (LMIC), typhoid fever is commonly suspected and treated empirically with antibiotics. This overuse of antibiotics creates a selective pressure for the development of antimicrobial resistance (AMR), that has resulted in the emergence and spread of typhoid strains that are resistant to all first-line antibiotics. Similarly, the low specificity of current rapid diagnostic tests (RDTs) can lead to an over diagnosis of typhoid fever that may result in the overuse of antibiotics and delay the proper treatment for underlying conditions. FIND in collaboration with international typhoid experts developed a target product profile outlining the ideal characteristics of point of care tests. As part of this activity it became apparent that no quality data are available that systematically compare all available commercially point of care tests against the same set of reference standards used in multiple populations (e.g. Africa vs Asia). This lack of benchmarking data significantly impedes health provider's ability to decide on the utility of commercial tests in different settings, ultimately restricting use and access. Further the lack of well characterized samples reduces the ability for targeted innovation in the typhoid space. The current study aims to benchmark different commercial typhoid tests against a defined reference standard applied in multiple population and simultaneously develop a sample set that can be used in future evaluations of emerging technologies and/or to support innovative test development.

NCT ID: NCT04772469 Not yet recruiting - HIV Infections Clinical Trials

Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 and 12 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 and 12 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.

NCT ID: NCT04766879 Not yet recruiting - Malaria Clinical Trials

Spatial Repellents for the Prevention of Malaria in Kenya

AEGIS
Start date: March 2021
Phase: N/A
Study type: Interventional

Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such as malaria and dengue. However, their efficacy in reducing mosquito biting and therefore malaria transmission has never been evaluated in Africa. This study will evaluate the efficacy of a spatial repellent in reducing mosquito biting on human beings and measure the impact any reduced biting will have on malaria transmission. The investigators will recruit and follow-up 6,120 children between 6 months and <10 years of age in Busia County to determine how many times they will be infected with malaria in villages where the investigators will have distributed spatial repellents and compare the rate of infection to villages where the investigators will not have distributed the repellent devices. Additionally, the investigators will measure whether the distribution of spatial repellents in one village will drive mosquitoes to their neighboring houses thereby increasing malaria transmission in those areas. The children participating in the study will be divided into 3 groups (cohorts). The first group will be followed up during the first 4 months before any intervention is distributed and the purpose here will be to determine that the villages are comparable. After this, the investigators will recruit the next group of participants and follow them up for 1 year and repeat this again for another year. During the follow-up, the children will be asked to come to the health facility where they will be tested for malaria using RDT or blood slide for microscopy. Every two weeks, a member of the study team will come to the participant's house and ask them if they had any history of fever. If the participants had fever, they will be tested for malaria. All children who turn out to be positive for malaria by RDT will be treated free of charge. At the same time, the investigators shall also perform mosquito collections to determine the impact of spatial repellents on the density of Anopheles mosquitoes.