Clinical trials: in Kenya
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance…
- Trial name
- INAVO122 (NCT05894239)
- Testing
- Inavolisib, Phesgo, Taxane-based Chemotherapy
- Where
- 192 sites in United States, Argentina and 27 more
- Volunteers
- 230 people
- Sponsor
- Hoffmann-La Roche
Stress, Psychological, Maternal Health
Caring for Providers to Improve Patient Experience (CPIPE) Trial
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e.
- Conditions
- Stress, Psychological, Maternal Health, Healthcare Provider, Adverse Outcomes
- Trial name
- CPIPE (NCT06085105)
- Testing
- CPIPE Training, Peer support groups, Mentorship
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 6,379 people
- Sponsor
- University of California, San Francisco
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Sickle Cell Disease
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult…
- Trial name
- SPARKLE (NCT06439082)
- Testing
- Crizanlizumab
- Where
- 36 sites in United States, Brazil and 3 more
- Volunteers
- 354 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811908)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Sepsis, Neonatal Mortality
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care…
- Conditions
- Sepsis, Neonatal Mortality, Antibiotic Resistant Infection, Enteric Infections
- Trial name
- CLEAN (NCT06824350)
- Testing
- chlorination for water disinfection and surface disinfection, infection prevention and control messaging
- Where
- 2 sites in United States, Kenya
- Volunteers
- 45,450 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
HIV-1-infection
Improving HIV-1 Control in Africa With Long Acting Antiretrovirals
IMPALA is a randomized, open-label, multicenter, interventional study of 540 virologically suppressed HIV-1 infected adults who have a history of sub-optimal adherence to daily oral ART and/or engagement in HIV care.
- Trial name
- IMPALA (NCT05546242)
- Testing
- Cabotegravir/Rilpivirine, Antiretroviral
- Where
- 7 sites in Kenya, South Africa and 1 more
- Volunteers
- 540 people
- Sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
Human Immunodeficiency Virus, Mental Disorder
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya.
- Trial name
- NCT06117163
- Testing
- Collaborative Care Model
- Where
- Kenya
- Volunteers
- 900 people
- Sponsor
- University of Colorado, Denver
Sexually Transmitted Infection (STI), HIV
Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women
In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI).
- Conditions
- Sexually Transmitted Infection (STI), HIV, Food Insecurity, Mental Health
- Trial name
- Vijana Shamba (NCT06953310)
- Where
- Kenya
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Rift Valley Fever, Hemorrhagic Fevers, Viral
RVF and Other Emerging Infectious Diseases in East and Central Africa
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…
- Trial name
- NCT05139524
- Testing
- Evidence of past or recent RVF exposure
- Where
- 10 sites in Democratic Republic of the Congo, Kenya and 2 more
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Washington State University
HIV-1 Infection
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with…
- Trial name
- NCT05705349
- Testing
- DOR/ISL, BIC/FTC/TAF
- Where
- 131 sites in United States, Argentina and 19 more
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Locally Advanced or Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human…
- Trial name
- NCT05296798
- Testing
- Phesgo, Giredestrant, Docetaxel
- Where
- 198 sites in United States, Argentina and 27 more
- Volunteers
- 922 people
- Sponsor
- Hoffmann-La Roche
Lead Exposure, High Blood Lead Level
Lead Exposure Intervention Program
The goal of this clinical trial is to learn if BLL (blood lead level) screening and "healthy home" lead prevention program created in the US is adaptable to a Sub-Saharan African context.
- Trial name
- LEIP (NCT07401251)
- Testing
- Home visit with tailored messages, In-clinic lead risk reduction intervention
- Where
- Kenya
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study is to determine if adding the option of CAB-LA as a prevention choice using a person-centered dynamic choice HIV (human…
- Trial name
- NCT05549726
- Testing
- Cabotegravir Injectable Suspension, Dynamic Choice Delivery Model, Standard of Care
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 984 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tuberculosis, Multidrug-Resistant
Bioneer Q-RFIA Clinical Evaluation
Robust evidence on the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is required to comprehensively evaluate validity of the Bioneer RFIA assay to support both…
- Trial name
- NCT05117788
- Testing
- Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection using culture as reference standard. Estimate the diagnostic accuracy of the Bioneer Ac
- Where
- 5 sites in Kenya, Moldova and 3 more
- Volunteers
- 2,350 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
HIV (Human Immunodeficiency Virus)
The DART DELIVER-02 Study
This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART).
- Trial name
- DELIVER-02 (NCT07217379)
- Testing
- MGD020, MGD014, Vorinostat
- Where
- 3 sites in United States, Kenya
- Volunteers
- 24 people
- Sponsor
- University of North Carolina, Chapel Hill
Kaposi Sarcoma
Precision Imaging to Evaluate Kaposi Sarcoma
AIMS 2 \& 3: In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method.
- Trial name
- PRIME-KS (NCT06898203)
- Testing
- SkinScan3D
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Type 1 Diabetes
Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya.
Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes.
- Trial name
- ACCEDE (NCT05944731)
- Testing
- Continuous glucose monitor
- Where
- Kenya
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Stunting, Anemia
Effectiveness Study During the First 1,000 Days in Kenya
Malnutrition is a public health problem in Kenya, with 26% of children underfive years of age stunted, and 26% of pre-school children, 26% of women of reproductive age and 42% of pregnant women being anaemic, respectively.
- Conditions
- Stunting, Anemia, Micronutrient Deficiency
- Trial name
- NCT03558464
- Testing
- Intervention (integrated package), Control
- Where
- Kenya
- Volunteers
- 1,199 people, healthy volunteers welcome
- Sponsor
- Fabian Rohner
Relapsing Multiple Sclerosis
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance (NCT04586010)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 158 sites in United States, Argentina and 21 more
- Volunteers
- 746 people
- Sponsor
- Hoffmann-La Roche