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NCT ID: NCT05421611 Not yet recruiting - Yellow Fever Clinical Trials

A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL

Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The study is designed as a Phase III, double-blind, multicenter, randomized, active-controlled, parallel-group design in which two groups of participants will receive either SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.

NCT ID: NCT05409274 Active, not recruiting - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Phase:
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

NCT ID: NCT05400655 Not yet recruiting - Malaria Clinical Trials

Anti-malaria MAb in Kenyan Children

Start date: August 25, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.

NCT ID: NCT05386875 Not yet recruiting - Clinical trials for Visceral Leishmaniasis

Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya

rK28-AccDemo
Start date: July 1, 2022
Phase:
Study type: Observational

Diagnosis of visceral leishmaniasis (VL) in eastern Africa is hampered by the availability of accurate diagnostic tests. Currently, diagnosis is based on testing suspected VL patients with the IT-Leish rK39 rapid diagnostic test (RDT) produced by Bio-Rad. If rK39 is negative on such patients, other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) are performed, following the recommended diagnostic algorithm by the Ministry of Health. The current diagnostic tools present several challenges. Simpler and easier to use tools are therefore needed. A new VL RDT - OnSite Leishmania rK28 Ab Rapid Test (CTK Biotech), is available as a Research Use Only (RUO) test. The test may be easier to use, more stable at higher temperatures than the IT-Leish rK39 RDT, and cheaper. Results of clinical studies (AfriKADIA) comparing the performance of rK28 with IT-Leish rK39 in Kenya have shown higher sensitivity of rK28 (95.93%) but low specificity (72.73%) in blood, while the IT-Leish rK39 had sensitivity and specificity values of 91.87% and 100% respectively. Despite the lower specificity, the improved sensitivity of the rK28 could enable its use to rule-in VL in resource limited settings, when used in combination with current tools, thus enabling the early detection of additional cases. WHO recommends the availability of two RDTs. Generating more data on the use cases and advantages of rK28 would inform the WHO recommendation and its adoption. Furthermore, this data can contribute to its approval for use in Kenya, thereby improving methods for VL surveillance and control. With the recent announcement of the discontinuation of the IT-Leish rK39 by Bio-Rad, this study would also evaluate the Kalazar Detect rK39 (InBios) as an alternative to the IT-Leish rK39.

NCT ID: NCT05385484 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

Start date: June 2022
Phase: N/A
Study type: Interventional

This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.

NCT ID: NCT05383755 Recruiting - HIV Clinical Trials

Digital Intervention to Address Stigma Among Pregnant Adolescents Living With HIV

Start date: March 30, 2022
Phase: N/A
Study type: Interventional

Pregnant adolescents living with HIV (ALHIV) in Kenya frequently experience stigma and difficulty telling a family member about their HIV and pregnancy status. This study will develop and evaluate a digital intervention for pregnant unmarried ALHIV to address the effects of stigma and strengthen communication skills. Family caregivers are an important yet underappreciated and understudied source of social support for pregnant unmarried ALHIV. The study will also identify acceptable approaches to involve family caregivers in addressing the detrimental effects of the intersecting stigmas faced by pregnant ALHIV. Together, these approaches are expected to improve engagement in PMTCT services among pregnant ALHIV. The study specific aims are to: (1) Develop and evaluate a digital intervention for pregnant unmarried ALHIV aged 15-19 to increase awareness of stigma and its consequences; improve disclosure self-efficacy and skills; and facilitate enlistment of family caregivers as social support allies to enhance uptake of PMTCT services; and (2) Identify acceptable approaches to increase awareness about stigma and enhance skills in communication and provision of social support among family caregivers. We will use data from individual interviews with pregnant ALHIV and joint interviews with pregnant ALHIV/caregiver dyads to develop initial intervention specifications and mock-ups. We will then conduct focus groups to obtain feedback on sample materials in order to refine the materials and develop an intervention prototype. We will then conduct a pilot to evaluate acceptability, usability, and preliminary efficacy of the prototype. All participating adolescents will receive a session in using the digital intervention with a mobile phone. The research team will ask questions both before the session and two weeks after the session in order to assess the intervention's usability and acceptability and preliminary improvements in the adolescents regarding stigma, disclosure, and social support. We will conduct focus groups with caregivers to identify acceptable approaches to involve them. Data will be used to finalize content and specifications of the digital intervention for pregnant ALHIV and will provide the framework for a future complementary intervention for caregivers, which will both be tested in a larger R34 or R01 trial.

NCT ID: NCT05383742 Not yet recruiting - Clinical trials for Tuberculous Meningitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Start date: August 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).

NCT ID: NCT05372887 Not yet recruiting - PTSD Clinical Trials

Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

Start date: June 2022
Phase: Phase 2
Study type: Interventional

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (2 x 2.8 mg tablets)-a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

NCT ID: NCT05369806 Recruiting - Depression Clinical Trials

Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya

AI-NEO
Start date: May 4, 2022
Phase: N/A
Study type: Interventional

Mobile health (mHealth) interventions such as interactive short message service (SMS) text messaging with healthcare workers (HCWs) have been proposed as efficient, accessible additions to traditional health care in resource-limited settings. Realizing the full public health potential of mHealth for maternal health requires use of new technological tools that dynamically adapt to user needs. This study will test use of a natural language processing computer algorithm on incoming SMS messages with pregnant people and new mothers in Kenya to see if it can help to identify urgent messages.

NCT ID: NCT05365503 Recruiting - Clinical trials for Mental Health Disorder

Dissemination Strategies and Implementation Outcomes of Adolescent Character Strength Interventions.

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

The present research study will involve investigating the efficacy of large-scale dissemination models of evidence-based character strength interventions in secondary schools in Kenya. This intervention, derived from a previously tested intervention named Shamiri, or thrive in Kiswahili, uses positive psychology and accessible life skills to build individual resilience and wellness. This will be a one-arm trial with participants recruited from 20 secondary schools in Nairobi, Kiambu and Makueni counties. The investigators estimate a sample size of 3000 youth, working on an intention to treat basis. All interested participants will be admitted to the program, with no exclusion criteria applied. The investigators will report on the efficacy of character strength interventions on wellbeing and mental health outcomes. Further, the investigators will also assess the scalability and acceptability of the program post intervention. Additionally, the investigators will examine moderator effects on the participants, baseline attributes of the participants, and potentially the effects of candidate mediators on intervention effects.