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NCT ID: NCT05254444 Active, not recruiting - Malnutrition, Child Clinical Trials

Samaki Salama: Small-scale Fisheries for Healthy Nutrition and Ecosystems

Start date: July 9, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of a bundled intervention to address malnutrition and its intersections with nutrition security and fisheries sustainability in Kilifi, Kenya.

NCT ID: NCT05243602 Completed - HIV-1-infection Clinical Trials

BFTAF Elderly Switch Study

BFTAF
Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

BACKGROUND: Current Kenya National Anti-retroviral (ARV) Guidelines and World Health Organization (WHO) Guidelines recommend first-line therapy of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and dolutegravir (DTG) for adult people living with HIV (PLHIV). This regimen has limitations, particularly for the aging PLHIV who are more likely to have pre-existing comorbidities and higher risk of developing comorbidities, including osteopenia, osteoporosis, and renal insufficiency. Abacavir, the preferred alternative nucleoside reverse transcriptase inhibitor (NRTI) in Kenya, is associated with increased cardiovascular risk that also limits its use in elderly populations. B/F/TAF is highly efficacious, well tolerated, co-formulated in a small pill, and does not have the same bone, renal or cardiovascular risks associated with currently recommended regimens in Kenya. We are not aware of any clinical trial to date that has been fully powered to compare ARV regimens for the increasing population of elderly PLHIV. BROAD OBJECTIVE: We will compare the efficacy, safety, and impact on bone mineral density of switching to B/F/TAF to that of remaining on current ARV regimen in a population of elderly patients (60 years old or greater) with no prior confirmed treatment failure in Kenya.

NCT ID: NCT05233956 Recruiting - Anemia Clinical Trials

Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya

LISA
Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Women with mild/moderate anemia who are seeking contraception will be randomized to a levonorgestrel (LNG) intrauterine system (IUS) or an LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen and followed prospectively for 18 months. Approximately 600 participants will be enrolled. The primary hypothesis is that the mean change in hemoglobin concentration will be significantly higher in the group assigned to the LNG IUS compared to the group assigned to COCs

NCT ID: NCT05224102 Recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

ELEVATUM
Start date: February 28, 2022
Phase: Phase 4
Study type: Interventional

This study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander; in addition, a cohort of Asian Indian participants will be enrolled in India.

NCT ID: NCT05219565 Completed - Malaria Clinical Trials

Evaluating ATSBs for Malaria Reduction in Kenya

Start date: March 7, 2022
Phase: N/A
Study type: Interventional

The effectiveness of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) in western Kenya are threatened by insecticide resistance and vector behaviour changes toward early evening and outdoor biting malaria vectors. New tools to control malaria are needed to reduce and even interrupt malaria transmission. Attractive Targeted Sugar Bait (ATSB) is a promising new intervention designed to attract and kill mosquitoes, including those that IRS and LLINs do not effectively target. The ATSB 'bait stations' are A4-sized panels containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran, to attract and kill the foraging vectors. Entomological field trials in western Mali showed that ATSBs successfully reduce mosquito densities and longevity and thus have the potential to reduce malaria transmission. In Kenya, the investigators will conduct an open-label cluster-randomized controlled trial in 80 village clusters (40 per arm) to evaluate the effect of ATSBs on the burden of malaria. During two years, households in half of these village clusters will receive two or three ATSB bait stations per household structure on exterior walls approximately 1.8 meters above the ground. ATSBs will be replaced every six months. The primary outcome will be the incidence of clinical malaria in children aged 1-<15 years enrolled in a prospective cohort followed monthly for about six months each during a 2-year period. Secondary outcomes include malaria infection prevalence assessed by rapid diagnostic tests through household surveys and the case burden of clinical malaria assessed by passive facility-based and community-based surveillance. The study includes entomological monitoring and nested acceptability, feasibility, and health economics studies. The stand-alone trial in western Kenya is a part of a multi-country ATSB consortium conducting similar trials in Zambia and Mali.

NCT ID: NCT05219552 Completed - Hiv Clinical Trials

Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

The investigators will recruit 40 pregnant women living with HIV divided into 2 groups (n=20 intervention group, n=20 control group). The intervention group will receive personalized lactation support and monthly unconditional cash transfers (100USD/month) from approximately 30 weeks pregnancy to approximately 6-months postpartum. The control group will receive the current standard care.

NCT ID: NCT05190146 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden

Start date: December 20, 2021
Phase:
Study type: Observational

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.

NCT ID: NCT05187897 Recruiting - Neonatal Death Clinical Trials

CHV-NEO: Community-based Digital Communication to Support Neonatal Health

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

Neonatal mortality (defined as death in the first 28 days of life) remains unacceptably high in sub-Sarahan Africa. The concentrated risk of neonatal illness in the first weeks of life and its potential to rapidly deteriorate means that expanding mothers' access to timely information and support during this period is critical to reducing neonatal mortality. This cluster-randomized control trial aims to integrate a 2 way interactive SMS text messaging intervention into existing digital infrastructure supporting Community Health Volunteer (CHV) workflow in Western Kenya (dCHT) to enable remote communication by mothers with CHVs between home visits.

NCT ID: NCT05184452 Completed - 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.