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NCT ID: NCT05184452 Recruiting - HIV Infections Clinical Trials

A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants

Start date: November 15, 2021
Phase: Phase 1
Study type: Interventional

Part A: The purpose of this part of the study is to understand how the body's immune system responds to a new lab-made antibody against HIV. The study is looking to see if the way the antibody is given affects the immune response. The study will also look at whether the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part of the study is to understand how the body's immune system responds to lab-made antibodies against HIV when they are given in combination at different doses. The study also wants to see if the way the antibodies are given affects the immune response.

NCT ID: NCT05177393 Recruiting - Esophageal Cancer Clinical Trials

Treatment Outcomes of Esophageal Cancer

Start date: February 28, 2019
Phase:
Study type: Observational

This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.

NCT ID: NCT05168813 Recruiting - HIV Infections Clinical Trials

Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

CoVPN3008
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT05154513 Recruiting - HIV Infection Clinical Trials

Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV

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

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.

NCT ID: NCT05147519 Recruiting - HIV Infections Clinical Trials

Protocol RV 583 Multinational Observational Cohort of HIV and Other Infections

MOCHI
Start date: November 5, 2021
Phase:
Study type: Observational

Multinational Observational Cohort of HIV and other Infections (MOCHI). This observational study is to gain information regarding the number of new HIV infections among people who engage in behaviors that make them vulnerable to acquiring HIV across multiple international sites.

NCT ID: NCT05140954 Not yet recruiting - HIV Infections Clinical Trials

The Women TAF-FTC Benchmark Study

Start date: March 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The study seeks to assess the safety and define blood and tissue benchmark concentrations of Tenofovir (TFV) and Tenofovir diphosphate (TFV-DP) in Cisgender women using directly observed tenofovir alafenamide (TAF)-emtricitabine (TAF-FTC) pre-exposure prophylaxis (PrEP). These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.

NCT ID: NCT05139524 Recruiting - Rift Valley Fever Clinical Trials

RVF and Other Emerging Infectious Diseases in East and Central Africa

Start date: October 8, 2021
Phase:
Study type: Observational

Rift Valley fever (RVF), a disease transmitted from livestock (cattle, sheep, goats, camels) to humans more commonly occurs in the East and Central Africa (ECA) regions where more than 15 major epidemics affecting more than one country have been reported over the past 50 years. Within the region, there are specific areas, referred to as hotspots, which support RVF virus maintenance via low-level virus circulation between animals, humans, and mosquitoes. Most outbreaks originate from these hotspots. Our goal is to conduct studies in RVF hotspots in four ECA countries, Kenya, Uganda, Tanzania, and Democratic Republic of Congo (DRC) to determine the burden of RVF disease among humans, wildlife and livestock during inter-epidemic periods (IEPs) and discover circulation of undetected infectious diseases. This information is important for use in developing an early warning system and possibly a vaccination strategy. The study will take place in Uganda, Kenya, Tanzania and Democratic Republic of Congo

NCT ID: NCT05117892 Recruiting - Child Nutrition Clinical Trials

MoreMilk Project: Milk Safety and Child Nutrition Impacts of a Training Scheme for Dairy Vendors in Eldoret, Kenya

Start date: July 23, 2021
Phase: N/A
Study type: Interventional

The objective of the MoreMilk trial is to assess the effect of a Training, Certification and Marketing intervention for milk vendors in the informal sector on the safety of the milk sold in the markets and on the nutrition of children in peri-urban areas of Kenya. The intervention is a training scheme for dairy vendors designed to improve the vendors' business skills and increase their capacity to handle milk hygienically and recognize good quality milk. It will also support vendors to adopt marketing strategies and pass on messages to their customers on the role of milk for nutrition and good food handling practices. The intervention consists of a 12hr face-to-face training, followed by quarterly visits where milk safety is tested and results are reported back to the participants. To assess the effect of this intervention on milk safety, and selected health and nutrition outcomes, the study will work with two groups of participants: dairy retailers, referred to as dairy vendors, operating in the informal sector and consumer households that purchase milk from recruited vendors. Dairy vendors will be randomly allocated to receiving the training at the beginning of the study (treatment group) or at the end of the study (control group). A baseline survey will be administered to participating vendors and households, and an endline survey will be conducted 12 months after baseline in the same vendors and households. The vendor baseline and endline surveys will include questionnaire modules on operations, milk handling practices, and business performance. A sample of milk will also be collected to test the microbiological quality and composition of the milk. Vendors will be visited 2 additional times during the 12 months between intervention and endline, to monitor practices and business performance and to collect a milk sample to be tested for microbiological quality and milk composition. The baseline and endline surveys in households will assess milk and food expenditure, milk handling and consumption practices, and a 24hr dietary recall for the index child.

NCT ID: NCT05117788 Not yet recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Bioneer Accupower Q-RFIA PCR Kit Clinical Evaluation

Start date: January 2022
Phase:
Study type: Observational

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.

NCT ID: NCT05110521 Recruiting - Quality of Care Clinical Trials

Evaluation of a Nurse Mentorship and Digital Health Package Intervention in Kenya

Start date: November 5, 2021
Phase: N/A
Study type: Interventional

The investigators will conduct a cluster randomized controlled trial in maternity facilities in Kenya to evaluate the impact of a maternal and neonatal health package intervention on patient and provider outcomes. This package intervention includes two programs: PROMPTS, a digital health platform for mothers aimed to improve knowledge and health behaviors and increase care-seeking behavior at the right time and place, and MENTORS, a facility-based program aimed to increase and sustain providers' knowledge and skills in basic and emergency obstetric and newborn care. Facilities will be randomized into a treatment group that receives the package or a control group that receives usual care. Patient outcomes include health knowledge, health behaviors and health care utilization in the prenatal and postnatal period; provider outcomes include knowledge and quality of care.